HIPAA For Research

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HIPAA For Research

• Understanding how the Health Insurance
  Portability Accountability Act of 1996 Affects
  Clinical Research

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HIPAA History

• Health Insurance Portability Accountability Act
  of 1996 (Kennedy-Kassebaum Act)
• Effective April 14, 2001
• Compliance Required by April 14, 2003 (October
  2003)

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HIPAA General Provisions

• Standardization of electronic patient health,
  administrative and financial data
• Unique identifiers for individuals, employers,
  health plans, and health care providers
• Security standards protecting the confidentiality
  and integrity of health information.

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What Is PHI?
PHI is all individually identifiable health
information, including demographic data and
biological specimens, that is transmitted or
maintained by a covered entity. PHI can be in
any form, including written, electronic, and
verbal.
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Protected Health Information (PHI)

• Is created or received by a health care provider,
  health plan, or health care clearinghouse
• Relates to past, present, or future
• Provision of care to an individual
• Physical or mental condition(s)
• Payment for provision of health care to an
  individual

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De-identification of PHIs

• Medical institutions can release de-identified
  health information without patient authorization.
• The following 18 specific identifiers must be
  deleted

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De-identification

• Names
• All geographic subdivisions smaller than a state.
• All dates (except year)
• Telephone numbers
• Fax numbers
• Electronic mail addresses
• Social Security numbers

• Medical record numbers
• Health plan beneficiary numbers
• Account numbers
• Certificate/license numbers
• Vehicle identifiers, including license plate
  numbers

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De-identification cont

• Device identifiers and serial numbers
• URLs
• Internet Protocol (IP) Addresses
• Biometric identifiers, including finger and voice
  prints

• Full face photographic images and any comparable
  images
• Any other unique identifying number,
  characteristic, or code.

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Impact on WVSOM Human Subject Research
-Access to PHI Researcher must understand the
permissible routes of access to PHI for research
activity AND -Restrictions on Use and Disclosure
of PHIs Researcher must implement necessary
safeguards to protect the PHI
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• The Privacy Rule permits a covered entity (WVSOM
  or Affiliated Hospitals) to use and disclose PHI
  for research
• When an individual Authorization has been
  obtained from a research participant, OR
• When a Waiver of Authorization has been obtained.

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• There are other limited situations where PHI can
  be used/disclosed without an Authorization e.g
  use of PHI on decedents, use of PHI for Reviews
  Preparatory to Research, limited data sets, etc.

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Existing IRB-Approved Studies

• The Transition Provision in the Privacy Rule
  permits covered entities (USF) to continue to use
  and disclose PHI for research, if it has obtained
  prior to April 14, 2003,
• An IRB approved consent form, or
• An IRB approved waiver of consent, or
• An express legal permission (e.g., a signed
  authorization)

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New Studies
To use/disclose PHI in research, the researcher
must obtain 1) An Authorization from the
individual participant. OR 2) A Waiver of
Authorization for the study. An Authorization
is the HIPAA equivalent of consent to use and
disclose data.
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AUTHORIZATIONS

• Valid authorization must include the following
• elements
• A description that identifies the information in
  a specific and meaningful fashion
• The name of the person(s) authorized to make the
  requested use or disclosure
• The name of the person(s) to whom the covered
  entity may make the requested use or disclosure

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Patient Authorization (Cont.)

• An expiration date/event that relates to the
  purpose of the use or disclosure
• A statement of the individuals right to revoke
  the authorization in writing and the exceptions
  to the right to revoke, together with a
  description of how the individual may revoke the
  authorization

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Patient Authorization (Cont.)

• A statement that information used may be subject
  to re-disclosure by the recipient and no longer
  be protected by this rule
• Signature of the individual and date
• If the authorization is signed by a personal
  representative of the individual, a description
  of such representatives authority to act for the
  individual

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Patient Authorization (Cont.)

• The authorization must be written in plain
  language.
• Can be combined with consent if research involves
  treatment, but not at WVSOM.
• Research including existing records would require
  a separate authorization.

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Waiver

• Disclosure involves no more than minimal risk to
  the individual
• The waiver will not adversely affect the privacy
  rights of the individual
• Research could not be conducted without the
  waiver
• Research could not be conducted without access to
  protected health information

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Waiver (Cont.)

