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June 2011
Policy and Advocacy
HHS Seeks Input on HIPAA’s Regulatory Burden on Research

The U.S. Department of Health and Human Services (HHS) is seeking comments on a  proposal to exempt research activities from one requirement of the Health Insurance Portability and Accountability Act (HIPAA)–specifically, the duty to produce for individuals a full account of whether their health information has been disclosed for research purposes.

The Institute of Medicine (IOM), the HHS Secretary’s Advisory Committee on Human Research Protections, and IDSA support the proposal, contending that the HIPAA requirement provides little value to patients while placing undue burden on research investigators and institutions.

HHS is seeking comment on what benefit an accounting of disclosures provides to individuals and what burdens it places on research institutions (see pages 31432-31433 of the proposed regulation).  

IDSA plans to submit comments on this requirement and on the other impediments HIPAA places on research, and is encouraging IDSA members and their institutions to do so as well. Comments are due Aug. 1. See the e-mail IDSA sent to members earlier this month.)

For more information, or to share comments with IDSA, contact Audrey Jackson, PhD, at IDSA (

Additional Resources:

IDSA policy statement: Grinding to a Halt: The Effects of the Increasing Regulatory Burden on Research and Quality Improvement Efforts

IOM report: Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research

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