Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving by Institute of Medicine, Board on Health Care Services, Board

By Institute of Medicine, Board on Health Care Services, Board on Health Sciences Policy, Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule, Lawrence O. Gostin, Laura A. Levit, Sharyl J. Nass

Within the realm of wellbeing and fitness care, privateness protections are had to guard sufferers' dignity and forestall attainable harms. Ten years in the past, to deal with those issues in addition to set directions for moral health and wellbeing learn, Congress known as for a suite of federal criteria referred to now because the HIPAA privateness Rule. In its 2009 file, past the HIPAA privateness Rule: improving privateness, enhancing wellbeing and fitness via learn, the Institute of Medicine's Committee on future health examine and the privateness of wellbeing and fitness details concludes that the HIPAA privateness Rule doesn't guard privateness in addition to it may, and that it impedes very important wellbeing and fitness learn.

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HHS should encourage greater use of partially ­deidentified data called “limited datasets” and develop clear guidance on how to set up and comply with the associated data use agreements more efficiently and effectively, in order to enhance privacy in research by expanding use and usability of data with direct identifiers removed. 3. HHS should clarify the distinctions between “research” and “practice” to ensure appropriate IRB and Privacy Board oversight of PHI disclosures for these activities.

Ultimately, committee members agreed to make two sets of recommendations. 15 Although a totally new approach may be harder to implement in the short term than more incremental changes, it might help to stimulate fresh ideas about the best ways to protect privacy and improve health research as the nation seeks the best way to support these two interconnected values over the next several years. Second, in the event that policy makers decide that HIPAA was—and continues to be—the most useful model for how to safeguard privacy in health research, the committee proposes a series of detailed proposals to improve the HIPAA Privacy Rule and associated guidance.

1. HHS should reform the requirements for the accounting of disclosures of PHI for research. 2. HHS should simplify the criteria that IRBs and Privacy Boards use in making determinations for when they can waive the requirements to obtain authorization from each patient whose PHI will be used for a research study, in order to facilitate appropriate authorization requirements for responsible research. Regardless of whether Recommendation I or II is implemented, the following recommendations, which are independent of the Privacy Rule, should be adopted: III.

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