Questions and Answers
What does 'retrospective research' under HIPAA generally require?
Either an authorization or meeting one of the criteria for a waiver of authorization.
What must be obtained for the use or disclosure of PHI for retrospective research studies?
Patient authorization or a waiver, alteration, or exception determination from an IRB or Privacy Board.
A covered entity may use or disclose PHI without authorization, documentation of waiver, or alteration of authorization for all of the following EXCEPT:
Under HIPAA, what is generally required if data in question meet the definition of PHI for research purposes?
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Who can you consult with if you have questions about HIPAA research requirements at your organization?
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Which protections do HIPAA's regulations supplement for health information used for research purposes?
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Under HIPAA, when is a disclosure accounting required?
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What remains the responsibility of Institutional Review Boards (IRBs) in relation to HIPAA's requirements?
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What characteristics does a HIPAA authorization have?
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When are authorizations required under HIPAA?
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Study Notes
HIPAA and Retrospective Research
- Retrospective research involves data mining of Protected Health Information (PHI) and requires either patient authorization or criteria for a waiver.
- Use or disclosure of PHI for retrospective studies mandates patient authorization, or necessitates a waiver or determination from an Institutional Review Board (IRB) or Privacy Board.
Disclosure of PHI
- A covered entity can disclose PHI without authorization for various reasons, except when data does not cross state lines.
- Explicit written authorization is generally required for research involving PHI, unless specific exemptions apply, such as minimal risk research or use of de-identified data.
Approval Necessities
- It is important to consult an organizational IRB, Privacy Board, or privacy/security officials for questions regarding HIPAA research requirements.
- Generic advice from colleagues or representatives of funding entities may not be authoritative or suitable for a specific organization’s rules.
HIPAA's Protections
- HIPAA provides protections that supplement existing regulations from the Common Rule and FDA, enhancing the safeguarding of health information in research.
- Disclosures using PHI for human subjects research require accounting unless they involve limited data sets.
Institutional Review Board (IRB) Protocols
- HIPAA's data protections, effective since 2003, complement rather than replace the Common Rule and FDA criteria.
- IRBs may review HIPAA's additional requirements or delegate responsibilities to Privacy Boards or privacy officers.
Disclosure Accounting Requirements
- Disclosure accounting is not required for instances where consent or authorization has been obtained or where information pertains to the subject themselves.
- Accounting is also not mandated for limited data set disclosures under data use agreements or for de-identified information.
Characteristics of HIPAA Authorization
- HIPAA authorizations must be written in "plain language" for understanding, similar to informed consent documents.
- Authorizations are mandatory unless the use conforms to specific exemptions; they must be signed by the research subject or their authorized representative.
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Description
This flashcard set covers essential concepts related to HIPAA privacy protections, specifically focusing on retrospective research and the use of Protected Health Information (PHI). Gain a deeper understanding of the regulations and the criteria for research authorization. Ideal for students studying health law or those in healthcare professions.