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CHA Comments on FDA Clinical Decision Support Software Draft Guidance

For CIOs, health information technology staff

This post has been archived and contains information that may be out of date.

CHA has submitted comments on the Food and Drug Administration’s (FDA) revised draft guidance on clinical decision support (CDS) software, as part of the agency’s ongoing efforts to implement Section 3060(a) of the 21st Century Cures Act.

In the letter, CHA expresses concern that the FDA’s interpretation of certain criteria established by the Cures Act could subject many existing CDS algorithms to the FDA approval process — ultimately slowing the pace of innovation and development of new software tools for better patient care and outcomes. CHA urges the FDA to continue to seek clarification and stakeholder feedback on its regulatory approach to device and non-device CDS functions.