<DOC>
[DOCID: f:45252.wais]
H.R. 52, THE FAIR HEALTH INFORMATION PRACTICES ACT OF 1997
=======================================================================
HEARING
before the
SUBCOMMITTEE ON GOVERNMENT MANAGEMENT,
INFORMATION, AND TECHNOLOGY
of the
COMMITTEE ON GOVERNMENT
REFORM AND OVERSIGHT
HOUSE OF REPRESENTATIVES
ONE HUNDRED FIFTH CONGRESS
FIRST SESSION
ON
H.R. 52
TO ESTABLISH A CODE OF FAIR INFORMATION PRACTICES FOR HEALTH
INFORMATION, TO AMEND SECTION 552A OF TITLE 5, UNITED STATES CODE, AND
FOR OTHER PURPOSES
__________
JUNE 5, 1997
__________
Serial No. 105-58
__________
Printed for the use of the Committee on Government Reform and Oversight
U.S. GOVERNMENT PRINTING OFFICE
45-252 WASHINGTON : 2002
_____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512-1800
Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001
COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
J. DENNIS HASTERT, Illinois TOM LANTOS, California
CONSTANCE A. MORELLA, Maryland ROBERT E. WISE, Jr., West Virginia
CHRISTOPHER SHAYS, Connecticut MAJOR R. OWENS, New York
STEVEN SCHIFF, New Mexico EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California PAUL E. KANJORSKI, Pennsylvania
ILEANA ROS-LEHTINEN, Florida GARY A. CONDIT, California
JOHN M. McHUGH, New York CAROLYN B. MALONEY, New York
STEPHEN HORN, California THOMAS M. BARRETT, Wisconsin
JOHN L. MICA, Florida ELEANOR HOLMES NORTON, Washington,
THOMAS M. DAVIS, Virginia DC
DAVID M. McINTOSH, Indiana CHAKA FATTAH, Pennsylvania
MARK E. SOUDER, Indiana ELIJAH E. CUMMINGS, Maryland
JOE SCARBOROUGH, Florida DENNIS J. KUCINICH, Ohio
JOHN B. SHADEGG, Arizona ROD R. BLAGOJEVICH, Illinois
STEVEN C. LaTOURETTE, Ohio DANNY K. DAVIS, Illinois
MARSHALL ``MARK'' SANFORD, South JOHN F. TIERNEY, Massachusetts
Carolina JIM TURNER, Texas
JOHN E. SUNUNU, New Hampshire THOMAS H. ALLEN, Maine
PETE SESSIONS, Texas HAROLD E. FORD, Jr., Tennessee
MICHAEL PAPPAS, New Jersey ------
VINCE SNOWBARGER, Kansas BERNARD SANDERS, Vermont
BOB BARR, Georgia (Independent)
ROB PORTMAN, Ohio
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
Judith McCoy, Chief Clerk
Phil Schiliro, Minority Staff Director
------
Subcommittee on Government Management, Information, and Technology
STEPHEN HORN, California, Chairman
PETE SESSIONS, Texas CAROLYN B. MALONEY, New York
THOMAS DAVIS, Virginia PAUL E. KANJORSKI, Pennsylvania
JOE SCARBOROUGH, Florida MAJOR R. OWENS, New York
MARSHALL ``MARK'' SANFORD, South ROD R. BLAGOJEVICH, Illinois
Carolina DANNY K. DAVIS, Illinois
JOHN E. SUNUNU, New Hampshire
------ ------
Ex Officio
DAN BURTON, Indiana HENRY A. WAXMAN, California
J. Russell George, Staff Director and Chief Counsel
Mark Uncapher, Counsel
John Hynes, Professional Staff Member
Andrea Miller, Clerk
David McMillen, Minority Professional Staff Member
C O N T E N T S
----------
Page
Hearing held on June 5, 1997..................................... 1
Text of H.R. 52.............................................. 1
Statement of:
Condit, Hon. Gary A., a Representative in Congress from the
State of California........................................ 27
Gabriel, Dr. Sherine, Department of Health Services Research,
Mayo Clinic, representing the Healthcare Leadership
Council; Dr. Elizabeth Andrews, Glaxo Wellcome Inc.,
representing the Pharmaceutical Research and Manufacturers
Association; and Dr. Steven Kenny Hoge, chair, Council on
Psychiatry and Law of the American Psychiatric Association. 97
Goldman, Janlori, visiting scholar, Georgetown University Law
Center, and affiliated with the Center for Democracy and
Technology; Dr. Donald J. Palmisano, member, Board of
Trustees, American Medical Association; and Merida L.
Johns, Ph.D., president, American Health Information
Management Association..................................... 53
Stearns, Hon. Cliff, a Representative in Congress from the
State of Florida........................................... 32
Letters, statements, etc., submitted for the record by:
Andrews, Dr. Elizabeth, Glaxo Wellcome Inc., representing the
Pharmaceutical Research and Manufacturers Association:
Information concerning informed consent.................. 158
Prepared statement of.................................... 116
Condit, Hon. Gary A., a Representative in Congress from the
State of California, prepared statement of................. 29
Gabriel, Dr. Sherine, Department of Health Services Research,
Mayo Clinic, representing the Healthcare Leadership
Council, prepared statement of............................. 100
Hoge, Dr. Steven Kenny, chair, Council on Psychiatry and Law
of the American Psychiatric Association, prepared statement
of......................................................... 128
Johns, Merida L., Ph.D., president, American Health
Information Management Association, prepared statement of.. 67
Maloney, Hon. Carolyn B., a Representative in Congress from
the State of New York, prepared statement of............... 49
Palmisano, Dr. Donald J., member, Board of Trustees, American
Medical Association, prepared statement of................. 59
Shays, Hon. Christopher, a Representative in Congress from
the State of Connecticut, prepared statement of............ 41
Slaughter, Hon. Louise M., a Representative in Congress from
the State of New York, prepared statement of............... 43
Stearns, Hon. Cliff, a Representative in Congress from the
State of Florida, prepared statement of.................... 34
H.R. 52: THE FAIR HEALTH INFORMATION PRACTICES ACT OF 1997
----------
THURSDAY, JUNE 5, 1997
House of Representatives,
Subcommittee on Government Management, Information,
and Technology,
Committee on Government Reform and Oversight,
Washington, DC.
The subcommittee met, pursuant to notice, at 9:32 a.m., in
room 2154, Rayburn House Office Building, Hon. Stephen Horn
(chairman of the subcommittee) presiding.
Present: Representatives Horn, Sessions, and Maloney.
Staff present: J. Russell George, staff director and chief
counsel; Mark Uncapher, counsel; John Hynes, professional staff
member; Andrea Miller, clerk; and David McMillen and Ron
Stroman, minority professional staff members.
Mr. Horn. The Subcommittee on Government Management,
Information, and Technology will come to order.
We are here today to consider the issue of medical records
privacy and H.R. 52, the Fair Health Information Practices Act
of 1997, introduced by Representative Condit of California.
[The text of H.R. 52 follows:]
105th CONGRESS
1st Session
H.R. 52
To establish a code of fair information practices for health
information, to amend section 552a of title 5, United States Code, and
for other purposes.
______
IN THE HOUSE OF REPRESENTATIVES
January 7, 1997
Mr. Condit introduced the following bill; which was referred to the
Committee on Commerce, and in addition to the Committees on Government
Reform and Oversight, and the Judiciary, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
______
A BILL
To establish a code of fair information practices for health
information, to amend section 552a of title 5, United States Code, and
for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Fair Health
Information Practices Act of 1997''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings and purposes.
Sec. 3. Definitions.
TITLE I--FAIR HEALTH INFORMATION PRACTICES
Subtitle A--Duties of Health Information Trustees
Sec. 101. Inspection of protected health information.
Sec. 102. Amendment of protected health information.
Sec. 103. Notice of information practices.
Sec. 104. Disclosure history.
Sec. 105. Security.
Subtitle B--Use and Disclosure of Protected Health Information
Sec. 111. General limitations on use and disclosure.
Sec. 112. Authorizations for disclosure of protected health
information.
Sec. 113. Treatment, payment, and oversight.
Sec. 114. Next of kin and directory information.
Sec. 115. Public health.
Sec. 116. Health research.
Sec. 117. Emergency circumstances.
Sec. 118. Judicial and administrative purposes.
Sec. 119. Law enforcement.
Sec. 120. Subpoenas, warrants, and search warrants.
Subtitle C--Access Procedures and Challenge Rights
Sec. 131. Access procedures for law enforcement subpoenas, warrants,
and search warrants.
Sec. 132. Challenge procedures for law enforcement subpoenas.
Sec. 133. Access and challenge procedures for other subpoenas.
Sec. 134. Construction of subtitle; suspension of statute of
limitations.
Sec. 135. Responsibilities of Secretary.
Subtitle D--Miscellaneous Provisions
Sec. 141. Payment card and electronic payment transactions.
Sec. 142. Access to protected health information outside of the United
States.
Sec. 143. Standards for electronic documents and communications.
Sec. 144. Duties and authorities of affiliated persons.
Sec. 145. Agents and attorneys.
Sec. 146. Minors.
Sec. 147. Maintenance of certain protected health information.
Subtitle E--Enforcement
Sec. 151. Civil actions.
Sec. 152. Civil money penalties.
Sec. 153. Alternative dispute resolution.
Sec. 154. Amendments to criminal law.
TITLE II--AMENDMENTS TO TITLE 5, UNITED STATES CODE
Sec. 201. Amendments to title 5, United States Code.
TITLE III--REGULATIONS, RESEARCH, AND EDUCATION; EFFECTIVE DATES;
APPLICABILITY; AND RELATIONSHIP TO OTHER LAWS
Sec. 301. Regulations; research and education.
Sec. 302. Effective dates.
Sec. 303. Applicability.
Sec. 304. Relationship to other laws.
SEC. 2. FINDINGS AND PURPOSES.
(a) Findings.--The Congress finds as follows:
(1) The right to privacy is a personal and fundamental
right protected by the Constitution of the United States.
(2) The improper use or disclosure of personally
identifiable health information about an individual may cause
significant harm to the interests of the individual in privacy
and health care, and may unfairly affect the ability of the
individual to obtain employment, education, insurance, credit,
and other necessities.
(3) Current legal protections for health information vary
from State to State and are inadequate to meet the need for
fair information practices standards.
(4) The movement of individuals and health information
across State lines, access to and exchange of health
information from automated data banks and networks, and the
emergence of multistate health care providers and payors create
a compelling need for uniform Federal law, rules, and
procedures governing the use, maintenance, and disclosure of
health information.
(5) Uniform rules governing the use, maintenance, and
disclosure of health information are an essential part of
health care reform, are necessary to support the
computerization of health information, and can reduce the cost
of providing health services by making the necessary transfer
of health information more efficient.
(6) An individual needs access to health information about
the individual as a matter of fairness, to enable the
individual to make informed decisions about health care, and to
correct inaccurate or incomplete information.
(b) Purposes.--The purposes of this Act are as follows:
(1) To define the rights of an individual with respect to
health information about the individual that is created or
maintained as part of the health treatment and payment process.
(2) To define the rights and responsibilities of a person
who creates or maintains individually identifiable health
information that originates or is used in the health treatment
or payment process.
(3) To establish effective mechanisms to enforce the rights
and responsibilities defined in this Act.
SEC. 3. DEFINITIONS.
(a) Definitions Relating to Protected Health Information.--For
purposes of this Act:
(1) Disclose.--The term ``disclose'', when used with
respect to protected health information that is held by a
health information trustee, means to provide access to the
information, but only if such access is provided by the trustee
to a person other than--
(A) the trustee or an officer or employee of the
trustee;
(B) an affiliated person of the trustee; or
(C) a protected individual who is a subject of the
information.
(2) Disclosure.--The term ``disclosure'' means the act or
an instance of disclosing.
(3) Protected health information.--The term ``protected
health information'' means any information, whether oral or
recorded in any form or medium--
(A) that is created or received in a State by--
(i) a health care provider;
(ii) a health benefit plan sponsor;
(iii) a health oversight agency; or
(iv) a public health authority;
(B) that relates in any way to the past, present,
or future physical or mental health or condition or
functional status of a protected individual, the
provision of health care to a protected individual, or
payment for the provision of health care to a protected
individual; and
(C) that--
(i) identifies the individual; or
(ii) with respect to which there is a
reasonable basis to believe that the
information can be used to identify the
individual.
(4) Protected individual.--The term ``protected
individual'' means an individual who, with respect to a date--
(A) is living on the date; or
(B) has died within the 2-year period ending on the
date.
(5) Use.--The term ``use'', when used with respect to
protected health information that is held by a health
information trustee, means--
(A) to use, or provide access to, the information
in any manner that does not constitute a disclosure; or
(B) any act or instance of using, or providing
access, described in subparagraph (A).
(b) Definitions Relating to Health Information Trustees.--For
purposes of this Act:
(1) Carrier.--The term ``carrier'' means a licensed
insurance company, a hospital or medical service corporation
(including an existing Blue Cross or Blue Shield organization,
within the meaning of section 833(c)(2) of the Internal Revenue
Code of 1986), a health maintenance organization, or other
entity licensed or certified by a State to provide health
insurance or health benefits.
(2) Health benefit plan.--The term ``health benefit plan''
means--
(A) any contract of health insurance, including any
hospital or medical service policy or certificate,
hospital or medical service plan contract, or health
maintenance organization group contract, that is
provided by a carrier; and
(B) an employee welfare benefit plan or other
arrangement insofar as the plan or arrangement provides
health benefits and is funded in a manner other than
through the purchase of one or more policies or
contracts described in subparagraph (A).
(3) Health benefit plan sponsor.--The term ``health benefit
plan sponsor'' means a person who, with respect to a specific
item of protected health information, receives, creates, uses,
maintains, or discloses the information while acting in whole
or in part in the capacity of--
(A) a carrier or other person providing a health
benefit plan, including any public entity that provides
payments for health care items and services under a
health benefit plan that are equivalent to payments
provided by a private person under such a plan; or
(B) an officer or employee of a person described in
subparagraph (A).
(4) Health care provider.--The term ``health care
provider'' means a person who, with respect to a specific item
of protected health information, receives, creates, uses,
maintains, or discloses the information while acting in whole
or in part in the capacity of--
(A) a person who is licensed, certified,
registered, or otherwise authorized by law to provide
an item or service that constitutes health care in the
ordinary course of business or practice of a
profession;
(B) a Federal or State program that directly
provides items or services that constitute health care
to beneficiaries; or
(C) an officer or employee of a person described in
subparagraph (A) or (B).
(5) Health information trustee.--The term ``health
information trustee'' means--
(A) a health care provider;
(B) a health oversight agency;
(C) a health benefit plan sponsor;
(D) a public health authority;
(E) a health researcher; or
(F) a person who, with respect to a specific item
of protected health information, is not described in
subparagraphs (A) through (E) but receives the
information--
(i) pursuant to--
(I) section 117 (relating to
emergency circumstances);
(II) section 118 (relating to
judicial and administrative purposes);
(III) section 119 (relating to law
enforcement); or
(IV) section 120 (relating to
subpoenas, warrants, and search
warrants); or
(ii) while acting in whole or in part in
the capacity of an officer or employee of a
person described in clause (i).
(6) Health oversight agency.--The term ``health oversight
agency'' means a person who, with respect to a specific item of
protected health information, receives, creates, uses,
maintains, or discloses the information while acting in whole
or in part in the capacity of--
(A) a person who performs or oversees the
performance of an assessment, evaluation,
determination, or investigation relating to the
licensing, accreditation, or certification of health
care providers;
(B) a person who--
(i) performs or oversees the performance of
an audit, assessment, evaluation,
determination, or investigation relating to the
effectiveness of, compliance with, or
applicability of, legal, fiscal, medical, or
scientific standards or aspects of performance
related to the delivery of, or payment for,
health care; and
(ii) is a public agency, acting on behalf
of a public agency, acting pursuant to a
requirement of a public agency, or carrying out
activities under a State or Federal statute
regulating the assessment, evaluation,
determination, or investigation; or
(C) an officer or employee of a person described in
subparagraph (A) or (B).
(7) Health researcher.--The term ``health researcher''
means a person who, with respect to a specific item of
protected health information, receives the information--
(A) pursuant to section 116 (relating to health
research); or
(B) while acting in whole or in part in the
capacity of an officer or employee of a person
described in subparagraph (A).
(8) Public health authority.--The term ``public health
authority'' means a person who, with respect to a specific item
of protected health information, receives, creates, uses,
maintains, or discloses the information while acting in whole
or in part in the capacity of--
(A) an authority of the United States, a State, or
a political subdivision of a State that is responsible
for public health matters;
(B) a person acting under the direction of such an
authority; or
(C) an officer or employee of a person described in
subparagraph (A) or (B).
(c) Other Definitions.--For purposes of this Act:
(1) Affiliated person.--The term ``affiliated person''
means a person who--
(A) is not a health information trustee;
(B) is a contractor, subcontractor, associate, or
subsidiary of a person who is a health information
trustee; and
(C) pursuant to an agreement or other relationship
with such trustee, receives, creates, uses, maintains,
or discloses protected health information.
(2) Approved health research project.--The term ``approved
health research project'' means a biomedical, epidemiological,
or health services research or statistics project, or a
research project on behavioral and social factors affecting
health, that has been approved by a certified institutional
review board.
(3) Certified institutional review board.--The term
``certified institutional review board'' means a board--
(A) established by an entity to review research
involving protected health information and the rights
of protected individuals conducted at or supported by
the entity;
(B) established in accordance with regulations of
the Secretary under section 116(d)(1); and
(C) certified by the Secretary under section
116(d)(2).
(4) Health care.--The term ``health care''--
(A) means--
(i) any preventive, diagnostic,
therapeutic, rehabilitative, maintenance, or
palliative care, counseling, service, or
procedure--
(I) with respect to the physical or
mental condition, or functional status,
of an individual; or
(II) affecting the structure or
function of the human body or any part
of the human body, including banking of
blood, sperm, organs, or any other
tissue; or
(ii) any sale or dispensing of a drug,
device, equipment, or other item to an
individual, or for the use of an individual,
pursuant to a prescription; but
(B) does not include any item or service that is
not furnished for the purpose of maintaining or
improving the health of an individual.
(5) Law enforcement inquiry.--The term ``law enforcement
inquiry'' means a lawful investigation or official proceeding
inquiring into a violation of, or failure to comply with, any
criminal or civil statute or any regulation, rule, or order
issued pursuant to such a statute.
(6) Person.--The term ``person'' includes an authority of
the United States, a State, or a political subdivision of a
State.
(7) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(8) State.--The term ``State'' includes the District of
Columbia, Puerto Rico, the Virgin Islands, Guam, American
Samoa, and the Northern Mariana Islands.
TITLE I--FAIR HEALTH INFORMATION PRACTICES
Subtitle A--Duties of Health Information Trustees
SEC. 101. INSPECTION OF PROTECTED HEALTH INFORMATION.
(a) In General.--Except as provided in subsection (b), a health
information trustee described in subsection (g)--
(1) shall permit a protected individual to inspect any
protected health information about the individual that the
trustee maintains, any record with respect to such information
required under section 104, and any copy of an authorization
required under section 112 that pertains to such information;
(2) shall provide the protected individual with a copy of
the information, upon request by the individual and subject to
any conditions imposed by the trustee under subsection (d), in
any form or format requested by the individual, if the
information is readily reproducible by the trustee in such form
or format;
(3) shall permit a person who has been designated in
writing by the protected individual to inspect the information
on behalf of the individual or to accompany the individual
during the inspection; and
(4) may offer to explain or interpret information that is
inspected or copied under this subsection.
(b) Exceptions.--A health information trustee is not required by
this section to permit inspection or copying of protected health
information by a protected individual if any of the following
conditions apply:
(1) Information about others.--The information relates to
an individual, other than the protected individual or a health
care provider, and the trustee determines in the exercise of
reasonable professional judgment that inspection or copying of
the information would cause sufficient harm to one or both of
the individuals so as to outweigh the desirability of
permitting access.
(2) Endangerment to life or safety.--Inspection or copying
of the information could reasonably be expected to endanger the
life or physical safety of an individual.
(3) Confidential source.--The information identifies or
could reasonably lead to the identification of an individual
(other than a health care provider) who provided information
under a promise of confidentiality to a health care provider
concerning a protected individual who is a subject of the
information.
(4) Administrative purposes.--The information--
(A) is used by the trustee solely for
administrative purposes and not in the provision of
health care to a protected individual who is a subject
of the information; and
(B) is not disclosed by the trustee to any person.
(5) Duplicative information.--The information duplicates
information available for inspection under subsection (a).
(6) Information compiled in anticipation of litigation.--
The information is compiled principally--
(A) in anticipation of a civil, criminal, or
administrative action or proceeding; or
(B) for use in such an action or proceeding.
(c) Inspection and Copying of Segregable Portion.--A health
information trustee shall permit inspection and copying under
subsection (a) of any reasonably segregable portion of a record after
deletion of any portion that is exempt under subsection (b).
(d) Conditions.--A health information trustee may--
(1) require a written request for the inspection and
copying of protected health information under this section; and
(2) charge a reasonable cost-based fee for--
(A) permitting inspection of information under this
section; and
(B) providing a copy of protected health
information under this section.
(e) Statement of Reasons for Denial.--If a health information
trustee denies in whole or in part a request for inspection or copying
under this section, the trustee shall provide the protected individual
who made the request with a written statement of the reasons for the
denial.
(f) Deadline.--A health information trustee shall comply with or
deny a request for inspection or copying of protected health
information under this section within the 30-day period beginning on
the date the trustee receives the request.
(g) Applicability.--This section applies to a health information
trustee who is--
(1) a health benefit plan sponsor;
(2) a health care provider;
(3) a health oversight agency; or
(4) a public health authority.
SEC. 102. AMENDMENT OF PROTECTED HEALTH INFORMATION.
(a) In General.--A health information trustee described in
subsection (f) shall, within the 45-day period beginning on the date
the trustee receives from a protected individual about whom the trustee
maintains protected health information a written request that the
trustee correct or amend the information, complete the duties described
in one of the following paragraphs:
(1) Correction or amendment and notification.--The trustee
shall--
(A) make the correction or amendment requested;
(B) inform the protected individual of the
amendment or correction that has been made;
(C) make reasonable efforts to inform any person
who is identified by the protected individual, who is
not an employee of the trustee, and to whom the
uncorrected or unamended portion of the information was
previously disclosed of the correction or amendment
that has been made; and
(D) at the request of the individual, make
reasonable efforts to inform any known source of the
uncorrected or unamended portion of the information
about the correction or amendment that has been made.
(2) Reasons for refusal and review procedures.--The trustee
shall inform the protected individual of--
(A) the reasons for the refusal of the trustee to
make the correction or amendment;
(B) any procedures for further review of the
refusal; and
(C) the individual's right to file with the trustee
a concise statement setting forth the requested
correction or amendment and the individual's reasons
for disagreeing with the refusal of the trustee.
(b) Standards for Correction or Amendment.--A trustee shall correct
or amend protected health information in accordance with a request made
under subsection (a) if the trustee determines that the information is
not accurate, relevant, timely, or complete for the purposes for which
the information may be used or disclosed by the trustee.
(c) Statement of Disagreement.--After a protected individual has
filed a statement of disagreement under subsection (a)(2)(C), the
trustee, in any subsequent disclosure of the disputed portion of the
information, shall include a copy of the individual's statement and may
include a concise statement of the trustee's reasons for not making the
requested correction or amendment.
(d) Construction.--This section may not be construed to require a
health information trustee to conduct a hearing or proceeding
concerning a request for a correction or amendment to protected health
information the trustee maintains.
(e) Correction.--For purposes of subsection (a), a correction is
deemed to have been made to protected health information when--
(1) information that is not timely, accurate, relevant, or
complete is clearly marked as incorrect; or
(2) supplementary correct information is made part of the
information and adequately cross-referenced.
(f) Applicability.--This section applies to a health information
trustee who is--
(1) a health benefit plan sponsor;
(2) a health care provider;
(3) a health oversight agency; or
(4) a public health authority.
SEC. 103. NOTICE OF INFORMATION PRACTICES.
(a) Preparation of Notice.--A health information trustee described
in subsection (d) shall prepare a written notice of information
practices describing the following:
(1) The rights under this Act of a protected individual who
is the subject of protected health information, including the
right to inspect and copy such information and the right to
seek amendments to such information, and the procedures for
authorizing disclosures of protected health information and for
revoking such authorizations.
(2) The procedures established by the trustee for the
exercise of such rights.
(3) The uses and disclosures of protected health
information that are authorized under this Act.
(b) Dissemination of Notice.--A health information trustee--
(1) shall, upon request, provide any person with a copy of
the trustee's notice of information practices (described in
subsection (a)); and
(2) shall make reasonable efforts to inform persons in a
clear and conspicuous manner of the existence and availability
of such notice.
(c) Model Notices.--Not later than July 1, 1999, the Secretary,
after notice and opportunity for public comment, shall develop and
disseminate model notices of information practices for use by health
information trustees under this section.
(d) Applicability.--This section applies to a health information
trustee who is--
(1) a health benefit plan sponsor;
(2) a health care provider; or
(3) a health oversight agency.
SEC. 104. DISCLOSURE HISTORY.
(a) In General.--Except as provided in subsection (b) and section
114, each health information trustee shall create and maintain, with
respect to any protected health information the trustee discloses, a
record of--
(1) the date and purpose of the disclosure;
(2) the name of the person to whom the disclosure was made;
(3) the address of the person to whom the disclosure was
made or the location to which the disclosure was made; and
(4) where practicable, a description of the information
disclosed.
(b) Regulations.--Not later than July 1, 1999, the Secretary shall
promulgate regulations that exempt a health information trustee from
maintaining a record under subsection (a) with respect protected health
information disclosed by the trustee for purposes of peer review,
licensing, certification, accreditation, and similar activities.
SEC. 105. SECURITY.
(a) In General.--Each health information trustee who receives or
creates protected health information that is subject to this Act shall
maintain reasonable and appropriate administrative, technical, and
physical safeguards--
(1) to ensure the integrity and confidentiality of the
information;
(2) to protect against any reasonably anticipated--
(A) threats or hazards to the security or integrity
of the information; and
(B) unauthorized uses or disclosures of the
information; and
(3) otherwise ensure compliance with this Act by the
trustee and the officers and employees of the trustee.
(b) Guidelines.--Not later than July 1, 1999, the Secretary, after
notice and opportunity for public comment, shall develop and
disseminate guidelines for the implementation of this section. The
guidelines shall take into account--
(1) the technical capabilities of record systems used to
maintain protected health information;
(2) the costs of security measures;
(3) the need for training persons who have access to
protected health information; and
(4) the value of audit trails in computerized record
systems.
Subtitle B--Use and Disclosure of Protected Health Information
SEC. 111. GENERAL LIMITATIONS ON USE AND DISCLOSURE.
