JD Supra

FDA Issues Long-Awaited Final Clinical Decision Support Software Guidance

On September 28, 2022, the US Food and Drug Administration (FDA) issued its final Clinical Decision Support Software Guidance three years after the issuance of its 2019 revised draft guidance. The ...
The American Journal of Managed Care

Artificial Intelligence in Medicare: Utilization, Spending, and Access to AI-Enabled Clinical Software

This study quantified the trends over time in utilization of, spending on, and access to CT fractional flow reserve, the first artificial intelligence (AI)–enabled clinical software reimbursed by ...
JD Supra

FDA Issues Final Clinical Decision Support Software Guidance

On September 28, 2022, the U.S. Food and Drug Administration (“FDA” or “the Agency”) issued its long-awaited final guidance, “Clinical Decision Support Software” (the “CDS Guidance”). The CDS Guidance ...