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Frequently Asked Questions by Vaccination Providers
Why
is the National Immunization Survey requesting information from providers?
Does
the Privacy Rule allow me to participate in the NIS?
Does the NIS
have any documentation of patient authorization?
Am I
required to comply with the HIPAA Privacy Rule?
What
is protected health information?
What
do I have to do to participate and comply with the Privacy Rule?
What
demonstrates that you are a public health authority?
Why
do I have to account for these disclosures?
Do I
have to have an Institutional Review Board (IRB) review this research project?
What
if I want to have my Institutional Review Board (IRB) review this project?
Where
can I find the requirements of the Privacy Rule?
Under
what legal authority do you collect this information?
How
do I return an Immunization History Questionnaire?
Is
it necessary to fill out the entire form?
Is
there someone I can talk with about the NIS Provider Record Check Study?
What
do I do if this child is not my patient or if I have no immunization
records for this child?
Click here to view the cover letter and the questionnaire for vaccination providers requested to participate in the National Immunization Survey Provider Study. You can also view the NIS Documentation Notice for HIPAA Accounting here.
WHY IS THE NATIONAL IMMUNIZATION SURVEY REQUESTING INFORMATION FROM PROVIDERS?
We have discovered that sources of vaccination information from doctors
and clinics are the most up-to-date and comprehensive and that the quality
of the study's results is much improved by combining the information given
by households with that given by these medical providers. It is important that we obtain the most reliable information
possible about children's vaccinations so that we can provide the public
with reliable estimates.
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Does the Privacy Rule allow me to participate in the NIS?
The Privacy Rule permits
you to make disclosures of protected health information without signed
patient authorization for public health purposes and for research that has
been approved by an Institutional Review Board (IRB). This survey
meets both of those criteria.
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DOES THE NIS HAVE ANY DOCUMENTATION OF PATIENT AUHORIZATION?
While
not required by the Privacy Rule, a parent or guardian has given verbal
authorization for the release of the child’s immunization history to us.
Documentation of this verbal consent is provided to you with the
request for immunization data.
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Am I required to comply with the HIPAA Privacy Rule?
Health
care providers who transmit financial and administrative health
information electronically must comply with the Rule as of April 14, 2003.
For example, if you submit claims electronically, you would be
required to comply with the Rule.
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What is protected health information?
Protected health information includes all medical records and other
individually identifiable information used or disclosed by an entity
subject to the Privacy Rule. This would include directly
identifiable information such as patient names, and other information such
as social security numbers that could be used to identify an individual.
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What do I have to do to participate and comply with the Privacy Rule?
There are several things that would ensure that you comply with the Rule when participating in the survey. First, the privacy notice that you provide to your patients must indicate that patient information may be disclosed for research or public health purposes. Many of the model notices that have been developed and made available by professional associations provide for this.
Also, we have provided and made available on our website the material that you may need to verify, under the requirements of the Privacy Rule, that you are allowed to disclose to CDC the information requested as part of this survey. This includes the authority under which CDC is collecting this information and that the information being collected is the minimum necessary.
Finally,
you will need to keep track of disclosures made for this survey. We will give you a document that contains the information that you
need to keep track of the disclosures.
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Is there any other information that I need to assess to ensure that my disclosure is authorized under the Privacy Rule?
No.
The letter that you received requesting that you participate in
this survey is from the Captain, United States Public
Health Service, Acting Director, Stephen L. Cochi, M.D. M.P.H., of
the National Immunization Program, which is part of CDC. The
Privacy Rule specifies that you are allowed to disclose information
requested for public health purposes to public health agencies such as CDC
without patient authorization. The
Rule also states that for research projects you may rely on documentation
that we have provided indicating that an Institutional Review Board (IRB)
has approved a waiver to allow you to disclose patient information without
signed authorization.
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What demonstrates that you are a public health authority?
The
survey is sponsored by the National Immunization Program and the National
Center for Health Statistics, agencies of the CDC. CDC is a public health authority whose mission is to protect the
health of the public. The
letter that we sent asking you to participate was sent on official CDC
letterhead and described our legislative authority to conduct this survey.
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Why do I have to account for these disclosures?