(a) Use.--Except as otherwise provided under this Act, a health
information trustee may use protected health information only for a
purpose--
(1) that is compatible with and directly related to the
purpose for which the information--
(A) was collected; or
(B) was received by the trustee; or
(2) for which the trustee is authorized to disclose the
information under this Act.
(b) Disclosure.--A health information trustee may disclose
protected health information only as authorized under this Act.
(c) Scope of Uses and Disclosures.--
(1) In general.--A use or disclosure of protected health
information by a health information trustee shall be limited,
when practicable, to the minimum amount of information
necessary to accomplish the purpose for which the information
is used or disclosed.
(2) Guidelines.--Not later than July 1, 1999, the
Secretary, after notice and opportunity for public comment,
shall issue guidelines to implement paragraph (1), which shall
take into account the technical capabilities of the record
systems used to maintain protected health information and the
costs of limiting use and disclosure.
(d) Identification of Disclosed Information as Protected
Information.--Except with respect to protected health information that
is disclosed under section 114 (relating to next of kin and directory
information), a health information trustee may disclose protected
health information only if the recipient has been notified that the
information is protected health information that is subject to this
Act.
(e) Agreement to Limit Use or Disclosure.--A health information
trustee who receives protected health information from any person
pursuant to a written agreement to restrict use or disclosure of the
information to a greater extent than otherwise would be required under
this Act shall comply with the terms of the agreement, except where use
or disclosure of the information in violation of the agreement is
required by law. A trustee who fails to comply with the preceding
sentence shall be subject to section 151 (relating to civil actions)
with respect to such failure.
(f) No General Requirement to Disclose.--Nothing in this Act shall
be construed to require a health information trustee to disclose
protected health information not otherwise required to be disclosed by
law.
SEC. 112. AUTHORIZATIONS FOR DISCLOSURE OF PROTECTED HEALTH
INFORMATION.
(a) Written Authorizations.--A health information trustee may
disclose protected health information pursuant to an authorization
executed by the protected individual who is the subject of the
information, if each of the following requirements is satisfied:
(1) Writing.--The authorization is in writing, signed by
the individual, and dated on the date of such signature.
(2) Separate form.--The authorization is not on a form used
to authorize or facilitate the provision of, or payment for,
health care.
(3) Trustee described.--The trustee is specifically named
or generically described in the authorization as authorized to
disclose such information.
(4) Recipient described.--The person to whom the
information is to be disclosed is specifically named or
generically described in the authorization as a person to whom
such information may be disclosed.
(5) Statement of intended uses and disclosures received.--
The authorization contains an acknowledgment that the
individual has received a statement described in subsection (b)
from such person.
(6) Information described.--The information to be disclosed
is described in the authorization.
(7) Authorization timely received.--The authorization is
received by the trustee during a period described in subsection
(c)(1).
(8) Disclosure timely made.--The disclosure occurs during a
period described in subsection (c)(2).
(b) Statement of Intended Uses and Disclosures.--
(1) In general.--A person who wishes to receive from a
health information trustee protected health information about a
protected individual pursuant to an authorization executed by
the individual shall supply the individual, in writing and on a
form that is distinct from the authorization, with a statement
of the uses for which the person intends the information and
the disclosures the person intends to make of the information.
Such statement shall be supplied before the authorization is
executed.
(2) Enforcement.--If the person uses or discloses the
information in a manner that is inconsistent with such
statement, the person shall be subject to section 151 (relating
to civil actions) with respect to such failure, except where
such use or disclosure is required by law.
(3) Model statements.--Not later than July 1, 1999, the
Secretary, after notice and opportunity for public comment,
shall develop and disseminate model statements of intended uses
and disclosures of the type described in paragraph (1).
(c) Time Limitations on Authorizations.--
(1) Receipt by trustee.--For purposes of subsection (a)(7),
an authorization is timely received if it is received by the
trustee during--
(A) the 1-year period beginning on the date that
the authorization is signed under subsection (a)(1), if
the authorization permits the disclosure of protected
health information to--
(i) a health benefit plan sponsor;
(ii) a health care provider;
(iii) a health oversight agency;
(iv) a public health authority;
(v) a health researcher; or
(vi) a person who provides counseling or
social services to individuals; or
(B) the 30-day period beginning on the date that
the authorization is signed under subsection (a)(1), if
the authorization permits the disclosure of protected
health information to a person other than a person
described in subparagraph (A).
(2) Disclosure by trustee.--For purposes of subsection
(a)(8), a disclosure is timely made if it occurs before--
(A) the date or event (if any) specified in the
authorization upon which the authorization expires; and
(B) the expiration of the 6-month period beginning
on the date the trustee receives the authorization.
(d) Revocation or Amendment of Authorization.--
(1) In general.--A protected individual in writing may
revoke or amend an authorization described in subsection (a),
in whole or in part, at any time, except insofar as--
(A) disclosure of protected health information has
been authorized to permit validation of expenditures
based on health condition by a government authority; or
(B) action has been taken in reliance on the
authorization.
(2) Notice of revocation.--A health information trustee who
discloses protected health information in reliance on an
authorization that has been revoked shall not be subject to any
liability or penalty under this Act if--
(A) the reliance was in good faith;
(B) the trustee had no notice of the revocation;
and
(C) the disclosure was otherwise in accordance with
the requirements of this section.
(e) Additional Requirements of Trustee.--A health information
trustee may impose requirements for an authorization that are in
addition to the requirements in this section.
(f) Copy.--A health information trustee who discloses protected
health information pursuant to an authorization under this section
shall maintain a copy of the authorization.
(g) Construction.--This section may not be construed--
(1) to require a health information trustee to disclose
protected health information; or
(2) to limit the right of a health information trustee to
charge a fee for the disclosure or reproduction of protected
health information.
(h) Subpoenas, Warrants, and Search Warrants.--If a health
information trustee discloses protected health information pursuant to
an authorization in order to comply with an administrative subpoena or
warrant or a judicial subpoena or search warrant, the authorization--
(1) shall specifically authorize the disclosure for the
purpose of permitting the trustee to comply with the subpoena,
warrant, or search warrant; and
(2) shall otherwise meet the requirements in this section.
SEC. 113. TREATMENT, PAYMENT, AND OVERSIGHT.
(a) Disclosures by Plans, Providers, and Oversight Agencies.--A
health information trustee described in subsection (d) may disclose
protected health information to a health benefit plan sponsor, health
care provider, or health oversight agency if the disclosure is--
(1) for the purpose of providing health care and a
protected individual who is a subject of the information has
not previously objected to the disclosure in writing;
(2) for the purpose of providing for the payment for health
care furnished to an individual; or
(3) for use by a health oversight agency for a purpose that
is described in subparagraph (A) or (B)(i) of section 3(b)(6).
(b) Disclosures by Certain Other Trustees.--A health information
trustee may disclose protected health information to a health care
provider if--
(1) the disclosure is for the purpose described in
subsection (a)(1); and
(2) the trustee--
(A) is a public health authority;
(B) received protected health information pursuant
to section 117 (relating to emergency circumstances);
or
(C) is an officer or employee of a trustee
described in subparagraph (B).
(c) Use in Action Against Individual.--A person who receives
protected health information about a protected individual through a
disclosure under this section may not use or disclose the information
in any administrative, civil, or criminal action or investigation
directed against the individual, except an action or investigation
arising out of and related to receipt of health care or payment for
health care.
(d) Applicability.--A health information trustee referred to in
subsection (a) is any of the following:
(1) A health benefit plan sponsor.
(2) A health care provider.
(3) A health oversight agency.
SEC. 114. NEXT OF KIN AND DIRECTORY INFORMATION.
(a) Next of Kin.--A health information trustee who is a health care
provider, who received protected health information pursuant to section
117 (relating to emergency circumstances), or who is an officer or
employee of such a recipient may orally disclose protected health
information about a protected individual to the next of kin of the
individual (as defined under State law), or to a person with whom the
individual has a close personal relationship, if--
(1) the trustee has no reason to believe that the
individual would consider the information especially sensitive;
(2) the individual has not previously objected to the
disclosure;
(3) the disclosure is consistent with good medical or other
professional practice; and
(4) the information disclosed is limited to information
about health care that is being provided to the individual at
or about the time of the disclosure.
(b) Directory Information.--
(1) In general.--A health information trustee who is a
health care provider, who received protected health information
pursuant to section 117 (relating to emergency circumstances),
or who is an officer or employee of such a recipient may
disclose to any person the information described in paragraph
(2) if--
(A) a protected individual who is a subject of the
information has not objected in writing to the
disclosure;
(B) the disclosure is otherwise consistent with
good medical and other professional practice; and
(C) the information does not reveal specific
information about the physical or mental condition or
functional status of a protected individual or about
the health care provided to a protected individual.
(2) Information described.--The information referred to in
paragraph (1) is the following:
(A) The name of an individual receiving health care
from a health care provider on a premises controlled by
the provider.
(B) The location of the individual on such
premises.
(C) The general health status of the individual,
described in terms of critical, poor, fair, stable,
satisfactory, or terms denoting similar conditions.
(c) No Disclosure Record Required.--A health information trustee
who discloses protected health information under this section is not
required to create and maintain a record of the disclosure under
section 104.
(d) Recipients.--A person to whom protected health information is
disclosed under this section shall not, by reason of such disclosure,
be subject to any requirement under this Act.
SEC. 115. PUBLIC HEALTH.
(a) In General.--A health information trustee who is a health care
provider or a public health authority may disclose protected health
information to--
(1) a public health authority for use in legally
authorized--
(A) disease or injury reporting;
(B) public health surveillance; or
(C) public health investigation or intervention; or
(2) an individual who is authorized by law to receive the
information in a public health intervention.
(b) Use in Action Against Individual.--A public health authority
who receives protected health information about a protected individual
through a disclosure under this section may not use or disclose the
information in any administrative, civil, or criminal action or
investigation directed against the individual, except where the use or
disclosure is authorized by law for protection of the public health.
(c) Individual Recipients.--An individual to whom protected health
information is disclosed under subsection (a)(2) shall not, by reason
of such disclosure, be subject to any requirement under this Act.
SEC. 116. HEALTH RESEARCH.
(a) In General.--A health information trustee described in
subsection (c) may disclose protected health information to a person
if--
(1) the person is conducting an approved health research
project;
(2) the information is to be used in the project; and
(3) the project has been determined by a certified
institutional review board to be--
(A) of sufficient importance so as to outweigh the
intrusion into the privacy of the protected individual
who is the subject of the information that would result
from the disclosure; and
(B) impracticable to conduct without the
information.
(b) Limitations on Use and Disclosure; Obligations of Recipient.--A
health researcher who receives protected health information about a
protected individual pursuant to subsection (a)--
(1) may use the information solely for purposes of an
approved health research project;
(2) may not use or disclose the information in any
administrative, civil, or criminal action or investigation
directed against the individual; and
(3) shall remove or destroy, at the earliest opportunity
consistent with the purposes of the approved health research
project in connection with which the disclosure was made,
information that would enable an individual to be identified,
unless a certified institutional review board has determined
that there is a health or research justification for retention
of such identifiers and there is an adequate plan to protect
the identifiers from use and disclosure that is inconsistent
with this Act.
(c) Applicability.--A health information trustee referred to in
subsection (a) is any health information trustee other than a person
who, with respect to the specific protected health information to be
disclosed under such subsection, received the information--
(1) pursuant to--
(A) section 118 (relating to judicial and
administrative purposes);
(B) paragraph (1), (2), (3), or (4) of section
119(a) (relating to law enforcement); or
(C) section 120 (relating to subpoenas, warrants,
and search warrants); or
(2) while acting in whole or in part in the capacity of an
officer or employee of a person described in paragraph (1).
(d) Requirements for Institutional Review Boards.--
(1) Regulations.--Not later than July 1, 1999, the
Secretary, after opportunity for notice and comment, shall
promulgate regulations establishing requirements for certified
institutional review boards under this Act. The regulations
shall be based on regulations promulgated under section 491(a)
of the Public Health Service Act and shall ensure that
certified institutional review boards are qualified to assess
and protect the confidentiality of research subjects.
(2) Certification.--The Secretary shall certify that an
institutional review board satisfies the requirements of the
regulations promulgated under paragraph (1).
SEC. 117. EMERGENCY CIRCUMSTANCES.
(a) In General.--A health information trustee may disclose
protected health information if the trustee believes, on reasonable
grounds, that the disclosure is necessary to prevent or lessen a
serious and imminent threat to the health or safety of an individual.
(b) Use in Action Against Individual.--A person who receives
protected health information about a protected individual through a
disclosure under this section may not use or disclose the information
in any administrative, civil, or criminal action or investigation
directed against the individual, except an action or investigation
arising out of and related to receipt of health care or payment for
health care.
SEC. 118. JUDICIAL AND ADMINISTRATIVE PURPOSES.
(a) In General.--A health information trustee described in
subsection (d) may disclose protected health information--
(1) pursuant to the Federal Rules of Civil Procedure, the
Federal Rules of Criminal Procedure, or comparable rules of
other courts or administrative agencies in connection with
litigation or proceedings to which a protected individual who
is a subject of the information is a party and in which the
individual has placed the individual's physical or mental
condition or functional status in issue;
(2) if directed by a court in connection with a court-
ordered examination of an individual; or
(3) to assist in the identification of a dead individual.
(b) Written Statement.--A person seeking protected health
information about a protected individual held by health information
trustee under--
(1) subsection (a)(1)--
(A) shall notify the protected individual or the
attorney of the protected individual of the request for
the information;
(B) shall provide the trustee with a signed
document attesting--
(i) that the protected individual is a
party to the litigation or proceedings for
which the information is sought;
(ii) that the individual has placed the
individual's physical or mental condition or
functional status in issue; and
(iii) the date on which the protected
individual or the attorney of the protected
individual was notified under subparagraph (A);
and
(C) shall not accept any requested protected health
information from the trustee until the termination of
the 10-day period beginning on the date notice was
given under subparagraph (A); or
(2) subsection (a)(3) shall provide the trustee with a
written statement that the information is sought to assist in
the identification of a dead individual.
(c) Use and Disclosure.--A person to whom protected health
information is disclosed under this section may use and disclose the
information only to accomplish the purpose for which the disclosure was
made.
(d) Applicability.--A health information trustee referred to in
subsection (a) is any of the following:
(1) A health benefit plan sponsor.
(2) A health care provider.
(3) A health oversight agency.
(4) A person who, with respect to the specific protected
health information to be disclosed under such subsection,
received the information--
(A) pursuant to--
(i) section 117 (relating to emergency
circumstances); or
(ii) section 120 (relating to subpoenas,
warrants, and search warrants); or
(B) while acting in whole or in part in the
capacity of an officer or employee of a person
described in subparagraph (A).
SEC. 119. LAW ENFORCEMENT.
(a) In General.--A health information trustee may disclose
protected health information to a law enforcement agency, other than a
health oversight agency--
(1) if the information is disclosed for use in an
investigation or prosecution of a health information trustee;
(2) in connection with criminal activity committed against
the trustee or an affiliated person of the trustee or on
premises controlled by the trustee; or
(3) if the information is needed to determine whether a
crime has been committed and the nature of any crime that may
have been committed (other than a crime that may have been
committed by the protected individual who is the subject of the
information).
(b) Additional Authority of Certain Trustees.--A health information
trustee who is not a public health authority or a health researcher may
disclose protected health information to a law enforcement agency
(other than a health oversight agency)--
(1) to assist in the identification or location of a
victim, fugitive, or witness in a law enforcement inquiry;
(2) pursuant to a law requiring the reporting of specific
health care information to law enforcement authorities; or
(3) if the information is specific health information
described in paragraph (2) and the trustee is operated by a
Federal agency;
(c) Certification.--Where a law enforcement agency requests a
health information trustee to disclose protected health information
under subsection (a) or (b)(1), the agency shall provide the trustee
with a written certification that--
(1) is signed by a supervisory official of a rank
designated by the head of the agency;
(2) specifies the information requested; and
(3) states that the information is needed for a lawful
purpose under this section.
(d) Restrictions on Disclosure and Use.--A person who receives
protected health information about a protected individual through a
disclosure under this section may not use or disclose the information--
(1) in any administrative, civil, or criminal action or
investigation directed against the individual, except an action
or investigation arising out of and directly related to the
action or investigation for which the information was obtained;
and
(2) otherwise unless the use or disclosure is necessary to
fulfill the purpose for which the information was obtained and
is not prohibited by any other provision of law.
SEC. 120. SUBPOENAS, WARRANTS, AND SEARCH WARRANTS.
(a) In General.--A health information trustee described in
subsection (g) may disclose protected health information if the
disclosure is pursuant to any of the following:
(1) A subpoena issued under the authority of a grand jury
and the trustee is provided a written certification by the
grand jury that the grand jury has complied with the applicable
access provisions of section 131.
(2) An administrative subpoena or warrant or a judicial
subpoena or search warrant and the trustee is provided a
written certification by the person seeking the information
that the person has complied with the applicable access
provisions of section 131 or 133(a).
(3) An administrative subpoena or warrant or a judicial
subpoena or search warrant and the disclosure otherwise meets
the conditions of one of sections 113 through 119.
(b) Authority of All Trustees.--Any health information trustee may
disclose protected health information if the disclosure is pursuant to
subsection (a)(3).
(c) Restrictions on Use and Disclosure.--Protected health
information about a protected individual that is disclosed by a health
information trustee pursuant to--
(1) subsection (a)(2) may not be otherwise used or
disclosed by the recipient unless the use or disclosure is
necessary to fulfill the purpose for which the information was
obtained; and
(2) subsection (a)(3) may not be used or disclosed by the
recipient unless the recipient complies with the conditions and
restrictions on use and disclosure with which the recipient
would have been required to comply if the disclosure by the
trustee had been made under the section referred to in
subsection (a)(3) the conditions of which were met by the
disclosure.
(d) Restrictions on Grand Juries.--Protected health information
that is disclosed by a health information trustee under subsection
(a)(1)--
(1) shall be returnable on a date when the grand jury is in
session and actually presented to the grand jury;
(2) shall be used only for the purpose of considering
whether to issue an indictment or report by that grand jury, or
for the purpose of prosecuting a crime for which that
indictment or report is issued, or for a purpose authorized by
rule 6(e) of the Federal Rules of Criminal Procedure or a
comparable State rule;
(3) shall be destroyed or returned to the trustee if not
used for one of the purposes specified in paragraph (2); and
(4) shall not be maintained, or a description of the
contents of such information shall not be maintained, by any
government authority other than in the sealed records of the
grand jury, unless such information has been used in the
prosecution of a crime for which the grand jury issued an
indictment or presentment or for a purpose authorized by rule
6(e) of the Federal Rules of Criminal Procedure or a comparable
State rule.
(e) Use in Action Against Individual.--A person who receives
protected health information about a protected individual through a
disclosure under this section may not use or disclose the information
in any administrative, civil, or criminal action or investigation
directed against the individual, except an action or investigation
arising out of and directly related to the inquiry for which the
information was obtained;
(f) Construction.--Nothing in this section shall be construed as
authority for a health information trustee to refuse to comply with a
valid administrative subpoena or warrant or a valid judicial subpoena
or search warrant that meets the requirements of this Act.
(g) Applicability.--A health information trustee referred to in
subsection (a) is any trustee other than the following:
(1) A public health authority.
(2) A health researcher.
Subtitle C--Access Procedures and Challenge Rights
SEC. 131. ACCESS PROCEDURES FOR LAW ENFORCEMENT SUBPOENAS, WARRANTS,
AND SEARCH WARRANTS.
(a) Probable Cause Requirement.--A government authority may not
obtain protected health information about a protected individual from a
health information trustee under paragraph (1) or (2) of section 120(a)
for use in a law enforcement inquiry unless there is probable cause to
believe that the information is relevant to a legitimate law
enforcement inquiry being conducted by the government authority.
(b) Warrants and Search Warrants.--A government authority that
obtains protected health information about a protected individual from
a health information trustee under circumstances described in
subsection (a) and pursuant to a warrant or search warrant shall, not
later than 30 days after the date the warrant was served on the
trustee, serve the individual with, or mail to the last known address
of the individual, a copy of the warrant.
(c) Subpoenas.--Except as provided in subsection (d), a government
authority may not obtain protected health information about a protected
individual from a health information trustee under circumstances
described in subsection (a) and pursuant to a subpoena unless a copy of
the subpoena has been served by hand delivery upon the individual, or
mailed to the last known address of the individual, on or before the
date on which the subpoena was served on the trustee, together with a
notice (published by the Secretary under section 135(1)) of the
individual's right to challenge the subpoena in accordance with section
132, and--
(1) 30 days have passed from the date of service, or 30
days have passed from the date of mailing, and within such time
period the individual has not initiated a challenge in
accordance with section 132; or
(2) disclosure is ordered by a court under section 132.
(d) Application for Delay.--
(1) In general.--A government authority may apply to an
appropriate court to delay (for an initial period of not longer
than 90 days) serving a copy of a subpoena and a notice
otherwise required under subsection (c) with respect to a law
enforcement inquiry. The government authority may apply to the
court for extensions of the delay.
(2) Reasons for delay.--An application for a delay, or
extension of a delay, under this subsection shall state, with
reasonable specificity, the reasons why the delay or extension
is being sought.
(3) Ex parte order.--The court shall enter an ex parte
order delaying, or extending the delay of, the notice and an
order prohibiting the trustee from revealing the request for,
or the disclosure of, the protected health information being
sought if the court finds that--
(A) the inquiry being conducted is within the
lawful jurisdiction of the government authority seeking
the protected health information;
(B) there is probable cause to believe that the
protected health information being sought is relevant
to a legitimate law enforcement inquiry being conducted
by the government authority;
(C) the government authority's need for the
information outweighs the privacy interest of the
protected individual who is the subject of the
information; and
(D) there are reasonable grounds to believe that
receipt of a notice by the individual will result in--
(i) endangering the life or physical safety
of any individual;
(ii) flight from prosecution;
(iii) destruction of or tampering with
evidence or the information being sought; or
(iv) intimidation of potential witnesses.
(4) Service of application on individual.--Upon the
expiration of a period of delay of notice under this
subsection, the government authority shall serve upon the
individual, with the service of the subpoena and the notice, a
copy of any applications filed and approved under this
subsection.
SEC. 132. CHALLENGE PROCEDURES FOR LAW ENFORCEMENT SUBPOENAS.
(a) Motion to Quash Subpoena.--Within 30 days of the date of
service, or 30 days of the date of mailing, of a subpoena of a
government authority seeking protected health information about a
protected individual from a health information trustee under paragraph
(1) or (2) of section 120(a) (except a subpoena to which section 133
applies), the individual may file (without filing fee) a motion to
quash the subpoena--
(1) in the case of a State judicial subpoena, in the court
which issued the subpoena;
(2) in the case of a subpoena issued under the authority of
a State that is not a State judicial subpoena, in a court of
competent jurisdiction;
(3) in the case of a subpoena issued under the authority of
a Federal court, in any court of the United States of competent
jurisdiction; or
(4) in the case of any other subpoena issued under the
authority of the United States, in--
(A) the United States district court for the
district in which the individual resides or in which
the subpoena was issued; or
(B) another United States district court of
competent jurisdiction.
(b) Copy.--A copy of the motion shall be served by the individual
upon the government authority by delivery of registered or certified
mail.
(c) Affidavits and Sworn Documents.--The government authority may
file with the court such affidavits and other sworn documents as
sustain the validity of the subpoena. The individual may file with the
court, within 5 days of the date of the authority's filing, affidavits
and sworn documents in response to the authority's filing. The court,
upon the request of the individual, the government authority, or both,
may proceed in camera.
(d) Proceedings and Decision on Motion.--The court may conduct such
proceedings as it deems appropriate to rule on the motion. All such
proceedings shall be completed, and the motion ruled on, within 10
calendar days of the date of the government authority's filing.
(e) Extension of Time Limits for Good Cause.--The court, for good
cause shown, may at any time in its discretion enlarge the time limits
established by subsections (c) and (d).
(f) Standard for Decision.--A court may deny a motion under
subsection (a) if it finds that there is probable cause to believe that
the protected health information being sought is relevant to a
legitimate law enforcement inquiry being conducted by the government
authority, unless the court finds that the individual's privacy
interest outweighs the government authority's need for the information.
The individual shall have the burden of demonstrating that the
individual's privacy interest outweighs the need established by the
government authority for the information.
(g) Specific Considerations With Respect to Privacy Interest.--In
determining under subsection (f) whether an individual's privacy
interest outweighs the government authority's need for the information,
the court shall consider--
(1) the particular purpose for which the information was
collected by the trustee;
(2) the degree to which disclosure of the information will
embarrass, injure, or invade the privacy of the individual;
(3) the effect of the disclosure on the individual's future
health care;
(4) the importance of the inquiry being conducted by the
government authority, and the importance of the information to
that inquiry; and
(5) any other factor deemed relevant by the court.
(h) Attorney's Fees.--In the case of any motion brought under
subsection (a) in which the individual has substantially prevailed, the
court, in its discretion, may assess against a government authority a
reasonable attorney's fee and other litigation costs (including expert
fees) reasonably incurred.
(i) No Interlocutory Appeal.--A court ruling denying a motion to
quash under this section shall not be deemed a final order and no
interlocutory appeal may be taken therefrom by the individual. An
appeal of such a ruling may be taken by the individual within such
period of time as is provided by law as part of any appeal from a final
order in any legal proceeding initiated against the individual arising
out of or based upon the protected health information disclosed.
SEC. 133. ACCESS AND CHALLENGE PROCEDURES FOR OTHER SUBPOENAS.
(a) In General.--A person (other than a government authority
seeking protected health information under circumstances described in
section 131(a)) may not obtain protected health information about a
protected individual from a health information trustee pursuant to a
subpoena under section 120(a)(2) unless--
(1) a copy of the subpoena has been served upon the
individual or mailed to the last known address of the
individual on or before the date on which the subpoena was
served on the trustee, together with a notice (published by the
Secretary under section 135(2)) of the individual's right to
challenge the subpoena, in accordance with subsection (b); and
(2) either--
(A) 30 days have passed from the date of service or
30 days have passed from the date of the mailing and
within such time period the individual has not
initiated a challenge in accordance with subsection
(b); or
(B) disclosure is ordered by a court under such
subsection.
(b) Motion to Quash.--Within 30 days of the date of service or 30
days of the date of mailing of a subpoena seeking protected health
information about a protected individual from a health information
trustee under subsection (a), the individual may file (without filing
fee) in any court of competent jurisdiction, a motion to quash the
subpoena, with a copy served on the person seeking the information. The
individual may oppose, or seek to limit, the subpoena on any grounds
that would otherwise be available if the individual were in possession
of the information.
(c) Standard for Decision.--The court shall grant an individual's
motion under subsection (b) if the person seeking the information has
not sustained the burden of demonstrating that--
(1) there are reasonable grounds to believe that the
information will be relevant to a lawsuit or other judicial or
administrative proceeding; and
(2) the need of the person for the information outweighs
the privacy interest of the individual.
