The workgroup recommends health IT products not be subject to FDA premarket requirements, except for medical device accessories and clinical decision support and other high-risk software.
However, the workgroup encourages post-market safety testing and reporting and a public process for consumer ratings to enhance transparency.
The report was required under the Food and Drug Administration Safety and Innovation Act of 2012.
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Tech Terms Cheat Sheet: The Health IT Vocabulary Non-CIOs Need to Know
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Innovation in Healthcare as Viewed by Non-Medical Actors