• The privacy risks are reasonable in relation to
  the anticipated benefits to the individuals and
  the importance of the knowledge gained through
  research
• There is a plan to protect patient identifiers
  from improper use and disclosure
• There is a plan to destroy patient identifiers at
  the earliest opportunity

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Waiver (Cont.)

• There are adequate written assurances that
  protected health information will not be reused
  or disclosed to others except as provided by the
  regulations and restricts most disclosures of
  information to the minimum intended purpose.

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Research Use/Disclosures That Do Not Require
Authorizations or Waivers
1. Review of PHI Preparatory to Research
2. Use of PHI of Decedents for Research Purposes
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Special Rules Regarding Databases

• Creating and maintaining databases containing
  PHI is considered research.
• If you will use existing databases containing PHI
  for research after April 14, 2003, you must
  obtain Authorizations or Waivers.
• If you will create or maintain databases for
  future analysis, you must comply with HIPAA in
  addition to obtaining IRB approval.

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Research Subject Recruitment

• Recruitment for research is subject to the
  general authorization requirement unless the
  researcher has a direct treatment relationship
  with the patient.
• Researchers could use the Waiver of Authorization
  mechanism to access PHI for recruiting
  prospective research subjects.

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Research Subject Recruitment cont

• A researcher who has a direct treatment
  relationship with the patient can engage in
  conversations related to recruitment without
  having to obtain Authorizations or Waivers.

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Revocation of Authorization

• Research subjects can revoke their Authorization
  in writing at any time. This is subject to an
  exception know as the Reliance Exception.
• A subject wishing to revoke the Authorization
  must be given a form for Revocation of
  Authorization

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Revocation of Authorization cont

• If the subject does not sign and return the form,
  then the researcher may continue to use the PHI
  and treat the Authorization as valid.

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Reliance Exception to Revocation

• The Reliance Exception allows researchers to use
  and disclose a subjects PHI that was obtained
  before the subjects revocation in the following
  ways
• To account for a subjects withdrawal from the
  study
• To conduct investigations of scientific
  misconduct
• To report adverse events
• As necessary to incorporate the information of a
  marketing application to FDA

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Research Subjects Rights

• Accounting of the following research related
  disclosures of PHI are required
• Disclosures as allowed by a Waiver of
  Authorization
• Reviews preparatory to research
• Research on PHI of decedents
• Disclosures made as allowed by law

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Research Subjects Rights cont

• The Following Disclosures are NOT required
• Disclosures made to the individual subject.
• Disclosures authorized by the subject (i.e., the
  research subject has signed an Authorization for
  this use/disclosure of PHI).
• De-identified data and limited data sets.

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Summary
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Sanctions for Non-Compliance

• Significant penalties may be imposed against
  WVSOM, Affiliate Hospitals, and individual
  researchers.
• Civil Penalties
• Based on patient complaints 100 per violation
  with 25,000 maximum per year

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• Criminal Penalties
• Knowingly wrongful disclosures fines up to
  50,000 and/or up to 1 year in prison
• Under false pretenses fines up to 100,000
  and/or up to 5 years in prison
• With intent to sell fines up to 250,000 and/or
  up to 10 years in prison

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Summary Researcher Responsibilities

• Preparing an extensive confidentiality plan
• Who will have access to the data?
• How long will access be needed?
• Will third party payers or other administrators
  need to have access?
• Time to gain approval from an additional
  committee
• Alternatives

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Summary IRB Responsibilities

• Have appropriate expertise in privacy and
  confidentiality concerns.
• Ensure that consent forms contain appropriate
  authorization requirements if applicable.

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Summary IRB Responsibilities

• Understand waiver criteria and document
  appropriately.
• Coordinate with Privacy Board, if applicable.

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HIPAA IRB AT WVSOM
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You must demonstrate both IRB and HIPAA
Compliance by Passing the Following Courses and
Quizzes
IRB http//cme.nci.nih.gov/
HIPAA http//www.wvu.edu/rc/irb/hipwebct.htm
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QUESTIONS!?

• Prepared By
• Jason S. Wrench, Ed. D.
• Medical Education Specialist
• West Virginia School of Osteopathic Medicine