(d) Specific Considerations With Respect to Privacy Interest.--In
determining under subsection (c) whether the need of the person for the
information outweighs the privacy interest of the individual, the court
shall consider--
(1) the particular purpose for which the information was
collected by the trustee;
(2) the degree to which disclosure of the information will
embarrass, injure, or invade the privacy of the individual;
(3) the effect of the disclosure on the individual's future
health care;
(4) the importance of the information to the lawsuit or
proceeding; and
(5) any other factor deemed relevant by the court.
(e) Attorney's Fees.--In the case of any motion brought under
subsection (b) by an individual against a person in which the
individual has substantially prevailed, the court, in its discretion,
may assess against the person a reasonable attorney's fee and other
litigation costs (including expert fees) reasonably incurred.
SEC. 134. CONSTRUCTION OF SUBTITLE; SUSPENSION OF STATUTE OF
LIMITATIONS.
(a) In General.--Nothing in this subtitle shall affect the right of
a health information trustee to challenge a request for protected
health information. Nothing in this subtitle shall entitle a protected
individual to assert the rights of a health information trustee.
(b) Effect of Motion on Statute of Limitations.--If an individual
who is the subject of protected health information files a motion under
this subtitle which has the effect of delaying the access of a
government authority to such information, the period beginning on the
date such motion was filed and ending on the date on which the motion
is decided shall be excluded in computing any period of limitations
within which the government authority may commence any civil or
criminal action in connection with which the access is sought.
SEC. 135. RESPONSIBILITIES OF SECRETARY.
Not later than July 1, 1999, the Secretary, after notice and
opportunity for public comment, shall develop and disseminate brief,
clear, and easily understood model notices--
(1) for use under subsection (c) of section 131, detailing
the rights of a protected individual who wishes to challenge,
under section 132, the disclosure of protected health
information about the individual under such subsection; and
(2) for use under subsection (a) of section 133, detailing
the rights of a protected individual who wishes to challenge,
under subsection (b) of such section, the disclosure of
protected health information about the individual under such
section.
Subtitle D--Miscellaneous Provisions
SEC. 141. PAYMENT CARD AND ELECTRONIC PAYMENT TRANSACTIONS.
(a) Payment for Health Care Through Card or Electronic Means.--If a
protected individual pays a health information trustee for health care
by presenting a debit, credit, or other payment card or account number,
or by any other electronic payment means, the trustee may disclose to a
person described in subsection (b) only such protected health
information about the individual as is necessary for the processing of
the payment transaction or the billing or collection of amounts charged
to, debited from, or otherwise paid by, the individual using the card,
number, or other electronic payment means.
(b) Transaction Processing.--A person who is a debit, credit, or
other payment card issuer, is otherwise directly involved in the
processing of payment transactions involving such cards or other
electronic payment transactions, or is otherwise directly involved in
the billing or collection of amounts paid through such means, may only
use or disclose protected health information about a protected
individual that has been disclosed in accordance with subsection (a)
when necessary for--
(1) the authorization, settlement, billing or collection of
amounts charged to, debited from, or otherwise paid by, the
individual using a debit, credit, or other payment card or
account number, or by other electronic payment means;
(2) the transfer of receivables, accounts, or interest
therein;
(3) the audit of the credit, debit, or other payment card
account information;
(4) compliance with Federal, State, or local law; or
(5) a properly authorized civil, criminal, or regulatory
investigation by Federal, State, or local authorities.
SEC. 142. ACCESS TO PROTECTED HEALTH INFORMATION OUTSIDE OF THE UNITED
STATES.
(a) In General.--Notwithstanding the provisions of subtitle B, and
except as provided in subsection (b), a health information trustee may
not permit any person who is not in a State to have access to protected
health information about a protected individual unless one or more of
the following conditions exist:
(1) Specific authorization.--The individual has
specifically consented to the provision of such access outside
of the United States in an authorization that meets the
requirements of section 112.
(2) Equivalent protection.--The provision of such access is
authorized under this Act and the Secretary has determined that
there are fair information practices for protected health
information in the jurisdiction where the access will be
provided that provide protections for individuals and protected
health information that are equivalent to the protections
provided for by this Act.
(3) Access required by law.--The provision of such access
is required under--
(A) a Federal statute; or
(B) a treaty or other international agreement
applicable to the United States.
(b) Exceptions.--Subsection (a) does not apply where the provision
of access to protected health information--
(1) is to a foreign public health authority;
(2) is authorized under section 114 (relating to next of
kin and directory information), 116 (relating to health
research), or 117 (relating to emergency circumstances); or
(3) is necessary for the purpose of providing for payment
for health care that has been provided to an individual.
SEC. 143. STANDARDS FOR ELECTRONIC DOCUMENTS AND COMMUNICATIONS.
(a) Standards.--Not later than July 1, 1999, the Secretary, after
notice and opportunity for public comment and in consultation with
appropriate private standard-setting organizations and other interested
parties, shall establish standards with respect to the
creation,transmission, receipt, and maintenance, in electronic and
magnetic form, of each type of written document specifically required
or authorized under this Act. Where a signature is required under any
other provision of this Act, such standards shall provide for an
electronic or magnetic substitute that serves the functional equivalent
of a signature.
(b) Treatment of Complying Documents and Communications.--An
electronic or magnetic document or communication that satisfies the
standards established under subsection (a) with respect to such
document or communication shall be treated as satisfying the
requirements of this Act that apply to an equivalent written document.
SEC. 144. DUTIES AND AUTHORITIES OF AFFILIATED PERSONS.
(a) Requirements on Trustees.--
(1) Provision of information.--A health information trustee
may provide protected health information to a person who, with
respect to the trustee, is an affiliated person and may permit
the affiliated person to use such information, only for the
purpose of conducting, supporting, or facilitating an activity
that the trustee is authorized to undertake.
(2) Notice to affiliated person.--A health information
trustee shall notify a person who, with respect to the trustee,
is an affiliated person of any duties under this Act that the
affiliated person is required to fulfill and of any authorities
under this Act that the affiliated person is authorized to
exercise.
(b) Duties of Affiliated Persons.--
(1) In general.--An affiliated person shall fulfill any
duty under this Act that--
(A) the health information trustee with whom the
person has an agreement or relationship described in
section 3(c)(1)(C) is required to fulfill; and
(B) the person has undertaken to fulfill pursuant
to such agreement or relationship.
(2) Construction of other subtitles.--With respect to a
duty described in paragraph (1) that an affiliated person is
required to fulfill, the person shall be considered a health
information trustee for purposes of this Act. The person shall
be subject to subtitle E (relating to enforcement) with respect
to any such duty that the person fails to fulfill.
(3) Effect on trustee.--An agreement or relationship with
an affiliated person does not relieve a health information
trustee of any duty or liability under this Act.
(b) Authorities of Affiliated Persons.--
(1) In general.--An affiliated person may only exercise an
authority under this Act that the health information trustee
with whom the person is affiliated may exercise and that the
person has been given by the trustee pursuant to an agreement
or relationship described in section 3(c)(1)(C). With respect
to any such authority, the person shall be considered a health
information trustee for purposes of this Act. The person shall
be subject to subtitle E (relating to enforcement) with respect
to any act that exceeds such authority.
(2) Effect on trustee.--An agreement or relationship with
an affiliated person does not affect the authority of a health
information trustee under this Act.
SEC. 145. AGENTS AND ATTORNEYS.
(a) In General.--Except as provided in subsections (b) and (c), a
person who is authorized by law (on grounds other than an individual's
minority), or by an instrument recognized under law, to act as an
agent, attorney, proxy, or other legal representative for a protected
individual or the estate of a protected individual, or otherwise to
exercise the rights of the individual or estate, may, to the extent
authorized, exercise and discharge the rights of the individual or
estate under this Act.
(b) Health Care Power of Attorney.--A person who is authorized by
law (on grounds other than an individual's minority), or by an
instrument recognized under law, to make decisions about the provision
of health care to an individual who is incapacitated may exercise and
discharge the rights of the individual under this Act to the extent
necessary to effectuate the terms or purposes of the grant of
authority.
(c) No Court Declaration.--If a health care provider determines
that an individual, who has not been declared to be legally
incompetent, suffers from a medical condition that prevents the
individual from acting knowingly or effectively on the individual's own
behalf, the right of the individual to authorize disclosure under
section 112 may be exercised and discharged in the best interest of the
individual by--
(1) a person described in subsection (b) with respect to
the individual;
(2) a person described in subsection (a) with respect to
the individual, but only if a person described in paragraph (1)
cannot be contacted after a reasonable effort;
(3) the next of kin of the individual, but only if a person
described in paragraph (1) or (2) cannot be contacted after a
reasonable effort; or
(4) the health care provider, but only if a person
described in paragraph (1), (2), or (3) cannot be contacted
after a reasonable effort.
SEC. 146. MINORS.
(a) Individuals Who Are 18 or Legally Capable.--In the case of an
individual--
(1) who is 18 years of age or older, all rights of the
individual shall be exercised by the individual, except as
provided in section 145; or
(2) who, acting alone, has the legal capacity to apply for
and obtain health care and has sought such care, the individual
shall exercise all rights of an individual under this Act with
respect to protected health information relating to such care.
(b) Individuals Under 18.--Except as provided in subsection (a)(2),
in the case of an individual who is--
(1) under 14 years of age, all the individual's rights
under this Act shall be exercised through the parent or legal
guardian of the individual; or
(2) 14, 15, 16, or 17 years of age, the right of inspection
(under section 101), the right of amendment (under section
102), and the right to authorize disclosure of protected health
information (under section 112) of the individual may be
exercised either by the individual or by the parent or legal
guardian of the individual.
SEC. 147. MAINTENANCE OF CERTAIN PROTECTED HEALTH INFORMATION.
(a) In General.--A State shall establish a process under which the
protected health information described in subsection (b) that is
maintained by a person described in subsection (c) is delivered to, and
maintained by, the State or an individual or entity designated by the
State.
(b) Information Described.--The protected health information
referred to in subsection (a) is protected health information that--
(1) is recorded in any form or medium;
(2) is created by--
(A) a health care provider; or
(B) a health benefit plan sponsor that provides
benefits in the form of items and services to enrollees
and not in the form of reimbursement for items and
services; and
(3) relates in any way to the past, present, or future
physical or mental health or condition or functional status of
a protected individual or the provision of health care to a
protected individual.
(c) Persons Described.--A person referred to in subsection (a) is
any of the following:
(1) A health care facility previously located in the State
that has closed.
(2) A professional practice previously operated by a health
care provider in the State that has closed.
(3) A health benefit plan sponsor that--
(A) previously provided benefits in the form of
items and services to enrollees in the State; and
(B) has ceased to do business.
Subtitle E--Enforcement
SEC. 151. CIVIL ACTIONS.
(a) In General.--Any individual whose right under this Act has been
knowingly or negligently violated--
(1) by a health information trustee, or any other person,
who is not described in paragraph (2), (3), (4), or (5) may
maintain a civil action for actual damages and for equitable
relief against the health information trustee or other person;
(2) by an officer or employee of the United States while
the officer or employee was acting within the scope of the
office or employment may maintain a civil action for actual
damages and for equitable relief against the United States;
(3) by an officer or employee of any government authority
of a State that has waived its sovereign immunity to a claim
for damages resulting from a violation of this Act while the
officer or employee was acting within the scope of the office
or employment may maintain a civil action for actual damages
and for equitable relief against the State government;
(4) by an officer or employee of a government of a State
that is not described in paragraph (3) may maintain a civil
action for actual damages and for equitable relief against the
officer or employee; or
(5) by an officer or employee of a government authority
while the officer or employee was not acting within the scope
of the office or employment may maintain a civil action for
actual damages and for equitable relief against the officer or
employee.
(b) Knowing Violations.--Any individual entitled to recover actual
damages under this section because of a knowing violation of a
provision of this Act (other than subsection (c) or (d) of section 111)
shall be entitled to recover the amount of the actual damages
demonstrated or $5000, whichever is greater.
(c) Actual Damages.--For purposes of this section, the term
``actual damages'' includes damages paid to compensate an individual
for nonpecuniary losses such as physical and mental injury as well as
damages paid to compensate for pecuniary losses.
(d) Punitive Damages; Attorney's Fees.--In any action brought under
this section in which the complainant has prevailed because of a
knowing violation of a provision of this Act (other than subsection (c)
or (d) of section 111), the court may, in addition to any relief
awarded under subsections (a) and (b), award such punitive damages as
may be warranted. In such an action, the court, in its discretion, may
allow the prevailing party a reasonable attorney's fee (including
expert fees) as part of the costs, and the United States shall be
liable for costs the same as a private person.
(e) Limitation.--A civil action under this section may not be
commenced more than 2 years after the date on which the aggrieved
individual discovered the violation or the date on which the aggrieved
individual had a reasonable opportunity to discover the violation,
whichever occurs first.
(f) Inspection and Amendment.--If a health information trustee has
established a formal internal procedure that allows an individual who
has been denied inspection or amendment of protected health information
to appeal the denial, the individual may not maintain a civil action in
connection with the denial until the earlier of--
(1) the date the appeal procedure has been exhausted; or
(2) the date that is 4 months after the date on which the
appeal procedure was initiated.
(g) No Liability for Permissible Disclosures.--A health information
trustee who makes a disclosure of protected health information about a
protected individual that is permitted by this Act and not otherwise
prohibited by State or Federal statute shall not be liable to the
individual for the disclosure under common law.
(h) No Liability for Institutional Review Board Determinations.--If
the members of a certified institutional review board have in good
faith determined that an approved health research project is of
sufficient importance so as to outweigh the intrusion into the privacy
of an individual pursuant to section 116(a)(1), the members, the board,
and the parent institution of the boardshall not be liable to the
individual as a result of such determination.
(i) Good Faith Reliance on Certification.--A health information
trustee who relies in good faith on a certification by a government
authority or other person and discloses protected health information
about an individual in accordance with this Act shall not be liable to
the individual for such disclosure.
SEC. 152. CIVIL MONEY PENALTIES.
(a) Violation.--Any health information trustee who the Secretary
determines has demonstrated a pattern or practice of failure to comply
with the provisions of this Act shall be subject, in addition to any
other penalties that may be prescribed by law, to a civil money penalty
of not more than $10,000 for each such failure. In determining the
amount of any penalty to be assessed under the procedures established
under subsection (b), the Secretary shall take into account the
previous record of compliance of the person being assessed with the
applicable requirements of this Act and the gravity of the violation.
(b) Procedures for Imposition of Penalties.--The provisions of
section 1128A of the Social Security Act (other than subsections (a)
and (b)) shall apply to the imposition of a civil monetary penalty
under this section in the same manner as such provisions apply with
respect to the imposition of a penalty under section 1128A of such Act.
SEC. 153. ALTERNATIVE DISPUTE RESOLUTION.
(a) In General.--Not later than July 1, 1999, the Secretary shall,
by regulation, develop alternative dispute resolution methods for use
by individuals, health information trustees, and other persons in
resolving claims under section 151.
(b) Effect on Initiation of Civil Actions.--
(1) In general.--Subject to paragraph (2), the regulations
established under subsection (a) may provide that an individual
alleging that a right of the individual under this Act has been
violated shall pursue at least one alternative dispute
resolution method developed under such subsection as a
condition precedent to commencing a civil action under section
151.
(2) Limitation.--Such regulations may not require an
individual to refrain from commencing a civil action to pursue
one or more alternative dispute resolution method for a period
that is greater than 6 months.
(3) Suspension of statute of limitations.--The regulations
established by the Secretary under subsection (a) may provide
that a period in which an individual described in paragraph (1)
pursues (as defined by the Secretary) an alternative dispute
resolution method under this section shall be excluded in
computing the period of limitations under section 151(e).
(c) Methods.--The methods under subsection (a) shall include at
least the following:
(1) Arbitration.--The use of arbitration.
(2) Mediation.--The use of mediation.
(3) Early offers of settlement.--The use of a process under
which parties make early offers of settlement.
(d) Standards for Establishing Methods.--In developing alternative
dispute resolution methods under subsection (a), the Secretary shall
ensure that the methods promote the resolution of claims in a manner
that--
(1) is affordable for the parties involved;
(2) provides for timely and fair resolution of claims; and
(3) provides for reasonably convenient access to dispute
resolution for individuals.
SEC. 154. AMENDMENTS TO CRIMINAL LAW.
(a) In General.--Title 18, United States Code, is amended by
inserting after chapter 73 the following:
``CHAPTER 74--OBTAINING PROTECTED HEALTH INFORMATION
``Sec.
``1531. Definitions.
``1532. Obtaining protected health information under false pretenses.
``1533. Monetary gain from obtaining protected health information under
false pretenses.
``1534. Knowing and unlawful obtaining of protected health information.
``1535. Monetary gain from knowing and unlawful obtaining of protected
health information.
``1536. Knowing and unlawful use or disclosure of protected health
information.
``1537. Monetary gain from knowing and unlawful sale, transfer, or use
of protected health information.
``Sec. 1531. Definitions
``As used in this chapter--
``(1) the term `health information trustee' has the meaning
given such term in section 3(b)(5) of the Fair Health
Information Practices Act of 1997;
``(2) the term `protected health information' has the
meaning given such term in section 3(a)(3) of such Act; and
``(3) the term `protected individual' has the meaning given
such term in section 3(a)(4) of such Act.
``Sec. 1532. Obtaining protected health information under false
pretenses
``Whoever under false pretenses--
``(1) requests or obtains protected health information from
a health information trustee; or
``(2) obtains from a protected individual an authorization
for the disclosure of protected health information about the
individual maintained by a health information trustee;
shall be fined under this title or imprisoned not more than 5 years, or
both.
``Sec. 1533. Monetary gain from obtaining protected health information
under false pretenses
``Whoever under false pretenses--
``(1) requests or obtains protected health information from
a health information trustee with the intent to sell, transfer,
or use such information for profit or monetary gain; or
``(2) obtains from a protected individual an authorization
for the disclosure of protected health information about the
individual maintained by a health information trustee with the
intent to sell, transfer, or use such authorization for profit
or monetary gain;
and knowingly sells, transfers, or uses such information or
authorization for profit or monetary gain shall be fined under this
title or imprisoned not more than 10 years, or both.
``Sec. 1534. Knowing and unlawful obtaining of protected health
information
``Whoever knowingly obtains protected health information from a
health information trustee in violation ofthe Fair Health Information
Practices Act of 1997, knowing that such obtaining is unlawful, shall
be fined under this title or imprisoned not more than 5 years, or both.
``Sec. 1535. Monetary gain from knowing and unlawful obtaining of
protected health information
``Whoever knowingly--
``(1) obtains protected health information from a health
information trustee in violation of the Fair Health Information
Practices Act of 1997, knowing that such obtaining is unlawful
and with the intent to sell, transfer, or use such information
for profit or monetary gain; and
``(2) knowingly sells, transfers, or uses such information
for profit or monetary gain;
shall be fined under this title or imprisoned not more than 10 years,
or both.
``Sec. 1536. Knowing and unlawful use or disclosure of protected health
information
``Whoever knowingly uses or discloses protected health information
in violation of the Fair Health Information Practices Act of 1997,
knowing that such use or disclosure is unlawful, shall be fined under
this title or imprisoned not more than 5 years, or both.
``Sec. 1537. Monetary gain from knowing and unlawful sale, transfer, or
use of protected health information
``Whoever knowingly sells, transfers, or uses protected health
information in violation of the Fair Health Information Practices Act
of 1997, knowing that such sale, transfer, or use is unlawful, shall be
fined under this title or imprisoned not more than 10 years, or
both.''.
(b) Clerical Amendment.--The table of chapters for part I of title
18, United States Code, is amended by inserting after the item relating
to chapter 73 the following:
``74. Obtaining protected health information.....................1531''.
TITLE II--AMENDMENTS TO TITLE 5, UNITED STATES CODE
SEC. 201. AMENDMENTS TO TITLE 5, UNITED STATES CODE.
(a) New Subsection.--Section 552a of title 5, United States Code,
is amended by adding at the end the following:
``(w) Medical Exemptions.--The head of an agency that is a health
information trustee (as defined in section 3(b)(5) of the Fair Health
Information Practices Act of 1997) shall promulgate rules, in
accordance with the requirements (including general notice) of
subsections (b)(1), (b)(2), (b)(3), (c), and (e) of section 553 of this
title, to exempt a system of records within the agency, to the extent
that the system of records contains protected health information (as
defined in section 3(a)(3) of such Act), from all provisions of this
section except subsections (e)(1), (e)(2), subparagraphs (A) through
(C) and (E) through (I) of subsection (e)(4), and subsections (e)(5),
(e)(6), (e)(9), (e)(12), (l), (n), (o), (p), (q), (r), and (u).''.
(b) Repeal.--Section 552a(f)(3) of title 5, United States Code, is
amended by striking ``pertaining to him,'' and all that follows through
the semicolon and inserting ``pertaining to the individual;''.
TITLE III--REGULATIONS, RESEARCH, AND EDUCATION; EFFECTIVE DATES;
APPLICABILITY; AND RELATIONSHIP TO OTHER LAWS
SEC. 301. REGULATIONS; RESEARCH AND EDUCATION.
(a) Regulations.--Not later than July 1, 1999, the Secretary shall
prescribe regulations to carry out this Act.
(b) Research and Technical Support.--The Secretary may sponsor--
(1) research relating to the privacy and security of
protected health information;
(2) the development of consent forms governing disclosure
of such information; and
(3) the development of technology to implement standards
regarding such information.
(c) Education.--The Secretary shall establish education and
awareness programs--
(1) to foster adequate security practices by health
information trustees;
(2) to train personnel of health information trustees
respecting the duties of such personnel with respect to
protected health information; and
(3) to inform individuals and employers who purchase health
care respecting their rights with respect to such information.
(d) Office of Information Privacy.--
(1) Establishment.--There is established in the Department
of Health and Human Services, within the Office of the
Secretary, an Office of Information Privacy. The Office of
Information Privacy shall be headed by a Director, who shall
also be the Privacy Adviser of the Department of Health and
Human Services. The Director shall be the principal adviser to
the Secretary on the effect of the use and disclosure of
personally-identifiable information on the privacy of
individuals.
(2) Duties.--The Director of the Office of Information
Privacy shall--
(A) monitor and participate in the development of
regulations under this Act;
(B) monitor the implementation of this Act within
the Department of Health and Human Services;
(C) advise the Secretary of the effects of current
activities and proposed statutory, regulatory,
administrative, and budgetary actions on the
information privacy of individuals;
(D) monitor the implementation within the
Department of Health and Human Services of laws and
policies affecting the confidentiality of personally-
identifiable health information or other personally-
identifiable information;
(E) advise the Secretary on the implications for
privacy of automated systems for the collection,
storage, analysis, or transfer of personally-
identifiable health information or other personally-
identifiable information;
(F) engage in, or commission, research and
technical studies on the implications of policies and
practices for information privacy promulgated by the
Secretary;
(G) serve as a point of contact within the
Department of Health and Human Services for persons,
such as other agencies of the Federal Government,
States, foreign governments, international
organizations, privacy and consumer advocacy
organizations, businesses, nonprofit organizations, and
individuals, interested in the effects on privacy of
the collection, maintenance, use, and disclosure of
personally-identifiable health information or other
personally-identifiable information; and
(H) report from time to time to the Secretary, the
Congress, and the public on privacy matters.
SEC. 302. EFFECTIVE DATES.
(a) In General.--Except as provided in subsection (b), this Act,
and the amendments made by this Act, shall take effect on January 1,
2000.
(b) Provisions Effective Immediately.--
(1) In general.--A provision of this Act shall take effect
on the date of the enactment of this Act if the provision--
(A) imposes a duty on the Secretary to develop,
establish, or promulgate regulations, guidelines,
notices, statements, or education and awareness
programs; or
(B) authorizes the Secretary to sponsor research or
the development of forms or technology.
(2) Office of information privacy.--Section 301(d)
(relating to the Office of Information Privacy) shall take
effect on the date of the enactment of this Act.
SEC. 303. APPLICABILITY.
(a) Protected Health Information.--Except as provided in
subsections (b) and (c), the provisions of this Act shall apply to any
protected health information that is received, created, used,
maintained, or disclosed by a health information trustee in a State on
or after January 1, 2000, regardless of whether the information existed
or was disclosed prior to such date.
(b) Exception.--
(1) In general.--The provisions of this Act shall not apply
to a trustee described in paragraph (2), except with respect to
protected health information that is received by the trustee on
or after January 1, 2000.
(2) Applicability.--A trustee referred to in paragraph (1)
is--
(A) a health researcher; or
(B) a person who, with respect to specific
protected health information, received the
information--
(i) pursuant to--
(I) section 117 (relating to
emergency circumstances);
(II) section 118 (relating to
judicial and administrative purposes);
(III) section 119 (relating to law
enforcement); or
(IV) section 120 (relating to
subpoenas, warrants, and search
warrants); or
(ii) while acting in whole or in part in
the capacity of an officer or employee of a
person described in clause (i).
(c) Authorizations for Disclosures.--An authorization for the
disclosure of protected health information about a protected individual
that is executed by the individual before January 1, 2000, and is
recognized and valid under State law on December 31, 1999, shall remain
valid and shall not be subject to the requirements of section 112 until
January 1, 2001, or the occurrence of the date or event (if any)
specified in the authorization upon which the authorization expires,
whichever occurs earlier.
SEC. 304. RELATIONSHIP TO OTHER LAWS.
(a) State Law.--Except as otherwise provided in subsections (b),
(c), (d), (e), and (g), a State may not establish, continue in effect,
or enforce any State law to the extent that the law is inconsistent
with, or imposes additional requirements with respect to, any of the
following:
(1) A duty of a health information trustee under this Act.
(2) An authority of a health information trustee under this
Act to disclose protected health information.
(3) A provision of subtitle C (relating to access
procedures and challenge rights), subtitle D (miscellaneous
provisions), or subtitle E (relating to enforcement).
(b) Laws Relating to Public Health and Mental Health.--This Act
does not preempt, supersede, or modify the operation of any State law
regarding public health or mental health to the extent that the law
prohibits or regulates a disclosure of protected health information
that is permitted under this Act.
(c) Criminal Penalties.--A State may establish and enforce criminal
penalties with respect to a failure to comply with a provision of this
Act.
(d) Requirements on State Agencies.--A State may establish,
continue in effect, and enforce any State law to the extent that the
law imposes on a judicial, legislative, or executive agency of the
State a requirement, limitation, or procedure with respect to the use
or disclosure of protected health information that is in addition to
the requirements, limitations, and procedures imposed under this Act.
(e) Privileges.--A privilege that a person has under law in a court
of a State or the United States or under the rules of any agency of a
State or the United States may not be diminished, waived, or otherwise
affected by--
(1) the execution by a protected individual of an
authorization for disclosure of protected health information
under this Act, if the authorization is executed for the
purpose of receiving health care or providing for the payment
for health care; or
(2) any provision of this Act that authorizes the
disclosure of protected health information for the purpose of
receiving health care or providing for the payment for health
care.
