The Clinical Decision Support Coalition comprises healthcare industry stakeholders – software developers, patient advocacy groups, clinical societies, providers and healthcare payers – working to ...
An industry coalition has finalized guidelines on the design and development of medium-risk clinical decision support software that aren’t subject to Food and Drug Administration review. The aim of ...
This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...
The Clinical Decision Support Coalition penned a 21-page letter Feb. 5 urging the FDA to rewrite its guidance on clinical decision support software to avoid “overregulation.” The CDS Coalition — which ...
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