An HHS workgroup charged with compiling a proposed strategy for both fostering health information technology innovation and protecting patient safety has recommended limited Food and Drug Administration oversight of health IT products.
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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