(f) Department of Veterans Affairs.--The limitations on use and
disclosure of protected health information under this Act shall not be
construed to prevent any exchange of such information within and among
components of the Department of Veterans Affairs that determine
eligibility for or entitlement to, or that provide, benefits under laws
administered by the Secretary of Veterans Affairs.
(g) Certain Duties Under State or Federal Law.--This Act shall not
be construed to preempt, supersede, or modify the operation of any of
the following:
(1) Any law that provides for the reporting of vital
statistics such as birth or death information.
(2) Any law requiring the reporting of abuse or neglect
information about any individual.
(3) Subpart II of part E of title XXVI of the Public Health
Service Act (relating to notifications of emergency response
employees of possible exposure to infectious diseases).
(4) The Americans with Disabilities Act of 1990.
(5) Any Federal or State statute that establishes a
privilege for records used in health professional peer review
activities.
(h) Secretarial Authority.--
(1) Secretary of health and human services.--A provision of
this Act does not preempt, supersede, or modify the operation
of section 543 of the Public Health Service Act, except to the
extent that the Secretary of Health and Human Services
determines through regulations promulgated by such Secretary
that the provision provides greater protection for protected
health information, and the rights of protected individuals,
than is provided under such section 543.
(2) Secretary of veterans affairs.--A provision of this Act
does not preempt, supersede, or modify the operation of section
7332 of title 38, United States Code, except to the extent that
the Secretary of Veterans Affairs determines through
regulations promulgated by such Secretary that the provision
provides greater protection for protected health information,
and the rights of protected individuals, than is provided under
such section 7332.
Mr. Horn. No one will make the mistake of thinking that
medical privacy is a new issue. It is worth recalling the words
of Hippocrates. His oath included the following pledge: ``All
that may come to my knowledge in the exercise of my profession,
which ought not to be spread abroad, I will keep secret and
will never reveal.''
Patient information acquired by medical experts is deeply
personal and should be kept private. The challenge we now face
is to protect the timeless value of confidentiality, the
privacy between doctor and patient, in a rapidly changing
health care environment. We face an enormous conflict between
an old value, the right to personal privacy, and the increasing
need of our health care system to exchange intimate information
about each of us. Managed health care systems must be able to
exchange information between doctors, insurers, and others. We
need to set the rules of the road.
At stake are the quality and the value of our health care.
The increasing use of information technology and the increasing
complexity of provider arrangements are inevitable. The
exchange of patient health care information is an integral part
of the existing health care system. Claims payments require
diagnostic information. Communications between primary care
providers and other providers, such as specialists or
hospitals, require patient information to be shared. Pharmacies
maintain data bases of past prescriptions.
Despite this highly fluid environment for exchanging health
care information, no uniform national standard currently exists
to protect the confidentiality of this information. Moreover,
there is little uniformity among State statutes regarding the
confidentiality of health care information. Most of the States'
laws lack penalties for misuse or misappropriation. Protections
vary according to both the holder and the type of information.
Under last year's Kassebaum-Kennedy act, the Secretary of
Health and Human Services is required to recommend privacy
standards for health care information to Congress by September
1997. If Congress does not enact health care privacy
legislation by August 1999, the Secretary of Health and Human
Services is required to promulgate such privacy regulations. In
effect, the Kassebaum-Kennedy act gave Congress a 3-year window
of opportunity to enact major health care privacy legislation.
An illustration of the difficulties we face is the
revolution in the science of genetics, with the mapping of the
human genome. Incredibly sensitive, precise genetic tests have
been developed, genetic screening has become commonplace, and
an extraordinary array of genetic interventions are being
explored.
Genetics privacy issues inevitably accompany the scientific
advances. Do genetic data differ fundamentally from other
health data? Genetic data could be used prejudicially, such as
ineligibility for employment, financial credit, or life or
health insurance.
Issues associated with genetic privacy and possible
discrimination based on genetic information have received
heightened attention. The House Committee on Commerce has
established a task force on health records and genetic privacy
chaired by Representative Stearns and Green. Any substantial
legislation on the issue of medical records privacy will
involve establishing uniform national rules on the collection
and protection of personally identifiable health data,
affirming the rights of patients, setting criteria and
procedures for disclosure, their use and security of health
care information, focusing responsibilities for ensuring proper
protection and use of health care information and establishing
penalties for wrongful use of the data.
The legislation before us today is H.R. 52, the Fair Health
Information Practices Act of 1997. Under this bill, medical
records created or used during the process of treatment become
protected health information. Furthermore, health care
providers are required to maintain appropriate administrative,
technical, and physical safeguards to protect the integrity and
privacy of health care information. H.R. 52 would allow
patients to review their medical records and correct inaccurate
information. It would also place restriction on the release of
information relating to the treatment of patients and on the
payment for health care services.
Three Members of Congress who have taken the lead on
medical records privacy issues will testify today as part of
our first panel. They are Representative Condit, who is author
of H.R. 52, as well as Representatives Slaughter and Stearns.
Representatives of privacy advocates, health care providers
and records management organizations will testify on panel II.
The witnesses are Ms. Janlori Goldman, visiting scholar at
Georgetown University Law Center, who is also affiliated with
the Center for Democracy and Technology; Dr. Donald J.
Palmisano, who is a member of the Board of Trustees, American
Medical Association; and Dr. Merida Johns, who is president of
the American Health Information Management Association.
Representatives of medical researchers will testify on
panel III. Witnesses are Dr. Sherine Gabriel of the Department
of Health Services Research, Mayo Clinic, representing the
Health Care Leadership Council; Dr. Elizabeth Andrews of Glaxo
Wellcome, representing the Pharmaceutical Research and
Manufacturers Association; and Dr. Steven Kenny Hoge, who
serves as chair of the Council on Psychiatry and Law at the
American Psychiatric Association.
We welcome all of today's witnesses.
I have just learned that Mrs. Slaughter will not be here.
She asks for her comments to be submitted for the record and
without objection, they will be. We are delighted to have the
author of this legislation with us, Mr. Condit, and it is all
yours.
STATEMENT OF HON. GARY A. CONDIT, A REPRESENTATIVE IN CONGRESS
FROM THE STATE OF CALIFORNIA
Mr. Condit. Thank you, Mr. Chairman. First of all, let me
commend you, Mr. Chairman, for gathering us here today to
discuss the privacy of medical records. This is an extremely
important step in addressing the anxiety of many patients and
citizens across this country. The time has come for us in
reforming the way we handle medical records; and this is a very
sensitive issue, and it is time for us to take a look at how we
have been doing this.
As more and more medical records are computerized, a
patient's confidentiality is put at risk, and we have examples
of that throughout our review of this issue. For this reason, I
have introduced the Fair Health Information Practices Act; and
you have been kind enough to work with us on that, Mr. Chairman
and I appreciate that very much.
Our guiding principle in drafting this bill is to protect
the confidential information contained in medical records and
protecting this information once it leaves the physician's
office. Under the bill, medical information is protected by
establishing uniform Federal rules for handling medical
records; holding those who handle this information accountable
for the security and privacy of the medical records.
Today, you will hear testimony from a number of people who
have expertise in this area, and I look forward to their
testimony. We have heard them speak before, over the last
couple of years, on this issue. You know, last year, with the
Kennedy-Kassebaum bill, we were given a target date, 1999, to
enact something. We think this is a good step in the right
direction, and I hope we can put something together.
Mr. Chairman, I have an extensive statement and some
background information that I would like to submit for the
record, and I would be available here for a few minutes to
respond to any comments or questions; and with that, I will
yield back.
Mr. Horn. Well, we appreciate you coming and your statement
will be, without objection, part of the record at this point.
Mr. Condit. Thank you.
[The prepared statement of Hon. Gary A. Condit follows:]
[GRAPHIC] [TIFF OMITTED] 45252.001
[GRAPHIC] [TIFF OMITTED] 45252.002
[GRAPHIC] [TIFF OMITTED] 45252.003
Mr. Horn. We now have the distinguished Member from
Florida, Mr. Stearns.
STATEMENT OF HON. CLIFF STEARNS, A REPRESENTATIVE IN CONGRESS
FROM THE STATE OF FLORIDA
Mr. Stearns. Good morning, Mr. Chairman. I am delighted to
be here and want to compliment you on your leadership in having
this hearing. While the scope of your hearing today covers
medical records in general, I would like to restrict my
comments to why I believe we must provide safeguards to prevent
discrimination based on a person's genetic profile.
The question of confidentiality of one's medical record is
something that should concern us all. The reason I am here
today is to discuss how we can find a way to ensure that
technological advances in genetic testing proceed while
protecting the interests of the individual.
Let me state, technology is good, research must be allowed.
It is the means and applications of this technology and
research that concerns us all. I believe genetic testing may
become, in fact, a civil rights issue. It could be the civil
rights issue of the 21st century. Should an insurance company
be able to deny children medical coverage because their mother
died of an inherited heart defect? Even if children may or may
not carry the defect this is a dilemma faced by a father in
California who could not get family medical coverage under his
group plan as a result of his wife's death.
In another case, a man lost his auto insurance coverage
because he had a genetic condition which affected his muscles.
Although he had a clean driving record stretching back 20
years, genetic information was used to cancel his policy.
One young woman was hired as a social worker, and for 8
months, she received promotions and positive performance
reviews. However, while conducting a training program on caring
for patients with Huntington's disease, she mentioned that she
had family members with that condition. She was soon fired and
informed by another colleague that it was due to a concern that
she might develop Huntington's disease.
As these cases show, access to genetic information can
result in being denied health insurance, cancellation of auto
insurance, and even the loss of a job. These people were
discriminated against based upon their genes. You might be
amazed to know how many of us here in this committee room carry
mutated genes. The fact is, we all do. Fortunately, most
genetic mutations are silent, exhibiting no significant
consequences.
The National Institutes for Health is home to the Human
Genome Project. This project is a 15-year study scheduled for
completion in the year 2005. The discoveries made from mapping
out the entire human genome will mean better early detection,
treatment of disease, and even their prevention. These are the
up sides of genetic research.
The examples I provided earlier show genetic information
can also be used to discriminate against people. That is where
Congress should take action to ensure continued progress in
genetic research while also protecting people from the misuse
of genetic information. This issue is moving very quickly, and
we need to make some sound public policy decisions now.
In the last Congress, I introduced the Genetic Privacy and
Nondiscrimination Act, H.R. 2690, to establish guidelines
concerning the disclosure and use of genetic information. My
goal was to protect the health privacy of the American people
while not disrupting genetic research efforts. I am currently
drafting a similar piece of legislation for the 105th Congress.
Last year, I was able to, with the help of others, insert
language into the Health Care Coverage and Affordability Act
while the measure was in the Commerce Committee, on which I
sit. As you know, we passed this measure and the President
signed it. One provision of this bill prohibits insurance
companies from denying coverage to an employee or beneficiary
on the basis of health status. Health status was defined as an
individual's medical condition, claims, experience, receipt of
health care, medical history, evidence of insurability, or
disability. The two words that I inserted in the commerce bill
were, quote, genetic information. These two words made a good
bill better, but additional protection and guidelines are still
needed. That is one of my priorities in the 105th Congress.
Chairman Tom Bliley of the Commerce Committee asked me to
take a leading role in establishing policy on these issues by
chairing the task force on health records and genetic privacy.
This bipartisan task force will consider these questions in a
series of briefings, meetings, and public hearings.
The job of the task force is to answer a number of
questions which certainly pertain to medical records and
privacy; and some of these are, Mr. Chairman, one, how will we
protect the health records of persons with genetic deficiencies
and still allow scientific research to go forward unimpeded?
Additionally, the whole area of, quote, informed consent, end
quote, must be clarified as it pertains to genetic privacy. How
will the thousands of available genetic tests created as a
result of the Human Genome Project affect our citizens? And
three, what issues are raised by the potential misuse of
genetic and other information about an individual?
Genetic information is personal, powerful, permanent, and
sensitive. It not only affects the individual, but it also has
an impact on offspring and other blood relatives. Genetic
privacy must be protected. On the other hand, it is a key to
the treatment, cure and prevention of disease, so genetic
research must continue. I see our job is to meet these goals as
best we can; it is also an issue of fairness.
In conclusion, Mr. Chairman, think about those two little
boys in California who were denied insurance coverage because
of an error in a genetic script. This is something that they
could not control and did not choose. As I noted, we all have
errors in our genetic blueprints. For most of us, it does not
harm us, but for many, the onset of disease is devastating. We
owe them a level of privacy and the hope for treatment and
cure. That is the central mission of my task force and
legislation.
Thank you, Mr. Chairman.
Mr. Horn. I thank you for that very fine statement.
[The prepared statement of Hon. Cliff Stearns follows:]
[GRAPHIC] [TIFF OMITTED] 45252.004
[GRAPHIC] [TIFF OMITTED] 45252.005
[GRAPHIC] [TIFF OMITTED] 45252.006
[GRAPHIC] [TIFF OMITTED] 45252.007
[GRAPHIC] [TIFF OMITTED] 45252.008
[GRAPHIC] [TIFF OMITTED] 45252.009
Mr. Horn. Let me just put in the record, without objection,
the comments of Representative Shays, who is chairman of the
Human Resources Subcommittee of our full committee and the
comments of Representative Slaughter, who is the author of H.R.
306, the Genetic Information Nondiscrimination and Health
Insurance Act. Any other remarks as Members arrive, those
opening statements will be put in the record.
[The prepared statements of Hon. Christopher Shays and Hon.
Louise M. Slaughter follow:]
[GRAPHIC] [TIFF OMITTED] 45252.010
[GRAPHIC] [TIFF OMITTED] 45252.011
[GRAPHIC] [TIFF OMITTED] 45252.012
[GRAPHIC] [TIFF OMITTED] 45252.013
[GRAPHIC] [TIFF OMITTED] 45252.014
Mr. Horn. Let us now, in your limited time, ask a few
questions. Given the situation on genetic information in those
cases, Representative Stearns, that you cited, are truly
important because I happen to have a college classmate whose
child had exactly that heart situation. No one thought the
child would live past 8, and that child is now in his late 30's
or early 40's. So genetic information doesn't always have an
inevitable consequence.
And I think the one question here is, should we separate
the genetic information aspect from the other privacy aspects
in the Condit bill, or should we just work on both in one
piece? What is your feeling on that?
Mr. Stearns. Well, I think what Gary is doing is important,
and I think separating them temporarily until we know enough
about it--because as you just pointed out, if a doctor sits
down with me and says, Cliff, you have a predisposition because
of your gene for X, Y, Z, what does that mean in terms of
probability theory? Does the environment, the fact I don't
drink or smoke or perhaps that I exercise, perhaps where I
live, how does that tie in? And what does that predisposition
mean? We just don't know.
We can say, in some genes, it means you are going to die at
a definite date. But for a lot of this, there is going to be a
high level of probability that we have to work out and we
should not have the health records impeded while we try to
understand the whole impact of this, in the legal aspect, in
terms of punitive--allowing research to go ahead, in terms of
counseling people. I mean, the issues just open up like
Pandora's box.
So I think the whole area of genetics is an issue unto
itself in how we deal with it, much like we are trying to deal
with cloning. And as you know, the President's Commission, I
think is going to reveal its recommendations this week or next.
And so this whole area is something that is staggering in terms
of implication.
Mr. Condit. May I respond?
As you know, you and I have had discussions, we are looking
for a comprehensive approach to medical records and the
confidentiality, and so we would like to eventually see
everything sort of on an even keel here. But I do acknowledge
that what Mr. Stearns has brought up here is sort of in a
special category. At this time, we don't have a lot of
information about it, so I do think that there is a time period
where we may want to do as he said, take a special look at it
and see whether or not it fits under this category. But we
probably could work to accommodate it either way, but I think
he makes a very good point and one we would probably agree
with.
I also, Mr. Chairman--if I may, I apologize to you; you
have been very kind to hold this hearing today, and I know you
are going to get a lot of good information. I have another
obligation I need to get to, but I do have a stack of
information I would like to leave for the record, if I may.
Mr. Horn. Without objection, it will be inserted at this
point.
I just have one question, if you have got a second.
On H.R. 52, as put in this year, is there an impact on law
enforcement investigations? I recall that some law enforcement
officials, representatives of the Department of Justice, in
particular, expressed concern about your previous legislation,
H.R. 435, and its effect on law enforcement investigations. Do
you know of any similar concerns?
Mr. Condit. That is a good point, and I am glad you brought
it up.
It is certainly not my intent to exclude law enforcement
from having access to information that is crucial to them,
maybe in a criminal case. So last session when we worked on
this issue, we spent a lot of time working with the law
enforcement industry, and I think we clarified, to their
satisfaction, language that they can accept. And I think they
are protected under this bill, and we have not received, to my
knowledge, any objection from them on this particular language.
They do have access to records when they need them.
Mr. Horn. Thank you very much.
Mr. Stearns, when I listened to your examples on genetics
and how insurance companies were doing this and that, it came
to my mind that the whole reason we have insurance is not just
to insure well people, but to insure a group of people, and
that is what the actuarial tables, it seems to me, are based
upon; and to deny an individual, just because science has
progressed, it bothers me a lot, and we have to do something to
figure out how to solve that one.
Do you have any other comments you want to make? I don't
want to hold you here. I know you have a lot of things to do.
Mr. Stearns. Well, Mr. Chairman, in the area of law
enforcement, also in the area of military, that is another area
that health records--in determining availability, access for
military people, military doctors, putting people in combat;
and with genetic predisposition, how does that work out if a
person has strong allergies or a person has some other problems
that would become apparent under stress or would become
apparent under certain conditions? How does that work out, and
how is the individual protected, and what does it mean? That is
an area that we need to have the wisdom of Solomon to figure
out how to protect health records and at the same time allow
the military, the law enforcement and research--most
importantly, research--to have access to the records.
So, I mean, it is something I commend you and others for
doing, and I am delighted to be here.
Mr. Horn. Let me just ask if Mr. Sessions has any questions
he would like to ask you before you leave.
Mr. Sessions. I really have no questions. I would just say
that I was unprepared before I walked in today. I knew the
general subject. I have a little boy with Down's Syndrome, so I
have had to ask a lot of these same questions, not only of
myself in dealing with him, but also of my son, and how we are
going to deal with him as he progresses.
So these are very thought-provoking issues, and I am very
interested in your comments today and those of Congressman
Condit.
Mr. Stearns. Dr. Collins, who heads up the Genome Project
out at the National Institutes of Health--I went out there and
toured the facility, and I urge all Members to go out there and
to actually meet with Dr. Collins and hear his presentation on
the future with genetic engineering. It is exciting.
For example, with your son and other children that many
Americans will have, the hope some day is we can actually go
back into your DNA and correct things and make things new
again, and that is a spectacular kind of thought. But at the
same time, for many Americans who have mutated genes, we need
to make sure that they have a full life and are not
discriminated against because of anything that medicine finds.
Mr. Sessions. What is interesting to me, since we are on
the subject--and I know you need to go--I struggle and I have
struggled in dealing with my child. Many people, in dealing
with all sorts of gene and genetic problems, as Down's Syndrome
is one of those, I am of a firm belief that God gave us baby
Alex the way he is, and we are simply trying to take him as far
as we can; and a lot of changes, I would not want to make to
him. We are trying to take him as far as he can go as he was
given to us.
And a lot of people do things with exercise or their facial
muscles so that the disability that this child has is not
recognizable. And so my wife and I have taken the perspective
in dealing with this that we want to massage him, we want to do
those things that help his facial muscles, that help him to be
able to speak and help him to do those things, but he should
not become unrecognizable for what he is to this world. He
could, at some point, be 25 years old on a street corner, be
lost, and a person would look at him and maybe not know what
they are looking at.
So I have found that I like baby Alex the way he is, and he
was a gift to us; and I would not go back and alter one single
thing, even if I knew he were Down's from the very beginning.
So there are a lot of things that come to us that may not be
exactly the way you and I think are perfect, but is in reality
a wonderful creation.
Mr. Stearns. Well, that is an inspiring attitude toward it,
and I think all of us should have that attitude on many things.
So I commend you for that attitude, and I think that is an
inspiration for many of us.
Mr. Sessions. Thank you.
Mr. Horn. I agree with the gentleman. When you mentioned
allergies, the thought crossed my mind that no one on Capitol
Hill would be able to get insurance. As I walk down the hall,
everybody seems to have allergies. And when our class arrived
in the fall of 1992, somebody said, you know, ``Why we all have
allergies?'' We apparently have one of every tree in America on
Capitol Hill. I don't know if it is true, but it is an
interesting source for what the problem is around here.
Would the gentlewoman from New York care to ask any
questions?
Mrs. Maloney. I would like to have my opening comments put
into the record as read.
Mr. Horn. That has automatically been done already.
[The prepared statement of Hon. Carolyn B. Maloney
follows:]
[GRAPHIC] [TIFF OMITTED] 45252.015
[GRAPHIC] [TIFF OMITTED] 45252.016
[GRAPHIC] [TIFF OMITTED] 45252.017
[GRAPHIC] [TIFF OMITTED] 45252.018
Mrs. Maloney. I am sorry Mr. Condit has already left. We
wouldn't be as far along as we are on this issue if it had not
been for the work he did in the 103d Congress.
I wanted to ask him, but maybe Mr. Stearns can answer, in
one of his bills, he had exempted mental health, and yet now he
dropped from his bill the exception for mental health
treatment, and I wanted to ask him why. Are you working with
him on his bill?
Mr. Stearns. No, I am not and it would not be fair for me
to comment on his bill. Gary is very knowledgeable.
Mrs. Maloney. Do you think the provisions in Congresswoman
Slaughter's bill are adequate or would you add to them?
Mr. Stearns. Well, this is a bill that we dropped pretty
much like we dropped last year. Senator Mack and Senator
Hatfield dropped it on the Senate side.
The bill we are going to drop this year is going to be a
little different, and we think that our bill is going to be
more specific and tailored. And we are seeking the
administration's help, because we think the administration has
some concern about certain things; and since we are trying to
get something passed, we are trying to work with them.
She has also been very active, and I admire her for her
leadership and her activities on this, and welcome the work
that she has done and working with her.
Mrs. Maloney. OK. Thank you very much.
Mr. Horn. Thank you for coming. We appreciate you having
shared your knowledge on the subject. When will that task force
of yours report, basically?
Mr. Stearns. Mr. Chairman, Gene Green of Texas represents
Houston. We are hoping to have some hearings at some of the
universities. University of Florida has a lot of research on
this and we are hoping to have a hearing in July, in which we
try to define where in this enormous panoramic subject that we
could go and get the most bang for the buck. We would seek your
advice and the members of this committee too.
Mr. Horn. Well, we thank you for the hard work you have
dedicated to this issue. It is very important.
We will now call forth the second panel, and that will be
Ms. Goldman, Mr. Palmisano, and Ms. Johns.
If you stand and raise your right hands, we have a
tradition that witnesses other than Members of Congress take
the oath.
[Witnesses sworn.]
Mr. Horn. All three witnesses affirmed, and we will start
with Ms. Goldman.
STATEMENTS OF JANLORI GOLDMAN, VISITING SCHOLAR, GEORGETOWN
UNIVERSITY LAW CENTER, AND AFFILIATED WITH THE CENTER FOR
DEMOCRACY AND TECHNOLOGY; DR. DONALD J. PALMISANO, MEMBER,
BOARD OF TRUSTEES, AMERICAN MEDICAL ASSOCIATION; AND MERIDA L.
JOHNS, Ph.D., PRESIDENT, AMERICAN HEALTH INFORMATION MANAGEMENT
ASSOCIATION
Ms. Goldman. Good morning, and thank you very much for
inviting me to testify today. I not only appreciate your
invitation, I appreciate this subcommittee's continued
commitment to this issue. I think this might be the third or
fourth hearing on this subject you have held in the last few
years, and I think it has advanced the policy discussions quite
a bit.
What I would like to do, since this has been an issue that
has been very well discussed and documented--there is quite a
record that this subcommittee alone has created--is just talk a
little bit about what has changed since the last hearing, which
was almost a year ago today. Congress passed the Health
Information Portability Act, the Kassebaum-Kennedy bill that
now--really what Congress did, in place of passing mandatory
privacy rules, was give itself a time limit and say, we must
act to pass legislation in the next few years on privacy of
health records, or else the Secretary of HHS will promulgate
regulations. So one way or another we are going to have a law
on enforceable regulations in the next few years.
It was, I think, a serious failing in the Kassebaum-Kennedy
law that the administrative simplification provisions did pass,
which require standard uniform format of health information,
essentially a computerized patient record in the next few
years, without saying at the outset what the privacy rules
should be.
What it means is that as the Secretary and as the computer
industry and the health information industry is moving to
computerize and standardize personal medical records, they are
doing so without knowing what privacy and security rules to put
in place. So when Congress does act or the Secretary acts, they
are going to have to go back and retrofit those systems.
It is expensive. I think it is a problem. I would urge the
Congress not to wait until the time limit it has been given,
but to act more swiftly so that people who are in those
offices, in those industries, that are working with health
information, know what to do at the outset.
In that law though that did pass, instead of passing the
rules, what Congress did do was say, we need to address the
privacy issues. A committee was created, the National Committee
on Vital and Health Statistics. It has held hearings on the
issue and created an even more extensive public record about
the need for health privacy legislation. The Secretary is going
to issue a report this summer.
In addition, since last year, the National Research Council
issued a report for the record, very detailed report about the
need for security in computerized health information systems.
They went around the country, they did case studies and they
found that even with the best of intentions, there was a lack
of strong privacy and security safeguards in place. And again
we have horror stories about people who acted with malice and
used information without permission, sold it to the press. We
have information about carelessness, we have horror stories,
but I think for the vast majority of people in this country who
want to do the right thing, they don't know where to start and
they are seeking Congress' guidance.
As well, the National Action Plan on Breast Cancer and the
Human Genome Project, which we have talked a little bit about,
is holding a series of workshops on privacy and genetic
information, because they are wrestling with the need to push
forward in genetic research. But the fear that so many
individuals who are participants in these studies are going to
have, is fear that they will be discriminated against in
insurance, even in employment. Even though the ADA should
protect them against that, they do not trust the research and
public health community to protect their confidentiality.
I don't think it is an overstatement to say we are rapidly,
and have been for years, approaching a crisis in health care
because of the lack of privacy rules. Fundamental critical
health care services are at risk of being undermined.
This is not a case of privacy practices being a barrier to
research and to public health and to managed care; that is
often how the issue is formulated in the press and by some in
the industry who say, ``privacy will be a barrier to us, if we
have to protect privacy, we are not going to get the
information we need because people won't consent to these
uses.''
I would actually say we have quite the opposite scenario.
We will have substantial barriers to treatment, research, and
public health if people do not believe that their privacy is
protected and that they don't have the following principles
guaranteed.
