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Clarify the HIPAA right of access to individuals’ research data

Nature Biotechnology volume 37, pages 850–852 (2019)Cite this article

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To the Editor — For almost two decades, individuals in the United States have enjoyed a broad right of access to their medical records and other protected health information under the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA)1. The exercise of this right is increasingly instrumental to efforts to promote patient engagement and data sharing. However, although it is clear that much clinical data is subject to the HIPAA access right, questions linger regarding its applicability to personal data generated in clinical research.

Under HIPAA, individuals have a legal right to access and obtain a copy of their ‘protected health information’ contained within a ‘designated record set’ (DRS) of a covered entity1, which includes researchers who provide healthcare or conduct clinical research at covered institutions. A common mistake is to construe these terms as meaning that individuals have a right to—and only to—their medical records. In fact, the access right encompasses a potentially large and diverse set of information.

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Fig. 1

US National Academies

References

  1. 45 C.F.R. § 164.524.

  2. National Academies of Sciences, Engineering, and Medicine. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm (National Academies Press, 2018).

  3. 45 C.F.R. § 160.103.

  4. 45 C.F.R. § 164.501.

  5. Federal Register 65, 82461–82829 (2000).

  6. Department of Health and Human Services. Individuals’ right under HIPAA to access their health information. 45 CFR § 164.524. https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html#newlyreleasedfaqs (2016).

  7. 45 C.F.R. §§ 160.312, 160.402, 160.404.

  8. Federal Register 79, 7289–7316 (2014).

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  10. Centers for Medicare and Medicaid Services. Research testing and Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/Research-Testing-and-CLIA.pdf (2014).

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  15. Evans, B. J. & Wolf, S. M. A Faustian bargain that undermines research participants' privacy rights and return of results. Florida Law Rev. https://ssrn.com/abstract=3368555 (2019).

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Acknowledgements

The views expressed in this article are those of the authors and, except where noted, do not represent the official position of the US National Academies of Sciences, Engineering, and Medicine or of the committee that produced the report discussed in this article.

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Authors and Affiliations

  1. Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX, USA

    Christi J. Guerrini & Amy L. McGuire

  2. The University of Utah School of Medicine, Salt Lake City, UT, USA

    Jeffrey R. Botkin

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  1. Christi J. Guerrini
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Contributions

C.J.G., J.R.B., and A.L.M. contributed to the conception and drafting of the manuscript. C.J.G. and A.L.M. conducted legal analysis.

Corresponding author

Correspondence to Amy L. McGuire.

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Competing interests

J.R.B. chaired, and A.L.M. was a member of, the committee that produced the report discussed in this article. C.J.G. was a consultant to the committee.

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Guerrini, C.J., Botkin, J.R. & McGuire, A.L. Clarify the HIPAA right of access to individuals’ research data. Nat Biotechnol 37, 850–852 (2019). https://doi.org/10.1038/s41587-019-0190-3

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