President Obama has signed the Food and Drug Administration Safety and Innovation Act, which includes language to establish federal regulation of the safety and functionality of health information technology applications, including mobile apps. The bill now is Public Law 112-144.
The new law has many changes for the FDA, including updated user fees that pay for regulatory programs, new policies to better manage drug shortages, and mandated establishment of unique medical device identifiers.
Section 618 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.
Text of the law is not yet available at the Government Printing Office, but Enrolled Bill S. 3187 (final version) that Obama signed is at congress.gov.
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