The Food and Drug Administration is seeking stakeholder feedback on the benefits and risks to health associated with the software functions excluded from the medical device definition by the 21st Century Cures Act.
Section 3060 of the Cures Act compels the FDA to exclude certain software functionalities from the definition, effectively prohibiting the agency from regulating that software as a device.
The FDA announced on Tuesday that it is specifically requesting input on the impact of the software functions that are intended for administrative support of a healthcare facility; maintaining or encouraging a healthy lifestyle; serving as electronic patient records; transferring, storing, converting formats or displaying data; or providing limited clinical decision support.
In December 2017, the FDA released draft guidance meant to clarify what types of clinical decision support will no longer be defined as medical devices and therefore will not be regulated—based on provisions of the Cures Act. According to the agency, the draft interpretations of the medical software provisions in the Cures Act were designed to “offer clarity about where FDA sees its role in digital health and where we do not see a need for FDA involvement.”
“FDA is developing a report to summarize the impact of such software functions on patient safety, including best practices to promote safety, education, and competency related to such functions,” states Tuesday’s announcement. “FDA intends to work with agencies in HHS, such as the Office of the National Coordinator for Health Information Technology, to gather and summarize information related to risks and benefits for these software functions.”
The FDA says it will incorporate stakeholder input into its final report. Comments for consideration in the development of the report must be submitted by June 28, according to the agency. Additional information is available here.
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