One is, they must have access to their own records. Half
the States in this country give people the right to see their
own medical records. It is a sham.
The other thing people must have is control over their own
records. When they go to a doctor, they should be able to
determine who else gets to see the record and under what
circumstances. Right now people sign blanket waivers, and even
where doctors want to maintain confidentiality and want to have
kind of the old-fashioned doctor-patient relationship, they are
unable to do so because of requirements on the part of payers,
insurance companies, sometimes researchers with whom they have
relationships, to disclose that information.
The other thing people must have are strong enforceable
remedies, individual remedies where they can pursue a lawsuit
against someone who has harmed them. There should be civil
penalties and criminal penalties. Most of the legislation that
has been introduced in both the House and the Senate has very
strong penalties.
Very quickly, on some of the issues raised, my view--and, I
think, the view of a number of people in the research community
at NIH in the Human Genome Project--is that we should treat
genetic information as health information and not treat it
separately and not isolate it as a separate, special
circumstance. In fact, H.R. 52, Congressman Condit's bill, does
incorporate genetic information now under the definition of
personal health information. It talks about past, present, or
future information, as do a number of the Senate proposals.
That is genetic information. It refers to information about
others who are not necessarily the record subject. That is also
genetic information.
As well, I think that the law enforcement provisions, which
I know and, Mr. Chairman, you raised in your questions, I
really believe that the law enforcement sections in a health
privacy law must be consistent with other law enforcement
provisions and privacy laws that we currently have at the
Federal level.
The Video Privacy Protection Act, better known as the Bork
bill by some, the Right to Financial Privacy Act, the Education
Privacy Act, all have law enforcement provisions that require a
warrant before access; and I think that we should have at least
the same level of protection for medical records that we have
for video rental records.
In addition, the pre-emption section which is in H.R. 52 is
different than some of the provisions on the Senate side, but I
think also needs some looking. Right now, we can't do any worse
than we currently have since there is no Federal standard.
Again let's look at the very serious consequences. Without
privacy protections, people are going to withhold information
from their doctors because they are going to be afraid the
doctor will have to convey it to somebody else, and they know
the protections aren't in place. They will withhold information
or they may lie to their doctors; they may give inaccurate
information, which will undermine the ability of the doctor to
give an accurate diagnosis. The other problem is that doctors
may actually lie in submitting the claim forms, and I don't
mean to suggest doctors are doing ill here, but they are trying
to protect their patients, so they often put inaccurate
diagnoses on the claim forms.
Or I think the more horrible consequence is that people
will not seek health care. They will stay away from health care
altogether because of fear, and we see it in the HIV area and
reproductive health; people are afraid of going to the doctor
at all in terms of discrimination and employment and insurance,
that their families may find out, reporters, marketers. The
personal consequences are very real, but I think the societal
consequences are even more startling and one that we tend to
overlook, which is that public health will be undermined if we
don't have accurate information; and research will be
undermined if we don't have accurate and reliable information.
So while the public health people and researchers often say
we are worried about how privacy rules will affect our work in
improving health care, we really need to look at the cost of
not protecting privacy. Privacy, I believe, is a necessary,
vital partner in other health care goals. It is not a barrier,
it is not an impediment, but it is a partner in achieving other
health care goals.
I appreciate your holding this hearing. Thank you.
Mr. Horn. We thank you for the most helpful statement.
[Note.--A copy of the report entitled, ``Privacy and Health
Information Systems: A Guide to Protecting Patient
Confidentiality,'' can be found in subcommittee files, and may
be obtained by calling (206) 682-2811.]
Mr. Horn. Dr. Palmisano, member of the Board of Trustees of
the American Medical Association.
Dr. Palmisano. Thank you Mr. Chairman and members of the
committee. My name is Donald Palmisano, and I am here
representing the American Medical Association and some 300,000
physicians and medical student members. I also bring to the
discussion today my 26 years' experience as a surgeon
practicing in New Orleans. We appreciate the time and energy
the subcommittee is devoting to this important issue.
Let me begin by stating medicine's underlying premise in
all of the discussions of patient confidentiality. The patient-
physician relationship is first built on trust. Confidentiality
of communications within this relationship is the cornerstone
of good medical practice and good medical care. Patients must
feel safe in disclosing to their physicians personal and
sometimes embarrassing facts and information that they do not
want others to know. We, as physicians, need this information
to provide the best and most appropriate medical care. Without
such assurances, patients may not provide the information
necessary for proper diagnosis and treatment. The cost of
medical care can increase when physicians do not have such
information.
Our professional and ethical responsibility is outlined in
our AMA Code of Medical Ethics and it is to keep our patients'
confidences, and it is no different because the medical records
are stored electronically rather than on paper. But the
evolution of electronic medical data has intensified our
existing concerns about access to and, now, even commerce in
patients' confidential medical information.
The growing number of third parties demanding information
has eroded our patients' confidence that information that they
share with their doctor is going to help in their individual
care. Any number of parties will give you arguments for a vast
array of supposedly compelling health and public safety reasons
as to why they need to know such private information.
But a need is not a right, and I would like to emphasize
that, a need is not a right. And because it may be happening
now, doesn't make it right.
AMA policy clearly states that conflicts between a
patient's right to privacy and a third party's need to know
should be resolved in favor of the patient except where that
would result in serious health hazard or harm to the patient,
or others; and we would suggest that all bills studied in the
Congress use that guideline so that the patient is the primary
protector of his or her own medical information, and not
someone else's right, desire, or belief in their right to get
that information.
We believe that patients have a basic right of privacy of
their medical information and records. We believe that the
patient's privacy should be honored, unless the patient waives
it in a meaningful way or in rare instances of strongly
countervailing public interests. And by ``meaningful,'' we mean
informed and not coerced.
We believe that you should limit the information disclosed
to that part of the medical record or abstract necessary to
fulfill the immediate and specific purpose--that is, no fishing
expeditions.
While you have our written statement, which goes into more
detail, I would like to highlight a few points. First, we
cannot forget that the primary purpose of the medical record is
to provide a reliable tool and to provide clinical diagnosis
and treatment for patients. Patients should generally have
access to information from their medical record. There are few
exceptions to protect the mental or physical safety of the
patient, but the physical record is the property of the
physician or provider, and this is where control of most
disclosures should emanate.
Second, on the issue of consent, a patient's first consent,
generally for treatment or payment, should not automatically
apply to subsequent disclosures unless the patient specifically
and freely waives defined rights. Insurers, of course, need
basic information to pay claims and have legitimate need for
information to conduct utilization review and quality assurance
and to monitor for fraud and abuse. The AMA cautions against
categorizing these activities as payment for treatment purposes
when they do not go directly to paying for a specific
individual's treatment.
Patients generally believe that their signature releases
personal information for their direct and specific benefit,
overly broad and legislative definitions should not exploit
patients' lack of knowledge regarding complex information
systems. For consent to be truly voluntary, it must be knowing
and that includes a patient knowing for what purpose their
records are being sought. Patients should not be coerced into
divulging any and all medical records, either their own or
their families by way of a nonspecific consent signed upon
enrolling in a plan as a condition of insurance payment, nor
should physicians have to sign agreements with insurers to
produce records without that patient's consent.
Third, exceptions to the requirement for patient consent to
disclosure should be minimally and narrowly drawn.
Last, whenever possible, medical information used for
research purposes should have all identifying information
removed, unless the patient specifically consents to the use of
his or her personally identifiable information.
In conclusion, the fact that we have vastly improved
technology to collect, sort and analyze patients' medical data
does not diminish our ethical obligation to protect our
patients' privacy. We all hear seemingly compelling arguments
for efficiency and technological potential, but we cannot allow
the vigorous standards of confidentiality required by the
medical profession's ethical code to be subverted once the
record gets into others' hands. We have to work to fit the goal
of efficiency within the larger framework of patient privacy,
not the other way around.
Thank you again for inviting the American Medical
Association to testify. I am happy to discuss our testimony in
more detail, and the AMA is happy to work with the subcommittee
to address concerns. Thank you very much, sir.
Mr. Horn. We thank you. That is a very well developed
statement, as I read it earlier.
[The prepared statement of Dr. Palmisano follows:]
[GRAPHIC] [TIFF OMITTED] 45252.019
[GRAPHIC] [TIFF OMITTED] 45252.020
[GRAPHIC] [TIFF OMITTED] 45252.021
[GRAPHIC] [TIFF OMITTED] 45252.022
[GRAPHIC] [TIFF OMITTED] 45252.023
Mr. Horn. Dr. Johns is President of the American Health
Information Management Association, a rather large
organization. Give us a little bit about its history. I know
you mentioned the numbers in your second paragraph, but I think
you could educate most of us about the extent of your
membership.
Ms. Johns. I will be happy to, Mr. Chairman.
Thank you, Mr. Chairman and members of the subcommittee.
AHIMA appreciates the opportunity to appear before the
subcommittee today in support of the Fair Health Information
Practices Act. AHIMA is an organization that was established 69
years ago and a professional organization that represents
37,000 credentialed health information managers. We have over
200 educational programs throughout the country, in colleges
and universities which prepare accredited record technicians
and record administrators.
Our organization, a professional organization, was
originally established for the purpose of managing, storing,
and protecting health information, and we have a long tradition
with the issues regarding confidentiality and privacy, and a
principal goal in the mission of our organization, since 1929,
for protection of health information. So certainly, we are not
new to the issues that are being posed today.
We are the credentialed specialists who manage and protect
patient health information. We work in a variety of health care
institutions and health-related organizations, and we are the
professionals that are responsible for handling requests for
information from third-party payers, from employers, from
researchers, attorneys, other health care providers, local,
State, and Federal agencies. Our members ensure that
information is disclosed pursuant to valid authorizations and
pursuant to statutes, regulations, and court orders. Our
efforts, however, to protect health information have been
complicated by a lack of Federal pre-emptive confidentiality
legislation.
Assuring confidentiality is important because it makes
patients feel comfortable enough to communicate openly with
their health care providers. Assuring confidentiality is also
important because it makes patients feel comfortable that the
information they are providing health care providers is going
to be protected. Unfortunately, current regulations and the
physician-patient privilege do not offer patients real
protection. Therefore, AHIMA believes H.R. 52 is a solution to
this dilemma, first, because the bill establishes a code of
fair information practices, and, second, because it provides a
uniform national health standard for the use and the disclosure
of individually identifiable health information.
It is true that some States have enacted confidentiality
legislation, but there is little uniformity with their
approaches. Most statutes do not even address the issue of
redisclosure of health information, and penalties for its
misuse are lacking. Protections also vary according to the
holder of the information, and for different types of
information.
For instance, several States have recently enacted genetic
privacy legislation. Segregating and creating special
protections for specific types of information, such as mental
health or genetic information could result in inadvertent
breaches of confidentiality. For that reason, AHIMA recommends
that comprehensive confidentiality legislation cover all types
of health information.
One of the greatest threats to patient privacy is the
increasing and growing demand for data, and while there are
Federal regulations that offer strong protections, they are
limited in their applicability. For example, the Federal
Privacy Act of 1974 was designed to provide citizens some
control over the information collected on them by the Federal
Government. However, this law does not apply to the private
sector. There are also Federal regulations in regard to alcohol
and substance abuse, but these only apply to Federal or
federally funded facilities that offer treatment for alcohol or
substance abuse.
As a result of the ongoing public policy debate, during the
past several years, Congress and the general public have come
to a consensus there is a need for Federal confidentiality
legislation. Reports of the Institutes of Medicine and from the
Office of Technology Assessment and, most recently, the
National Research Council have all underscored the need for
Federal action.
In order to address the need for Federal legislation, AHIMA
in 1993 drafted model legislative language that outlined a code
of fair health information practices. This language was
published in the Office of Technology Assessment report,
protecting privacy in computerized medical information as a
model code, and was used in drafting the Fair Health
Information Practices Act.
There are a number of key provisions in the model language
that are essential to any legislation governing the collection,
use and disclosure of health information. These include, first,
a patient's right to know and access his or her own health
information; the provision--providing provisions for
restrictions on information used and provisions for criminal
and civil penalties to protect the misuse of information. We
are pleased to note that H.R. 52 covers all of these key
provisions.
We are also pleased to note that H.R. 52, in sections 101
and 102, provides individuals with the right to access and copy
the personal health information and also to amend errors as
well. Currently, only 28 States allow patients access to their
health information, and even within these particular statutes,
they are not uniform.
We note, however, one principal concern with sections 101
and 102. These require health information trustees such as
health benefit plan sponsors, health care providers, health
oversight agencies and public health authorities to permit
patients to inspect and copy their records. They also require
that these trustees correct or amend protected health
information upon request, or take certain actions if they
refuse to make such changes.
Because medical records are the physician's or health care
facility's legal record, they are an important element of
patient care, and we urge that the language be amended that
only providers be permitted to correct health information. In
other words, information should be corrected at its source.
AHIMA believes that the passage of pre-emptive
confidentiality legislation is imperative, and we thank the
subcommittee for holding this very important hearing. We
sincerely hope that our testimony will prove helpful. In
addition to the points we have made here today, we would be
more than willing to offer our technical comments to you, as
you continue to discuss the provisions of the Fair Health
Information Practices Act.
[The prepared statement of Ms. Johns follows:]
[GRAPHIC] [TIFF OMITTED] 45252.024
[GRAPHIC] [TIFF OMITTED] 45252.025
[GRAPHIC] [TIFF OMITTED] 45252.026
[GRAPHIC] [TIFF OMITTED] 45252.027
[GRAPHIC] [TIFF OMITTED] 45252.028
[GRAPHIC] [TIFF OMITTED] 45252.029
[GRAPHIC] [TIFF OMITTED] 45252.030
[GRAPHIC] [TIFF OMITTED] 45252.031
[GRAPHIC] [TIFF OMITTED] 45252.032
[GRAPHIC] [TIFF OMITTED] 45252.033
[GRAPHIC] [TIFF OMITTED] 45252.034
[GRAPHIC] [TIFF OMITTED] 45252.035
[GRAPHIC] [TIFF OMITTED] 45252.036
[GRAPHIC] [TIFF OMITTED] 45252.037
[GRAPHIC] [TIFF OMITTED] 45252.038
[GRAPHIC] [TIFF OMITTED] 45252.039
[GRAPHIC] [TIFF OMITTED] 45252.040
[GRAPHIC] [TIFF OMITTED] 45252.041
[GRAPHIC] [TIFF OMITTED] 45252.042
[GRAPHIC] [TIFF OMITTED] 45252.043
Mr. Horn. Well, we appreciate that very thorough statement,
and we will take you and others up on that because this is a
continuing dialog. We don't claim to know it all up here. That
is why we have hearings, and in hearings we try to bring out
what are the similarities and differences.
Let's start with you, Ms. Goldman. From what you heard from
two of your colleagues, where do you differ from them?
Ms. Goldman. Well, I wouldn't want to pass up the
opportunity to find differences with my colleagues, but in
truth, I am extremely heartened by how much agreement we all
have. It has been the true history of this issue that all of us
at this table, representing the various organizations, have
worked closely together and believe that we must have health
privacy legislation. On the broad principles, it seems to me
that we have very strong agreement and we have worked together
over the years to try to fashion some kind of a consensus. I am
not sure there is vast disagreement or even significant
disagreement at this time.
Mr. Horn. So you are OK on the principles, but it is the
nitty-gritty that sometimes brings the Congress to a halt. Does
any of the nitty-gritty bother you?
Ms. Goldman. There are probably some vast differences among
folks who are not at this table, but I think if it were left to
the three of us we could probably come up with something----
Mr. Horn. The next panel is going to join us, and we asked
you all to stay here to get a dialog between the six of you;
but I thought we would do some of it first so we could have a
few things that are strictly in your testimony.
Ms. Goldman. I think what is remarkable about this issue
is, you have organizations such as the American Medical
Association and the American Civil Liberties Union and the
Center for Democracy and Technology. You have such a broad
range of groups who are involved in various aspects of the
health care system who realize, from a very first-hand
knowledge, how important it is to have enforceable rules.
Mr. Horn. Dr. Palmisano, how about the AMA? Where do you
agree and where do you disagree about what you have heard by
the fine witnesses on either side of you?
Dr. Palmisano. Well, I would second what we just heard. I
think we are in basic agreement.
What I would like to emphasize is, I think the patient
rights need to be superior to the Government's need to know or
some other third parties need to know and we should follow
established procedure. Certainly nothing less than probable
cause to get into the medical record, and we must always
protect that right; and we think very strongly the code of
medical ethics is something that we rely on very heavily and it
states very clearly that the patients' rights are primary. I
believe our society is a society that has decided we go to the
patient first. It is a philosophical base where the patient has
the right to make a decision, even if it is the wrong decision,
as opposed to teleological society, where we do what we think
is right for the patient and the patients' desires become
secondary. So I think we are all in sync on these issues.
We are concerned about some aspects in the bill. We are
concerned about the definition of ``health oversight agency''
seems overly broad. We understand there may be some agencies
that look at this with proper credentials, but maybe there are
agencies like XYZ that is a for-profit corporation that gets a
hold of this information.
We are very concerned about anything that would allow
people who don't have the knowledge and the ethical base to
protect the patients' rights having control of these records.
We are concerned about anything that would link to Social
Security numbers, where someone could get in. We are concerned
about crackers or perhaps hackers getting in this information,
if it is a clearinghouse. We see the Central Intelligence
Agency, recently in the news, reports where some hacker--
cracker, I am not sure what the right term is.
Mr. Horn. You can use both, if you want.
Dr. Palmisano. The evil people that get in without our
permission--and they said the Central Stupidity Agency; and we
think that is one of our most secure and secret agencies, if
people can get through their fire walls, that is what bothers
us. And once people know this information is available in
electronic form on a central data base, we think there will be
great incentives. Right now they are just people doing it to
show they can, quote, ``beat the system,'' perhaps, but there
will be people selling this information.
So we are very concerned. We appreciate the opportunity,
and I will be happy to deal with any specific questions. Thank
you.
Mr. Horn. Dr. Johns, what is your feeling based on the
testimony your two colleagues have given? Any agreement, any
disagreement?
Ms. Johns. Very much agreement, Mr. Chairman, and I think
as a result of the ongoing policy debate, which occurred over
the past several years, we have come as a group to a consensus
about the need for this type of Federal confidentiality
legislation.
Mr. Horn. Let me ask a few questions before we go to the
next panel.
Ms. Goldman, some patients may be willing to volunteer
information about themselves or even waive their right of
record confidentiality if the waiver is incorporated into an
offer from a health care marketer to provide free samples or
coupons that might fit the patients' needs. Is a purpose of
H.R. 52 to discourage that activity, and should it or shouldn't
it?
Ms. Goldman. I think you raise one of the critical issues
in privacy legislation, which is consent. It's usually the
cornerstone of any piece of privacy legislation, as you may not
use the information in an unrelated way, without the
individual's consent.
And as we heard from other testimony, consent is a big
term, but it doesn't mean anything if it is not voluntary, if
it is not informed. It is not meaningful if it doesn't have
those qualities to it. And I think the way to ensure consent is
meaningful and informed and voluntary is to make sure that
obtaining that consent is not a condition of receiving certain
benefits and services.
I should be able to go to a doctor and say, I do not want
you to release this information to a researcher, or I don't
want this information to be released to another doctor without
my knowledge; and I should still be able to receive treatment
even if, as Dr. Palmisano said, it may not be in the patient's
best medical interest. That is a decision he or she should be
able to make without suffering the consequence of not getting
care.
Most people who sign the broad waivers, when they go to get
health care, the broad waivers that say this information may be
released for any purpose to anybody under any circumstances--
and I have signed many of them recently since I had surgery on
my foot a few months ago, and you sign them because you know
that it is not a choice. These are not real choices people are
making; and what we should do is build in a way of removing the
authorization process or consent process from the receiving of
certain benefits and services, and then I think we will see.
In fact, the Video Privacy Act, which I keep raising as an
example of what we can do when there is consensus in the
Congress, says you may not disclose without permission and you
may not request that authorization as a condition of giving
someone a video, so can't we do the same thing here?
Mr. Horn. Any comments either of you have on that question?
Dr. Palmisano. Mr. Chairman, I would just agree with that.
In my personal practice over the years, it is not uncommon to
get a request about treatment I have given to a patient that
may be unrelated to the treatment I just gave, and they make a
photocopy of this blanket consent. It is our policy and has
been ever since I started medical practice 26 or 27 years ago
to always call the patient, and if the patient is not
immediately available, I have my staff continue to try and say
this information they want is really not related.
I want you to know what is in your medical record. If you
have questions, you are welcome to come by and look at it, but
you did confide to me some information that has a bearing on
why you might have this ulcer, because of the stress, the
family problems at home, and I don't believe that is anybody's
business, unless you want it to be somebody's business.
So patients feel rather intimidated. They are afraid they
are going to lose their insurance, and now in this era of
managed care, they could really have additional pressure put on
them. They feel rather intimidated, so I think what we have
advocated today and what you all are very wisely looking into
is in the patients' best interest.
Thank you.
Mr. Horn. Dr. Johns, any comments?
Ms. Johns. We fully agree with the statements that have
been previously stated.
Mr. Horn. OK. Let's move to the disclosure to spouses. I
understand physicians are often faced with difficult choices in
sharing that information about the condition and care of a
patient with spouses and family members. Assuming a patient had
not previously authorized disclosure nor prohibited it, how
would H.R. 52 affect the ability of a health care provider,
such as physician, to share information with a spouse, and what
is your feeling on that, any one of the three of you?
Ms. Goldman. Spouses are not necessarily treated
differently from others who are requesting information. The one
area where there may be slightly different treatment is called
the next-of-kin provision, which allows a doctor to disclose to
the next-of-kin, which could be a spouse, it could be a cousin,
it could be someone with whom the individual has a significant
relationship. It allows the physician to disclose to that
person, for instance, after surgery, unless the individual has
objected and said, I don't want you to talk to my spouse about
my condition or about the results of my surgery, and so the
spouse still has that option.
I assume you would be able to talk with more knowledge
about how it works in the real world, but there is usually a
more comfortable relationship there unless the individuals
suggest they don't want that shared. I think H.R. 52 deals with
that pretty well.
Dr. Palmisano. Well, I think this is a balancing act and
something we face all the time. If I am examining a patient--
let's say, a woman and she requires an operation--and she says,
``please allow my husband to come into the room during this
discussion,'' then I know that she wants her husband to know
everything and would want him to know everything in the
immediate postoperative period, perhaps, and so on, so there is
no problem.
But if someone comes to me, man or woman, and I treat the
individual, and someone calls up from another State and says,
``Hi, I am the spouse,'' or whatever, I don't give that
information out. There has to be identification, and I have to
find out from the patient, ``Do you want me to release this
information?'' Sometimes we find people are judicially
separated, for instance; we don't really know they are
judicially separated, and they are in the midst of a battle
that would affect the division of their assets and so on, so I
always go back to the patient.
Basically, our reading of the next-of-kin provision on page
35 is that they would be basically granted the right to give
that information, unless the patient objected to that; and that
is a balancing act that needs to be decided. So I don't know
what is the correct answer to that.
We always go back to the patient, and if the patient is
unconscious, comes in from an automobile accident, for
instance, in our State in Louisiana, there are provisions that
state you can release the information to a next-of-kin. If
someone is in a terminal, irreversible coma and hasn't made out
a living will, we have a provision in many of the State laws
that says the next-of-kin, if not judicially separated, is the
individual that can make the decision whether or not to
continue life-sustaining treatments if imminent death is there.
Mr. Horn. Suppose it is a transmittable disease that could
lead to death; does the spouse have a right to know?
Dr. Palmisano. Well, of course that is under State law. In
almost every State there is a reporting requirement. Some
States require you name the individual; other States, they say
you give the information immediately to the health officer, and
if it looks like it could be something that could affect, for
instance, someone with tuberculosis, with a productive cough
that has the actual bacteria that causes tuberculosis, if that
is being spread around, they need to know the name of the
individual and so on. Our medical ethics say that you release
the information if someone could do grievous harm to someone
else.
So you have to then make a decision. You advise the
individual that it is best for you to disclose this, if you are
talking about a sexually transmitted disease, such as AIDS,
which usually is considered fatal, but now we have some drugs
that may change our perspective on that. Then if the individual
says, ``no, I am going to continue to do this,'' I think the
physician has an ethical obligation to take the next step and
decide whether or not you will transmit the information.
First of all, you have to do it to the health officer,
usually, in your State and call the individual. It is one of
those ethical dilemmas that the physician needs to make sure
that he or she really has all the facts. If someone had a
plague that was transmittable by just exhaling and so on, we
would need to isolate that individual; and if the individual
says, I am out of here, it would be the physician's obligation
to notify not only the next-of-kin, but the health authorities,
so we wouldn't have a plague throughout the Nation.
Mr. Horn. Dr. Johns, any comments?
Ms. Johns. No, basically the comments and the sections
within H.R. 52 that have been already been elaborated on, we
feel comfortable with.
Mr. Horn. Let me move to another area then on correcting
patient records. Dr. Palmisano, H.R. 52, subtitle (a) permits
patients to inspect their health care records to make
corrections. With what frequency do patients currently ask you,
or other doctors, to see their records and attempt to make
corrections? And to what degree does that even occur?
Dr. Palmisano. Mr. Chairman, that is a rarity. It is not
unusual for people to request a copy of the records because
they may be moving to another State, but it is a rarity for
someone to come in and say--in fact, in 26 years of private
practice, I have never had anybody come in and say they wanted
to change the record. They see me do the record for the office
visit right in the office, because after I do the history and
physical examination, I usually start writing in front of the
patient and ask if they have additional questions, and I tell
them of their lab reports and so on, and offer a copy to them.
So I have had people ask for copies of the records, and we
give them that information. And in the field I am in, in
surgery, it would be rare for me to have something in there
that might affect the health of the individual, their mental
health, such as psychiatrists might have. There might be
information that if the patient got that information
immediately--and Dr. Hoge can address that better--but the
patient may get even more depressed and commit suicide. So it
is a rarity in actual practice, but there is no hesitation on
our part for the patient to get a copy of the record.
We believe that the record is the record of the physician,
and certainly we wouldn't want to give the original record and
have them start changing, and mark out things and so on. But if
they want to give me additional information--it is not
uncommon, they would say, Doctor, I would like this medicine
listed that I have here put in my record; I would say,
certainly, and we will photocopy it and give them a copy back,
and we will keep the copy, the original or the copy, whatever
they prefer, in the record.
It is a rarity that someone would want to take my records
and change what is in my record.
Mr. Horn. What State do you practice in?
Dr. Palmisano. I am in the State of Louisiana.
Mr. Horn. Does Louisiana have a law that relates to this
type of situation, or do you follow an AMA protocol, or how do
doctors sort of make up their minds how to handle the
questions, rare though the question might be?
