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IRB, HIPAA Changes To Be Folded Into 21st Century Cures Bill Next Year

Centralized institutional review board approvals for device trials, and removal of HIPAA privacy provisions that block registry data-sharing are among the ideas that are likely to make it into a draft bill planned for release in January as the next step in the House’s 21st Century Cures initiative.

Two key lawmakers said they intend to incorporate ideas that would hasten device development into legislation expected out early next year under the 21st Century Cures initiative. Among the ideas are centralization of Institutional Review Board approvals and removal of Health Insurance Portability and Accountability Act (HIPAA) privacy provisions that stand in the way of medical researchers sharing data from large trials and registries.

The information-gathering phase of the House Energy and Commerce Committee’s 21st Century Cures project is coming to an end and draft legislation incorporating ideas from the months of hearings is...

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