The FDASIA, the risk-based regulatory framework of the FDA, has been called into question by a number of healthcare tech groups. Published in April, the report has drawn criticism from the American Hospital Association for failing to address “interoperability of information across data sources; product usability; and accurate patient matching”. Both the College of Healthcare Information Management Executives, and the Association of Medical Directors of Information Systems also chimed in on the report, saying, “The single biggest action federal regulators could take to improve patient safety is to identify clear standards and require strict adherence to those standards.” The lone supporter of the FDA appears to be the Bipartisan Policy Center.

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