Healthcare IT News February 10, 2023
The group’s citizens petition asks the U.S. Food and Drug Administration to repurpose its Final Guidance on Clinical Decision Support Software, claiming it’s at odds with other federal policies.
The CDS Coalition is asking the U.S. Food and Drug Administration to pull back on its clinical decision support guidance in order to ensure that the agency better balances its regulatory oversight with the healthcare sector’s need for innovation while comporting with the statutory language of the 21st Century Cures Act.
‘Flagrant’ disregard for Congressional law and intent
The coalition’s stakeholders – clinical decision support software developers, patient advocacy organizations, clinical societies, healthcare providers and healthcare payers – say FDA’s guidance exceeds Congress’s statutory definitions of what is considered CDS...
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