Under
the Privacy Rule, patients have a right to an accounting of disclosures
that have been made of their identifiable information for various
purposes, including disclosures for public health and research purposes.
We will provide you with the information you need to account
for the disclosures made as part of this survey.
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Do I need to worry about whether this is the minimum necessary information for the purposes of the project?
No.
The Privacy Rule specifies that in providing information to public
agencies, such as CDC, you may rely on our representation that the request
constitutes the minimum necessary information required. This issue is also considered as part of the Institutional Review
Board (IRB) approval process, and the Privacy Rule specifies that you may
rely on the documentation of IRB approval that the information requested
is the minimum necessary for the research purpose.
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Do I have to have an Institutional Review Board (IRB) review this research project?
No.
For research projects, only one IRB must review the project and CDC’s
IRB, know as the Research Ethics Review Board, ERB, (which has the authority to review such projects under the Regulations
for the Protection of Human Subjects) has done so. We have a document that indicates that a waiver has been approved
by an IRB for this survey, and contains the documentation that is required
by the Privacy Rule. If you
desire, your IRB may review the project as well.
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What if I want my Institutional Review Board (IRB) to review this project?
Your
IRB could verify that the documentation we have provided adheres to the
requirements of the Privacy Rule.
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Where can I find the requirements of the Privacy Rule?
The entire text of the Privacy Rule can be found at http://www.hhs.gov/ocr/hipaa/finalreg.html
The following parts of the rule were referred to above:
Disclosures without patient authorization – 45 CFR 164.512
Disclosures for public health activities – 45 CFR 164.512(b)
Disclosures for research purposes – 45 CFR 164.512(i)
Verification requirements – 45 CFR 164.514(h)
Privacy notice – 45 CFR 164.520
Accounting of disclosures – 45 CFR 164.528
Minimum necessary requirements – 45 CFR 164.502(b) and 45 CFR 164.514(d)
HIPAA
guidelines are also available at the following website:
http://www.hhs.gov/ocr/hipaa/
Return
to Top
UNDER
WHAT LEGAL AUTHORITY DO YOU COLLECT THIS INFORMATION?
This
study is authorized by Section 306 of the Public Health Service Act and
The National Childhood Vaccine Injury Act of 1986. The information you supply will be treated confidentially, as
specified by law in Section 308(d) of the
Public Health Service Act. The Centers for Disease Control and Prevention, its
contractors, and staff of State and local immunization programs who are
participating in this study will use the information for statistical
purposes only. We will not
release any information that could identify you, your practice, your
facility, the child, or the child's family. Although your participation is voluntary, we hope that you will
choose to participate.
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HOW DO I RETURN AN IMMUNIZATION HISTORY QUESTIONNAIRE?
A pre-paid, addressed envelope was included in the packet of materials along with the request for information about the child’s immunizations. If you do not have the envelope, the address is:
National
Opinion Research Center
National Immunization Survey
1 North State Street, FL 16
Chicago, IL 60602
If it is more convenient
you may fax the information to our toll-free number: 1-866-324-8659
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IS IT NECESSARY TO FILL OUT THE ENTIRE FORM?
If you prefer, you may attach a photocopy of the child’s immunization
history to the questionnaire and just complete the items on the first
page.
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IS THERE SOMEONE I CAN TALK WITH ABOUT THE NIS PROVIDER STUDY?
If you have any questions or comments
about the materials being requested, please call 1-800-817-4316. If you
would like additional information about the National Immunization Survey,
please call Ms. Marcie Cynamon at (301) 458-4174, with the National Center
for Health Statistics. Your participation in the National
Immunization Survey Provider Record Check Study is greatly appreciated.
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WHAT DO I DO IF THIS CHILD IS NOT MY PATIENT OR IF I HAVE NO IMMUNIZATION RECORDS FOR THIS CHILD?
The first item on the front page of the questionnaire (see below)
allows you to indicate this. Please check the appropriate option and
return the form so that we do not send you a second request for the
information.
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to Top
1. Which of the following best describes your immunization records for this child?
[] You have all or partial immunization records for this child.
[] This facility gives immunizations only at birth (hospital).
[] Other – Explain
[] You have provided care to this child, but do not have immunization
records.
[] You have no record of providing care to this child.
This page last reviewed
April 17, 2006
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