The Clinical Decision Support Coalition comprises healthcare industry stakeholders – software developers, patient advocacy groups, clinical societies, providers and healthcare payers – working to ...

The U.S. Food and Drug Administration (FDA or Agency) recently issued a revised final guidance document addressing Clinical Decision Support (CDS) Software (the 2026 CDS Guidance). The 2026 CDS ...

FDA has long expressed an interest in digital health products. The extent to which FDA should assert jurisdiction over digital health products, however, has been the subject of considerable debate.

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 ...

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 ...

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 The first is a draft guidance outlining categories of clinical decision ...

Computers, whether through simple decision trees or complex neural networks, are increasingly playing a larger and larger role in helping healthcare providers make treatment decisions. As the role of ...