Dr. Palmisano. Specifically, we follow the AMA ethical
guidelines throughout the Nation, the people who are members of
the AMA and many physicians who are not members also follow,
whether or not they have sent their dues in. This seems to be
the bible of what is the right thing to do.
In Louisiana, on that specific issue--I don't recall if
there is any--well, I take that back. We have a statute, in
fact, patients have the right to get their record at any time.
They can come in and ask for the record, and the record would
be given to the patient. If an attorney sends a subpoena in
Louisiana--and this law changes every year, but now it will
change every other year, because Louisiana now will have a
fiscal session 1 year and everything else the other year. But
between the medical association, the trial lawyers and
everybody else, there is a battle on how to get the record.
What we have is a very rigid way of getting the medical record.
A patient can come, request the record, sign for the record and
get a copy of the record.
If an attorney wants the record through subpoena, that
attorney is obligated to send a notification to the patient, if
it is an adverse attorney, to the patient or the patient's
attorney; and after 10 days to 15 days--it changes from year to
year--if there is no protest at the court level, then the
physician is allowed to give the record out. But you cannot
give the record out until that number of days have passed and
you also have this notification; it is an affidavit that the
attorney must submit.
So we are very cautious about who can get the record.
Mr. Horn. Do you, in your own practice, or do doctors you
know, have they ever refused to grant a patient's request to
access to the record; and if so, what is the policy of the AMA
on that?
Dr. Palmisano. No, I don't personally know anyone who has
refused to grant access of the patients to the record. I have
seen situations where a patient said, don't give that record;
and a subpoena came for the record, and the doctor says, what
am I supposed to do; and they will usually call the legal
counsel or the medical society or their professional liability
carrier, and they all get together and try to work something
out. They usually end up going to the judge and trying to
explain the situation.
But there is no problem in giving that information, and it
is the policy of the AMA that the patient has a right to
inspect his or her records, unless there is some overriding
reason that might, as I said, in a psychiatric situation--my
counsel here just pointed out that the patient has access
unless in the professional judgment of the medical doctor it
would harm the patient--then it goes to some designee, for
instance. And this usually occurs in a psychiatric situation,
and it is not only in our policy, but it is also in our code of
medical ethics book and the patient has a right to that
information.
We deal with informed consent, Mr. Chairman, all the time,
and it is a very strict law of informed consent that has
evolved throughout the Nation and especially in Louisiana.
Mr. Horn. If we use an analogy to an audit report of an
organization, often when an auditor makes a statement--let's
say it is a Government auditor--the agency would be given the
right to respond to that statement; but both items would remain
in the record, in other words, the audit initiation and the
agency response.
Now, in terms of using medical information--and we talk
about the patient's right to correct the record--would that
mean we simply add, as you suggested earlier, another sheet of
paper to the record, that this is the patient's view of this
record, or would there have to be integration in what is
presumably your record on the patient?
Dr. Palmisano. Well, the original record is never changed
unless there is an error in the record. For instance, if the
physician wrote down the patient was on XYZ medication and, in
reality, the physician did not hear that correctly and the
patient says, gee, I looked at my record and I am not on that
medication, then we don't want to go back and alter the record
incorrectly. We want to do it in the approved methodology and
make a new note, put an asterisk or some note saying, this is
an error up above, put a line through it, date it, initial it;
and then go down to the next area for writing and say, this
area was corrected, the patient brought it to my attention, the
patient is on this medication and not what we wrote. You would
then, just move on and that would be the way to correct it.
Now, on the other hand, if what the physician found was
absolutely correct, such as the physician did an abdominal
palpation and found a pulsating mass or suspected it to be an
abdominal aneurysm, that was the physician's impression, based
on the history and the physical examination at that time, the
symptoms in the physical examination. So if the patient came in
and said, ``I want that changed, I don't want that on my record
because I am going to such and such--I am applying for new
insurance,'' the physician could not ethically or medically or
legally do that. That would be wrong.
And if the patient wanted to insert that in there, I
personally would have no objection; I don't think it would be
in the patient's best interest, but I would put it in the
record and say, I will make an attachment page. If the patient
came in and wanted the record changed, I don't believe that is
the appropriate thing to do.
Here is the patient's statement and put it in there.
Mr. Horn. Any comments on this aspect of record changing,
correction or revision?
Ms. Johns. The general practice, just as Dr. Palmisano has
stated, where there is an error in the record, it is corrected
by putting a line through the error, indicating that there is
an error, and writing a correct entry for that; and the issue
of the amendment to the record is common practice. Good
information practice is to include the amendment to the record,
if the patient and the health care provider are in
disagreement.
Mr. Horn. Is that practice sort of the basic code of your
organization, and is that actually carried out in most State
laws with which you are familiar?
Ms. Johns. It is a practice. Our best practice--our
association puts out practice briefs, and that procedure that I
have just stated is included as best practice. Whether or not
it is carried out in each State would be another issue, but as
far as our credentialed, certified people, this is what we
would expect.
Mr. Horn. Did you have a comment on that?
Ms. Goldman. Just a small comment.
While I appreciate what the code of ethics is and how, in
particular, Dr. Palmisano operates in his practice, my recent
experience has been a little disconcerting.
I was in a surgeon's office recently where the patient in
front of me requested a copy of her medical record and she
said, ``May I get a copy of my medical records, please?'' And
the person behind the desk said, ``To whom should we send the
record?'' And she said, ``I would like a copy for myself.'' And
she said, ``I can't release the record to you, but if you would
like to tell us who you would like us to send them to, we will
make sure the doctor gets the record.''
She went through a huge struggle, and I then couldn't help
myself and suggested there was a law in the District of
Columbia that required that she get a copy of her record. And
the nurse was furious and said, ``That is not our policy in
this office, we don't release records to the patients;'' and my
understanding, in talking to the nurse later on and the
doctor--who, by the way, I chose for his surgical ability and
not his adherence to privacy principles--I was really surprised
to find that at least in the District, there is something that
is considered to be common practice which is not to give the
record directly to the individual, even though there is a law
that requires it.
So I think that, at least in my little experience, there
may be a real disjuncture between what the code of ethics is
and how people practice.
Mr. Horn. On, quote, the record, unquote, what about a
xerox of the record? Are they worried about the complete loss
of the record? That is a legitimate worry for a doctor.
Ms. Goldman. I assume so.
Mr. Horn. I assume they would make a xerox to send it even
to another doctor, rather than lose that record. I would never
release a record like that.
Ms. Goldman. The issue, at least in the circumstances I am
giving, is not so much whether it was xeroxed or not xeroxed,
but that the practice, the policy of that office was not to
release directly to the patient.
Mr. Horn. I understand that; and I think the law is right
and the doctor's office was wrong, that the patient ought to
have a right to know, even if they can't translate the doctor's
handwriting and even if they don't know what some of the words
mean.
Let me ask you, Dr. Johns, about audit tracing. Many
information technology systems can incorporate these records,
handling audit trails that maintain a log of each instance--
when each individual is looking at an electronic file. We have
that argument in Government as to who had access to these
files. This makes it possible to generate a list of each time
and each individual who has looked at a patient's electronic
record.
How prevalent are such tracing procedures in existing
health care information systems? Do they have that type of
situation?
Ms. Johns. With electronic information systems, there are
usually provisions or functions for audit trails, and audit
trails are used in various ways. It is not that they are
included with the patient's medical record, but they are used
as one mechanism in a total security policy; and I think that
is important, to recognize that audit trails or tracings are
one avenue by which you can protect or identify breaches of
confidentiality or at least identify breaches of access into
the record.
A total security policy should include good policies, good
procedures, very good employee education and training, in
addition to being able to select various types of technical
types of mechanisms that can protect information in an
electronic environment.
Mr. Horn. I think one thing that worries a lot of us--and I
remember the testimony very clearly when Mr. Condit chaired the
subcommittee under the Democratic Congress, one of our
colleagues from New York had had her records stolen, and
entered into her political campaign. In other words, her
records were used against her.
That was a very serious situation, and I think all of us
worry about the person who has access to those records in a
doctor's office, in a hospital, in an insurance company,
whatever the case may be. You could have a disgruntled employee
who decides to take copies of the records of the mayor of the
city and the biggest developer in town. They would be subjected
to blackmail are subjected to revelation of an embarrassing
situation by sending the information to the local newspaper.
Now, what kind of audit system do we have in one's office
to say, who has access to these files? As I go into offices,
what I see are rows and rows of paper folders. And often when I
go in, there is nobody behind the desk; if it is the noon hour
or whatever, somebody could walk through and say, that is an
interesting folder, I think I heard her on TV the other night.
So what do we do about that?
Ms. Johns. In relationship to access to paper records,
normal practice is that when records are released, there is a
log that is kept as to who has requested that information and
for what purpose. This would be occurring in hospital medical
records departments.
In regards to the instance that you were giving, as far as
like an employee who might want to access records, if they felt
they were going to be terminated, another good practice is that
individuals who are going to be terminated, their access
rights, in addition to audit trails, need to be terminated
prior to them being informed of their termination, or at the
same time, so that you have dual types of counterbalances, as
far as protecting that information.
Audit trails, too, can have intelligence built into them so
that flags are set as to identifying potentially suspicious
types of activity. For instance, if an employee of the health
care facility was being treated in the hospital, any accesses
to that record would be monitored and flagged, if it would be a
health care provider that would be looking at the record who
didn't have the direct patient contact relationship, or if it
would be an employee within the institution someplace, where
they should not have access.
So I think an important consideration with audit trails, as
well, or tracings, is that there is some mechanism by which
potentially suspicious activities can be identified.
Mr. Horn. Should hospitals, insurers, doctors, and other
health care providers be required to incorporate such tracking
procedures in all the information systems?
Ms. Johns. I think that is an issue you have to look at in
context, and again, as I mentioned, audit trails are only one
technical aspect of a security program. You have other aspects,
such as passwords, access levels, audit trails, certainly, and
policies and procedures, as well as employee education and
training.
So, I think you really need to look at the specific
application--how large the institution is, for instance--in a
smaller physician's office practice, the need for audit trails
when you have three people working in an office may really not
make much sense, as opposed to an institution where you have
5,000 individuals working and more people who have access, and
clearly all of them would not be involved with the direct
patient care.
So I think it needs to be done, all of the guidelines need
to be presented, and then a mechanism of procedure for a whole
security program needs to be developed. I think that is going
to be varied from institution to institution.
Mr. Horn. One last question before we move to the next
panel concerns administrative simplification.
One of the objectives of the Kassebaum-Kennedy bill, which
was enacted into law, as I mentioned in my opening statement,
was to foster administrative simplification. This includes
creating common definitions for data elements and coding
practices.
Three weeks ago, this subcommittee heard testimony on the
medical transaction system of the Medicare operation, and the
Department of Health and Human Services and their efforts to
develop a common provider identification number. Are we making
progress toward streamlining health care administration
practices and what barriers continue to exist? What do you see
happening in that area, Dr. Johns?
Ms. Johns. As far as barriers in electronic patient
records?
Mr. Horn. Yes, and just how far are we from it.
Are we getting into standardization based on software of a
particular vendor, or is that software related to the best
practices of your organization, the AMA and others?
Ms. Johns. I think one very large barrier--and it has been
cited by other reports--the Institutes of Medicine and their
computer-based patient record report even back in 1991 cited
one of the biggest barriers is lack of standard, and a barrier
we certainly are experiencing is the barrier in regards to
confidentiality and having Federal legislation in regards to a
standard, uniform practice. And so, without some standard,
uniform practice, it makes it very difficult to either transfer
information--we have problems with standards in vocabularies
which, of course, agencies or groups like the National Library
of Medicine are certainly working on, other groups like HL-7
and ASTM standard organizations are working on. I think that,
because HIPA requires the Secretary of Health and Human
Services to adopt standards for national providers,
identification, payers, and patients by February 1998.
We feel that this is a very good first step in helping us
get the standards that we need to build a national information
infrastructure, and I believe the NCVHS is currently holding
hearings on these issues, and additional information will be
available later this year, which certainly we will comment on
at that time.
Mr. Horn. Well, we thank you for your comments on this
series of questions.
We are now going to ask panel III to come forward and sit
with you. You can relax for a while and then we have some
comments, questions for both panels II and III. So if Dr.
Gabriel, Drs. Andrews and Hoge will come forward, we will
appreciate it. If the new witnesses will stand and raise their
right hands.
[Witnesses sworn.].
Mr. Horn. All three witnesses have affirmed.
Let's just go down the line, the way the agenda is.
Dr. Sherine Gabriel, Department of Health Services
Research, Mayo Clinic, representing the Healthcare Leadership
Council, is first.
STATEMENTS OF DR. SHERINE GABRIEL, DEPARTMENT OF HEALTH
SERVICES RESEARCH, MAYO CLINIC, REPRESENTING THE HEALTHCARE
LEADERSHIP COUNCIL; DR. ELIZABETH ANDREWS, GLAXO WELLCOME INC.,
REPRESENTING THE PHARMACEUTICAL RESEARCH AND MANUFACTURERS
ASSOCIATION; AND DR. STEVEN KENNY HOGE, CHAIR, COUNCIL ON
PSYCHIATRY AND LAW OF THE AMERICAN PSYCHIATRIC ASSOCIATION
Dr. Gabriel. Mr. Chairman, members of the committee, I am
Dr. Sherine Gabriel, a physician and researcher at the Mayo
Clinic. Thank you for the opportunity to testify before you
today regarding the issue of medical records confidentiality.
I am here this morning, as you just heard, on behalf of the
Healthcare Leadership Council. My testimony, however, will
reflect my own perspectives as a health care researcher. I will
address two fundamental questions: What is the importance of
medical records-based research to the public, and what is the
impact of legislation restricting access to medical records on
such research?
I am privileged to work at a world-renowned medical
institution. Mayo Clinic's international reputation is a center
of excellence in medicine, which grew out of the commitment of
our founders, Drs. Will and Charlie Mayo, to integrate medical
research and education with clinical practice.
The Mayo brothers perceived a duty to use the information
from medical records to answer important public health
questions, and in 1907, pioneered the concept of the unit
medical record, where medical data on each patient is stored in
one self-contained packet and kept in perpetuity. This led to
the formation of the Rochester Epidemiology Project, the unique
national research resource which has been funded by the
National Institutes of Health for over three decades. It has
resulted in approximately 1,000 scientific publications,
analyzing thousands of diseases and medical conditions, and was
ranked in the top 1 percent of all NIH proposals when it was
last reviewed in 1995. The central element of the REP is access
to the complete medical records of all residents within a
geographically defined population.
Medical records research is vital to maintaining and
improving the health of the American public. Virtually every
health hazard we know of today and countless medical advances
have been identified using information from medical records.
For example, if researchers had not been allowed to study the
medical records of patients with unusual immune deficiency
problems in the late 1970's, the characterization of the AIDS
epidemic would have been delayed at a huge cost to the public's
health. Similarly, characterization of Lyme disease required
collation of information from the medical records of the
children who presented with this condition in Lyme, CT.
Other examples include examining the benefits and risks of
estrogen treatment, the health risks of smoking, of dietary
fats, obesity, certain occupations, studies leading to the
development of vaccines for polio and measles, and studies
showing the benefits of breast cancer screening. Without
medical records research, problems such as the Thalidomide
tragedy and the role of prostate specific antigens, the
controversial tests for prostate cancer, could not have been
resolved to the extent they are.
You may have read in the newspapers last year that an
outbreak of flesh-eating strep was identified at Mayo in 1995.
Without access to the medical records of patients with these
unusual infections, characterization of this syndrome and
isolation of this deadly bacterial strain would have been
delayed and over 100 school children, which our research showed
were the unwitting carriers of this deadly germ in their
throats, would have gone untreated.
Let's now turn to the second question: What is the impact
of legislation which restricts access to medical records? Such
legislation, in my opinion, threatens the very existence of
this entire category of medical research. This is because
people who do not consent are systematically different in
important ways from people who do.
For example, people who don't consent may have had worse
outcomes, or they may be less satisfied with their care.
Studies which exclude these people would be biased; they would
simply give the wrong answer.
Moreover, while research is clear on the point that people
who do not consent are systematically different from those who
do, the direction and magnitude of those differences are
completely unpredictable from study to study. So not only will
such research result in the wrong answers, but it will be
impossible to determine how wrong they are or in what
direction. Thus, the reliability and validity of the findings
from such research will be weakened.
Inclusion of all qualifying individuals is the only way to
ensure that accurate conclusions are drawn in public health
medical records-based research. Of course, such research--and
we recognize this--must be done while taking appropriate
measures for maintaining patient confidentiality, including
careful review and oversight by institutional review boards and
strict adherence to procedures restricting access to patients'
specific medical information.
In closing, I want to comment briefly on what I believe is
an important driving force behind all of this, which is the
desire to keep personal medical information between the patient
and his or her physician, the old Hippocratic idea. As a
physician, a patient and a mother, I understand why this idea
is so appealing; however, in a complex health care environment,
it is an unattainable ideal.
For example, in an average medical visit, the following
individuals and groups must have access to the patient's
medical record in order to best serve the patient: the
appointment office; the registration desk; all physicians,
physician assistants and nurses who provide care for the
patients, as well as receptionists and secretaries; medical,
nursing and other students and their mentors; all laboratory,
EKG, x-ray technicians who perform the necessary tests;
infection control officers who regularly survey medical records
for reportable diseases; continuous improvements staff who
strive to improve our health care processes; members of the
marketing department who seek to ensure patient satisfaction;
the business office for billing, the legal department,
insurers, and third-party payers.
After all of this is taken care of, a qualified nurse
researcher, bound by the rules of the IRB and strict patient
confidentiality regulations could be abstracting clinical data
from the medical record which, after being stripped of patient
identifiers, will be combined with similar data from hundreds
of other patients to answer a specific public health question.
The type of legislation we currently have in Minnesota
influences only that nurse's access to the medical record and
has no impact on any of the other points of access.
Mr. Chairman, legislation must be carefully crafted, such
that it ensures privacy of medical information, a very
important goal, and does not hinder medical scientific
research, as such interference will put the public's health and
well-being at risk for serious harm.
Thank you for your attention.
Mr. Horn. Well, thank you. You have raised some very
interesting questions that we are all going to have to grapple
with.
[The prepared statement of Dr. Gabriel follows:]
[GRAPHIC] [TIFF OMITTED] 45252.044
[GRAPHIC] [TIFF OMITTED] 45252.045
[GRAPHIC] [TIFF OMITTED] 45252.046
[GRAPHIC] [TIFF OMITTED] 45252.047
[GRAPHIC] [TIFF OMITTED] 45252.048
[GRAPHIC] [TIFF OMITTED] 45252.049
[GRAPHIC] [TIFF OMITTED] 45252.050
[GRAPHIC] [TIFF OMITTED] 45252.051
[GRAPHIC] [TIFF OMITTED] 45252.052
[GRAPHIC] [TIFF OMITTED] 45252.053
[GRAPHIC] [TIFF OMITTED] 45252.054
[GRAPHIC] [TIFF OMITTED] 45252.055
[GRAPHIC] [TIFF OMITTED] 45252.056
[GRAPHIC] [TIFF OMITTED] 45252.057
Mr. Horn. Our next witness is Dr. Elizabeth Andrews--I hope
I am pronouncing this right--Glaxo Wellcome Inc., representing
the Pharmaceutical Research and Manufacturers Association.
Dr. Andrews. Thank you, Mr. Chairman, and thank you for the
opportunity to present our information. My name is Elizabeth
Andrews and I am director of Worldwide Epidemiology at Glaxo
Wellcome. I appear before the committee on behalf of the
Pharmaceutical Research and Manufacturers of America, or PhRMA,
to discuss our industry's views on data privacy in general and
H.R. 52 in particular. I will summarize our full statement,
which will be provided for the record.
It is clear that patients deserve to have medical
information kept in strictest confidence by those to whom they
entrust it. PhRMA companies honor that trust. Patients also
deserve answers to their unmet medical needs.
This past year, the research conducted by our companies
yielded 53 new FDA-approved medicines, new weapons in the war
against 40 diseases, including AIDS, cancer, heart ailments,
and mental illness. Our continued progress depends on
aggressive, multifaceted research, including basic science that
allows us to understand disease processes, practical research
and development that enables us to discover and develop drugs
to treat disease. Clinical trials that demonstrate project
safety and efficacy, epidemiologic research that helps us to
know how drugs perform in the real world, identifying and
characterizing rare side effects or unsuspected benefits and
health services research that leads toward improvements and the
quality and cost-effectiveness of patient care. Federal policy
must accomplish twin objectives, protecting the privacy of
individual patients, while also protecting the continued
viability of research that promotes improved health care for
all persons.
We believe these objectives can best be met by establishing
uniform national requirements for the handling of medical
information, defined to include genetic information. PhRMA has
three primary suggestions that should be included in Federal
requirements, but need specifically to be addressed in H.R. 52.
First, the bill should recognize the process already in
place under regulations adopted by FDA and 16 other Federal
agencies to protect patient identifiable information used in
biomedical research. Second, any new legislation or regulations
should preserve researchers' access to the full range of
potentially useful information about the incidence, prevalence,
and outcomes of illness, as long as individual privacy is
properly safeguarded. Only those data sources that directly
identify individuals need to be kept confidential.
Third, uniform national requirements should provide
effective Federal pre-emption of State statutes. One of the
compelling reasons for establishing Federal requirements is to
provide a uniform set of rules that can be applied consistently
from State to State for research. With respect to clinical
trials, the current controls regulating FDA-monitored trials
are quite strict.
Through standard operating procedures, companies ensure,
under Federal Rules, that personally identifiable information
remains secure in the offices of individual health care
practitioners who serve as the study investigators. The
sponsoring company has access only to the information that
needs to report to FDA, to verify results and to protect
patient safety. We are concerned that H.R. 52 does not
recognize the existing safeguards, the regulatory processes and
oversight mechanisms that exist. The National Institutes of
Health and the President's National Bioethics Advisory
Commission are already charged with examining the IRB process
and will develop recommendations for any improvements that are
deemed necessary.
PhRMA is also concerned that H.R. 52 would restrict access
to certain data bases if they could be linked by codes to data
sources that identify individuals. These data bases contain
crypted identifiers and only through the use of a secure and
confidential key can specific patients be identified. In some
studies, it is necessary to use this key to link to other
sources of information about the patients to create a richer
more scientifically informed set of data. These type of studies
need special precautions to ensure confidentiality of patient
information, but these studies are not concerned with the
identity of the patient, only with the scientific content, that
a patient's information can contribute to a study.
A wide range of health-related data could be affected by
the provisions of H.R. 52, from Medicare, Medicaid and private
insurance claims data, to State-collected vital and health
statistics. Access to these data is important to generate
answers to many of today's pressing health issues that cannot
be answered through other mechanisms. Analyses of such data
have contributed to demonstrating the higher risk of hip
fracture in the elderly among those taking psychotropic drugs,
quantifying the risks and benefits of hormone replacement
therapy, documenting the underuse of beta blockers following
heart attacks and the resulting increase in mortality and
morbidity.
Under H.R. 52, access to these data bases could be
construed to require for each reanalysis of the data, either
specific consent of each of the subjects whose medical
information is contained in the data base or the approval of a
certified IRB. Current regulations exempt such data from IRB
review and informed consent requirements. Such requirements are
unnecessary and do nothing to protect human research subjects,
whose identity is not revealed in such data bases. Instead, we
can protect patients' privacy without impeding research,
through careful encryption of data, effective security for the
key to encrypted data, tight security safeguards whenever
confidential information is accessed directly, and guarantees
of confidentiality by each individual who obtains confidential
information.
In conclusion, the research-based pharmaceutical industry
respects the privacy of patients and the confidentiality of
information about them. We could not conduct our research if we
did not do so. We urge that any changes in Federal
confidentiality requirements be drafted with great care to
ensure that medical research can continue to yield new remedies
and better ways of caring for patients. Thank you.
[The prepared statement of Dr. Andrews follows:]
[GRAPHIC] [TIFF OMITTED] 45252.058
[GRAPHIC] [TIFF OMITTED] 45252.059
[GRAPHIC] [TIFF OMITTED] 45252.060
[GRAPHIC] [TIFF OMITTED] 45252.061
[GRAPHIC] [TIFF OMITTED] 45252.062
[GRAPHIC] [TIFF OMITTED] 45252.063
[GRAPHIC] [TIFF OMITTED] 45252.064
[GRAPHIC] [TIFF OMITTED] 45252.065
[GRAPHIC] [TIFF OMITTED] 45252.066
[GRAPHIC] [TIFF OMITTED] 45252.067
Mr. Horn. Well, thank you very much. We appreciate that
testimony. We now have Dr. Steven Kenny Hoge, the chair of the
Council on Psychiatry and Law of the American Psychiatric
Association.
Dr. Hoge. Thank you. Mr. Chairman, I am Dr. Ken Hoge. I am
testifying on behalf of the American Psychiatric Association, a
medical specialty society representing more than 40,000
psychiatric physicians nationwide. We are pleased to have the
opportunity to discuss with you privacy protections for medical
records.
Patients come to physicians and entrust them with
sensitive, private, personal, and sometimes embarrassing
information because they believe that it will be used to help
them. Physicians acting in the interests of their patients have
controlled access to this information. As the guardian of
confidential medical record information, physicians have
protected patients' privacy. When third parties inappropriately
demand access to medical records, physicians refuse. When the
third party's right to access is uncertain, physicians have
acted as sentinels, alerting patients that others are trying to
seek the records.
Physicians may take steps to protect records even in the
face of legal pressures. Physicians have guided patients so
that even voluntary disclosures of medical information minimize
privacy intrusions. The physician's role as guardian of the
medical record has been recognized in professional standards,
impressed upon physicians in their training and acknowledged as
legitimate by the courts.
Recently, the traditional role of the physician as guardian
of patient privacy has come under serious attack. Medical
information has increasingly been put to uses that are not
intended to serve patient interests. Third party demands for
access have increased with attended risks to patient privacy.
Electronic storage of medical information raises serious
privacy concerns, since these systems, by design, facilitate
access, transmission, and duplication of medical records.
In our written statement, we have submitted several
principles that are important to maintaining the privacy of
medical records. Let me emphasize the following now. Medical
data is generated for the care and treatment of patients and
should be used to serve their interests. This can only be done
if physicians continue to play an active role as guardians of
the medical record.
New information technologies should not be employed to
stretch the limits of appropriate access that have been
established in professional custom and law. Third, legal and
ethical sanctions for violations of patient privacy should keep
pace with developments in technology. Existing legal sanctions,
such as breach of fiduciary duties, malpractice, breach of
implied contract, all help to protect confidentiality and
provider patient relationships. These protections, which have
been established in professional standards, statutes and case
law, should not be undermined.
Appropriate legal sanctions need to be developed to cover
insurers, managed-care entities, and medical record data banks
that handle and store sensitive medical information but do not
have the
tradition of the physician/patient relationship. Throughout
your deliberations, please remember that patient privacy is
fragile, and that once it is lost, it cannot be regained and
its loss cannot be truly compensated. I will be happy to answer
your questions.
