HIPAA and research

On this page

HIPAA & Research - The Privacy Rulebook

Patient authorization is the default for using Protected Health Information (PHI) in research. Key exceptions allow access while protecting privacy.

  • Authorization Exceptions:
    • De-identified Data: Not PHI if all 18 identifiers are removed. HIPAA's Privacy Rule does not apply.
    • Limited Data Set (LDS): PHI with direct identifiers removed. Requires a Data Use Agreement (DUA).
    • IRB/Privacy Board Waiver: Granted if research poses minimal privacy risk and obtaining authorization is impracticable.

⭐ Research preparatory activities (e.g., assessing study feasibility) and research on decedents' PHI are also permitted without individual authorization under specific HIPAA provisions.

De-identification Methods - Anonymizing PHI

  • De-identified health information is not considered Protected Health Information (PHI) and is exempt from the HIPAA Privacy Rule. It is achieved via two pathways:

  • 1. Safe Harbor Method:

    • Mandates the removal of 18 specific personal identifiers.
    • Key removals include names, all geographic units smaller than a state, all date elements (except year), medical record numbers, and biometric data.
    • The provider must have no actual knowledge that the remaining information could identify the subject.
  • 2. Expert Determination Method:

    • A statistical expert applies methods to determine that the risk of re-identification is "very small."
    • Requires formal documentation of the statistical analysis.

HIPAA Privacy Rule De-identification Methods

High-Yield: Under Safe Harbor, the first 3 digits of a zip code can be kept if the corresponding geographic area contains >20,000 people. All other geographic data smaller than a state must be removed.

Authorization & Waivers - Getting Permission

  • Authorization: The default method. Researchers must obtain signed, patient-specific permission to use or disclose Protected Health Information (PHI) for research.

    • Core Elements: Plain language, specific purpose, expiration date, and right to revoke.
  • Waiver of Authorization: An Institutional Review Board (IRB) or Privacy Board can waive authorization if:

    • Research poses minimal risk to privacy.
    • Research is not practicable without the waiver.
    • Waiver won't adversely affect patient rights.

⭐ Research is designed to create generalizable knowledge. Quality Improvement (QI) is for internal processes. This distinction determines if IRB oversight/waiver is needed.

  • Other Data Types:

    • Limited Data Set: PHI with direct identifiers removed. Requires a Data Use Agreement (DUA).
    • De-identified Data: All 18 HIPAA identifiers removed. No longer PHI; HIPAA rules do not apply.
  • Decision Flow:

High-Yield Points - ⚡ Biggest Takeaways

  • De-identified health information is not PHI and can be used for research without authorization.
  • Research with PHI requires either written patient authorization or a waiver of authorization from an IRB/Privacy Board.
  • A Limited Data Set (LDS), which excludes direct identifiers, can be used for research with a Data Use Agreement (DUA).
  • Authorization forms for research must be specific and are separate from the informed consent.
  • Recruitment can involve PHI but is strictly regulated.

Practice Questions: HIPAA and research

Test your understanding with these related questions

A research team develops a new monoclonal antibody checkpoint inhibitor for advanced melanoma that has shown promise in animal studies as well as high efficacy and low toxicity in early phase human clinical trials. The research team would now like to compare this drug to existing standard of care immunotherapy for advanced melanoma. The research team decides to conduct a non-randomized study where the novel drug will be offered to patients who are deemed to be at risk for toxicity with the current standard of care immunotherapy, while patients without such risk factors will receive the standard treatment. Which of the following best describes the level of evidence that this study can offer?

1 of 5

Flashcards: HIPAA and research

1/9

The Beers criteria are used to reduce potential inappropriate prescribing and harmful polypharmacy in the _____ population

TAP TO REVEAL ANSWER

The Beers criteria are used to reduce potential inappropriate prescribing and harmful polypharmacy in the _____ population

geriatric

browseSpaceflip

Enjoying this lesson?

Get full access to all lessons, practice questions, and more.

Start Your Free Trial