Clinical Data as the Basic Staple of Health Learning Creating and Protecting a Public Good: Workshop Summary (2010) / Chapter Skim
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Appendix D: The IOM Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule
Appendix D: The IOM Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule
Pages 311-315
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From page 311... ...
A HHS should reduce variability in interpretations of the HIPAA Privacy Rule in health research by covered entities, IRBs, and Privacy Boards through revised and expanded guidance and harmonization.
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From page 312... ...
4. HHS guidance documents should simplify the HIPAA Privacy Rule's provisions regarding the use of PHI in activities preparatory to research and harmonize those provisions with the Common Rule, in order to facilitate appropriate IRB and Privacy Board oversight of identification and recruitment of potential research participants.
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From page 313... ...
2. HHS should simplify the criteria that IRBs and Privacy Boards use in making determinations for when they can waive the require ments 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.
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