Legislation soon to be voted on in Congress and expected to pass lays the framework for federal regulation of health information technologies.
The health I.T. language is part of a final version of the Prescription Drug User Fee Amendments Act of 2012, worked out in a House-Senate conference committee. Companies pay user fees, which in turn help pay for FDA regulatory programs.
The bill requires the Department of Health and Human Services within 18 months of enactment to publish a report “that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety and avoids regulatory duplication.”
The regulatory strategy and recommendations would be published on the Web sites of the FDA, Federal Communications Commission, and Office of the National Coordinator for Health Information Technology. The HHS Secretary could convene a working group of stakeholders to give input on the strategy and recommendations.
The conference committee agreement has been placed in S. 3187, which the full House and Senate will vote on before being sent to President Obama for his signature. The bill includes several steps to combat drug shortages. It enables delivery systems to repackage drugs in shortage and distribute them to affiliate hospitals, and requires FDA to list drugs in shortage by name and NDC code, among other provisions.
The legislation also sets deadlines for establishment of unique medical device identifiers. For a copy of the bill, send an email to firstname.lastname@example.org.
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