Physicians take a stand on reuse of health data

The American College of Physicians, which represents 132,000 internal medicine specialists, is proposing a privacy rule that says researchers should maximize appropriate uses of information to achieve scientific advances without compromising ethical obligations to protect individual welfare and privacy.

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The ACP discusses its members fears about re-uses of personal data as well as re-uses of research data and samples a new document, which is an update of a paper produced by ACP two years ago.

The release of “Health Information Technology & Privacy” comes near the close of the comment period Oct. 26 for the Advance Notice of Proposed Rulemaking (ANPRM) of “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators." The proposed changes, which will be highlighted in ACP’s ANPRM comments, are designed to strengthen protections for human research subjects.

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“While coming changes did not prompt this paper, its production and release are turning out to be quite timely,” noted Virginia L. Hood, P, president of ACP. “The paper suggests revisions to the current regulations, which are now being considered because the Department of Health and Human Services (HHS) believes these changes will strengthen protections for research subjects in a number of important ways.”

In its 15-page policy paper, ACP proposes 13 policy positions to guide the development of the comprehensive framework. The new policy position, number 4, says:

New Position 4: Regarding research, a revised privacy rule should maximize appropriate uses of information to achieve scientific advances without compromising ethical obligations to protect individual welfare and privacy.

Participation in prospective clinical research requires fully informed and transparent consent that discloses all potential uses of PHI and IIHI, and an explanation of any limitations on withdrawing consent for use of data, including biological materials.

ACP recognizes that further study is needed to resolve informed consent issues related to future research use of Protected Health Information (PHI) and Individually Identifiable Health Information (IIHI) associated with existing data, including biologic materials.

Informed consent documents should clearly disclose whether law enforcement agencies would have access to biobank data without a warrant.

ACP recommends that regulations governing IRB review be expanded to include consideration of the preferences of research subjects whose tissue has been stored.

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