[The prepared statement of Dr. Hoge follows:]
[GRAPHIC] [TIFF OMITTED] 45252.068
[GRAPHIC] [TIFF OMITTED] 45252.069
[GRAPHIC] [TIFF OMITTED] 45252.070
[GRAPHIC] [TIFF OMITTED] 45252.071
[GRAPHIC] [TIFF OMITTED] 45252.072
[GRAPHIC] [TIFF OMITTED] 45252.073
[GRAPHIC] [TIFF OMITTED] 45252.074
[GRAPHIC] [TIFF OMITTED] 45252.075
[GRAPHIC] [TIFF OMITTED] 45252.076
[GRAPHIC] [TIFF OMITTED] 45252.077
Mr. Horn. We thank you very much for that statement and I
am going to put in the record the comments of the Health
Insurance Association of America. They were invited to testify,
but they were not able to make it, so their statement, without
objection, will go in the record at this particular point. They
raise some interesting questions, which we might get into
during the question period here.
Let me just ask all of you here, what type of penalties are
appropriate for individual medical privacy rights and if
someone violates them, what do you suggest? Let's just go right
down the line.
Ms. Goldman.
Ms. Goldman. Thank you. Well, I certainly believe----
Mr. Horn. You did the right thing. You pulled the
microphone toward you. All those microphones need to be pulled
toward you. This was built in the 1960's, but they use the
1890's sound system, so we have a problem.
Ms. Goldman. I certainly believe that any Federal law
should incorporate a variety of remedies. One remedy is not
going to be sufficient. There should be a private right of
action that gives an individual the ability to come in and
bring a lawsuit against someone who has harmed them. Also, I
think that an appropriate Federal agency, such as HHS, should
be able to assess a civil penalty, so if the individual can't
afford a lawyer, the Government can come in and say you have
done wrong. And I also think, under very egregious
circumstances, there should be criminal penalties as well.
Mr. Horn. Well, if there is a criminal penalty, what should
it be? I mean, is it a misdemeanor or is it a felony, let us
start there.
Ms. Goldman. Well, I think that by the time you reach the
level at which you would be liable for criminal penalty, I
think you should be looking at a felony. A criminal penalty,
particularly under a number of the proposals that are out
there, would be where there has been intentional, malicious
disclosure of personal information, where there is a course of
conduct over a period of time, the person----
Mr. Horn. Pattern and practice.
Ms. Goldman. Pattern and practice, flagrant violator,
should certainly be a felony.
Mr. Horn. What is your feeling, Dr. Palmisano?
Dr. Palmisano. Thank you, Mr. Chairman. The American
Medical Association believes penalties and sanctions for
unintentional disclosures of identifiable patient information,
where the disclosure does not result in demonstrable harm to
the subject of the disclosure should be commensurate with the
violation. Repeated such unintentional disclosure should
receive stronger penalties if they indicate a negligent
business practice.
Penalties and sanctions related to improper disclosure for
commercial purposes, profit malicious purposes or where there
is significant patient harm should be more stringent. In
addition to monetary sanctions, legislation could include the
loss by a data base company, for example, of its privilege to
hold or transmit protected medical information, thus reducing
the potential for companies to accept the monetary penalties
for improper, intentional disclosures, as a cost of doing
business.
In other words, we don't want them to say, well, gee, there
is this little penalty. We will just pay it because we are
making so much money here, but they would lose the right to
function in that capacity in the future.
Mr. Horn. Has your association considered the thought of
compulsory arbitration, rather than going through the court
system? Some associations do this. I mean, the patient would
sign either mediation, which is not compulsory or a compulsory
arbitration agreement. Rather than going into court on some of
these, they would sign that if something happens to the record,
let's say, you would have compulsory arbitration, and that
would be, perhaps, an arbitrator picked by the patient, one
picked by whoever, the doctor or hospital, whatever the
violation source is, and the two usually pick a third.
Dr. Palmisano. The American Medical Association for years
has been in favor of alternative resolution mechanisms to the
current court system. We believe it is expensive and very
inefficient and that does not serve both sides very well, in
our opinion. In this situation, I guess there would be two
issues. The first issue would be how would you resolve the
issue and we certainly have been in favor, as an association,
of voluntary binding arbitration?
For instance, in Louisiana, we have that as an alternative
to the court system, if both sides agree prior to the event
occurring, and there is a period of time, a cooling off period
where you can change your mind, but after that, it is a binding
arbitration. So in general, we are in favor of that. The next
issue goes to the penalty phase of it. Would the arbitrator
have available to him or her certain penalties that would be
mandated to follow, based on how egregious the act was and so
on?
Mr. Horn. That would be the civil side of it, certainly.
Obviously, they wouldn't be getting into the criminal side. But
you also have the sort of rent-a-judge approach in many
jurisdictions where X judges regularly decide very difficult
disputes and both parties agree and it gets it out of waiting 1
or 2 or 3 years to come up in some court systems.
Dr. Palmisano. In general, the AMA has been in favor of
such methods, where we could have alternative ways to resolve
that. We just want to make sure there is fairness, due process
and so on.
Mr. Horn. Dr. Johns, any feelings on this?
Ms. Johns. Mr. Chairman, part of our model legislative
language and key provisions for national regulations in regard
to this included civil and criminal penalties. Now, as far as
distinguishing felony and when that should occur and so forth,
I don't believe that we had gotten into that particular detail.
I do feel comfortable in testifying, however, that the
provisions, as they are stated in H.R. 52, is something that
our association supports.
Mr. Horn. Dr. Gabriel, do you have any thoughts on that?
Dr. Gabriel. Not really. I would agree with what has been
said before. I think it really depends a lot on the type of
abuse, the motivation for it, whether the abuse is for
commercial reasons, whether there has been patient harm, and I
can tell you that in our own institution and I know in many
others, even the mildest level of abuse results in termination
of employment. So I think there has to be that and that the IRB
has an important role in monitoring it and making sure those
abuses do not occur.
Mr. Horn. Dr. Andrews.
Dr. Andrews. Well, first tight controls over data within
the research setting are effective in preventing these types of
violations. However, we do also concur that there should be
penalties and that those penalties should be commensurate with
the disclosures. PhRMA has developed no specific
recommendations about penalties.
Mr. Horn. Dr. Hoge.
Dr. Hoge. I think the only thing I would add, I think it is
important for all of us to keep in mind confidentiality is sort
of a tricky thing to regulate, that once privacy has been
breached, suing someone doesn't do you much good. The fact they
are punished may not do you much good. Internally, in a
hospital, terminating an employee, I think obviously makes a
lot of sense, but what we see over and over again is that the
result of bringing a lawsuit or seeking some kind of legal
redress would be wider dissemination of the information that
the person wanted to keep confidential in the first place. So
there is a little difficulty here.
At the APA, we have seen criminal penalties wax and wane in
various versions of the bills. No penalty is too severe if the
transgression is severe, assuming the underlying rules are set
appropriately.
I do want to add one other comment. You asked the earlier
panelists if they had any disagreements. I think the biggest
fault line I perceive in this issue over the last 3\1/2\ years
pertains to the pre-emption issue. I think it is--my view is it
is beyond a doubt, the APA has spent countless, hundreds of
thousands, if not millions of dollars over the last generation,
developing case law, statutes in States all over the country.
We were instrumental in the Jaffey v. Rudman case. It is
cited prominently in your draft bill. I think it is not correct
to say that privacy is not protected in this country or that
the States aren't doing an adequate job. Many States and many
courts are doing a very adequate job. So I think the pre-
emption issue is an issue, and I think to put the whole moose
on the table, that the people who are interested in pre-emption
are interested in the efficiencies that pre-emption would
provide, not in privacy protection.
I think it is clear if a State wants to come along and
raise the bar from any Federal law that might be passed, that
that can only help patient privacy. I don't see any logical way
of getting around that conclusion. So I think we need to
understand now we are talking about privacy versus efficiency,
and obviously the APA is going to come down on the side of
patient privacy.
Mr. Horn. I note in the Health Insurance Association of
America testimony, this is the last time I will cite it, but it
is relevant to this question. They say under Subtitle E,
enforcement of the Condit bill: ``We find it troublesome that
the act creates a private right of action and the right to
obtain punitive damages. Such provisions raise the potential
for a large increase in frivolous litigation. Regulating health
information does not require creating a new cause of action. We
suggest that broad exceptions should exist for inadvertent
disclosures and those made in good faith and plaintiffs should
be required to show specific harm.''
Are there any reactions, anybody, to that? It is a little
different than some of your testimony, so I thought I would
throw that in for the record.
Dr. Palmisano. Mr. Chairman, just one comment about
frivolous actions. The American Medical Association is on
record repeatedly that we are in favor of anything that
discourages frivolous actions and certainly in the Health Care
Quality Improvement Act, which created certain protections for
peer review and also created the National Practitioner Data
Bank.
There is a provision in there that if someone files a claim
without merit, and so on, that the individual can be
sanctioned. And certainly I think in any legislation that we
need to look at situations for people who don't really have a
basis for it, and do this just to harass. So we would be in
favor of something of that nature.
Mr. Horn. That is a serious problem, without question, in
some types of litigation. I think I said a year ago, when we
were able to override the President's veto, when he was sort of
defending that, 1 or 2 years ago, I guess it was, the fact is
the American Bar Association, if it wants to be a professional
organization, ought to be dealing with these matters. That is
what professions are supposed to do, regulate their members. We
haven't seen it yet. Maybe some day they will decide they are a
profession and do something about it. It is despicable, some of
the filings, absolute blackmail. And that is what has Congress
upset in this area.
For those where you have a true pattern and practice, that
is something else. However, where you simply have somebody
fishing around, trying to, in essence--and I went through this
as a university executive and president. They filed suits and
they figure you will buy them off at $10,000 a month or
something, and if you got 50 suits filed, that is a pretty good
income. So that is serious, how we deal with this and try to
get the people that are really violating the law, versus the
sort of snooping expeditions or whatever we call it, where we
just have that kind of conduct by a small handful, less than 1
percent or one-tenth of 1 percent, but enough to be annoying.
So let us see here.
All the panel has really taken a look at this one. Under
H.R. 52, Secretary of Health and Human Services would be
required to develop standards for maintaining the
confidentiality of patient health records. Health care is
provided in a wide diversity of settings in the country and
they are pretty well represented here. We could have had
another panel there 50 feet long and health care is provided in
these settings, ranging from single practitioners in rural
areas who provide care at multiple locations to large
centralized hospitals. Can we expect a single records
maintenance standard to be appropriate in all these different
settings? If not, how should we take the differences into
account?
Any feelings on that? Let's start with Dr. Hoge.
Dr. Hoge. Are you asking me about my feelings because I am
a psychiatrist?
Mr. Horn. Sure, that is what I hear psychiatrists ask
about. My one course in psychology taught me that.
Dr. Hoge. I have some thoughts on that. I think it is
extremely difficult to regulate the use of medical information
in all the various contexts.
You mentioned going from research to data base to provision
of health care, and I think that is one way in which many of
the draft bills have gone off course. We know a lot about how
to regulate physicians because we have had physicians and
patients for as long as we can remember, and we have had case
law and profession--we have had professional standards and
professional training now for, again, as long as we can
remember, as long as our grandfathers can remember. So we know
a lot about that.
And the bills kind of take an outline from how we think
about doctors and try to make everyone else fit into that
outline. I don't think it does a very good job. I think this is
a strange way to make a law. I think it would make a lot more
sense, if we need a Federal bill concerning physicians and it
doesn't undermine existing State laws and case laws of
malpractice, so be it.
I think what is really needed in 1997 and in the future are
laws that regulate data banks, managed care companies,
insurers, and all of the entities now that have come to hold
medical information that 30 or 40 or 50 years ago no one had
even heard of these entities. I think it is particularly
important because of the march on information technology. If
you think up an information technology journal, you will see
that some people believe that the insurance record and the
medical record will be the same thing when we have all the
computers up and running and software available. I find that a
frightening Orwellian future. So I think what we need is some
sort of regulation that starts to look at these other entities.
I think we also need to keep in mind, like the various
panelists earlier acknowledged, the physician should be the
only one to change the record. They know the patients. They
know what they are worried about, their privacy concerns, and
their health care problems.
Our professional standard requires that physicians look out
after the best interest of patients. That is not true of any of
the other entities that I have mentioned. So we need to have--
just like the physician should have certain prerogatives in
that setting, with regard to that question--certain
prerogatives with regard to the use, disclosure and
dissemination of all health care records. Data banks should be
relatively restricted and tightly regulated ways in which they
can use health care information.
Mr. Horn. You mentioned Orwell. Do you see physicians sort
of using their own personal code in some of their records so if
they did get misused by one of their staff or any of the food
chain along the way, so to speak, that it would be very
difficult to know what that number or that letter meant unless
you had a subpoena and you were a witness in court where you
were asked to translate it, something like that? But the
average person who wants to make trouble in the publicity sense
would not know what that means.
Dr. Hoge. Well, of course we spend 4 years in medical
school learning terms that no one else can understand.
Mr. Horn. That is the making of a profession.
Dr. Hoge. Right, make up your own language.
But the serious answer to that I think would be this: I
hear psychiatrists increasingly tell me I have changed the way
I write my notes now, changed the way I keep records, because I
don't know who is going to see it. When the insurance people
come in and review the charts, I don't know if the insurance
reviewer is really a friend, a neighbor of the patient. Some of
that gets entered into various data banks. I don't know who is
going to see that. So we have a number of things.
We have patients who say, I have insurance and it does
cover some mental health care, but I don't want to use it
because I know it is going to go and the records are going to
be reviewed by--it may make its way back to my corporation
because we have our own in-house review of insurance payments.
So I don't want to use it. I want to pay out-of-pocket.
Of course, it is a sorry state of affairs in this country
that we don't have mental health coverage on par with many
other countries, however even when we do, people feel they
can't use it. Prominent politicians, on occasion they have many
ways they can be hurt by mental health treatment records.
Then I have physicians telling me, psychiatrists telling me
I don't put very much in the record now. So if I want to go
back now and look 5 years ago, my records are very detailed.
But 5 years from now, if I want to look at my record, I am not
going to have exactly the same kind of information. It's going
to take more reconstruction to get to that.
So what we are seeing, because of this march of technology,
the lack of regulation of insurance companies and other people,
I think we are seeing an erosion of the quality of medical
recordkeeping in this country already.
Mr. Horn. Let me throw another question into it, and maybe
you can all just go down the line and answer two of them,
because it is relevant here.
That question is, should a Federal medical privacy law such
as we are considering, not necessarily the one we are
considering but a law, pre-empt all State laws, or should we--
and a lot of Californians feel this way when it gets to air
pollution and control of frozen chicken and other hearings we
have held around here--if the State has a stricter standard, to
let the State standard apply if it is stricter than the Federal
standard?
And I would also like to hear from all of you some time
today, is there a State law that you think is the best law in
this area right now? And of course States, as you know, have a
system, if we have got a good law, trying to get the uniform
code activity of other States with that model statute across
the country.
So we face the problem of what is that relationship if we
do do something in Federal law and we have sort of given the
HHS Secretary an anointment which maybe she shouldn't have, and
maybe Congress ought to battle these things out. Because they
don't have to listen to people. We do have to listen to people.
That is where we are on that one, and I would just like to
know what your feelings are in that whole jumble: What is the
best State law and should there be Federal pre-emption, et
cetera?
Dr. Hoge. On what is the best State law, I think that is
difficult to sort out, because much of the law is incorporated
in either State laws or it is instilled in professional case
law and practice, and that may vary somewhat from jurisdiction
to jurisdiction. But, increasingly, physicians are held to a
single national standard. So I think finding out where the best
practices are and the best regulation will be a very, very
difficult thing to sort out.
Regarding pre-emption, as I alluded to earlier, I think
that is the major fault line in this legislation. Because many
of the bills that I have seen I think would erode existing
privacy protections in this country, with regard to physician/patient relationships and the systems that physician control,
which are held to, I think, a fairly stringent standard under
malpractice law and existing case law.
I think we need to keep in mind that the only arguments for
pre-emption are arguments of efficiency and ease of
transmission of information. There is no way to justify, if you
do come out with a law which sets the bar at a certain level,
if a State wants to raise the bar, that can only be protective
of privacy. I don't see any privacy argument against a nonpre-
emptive Federal law.
Mr. Horn. Dr. Andrews.
Dr. Andrews. Yes. First, I would like to respond to your
earlier question about different controls in different
settings.
There are certain universal principles about data
protection such as the need of safeguards for personally
identifiable data and penalties for severe breaches as we
discussed. But the specifics are very different, as you
mentioned earlier today, and in writing the legislation, the
devil really will be in the detail; and we should be extremely
careful in those details should they be put in the legislation
so that those details do not inadvertently create barriers to
research that will ultimately benefit the public in the long
run.
Regarding specific State legislation, first of all, let's
not use Minnesota as an example of model legislation. I think
that was probably very carefully crafted legislation and yet,
as you have already heard, the Mayo Clinic has an incredible
record of some of the most distinguished, productive, and
tightly controlled research; and we have already seen that the
Minnesota law creates some impediments to future research using
that valuable resource.
Regarding pre-emption, one of the compelling reasons for
Federal requirements is to provide a uniform set of rules; and
if individual States are permitted to add additional
requirements, then the benefits of those uniform rules may be
lost and researchers will again be faced with an inconsistent
patchwork of requirements that may impede research and hurt
patients. We need to remember that much research today does not
know geographic boundaries and involves multiple States and
multiple countries.
Mr. Horn. Dr. Gabriel, how about it, in terms of the single
records maintenance standard appropriate in all settings? And
do you agree that the Minnesota law has those major problems
you have heard about from yourself and others?
Dr. Gabriel. I absolutely agree. In response to both of
your questions, one size does not fit all. Integrated health
care delivery systems like Mayo are different. A patient can
access the system at 100 different points, can see numerous
providers. There are dozens of, referrals going on all the
time. It is hard to even define what constitutes a point of
access. So I don't think the same rules can apply to an
individual provider as to integrated health care delivery
systems like Mayo.
There really has to be a way to facilitate the appropriate
flow of information, because that is our strength, is that we
can do all of this, that the lines are going in all different
directions to the benefit of the patient.
In fact, with our recent experience with the Minnesota law,
we have a partner in Rochester, a much smaller center, who have
had far fewer problems. Because everyone comes in the same
front door, and their system is basically sticking a red sticky
on the chart, and if you see a red sticky, don't read the
record. But we have to have a very complicated information
management system that is constantly updated, and we are always
looking at where the patients are going, so it is an entirely
different kettle of fish.
We favor pre-emption to the State law, again, for the same
reason. Mayo operates in five different States. Our patients go
back and forth from one State to another. Our research covers
more than one State. So it just makes a whole lot of sense to
have uniformity.
Mr. Horn. If Minnesota law doesn't meet the test of your
particular standards, are you aware of any State law that comes
closer than Minnesota?
Dr. Gabriel. I am not.
Mr. Horn. OK. Well, I would say to all of you when you go
back on the plane or train or bus or whatever and have some
thoughts in this area, please write us. We will put it in the
record at this point and others. Because what we are interested
in is the best thinking in this area that is going on.
Obviously, six people don't represent all of the best thinking
in America, but it is a start.
For your professional associations and their high-paid
staff, we would certainly welcome actual line-by-line criticism
of the bill. That might not be the bill, but that is a start--
or the Slaughter bill or whatever you want. And we would like
your specific criticisms so we can get the total picture.
We don't enter into this with a lot of preset ideas, except
maybe on frivolous lawsuits. But we would like your thinking
line-by-line. If you have a thought, don't be bashful.
So lets ask Dr. Johns. How do you feel on the diversity of
the setting? Do you think we can do a law that has the basic
standard that can cover all that diversity? And if you know of
a State law that does this well, we would like to hear about
it. And do you think there ought to be Federal pre-emption?
Ms. Johns. First of all, HIMA is in favor of pre-emption.
And I think when we look at the issue of confidentiality we
also have to separate issues of confidentiality and security
practice.
In regards to the confidentiality in H.R. 52, we are
looking at inclusions of key provisions in regards to health
information, as opposed to carving out regulations for specific
types of entities.
New entities in the health care industry arrive on almost a
daily basis, so to regulate individual entities does not, in
our minds, seem to be either feasible or reasonable. However,
focusing directly on the health information that can be within
any type of entity is the important part of H.R. 52; and we
have key provisions such as access, such as disclosure, such as
limiting information in order to--for specific use to perform a
specific responsibility, and also provisions on redisclosure.
So from that aspect, looking at it from that perspective as
opposed to separate entities we think is very, very important.
We also feel, as I mentioned, that we need a national
standard. We don't have that now. And we need to--it is so
imperative that we begin to address this issue on a national
standard.
Also, data does cross State lines. Integrated delivery
systems themselves may have facilities in two, three, four,
five, and many more States. So the issues regarding the health
information need to be standardized across the country.
Another point that was made by Dr. Hoge is the issue of
patients feeling comfortable with being able to confide in
their health care providers. And certainly previously I pointed
that out in our testimony, that one of the mainstays of
confidentiality is this confidence that the patient has in
being able to share information.
The kinds of situations that we are encountering today
where patients withhold information and providers are not as
specific with regards to their documentation result from not
having general pre-emptive legislation that ensures all of us
that we will have confidentiality and privacy.
In regards to identifying a specific bill throughout the
country and the State, I am not aware of that; and I am not
prepared to provide that information at this time.
Mr. Horn. Well, we would certainly welcome any thoughts
your organization has. You have got a vast group out there. Or
complaints where--please don't take this portion of law; it
doesn't work.
Ms. Johns. We would be happy to provide that.
Mr. Horn. Dr. Palmisano.
Dr. Palmisano. Thank you, Mr. Chairman.
Regarding pre-emption, the American Medical Association is
of the opinion that without a showing that the proposed Federal
standard would be properly protective of patient privacy, any
Federal law should provide a floor rather than a ceiling when
applied to patient confidentiality protections. It is
understood that there are many who believe that there should be
a uniform Federal standard to facilitate electronic data
interchange.
The AMA is concerned, however, that heightened standards
will be lost to Federal legislation. If, however, the law is
high enough to secure protection of patient information in the
Federal language, the AMA would revisit the pre-emption issue.
I think Dr. Hoge's comments are issues we share concerns
about. We think there are many concerns in States, and tomorrow
they may pass a new law in a State that is ideal, and it is
perhaps quicker to go through a State if we see a problem with
confidentiality and raise a standard at a State level. So we
think at the present time it should be a floor, not a ceiling.
Regarding the uniform coding issue, we don't have a
problem--for simplification, we don't have a problem with the
provider identification number. For instance, the American
Medical Association has an identification number for
physicians. We would like that to be considered as a number
that would be appropriate for physicians.
Regarding a patient identification number for
simplification, we are very much concerned about that; and we
continue to study that. Our testimony in the past and continues
to be at the present time, we are opposed to a unique patient
identifier because it can too easily be linked up with Social
Security numbers and other mechanisms that would allow someone
who doesn't have the right to get there to gather a lot of
information about the patient. We have a lot of concern about
that.
The other issue on uniform coding and so on, we certainly
think that the current procedural terminology that is in place,
CPT coding system, it is in common use; and we hope that the
choice of coding system will allow for the CPT to compete
fairly with any other system that is being considered.
Regarding the wide range of practices throughout the United
States, from clinics to small practitioner, I certainly don't
want us to forget the small practitioner who may be a family
practitioner in a small town, and this individual finds the
administrative burdens continue to increase. Managed care has
drastically affected the practice of medicine throughout the
United States, and any other burdens might cause that
practitioner to say it is not any fun, I can't do for my
patients what I need to do for my patients, and we will see
physicians retiring earlier, leaving communities, and that is a
problem.
So any law that would eventually be passed by Congress, we
would hope that it would not create burdens on individuals who
elect not to get involved in that methodology. If they are
working just in their area and not transmitting the data, it
would be on a voluntary basis. So someone doesn't say, now I
have to buy a very expensive computer system; I have to bring
in consultants. And many times, after that is over with, the
physicians find out after they have spent a lot of money and
they are not any better off. In fact, they are worse off
because nobody understands the system.
So we want to make sure that those who elect not to be
involved in transmission of data to central data bases, they
don't have to do that. And whatever comes out of Congress we
are concerned about some clearinghouse in the sky where all of
this data is going to be there. We are concerned about someone
getting in and cracking into that information; and, as you have
heard multiple times today, privacy has to take the No. 1
position over efficiency.
Mr. Horn. Since I grew up in rural America, I am very
sympathetic with the type of examples you have cited and
others.
Now it seems to me the AMA, as a professional association,
may sponsor workshops in which physicians or their office
administrators could be educated and trained and specialized
software. Do you develop software that can be used nationwide
that would solve a lot of these problems? We do not want to
drive that poor individual physician who was taught to do good
in medical school out of serving rural America.
Dr. Palmisano. Yes, sir, we have extensive programs at the
State level and the American Medical Association level.
And I know I will hear this--I am in practice before the
colleagues, and when I get back and sort of give them a recap
on how we are participating, our great civics lesson, in
America, the greatest land in the world, how through democracy
we can give our voice. And then my partner, who is my mentor in
training, he just always looks at me and says, come back to the
real world here. Do you realize what we have to do here? Do you
realize the administrative burden? Why I don't leave here until
8 at night even though I have an office manager. We have to
hire consultants to come in.
He is as sophisticated as anyone I ever met with computers,
with the methodology to make sure everything is kept proper.
But he says it is a tremendous burden.
So I always listen sympathetically and say, ``well, I know,
but we just want to make it simple and make sure our voice is
heard.''
And he says, ``we already know how to do it. The problem is
the rules keep changing.''
For instance, when the fraud alert two came out, I had
occasion to be treating a very prominent member of our
community. His wife and he had some connection with the
judicial system, and he was upset because I was an hour late. I
sent word because there was an emergency I had to run into the
operating room and lend a hand with a very critical patient,
and when I got there he started to lecture me as he often does.
And I like him a lot, and I listened, and I said, ``Sir, if
you would sit down and help me understand an alert I just got
from our Federal Government about fraud alert two, which had to
do with if you write off the balance of a patient, that is
considered a crime.'' I said I don't quite understand that. It
looks like it says that in English. And he said that just can't
be so.
So I went and treated his wife and came back, and he says,
``I just can't believe that.'' I said, ``That is part of the
administrative burden.'' We have patients that come up. I don't
want to do means testing on my patients when they say,
``Doctor, can you just accept the assignment?'' Sure, I will
accept the assignment, but now I have to do means testing.
Those are the many, many little things that keep coming up;
and one little thing doesn't sound like a lot, but if you add
another thing and another thing and another thing, that gets to
be a lot.
