The bill has many changes for the FDA, particularly in setting manufacturer user fees that pay for regulation of drugs, devices and biological products, along with provisions to better manage drug shortages. For instance, 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.
But Section 618 of the bill clearly sets the framework for government oversight of the safety and functionality of health information technology applications, including those used on mobile computing devices.
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.
Text of the enrolled bill, S. 3187, is available at congress.gov.