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From today's edition

High CMS

CMS Stands Up New Health Tech Office to Drive Interoperability and Digital Product Strategy

The agency is formalizing its ambitions in health-IT modernization by creating a dedicated organizational unit to lead interoperability initiatives and digital product development. The Centers for Medicare & Medicaid Services (CMS) has established a new health technology office designed to...

High FDA

FDA Draft Guidance Reframes Safety Rules for AI-Enabled Medical Devices That Evolve Post-Market

The FDA's new framework explicitly acknowledges that AI software changes over time, shifting regulatory emphasis toward ongoing risk controls, transparency, and accountability rather than one-time pre-market review. The Food and Drug Administration has released draft guidance specifically...

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