107th Congress

Medical Information and Research Enhancement Act of 2001

H.R. 1215

Background

On March 27, 2001, Representative Jim Greenwood (R-PA), introduced H.R. 1215, the Medical Information and Research Enhancement Act of 2001, a bill to ensure confidentiality with respect to medical records and health care-related information.

Provisions of the Legislation/Impact on NIH

The research provisions of the bill would have permitted the use and disclosure of protected health information for interventional research where the research had been reviewed by an institutional review board pursuant to the Common Rule. In addition, it would have permitted use and disclosure of protected health information for purposes of conducting analyses of health care records and archives (i.e., that which did not involve the human subject directly) only where 1) sufficient safeguards had been established to protect the confidentiality of the information, 2) an internal board or committee was designated with responsibility to review research programs, and 3) the person maintaining the information had policies and procedures in place to specify the permissible and impermissible uses of such information. Disclosure of protected health information could have been made to a manufacturer of a drug, biologic, or medical device for use in verifying the safety or efficacy of the manufacturer's approved product. Researchers could not have been compelled to disclose protected health information in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, except where such disclosure was required pursuant to an audit or lawful investigation of a research project conducted, supported, or subject to regulation by a Federal department or agency.

Status and Outlook

H.R. 1215 was introduced on March 27, 2001, and referred to the House Committees on Energy and Commerce and on the Judiciary. On April 16, the bill was referred to the House Energy and Commerce Subcommittee on Health. On May 9, it was referred to the House Judiciary Subcommittee on Crime. The bill had three cosponsors.

The hearings held in the 107th Congress were forums to critique the shortcomings of the Administration's final privacy rule. In order to appease the business community, a second comment period was permitted, and a modified final rule was published on August 14, 2002. The compliance date of April 13, 2003, was retained, however, leaving open the possibility for medical privacy-related legislation next session.