Draft Clinical-Decision-Support Software Guide Paves A Path, But May Need Some Work
US FDA dropped three big digital-health guidances related to medical software as part of its initiative to help to streamline a path to market for a sector that is "increasingly embraced" by the health system and needs regulatory certainty, according to agency. But initial industry reaction to perhaps the most highly anticipated of the document, on clinical-decision-support software, is somewhat critical.
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After strong pushback to a clinical decision support (CDS) software draft guidance, it seems the US agency has decided to heed industry concerns to take a more risk-based approach by issuing another draft of the guidance. Industry sources are applauding the FDA's move, saying it gives them another opportunity to fine-tune the regulations, which could mean fewer CDS manufacturers would be regulated by the agency.
FDA is writing a report on key safety impacts from health software products that fall outside of its regulatory purview under the 21st Century Cures Act. To help the effort, the agency is asking industry, patient groups and other stakeholders to chime in by June 28.
In a new American Medical Association survey, more than nine in 10 physicians – 92% – said prior authorizations needed from insurers to order medical services and treatments delay and negatively impact patient care.