I am trying to treat the sick and help people. When I can't
cure them, I want to comfort them. But I am just getting
overwhelmed by the burden. And no matter what comes out,
whatever we call it--we can call it simplification, call it
privacy, but we don't want to create a burden that is more
burdensome. We don't want to create a system that allows
someone--like in other countries that kick down the door in the
middle of the night and say I am just here to inspect and make
sure there is no fraud going on in this home. This is the land
of America. So that is our plea.
Thank you.
Mr. Horn. Well, I know a lot of doctors in my urban
community that completely agree with you about the burdens that
have been placed on the private physician; and, as you suggest,
some of them are being driven out of the profession by simply
the water treatment harassment that they are getting. Whereas
one or two drops wouldn't bother you, but when it adds up to
Niagara Falls coming in your direction, you worry a little bit.
Ms. Goldman.
Ms. Goldman. The position that I am taking on pre-emption
in this Congress is slightly different than the one I took last
Congress, and I would like to just lay out how I have arrived
here.
I have come to believe that pre-emption of State law in the
privacy area is not the right approach to take. First of all,
the States that currently have laws on the books that deal with
access to records and allow people to limit disclosure of their
own records are being complied with right now by the people
sitting at this table who say it would be unworkable to have a
Federal law that allowed for States to pass those. Right now,
we have 50 different States with 50 different approaches, and
people are not only managing to comply with those different
laws, they are flourishing and doing quite well.
The second thing is that, with the passage of a Federal
privacy law, regardless of where the floor was, most States, I
think, would feel that the issue had been addressed. The States
that have been extremely active right now in passing
legislation are doing so because there is a vacuum, because
there is a serious need, either because there has been a story
in their State or a problem in their State and they have to
address it.
And the States that have been particularly active are your
home State, Mr. Chairman--California--Minnesota, New York, and
Massachusetts. Where they have active consumer groups, the
States' attorneys general have been active in those States; and
while they may have passed laws that are imperfect from the
perspective of the pharmaceutical industry and the health
information industry, they are fulfilling a need.
So I would say in this area we cannot only create a floor
which is a high floor so those States that are weaker or
problematic are, in effect, pre-empted, because the State law
must meet that floor, but it would discourage other States that
would say ``finally Congress has addressed the issue, we don't
need to be tinkering with it.'' And I think it would allay a
lot of concerns that the pro-pre-emption folks have been
pressing, which is how would we comply with a few variations in
the Federal law, when right now they are dealing with 50
variations.
The only other point I want to make is to pick up on
something Dr. Gabriel said, that one size doesn't fit all. One
size probably doesn't fit all, that if we do create a Federal
flaw--floor--excuse my New York accent----
Mr. Horn. It is either a Freudian or Jungian slip.
Ms. Goldman. No, it is my accent. If we do create a floor
which is a high one, I think then only States where there have
been very serious, egregious violations and States with
particular instances they want to address will enact
legislation. The context is very important as well.
I have worked in the privacy and civil rights area for a
decade, and there is no other Federal privacy law or Federal
civil rights law that pre-empts State law, and I think it would
be a dangerous precedent to set. Those laws recognize that the
privacy law is meant to do something good, to protect an
interest that is considered vital to a national interest; and
if a State finds it is important to go above that floor, they
should be free to do so. I think particularly in this instance
it would be wrong to constrain the States.
Mr. Horn. OK. Any other comments you have heard your
colleagues on that you would like to correct now that we are
down to number 6?
Dr. Hoge. No corrections.
I might bring to your attention Senator Leahy's draft bill
which is, I think, going to be introduced in the next couple of
weeks which I think provides a reasonable platform on many of
these issues.
Mr. Horn. We are in contact with the Senator's staff on
that, and we have worked with Senator Leahy on various
occasions.
Let me get back to fraud detection. One criticism leveled
at H.R. 52 by the insurance community is that it would inhibit
antifraud activities. Insurance companies would be limited in
the claims investigations they would perform. Should there be a
specific exemption for claims investigation and antifraud
investigations? Anybody have a strong view on that?
Dr. Hoge. Yes, I do. It is not clear to me why the
insurance industry would say that. There are many countries
that have national health care systems that don't intrude on
patients' privacy the way they are proposing. There are many
ways of detecting fraud and abuse through billing patterns,
number of billings today, without getting access to
identifiable, protected, sensitive health care information.
It is just being done throughout the world in other ways,
including Canada which has a society not so different from
ours, again by looking at patterns of billing rather than
specific, identifiable information.
So I think once they have justification----
Mr. Horn. Let me stop you right there. Let me be sure I
understand you.
Often what we are talking about is some software has been
developed that when a certain type of operation is performed,
lets say, there are certain things that relate to that; and one
can look through the bill in a systematic way and even by
software that would say, well, gee, I wonder why this was done.
That isn't normal or usual with this particular operation.
To give you a real horrible example, a woman, not in my
district, but in a neighboring district, wrote about going to a
hospital, having a particular type of operation she went in
for. In the process of being there, they also did a mastectomy,
claimed the bill. She thought that was strange since she had
had a mastectomy 10 years before.
So, obviously, there are some things thrown on these bills
by unscrupulous hospitals and unscrupulous physicians and
unscrupulous HMOs, whatever. There are a few bad apples we
always find somewhere, and that is sort of what we are
confronted with. I don't see how you deal with that operation
without knowing the name of the patient.
Dr. Hoge. Well, I think the example you gave probably would
be sufficient to get a court order to get access to the records
or maybe it is the first step to ask the hospital or doctor
whether there was an error or whether they wanted to correct
this or so on.
Maybe I jumped too early. Because the law enforcement, the
insurance company, they would love to have access--relatively
free, unfettered access to records and look for lots of things.
I think the question is how much access to allow people to have
without having any demonstrable cause.
Dr. Palmisano a minute ago talked about kicking down the
doors. Once you have things on-line, we are talking about the
computer equivalent of kicking down doors when law enforcement
and insurance companies have unfettered access.
I think the standard that is common in this country in
almost every State that I am familiar with is if there is
probable cause, a reasonable demonstration that records have to
be accessed and that can be proven to a judge, that you get a
court order; and sometimes you have to make accommodations to
patient privacy.
There are a couple of Federal cases that you should be
aware of. The Ariyoshi case----
Mr. Horn. Do you want to spell that for the record?
Dr. Hoge. I think it's A-R-I-Y-O-S-H-I. It is a Hawaii
State--State of Hawaii or Attorney General of Hawaii v.
Ariyoshi, I believe, where the Medicare fraud investigation
unit came in and grabbed a psychologist's records, snapped them
all up. They were sealed by the judge. There was a court case
that ultimately ensued, and the resolution was the court said
you do have reasonable basis for looking at certain parts of
this information, the billing aspects and so on, but you don't
have a right to look at their private information, what the
psychologist wrote about their fantasies or their fears or
their personal life.
So judicial supervision of access to records or access to
private information I think is ingrained in our society. We
don't allow the police, even if they think there might be a
crack house somewhere if the neighborhood, to go door to door
and look in every house looking for it; and that may deter--may
lead to some decrement in law enforcement. I am not pro-crack
house, but I think we have to protect privacy, and the result
of that is we have some decrement in law enforcement and fraud
and abuse investigation.
Mr. Horn. Any comment you want to make on that, Dr.
Palmisano?
Dr. Palmisano. Yes, sir. The American Medical Association
certainly is against fraud, but we do not want the standard for
investigation lowered beyond probable cause.
The example you gave, if someone had a mastectomy 10 years
ago and is being billed for it now, that should be corrected.
If it was a clerical error, to determine if it's a clerical
error or knowingly and intentionally done to defraud, those
have to be investigated.
But when you have a reasonable belief and evidence to show
that there probably is more than likely fraud going on, you can
get that order to go search that information; and it ought to
be limited to the information you need to search and not go
through all the other information.
When individuals have the power to invade your office
records or hospital records at will with a very low standard,
not only is it--it is unAmerican in our opinion, but also it is
very expensive. Because you have the finances of the Federal
Government basically funding this, your taxpayers' money
funding this. You are paying all these different lawyers to
come in to advise you what to do, and it gets extremely
expensive.
Mr. Horn. Well, this example, in fact, was on the
information company where the doctor is sending forth the bill,
lets say, where the patient has given them their health care
information as to what insurance company and then the insurance
company's attempt to apply whatever antifraud standard is the
usual procedure with that company, and the degree to which they
are saying that companies would be limited in the claims
investigations they could perform under H.R. 52. I don't know
if they are right on that or not. Obviously, we are going to
explore it.
And the question was, should there be a specific exception
for claims investigations and antifraud investigation from the
privacy standard which might be very high. But the whole reason
you take insurance, presumably, is to get the payment. But it
ought to be the accurate, truthful payment that justifies that.
Dr. Palmisano. Well, we don't think there ought to be an
exemption.
The American Medical Association, first, we are against
fraud. We have helped the FBI to help root out fraud, so we are
on record for that. But we think the standard ought to be kept
high so they are not fishing expeditions.
Also, the approach that would solve a lot of so-called
fraud problems is the approach that the American Medical
Association put forward on the Worldwide Web site called Saving
Medicare. It has been distributed to Congress. Basically, let
the patient get more involved, let the patient get back in the
driver's seat, let the patient be a fraud investigator so the
patient has some responsibility in looking at the bill. The
patient will know she didn't have a mastectomy and know right
off the bat that is an error.
The fact of getting rid of controlling prices, get down to
letting the doctors set their own conversion factors and
publicize that. Then the patients and the physicians get
involved and we get back to a society with less regulations. It
is impossible to write regulations to cover all possible
situations.
I think in terms of the heroic American effort when we were
involved in the Normandy invasion after the people on the beach
were killed--at Omaha beach. Ninety percent of the people that
hit the beaches that day from the 116th, from Virginia, they
were killed on the spot. Their ship was sunk, and they swam to
shore and had to get up.
The reason we were able to get up there and knock out the
machine guns--the reason we were able to knock out those big
guns is because Americans were resourceful. If they had to
follow some little rule book and regulation--now, if the German
Army does this--they would have all been killed that day. In
fact, Colonel Rudder couldn't lead the attack. The General
said, ``Colonel Rudder, don't do this attack;'' and he said,
``I am going to have to disobey you, sir. I have got to lead
the men. Otherwise, it won't get done.'' And he did it.
That is why they say Hitler's Youth Crew lost out to the
American Boy Scouts. The Boy Scouts were very resourceful.
Every time we come up with more harassment on physicians
and patients, we end with a system that really doesn't work. It
becomes more burdensome. So we would hope that would remain on
the forefront.
Today we are talking about privacy and confidentiality, and
we want to enhance that, protect that. But, on the other hand,
we don't want to have rules and regulations that end up
creating more burden and don't protect that.
Mr. Horn. Ms. Goldman.
Ms. Goldman. My only comment to add to the ones that have
been made is I think it is really important that we recognize
that there should be fourth-amendment-type limits on Government
access to certainly health information. H.R. 52 and the other
bills that have been discussed do that. We do it to varying
degrees, and the Justice Department has expressed concern about
those provisions, and I am not aware that they have signed off
on any of them.
I think it is a natural response on the Justice
Department's part to say we now have unfettered access to
personal health information. Please don't make us be bound by
the fourth amendment. That is an understandable response, but
it is certainly not the right one.
The fourth amendment is not an absolute bar to law
enforcement access to records. What it says is, you must meet
the standards, probable cause or clear and convincing standard
before you can get access; and it is a protection on the
individual. It is certainly not an absolute bar. And it is one,
again, we see in the privacy laws we already have at the
Federal level and ones that should be built into this Federal
policy as well.
Mr. Horn. I must state one of the goofier implementations
of privacy law in my field of education was when the Department
of Education--and I happened to head a national coalition to
create it, so I favored the Department--that we had strict
rules written into that law that you could not impose curricula
on States, et cetera. But they visited Pennsylvania State
University and later California State University at Long Beach;
and they said, oh, you can't display the thesis of a student in
the library without the signed exception to the Buckley Act--of
the privacy right.
Now only an idiot would make that kind of ruling.
Unfortunately, it went up the high hierarchy. And the
Secretary, when the complaint was given to him, stuck by that
stupid policy.
Now the whole purpose of the dissertation and thesis is to
be examined by the outside world. So here we have the case of a
Federal law being used where the thesis writer could have
massive plagiarism. The professors might have missed it. You
can't keep up on everything in every field. That thesis is
signed off, and it is normally deposited everywhere in America
in the university library or the microfilm operation for
dissertations in Michigan.
There is an example of people going haywire with a, quote,
privacy right, unquote. There is no privacy right, it seems to
me; and yet they could get away with it. They could have
plagiarized; and under the Department of Education's great
interpretation, they can be free because no one will ever see
it. It is not on the library shelf. I don't know if they are
still doing it, but they were doing that several years ago.
Ms. Goldman. I would agree with you. That is an unfortunate
application of a privacy law.
My experience has been a little bit different in that what
I tend to see is underenforcement of existing privacy laws or
weak construction of the existing privacy laws and not
overzealous application. But it would be interesting to see if
that is still the interpretation, because I agree with you that
what is a public record ought to be available.
Mr. Horn. All right. Let us move to the next series of
questions, and H.R. 52 requires health researchers to receive
approval from a certified institutional review board in order
to review patient records. Is that acceptable to most of you or
how do you feel on that? Are there any problems with that
section, which is 152 of the bill?
Ms. Goldman. Well, what is interesting is that the approach
taken by H.R. 52 and the one taken in last year's bill
introduced by Senators Leahy and Bennett is one that at least
recognizes there are Federal regulations right now that require
all federally funded researchers to get the informed consent of
individuals whose information may be the subject of research.
So, as Dr. Gabriel said earlier, there are already requirements
on federally funded researchers to have to get the informed
consent, unless the IRB agrees that a waiver is appropriate and
there is a standard for the waiver.
The Senate approach basically said, lets codify those
regulations so that all researchers--not just federally funded
researchers but all researchers will have to comply with
informed consent. I think the pharmaceutical industry last year
had concerns about that, but that has a fair amount of
unanimity that that is a pretty good start.
I think H.R. 52, again, tries to bring in the Institutional
Review Board and create another level of hierarchy, which I
don't think is a bad idea, to say someone should be watching
the IRBs. Because even though there has been some studies
commissioned in recent months, there is no record, no factual
basis to know how IRBs work as a whole, how we look at the
consent mechanism, when and where they approve waiver
applications. So we know little about how IRBs work. We do know
they adhere to privacy issues, consider them in the application
for research.
Mr. Horn. Now is there any type of research that does not
require such approval?
Ms. Goldman. The research that does not require approval
are ones that do not involve identifiable data. And I would
agree, if you are not using identifiable data, you should not
have to get the consent of the records covered, because it is
not within the privacy scope. Nonidentifiable data has to be
clearly nonidentifiable data, and there is discussion about
what that means. But I would agree that nonidentifiable data is
outside the scope of a privacy bill.
Dr. Andrews. I would like to make a couple of comments.
First, relating to IRB review and approval----
Mr. Horn. It is Institutional Review Boards. I just want
the audience to know what we are talking about.
Dr. Andrews [continuing]. The regulations are quite strict
on IRBs. There is currently a commission that is looking at the
IRB process and that, I assume, will also be looking at not
only the protection of patients against medical risk but also
privacy risks. There seems to be no need for additional
legislation on this point which might pre-empt or prematurely
set some legislation in place to pre-empt the outcome of that
commission's reports.
Regarding what information is considered identifiable, I
think that is a key point; and we feel that the language in the
current H.R. 52 is a little too broad in identifying what would
be considered personally identifiable data. For studies that
use data bases that contain a key or an encrypted code that
could potentially be used to link back to medical records,
those studies currently do not require IRB approval or patient-
informed consent. They generally are considered to fall below
the level of minimal risk that would determine the need to have
informed consent.
In addition, as you have also heard from Dr. Gabriel,
informed consent is frequently not feasible in these
circumstances in using very large data bases answering
questions that may arise many years after the information was
collected, because there is difficulty locating patients in our
highly mobile society, getting consent itself may introduce a
bias, and because contacting patients may also constitute a
violation of patient privacy.
In addition, as you have also already heard, if you use
only the patient data from those who have been located and
provided consent, you may introduce a bias in the study which
may invalidate the study findings.
Mr. Horn. Dr. Hoge has a comment.
Dr. Hoge. Actually, yes, and maybe in the way of a
question. I am a little unclear if a doctor enters in the data
base that you are talking about has a code, could be stripped
of that code.
I guess the point I am asking, it seems it would be
reasonable to ask IRB approval if there is going to be the
future capacity to relink that code to the person's actual
identity, because now you have got a privacy concern that
someone should be overseeing. But if you are going to take the
information, strip it, it doesn't seem to be a problem, but
maybe I am misunderstanding.
Dr. Andrews. I think there is something in between that. I
believe that data bases totally stripped of identifiers should
be excluded. Then there are data bases that have an encrypted
code that could be linked back, and we also feel those should
be exempted.
I think the actual relinking, which I think is what you are
referring to--someone is taking the code, relinking,
identifying patients and abstracting additional information to
supplement the original study; and those do need very tight
security over the relinking and may need and usually are, I
believe, covered by IRB review and approval at the moment.
Dr. Hoge. If I might--but, again, if there is a potential
to relink through the code, that means you either have the plan
or some expectation of relinking it; and, therefore, there is
some privacy risk--I don't understand. It seems a little
disingenuous. If you are not planning on relinking, why don't
you just strip it? And if you are planning to relink it, it
seems to me you are back at a point where you have got to get
IRB.
Mr. Horn. Do you want to respond to that, Dr. Andrews?
Dr. Andrews. The reality is these data bases often have
been so carefully developed that this encrypted code is
available for the researcher. The researcher cannot by
themselves identify the patient, and they have no interest in
doing so. They are interested in the aggregate data. It is the
local physician or a third party that would be able to take
that encrypted code and link back.
Mr. Horn. Dr. Gabriel.
Dr. Gabriel. I just wanted to make the point that all of
the research that I mentioned in my statement is already
covered by the IRB. In fact, at our IRB we apply the
regulations to everything, federally funded or not. So I would
endorse having the IRB approval for all of these studies.
Mr. Horn. Dr. Palmisano.
Dr. Palmisano. Thank you, Mr. Chairman.
I just wanted to emphasize that when we put in the
statement--both oral statement and written statement--that
medical information used for research purposes should have all
identifying information removed unless a patient specifically
consents to the use of his or her personally identifiable
information; and on the subject of research it can be a
troublesome category of exceptions to the general requirement
for patient consent. Although in conclusion, we are generally
satisfied that the IRB patient protections are adequate, we
believe that a scientist should be able to pursue legitimate
research without unreasonable barriers and that it is possible
to do this while still protecting patients' privacy. What we
don't want to see is the term research applied to a whole
spectrum of economic analysis that solely benefits shareholders
rather than patients.
I guess I would like to pose a question back on H.R. 52. On
page 39, it states that the project has been determined by a
certified Institutional Review Board to be of sufficient
importance to outweigh the intrusion into the privacy of the
protected individual who is the subject of the information that
will result from the disclosure. So it appears from this
reading that privacy will be invaded, and the IRB is saying
that the research is of sufficient importance. So it is not
being treated as an IRB study.
Consultation is being obtained with the IRB to decide
whether or not it is of sufficient merit to invade privacy, and
what we say is that medical information used for research
purposes should have all identifying information removed unless
a patient voluntarily and knowingly and willingly consents to
that information.
So it is right to go through the Institutional Review
Board. We think--a lot of them we hold in high regard.
On the other hand, we don't know that this is going to
protect the privacy--it goes back to the philosophical
discussion, is the teleological approach to the philosophical
base whereby you say, well, the end justifies the means, so we
are going to invade privacy to do this research and find out
these potentially good things. We think the patient's privacy
must be paramount.
Thank you.
Mr. Horn. Dr. Gabriel.
Dr. Gabriel. I wanted to respond to that a little bit.
As we said before, the researcher is not aware that this is
Mrs. Jones' data. The only place that privacy might be
invaded--there has to be a point somewhere where you collect
the data from the medical records, put it in a data base, strip
the identifiers, and that is where the analysis happens.
So I have a question. How do you define nonidentifiable
data? There has to be--so the point, at least in the way we do
things, we have usually a nurse administrator abstract a piece
of information from a medical record and then that is put in a
data base with hundreds of other people's data and then the
information or the patient identifiers are removed. So when you
were reading that I was thinking maybe that was what they were
referring to.
Dr. Palmisano. Mr. Chairman, it is just a question. I am
not sure what is being referred to. I think it is vague as
written here. It may be because of my ignorance, I don't know,
but I would like it clarified.
I certainly understand how I could see a scenario. I don't
consider myself a computer wizard, but I would see where you
could send someone who understood confidentiality and taken an
oath, could go to medical records and say, all names will be
removed and codes will go in there and these codes don't
necessarily link up, but it identifies whatever you need to
identify without identifying the individual and that would be
given to the researcher. It appears from what I have heard that
would satisfy the researcher.
So I think that could be done from a technological basis,
and those who are much smarter than I am in computer
methodology could come up with an even better way than that.
But it appears that the information could be interpreted by a
reasonable individual to say that we are going to allow the
name to be kept with this record because the research is of
such moment that the IRB, they agree, is really of great
moment. So they have this invasion of privacy without the
individual knowing; and the individual may say, no, I did not
want you to allow that. I did not want to take the risk,
however small, 10th of 1 percent that it would be discovered by
someone else.
Mr. Horn. Perhaps we should have staff talk to the National
Institutes of Health. Because you could have a project that
takes 5 to 10 years, maybe, to come to some conclusion; and the
question is, if you do discover something that relates to that
sample or you want a later subsample of that, is there a way
you can tie that back to the good of the patient?
Yes, Dr. Andrews.
Dr. Andrews. Let me address this question of relinkage.
While I may strip a data set, there are some circumstances
where you would want to have the ability to go back and relink;
for example, if you are doing a study on the safety of a
particular kind of drug and you may follow patients for 6
months. If you obtain a signal that this drug may be causing
cancer and the latency period is longer than 6 months, then you
might want to use that same cohort of patients, extended for a
longer period of time, in which case you need to take the data
set back to its origin, relink through a very careful time-
limited linkage, and gather the information that would then go
into the data base that would no longer have the identity. It
would be that linkage process that would need to be carefully
safeguarded, rather than the whole data base. So I think we are
all saying the same thing.
[The information referred to follows:]
[GRAPHIC] [TIFF OMITTED] 45252.078
[GRAPHIC] [TIFF OMITTED] 45252.079
[GRAPHIC] [TIFF OMITTED] 45252.080
[GRAPHIC] [TIFF OMITTED] 45252.081
Ms. Goldman. I have to add one thing on the research.
I think there is a fair amount of agreement the vast amount
of research that is done in this country is done with the
deidentified data, out the personal identifiers. For that small
group of research that is done with identifiers, I again say
that it is very important that informed consent of patients be
obtained. Because, as a few people have testified, there is a
concern about there being a bias, that those that opt out would
create a bias. At least it is a known bias.
You know, there are a small group of people who say, I am
uncomfortable being a part of this research project because I
am concerned with confidentiality or I am concerned about
losing my job or whatever it is, which are real concerns on the
part of the individual.
The current situation we have, where identifiable data is
used in research without individuals' consents, the bias in
those research projects involve people who give inaccurate
information because they are afraid of the lack of privacy.
People who lie, people who don't seek treatment, those create
biases; but we don't know about them. We can't quantify them.
At least--if they opt out and the information is asked for and
it is withheld, at least you know who is saying I do not want
to be a part of this research project.
Mr. Horn. Well, that leads to the next question. If some
patients are willing to give general waivers at the outset of
their treatment permitting future disclosures of records to
providers, researchers and others, should H.R. 52 prevent that
or should each research project require informed consent of the
patient to be sampled at that particular time?
Ms. Goldman. The way H.R. 52 is written is in authorization
there has to be an identification of who the recipients would
be and what the information would be used for.
If the authorization is written broadly enough--and, again,
getting that authorization does not then condition whether or
not you deliver benefits or services. If people want to be part
of ongoing research and that research is specified, it is not
my judgment to make. I think these are individual judgments
that people should make.
The beauty of the privacy law that is crafted like this, it
lets people make those choices. It lets doctors talk to the
patients and say, I would like you to be involved with this; I
think it would benefit you. It allows researchers to come in
and have contact with people and talk to them about the
benefits and risk. That is what is allowed here. It allows
people to make their own choices and not myself or anyone else
in this room to say here is the standard, here is what should
apply.
Mr. Horn. OK. We are going to wind this up.
Anything any of you have on your mind that we haven't asked
about in this hearing record?
Dr. Hoge. I think you were a born therapist.
Mr. Horn. We don't get those wages--sorry--salary,
whatever, bills paid.
OK, I want to thank you all very much for coming. You have
all raised some new questions, as any good hearing does; and we
will be following up. Just like your comments, as we go, if
there is a new draft bill put together, we will send them to
you. We would like your comments. Those of your association
would be very helpful.
With that, this hearing is adjourned.
Oh, let me just put the staff on the record. I want to
thank the following people that worked on this.
J. Russell George, the staff director and chief counsel;
and Mark Uncapher, who is on my left, your right, the counsel
for this hearing; John Hynes, professional staff member; Andrea
Miller, clerk. David McMillen, professional staff member for
the minority; Ron Strohman, professional staff member for the
minority; Jean Gosa, clerk for the minority; and Sheridan
Parker, minority research assistant.
We have had interns with this particular hearing: Mike
Pressicci, Grant Newman, Melissa Holder; and our court
reporters are Katrina Wright and Tracy Petty.
Now we are adjourned.
[Whereupon, at 12:30 p.m., the subcommittee was adjourned.]
[Additional information submitted for the hearing record
follows:]
[GRAPHIC] [TIFF OMITTED] 45252.082
[GRAPHIC] [TIFF OMITTED] 45252.083
[GRAPHIC] [TIFF OMITTED] 45252.084
[GRAPHIC] [TIFF OMITTED] 45252.085
[GRAPHIC] [TIFF OMITTED] 45252.086
[GRAPHIC] [TIFF OMITTED] 45252.087
[GRAPHIC] [TIFF OMITTED] 45252.088
[GRAPHIC] [TIFF OMITTED] 45252.089
[GRAPHIC] [TIFF OMITTED] 45252.090
[GRAPHIC] [TIFF OMITTED] 45252.091
[GRAPHIC] [TIFF OMITTED] 45252.092
[GRAPHIC] [TIFF OMITTED] 45252.093
[GRAPHIC] [TIFF OMITTED] 45252.094
[GRAPHIC] [TIFF OMITTED] 45252.095
[GRAPHIC] [TIFF OMITTED] 45252.096
[GRAPHIC] [TIFF OMITTED] 45252.097
[GRAPHIC] [TIFF OMITTED] 45252.098
[GRAPHIC] [TIFF OMITTED] 45252.099
[GRAPHIC] [TIFF OMITTED] 45252.100
[GRAPHIC] [TIFF OMITTED] 45252.101
[GRAPHIC] [TIFF OMITTED] 45252.102
-