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Despite Draft Framework, Health IT Legislation Still Needed, Senators Say

This article was originally published in The Gray Sheet

Executive Summary

FDA joined two other agencies last week in issuing a proposed new health information technology regulatory framework that would include risk-based oversight and only patient role for FDA. While Senators sponsoring health IT legislation to restrict FDA’s role praised some aspects of the report, they insisted their bill was still necessary. Meanwhile, Device trade groups, in balance, were positive about the propose framework.

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