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Industry Issues Guidelines To Head Off Potential CDS Software Regs

The US Congress and FDA have established that the agency will only oversee high-risk clinical decision-support (CDS) software, but a key CDS industry groups says too much ambiguity remains. The Clinical Decision Support Coalition has published guidelines in a bid to allow industry to self-regulate as much as possible.

A new set of guidelines published by the industry Clinical Decision Support (CDS) Coalition is meant to head off any potential regulations from FDA, even following enactment of provisions in the 21st Century Cures Act that limits the federal regulator's authority in overseeing such technology.

The CDS Coalition guideline outlines voluntary measures manufacturers of medium-risk CDS software could take when designing their product to ensure a level of trust in the products and...

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