On December 6, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a Proposed Rule that would (i) further enhance health data exchange by establishing data exchange standards for certain payers, (ii) improve patient and provider access to health information, and (iii) streamline processes related to prior authorization for medical items and services. The
FDA Issues Final Guidance on Clinical Decision Support Software
On September 28, 2022, the Food and Drug Administration (FDA) issued Clinical Decision Support Software final guidance. The guidance clarifies the agency’s scope of oversight and regulation of clinical decision support software based on the definition of a device in the Federal Food, Drug, and Cosmetic Act (FD&C Act). It also describes the criteria