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.
More Articles on Health IT Regulations:
Tech Terms Cheat Sheet: The Health IT Vocabulary Non-CIOs Need to Know
Review Finds Visitation Rules on New York Hospital Websites Contradict Law
Innovation in Healthcare as Viewed by Non-Medical Actors
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
