Follow ONC/ASTP health-IT certification criteria, USCDI data classes and the information-sharing rules your roadmap is built on — concise, fully-sourced, and tracked across their lifecycle.
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New conflict-of-interest protections and updated performance-review requirements will reshape how the nine CMS-recognized accrediting organizations survey more than 9,000 Medicare-participating providers. CMS has issued a final rule updating the regulatory framework governing the organizations...
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...
The classification establishes a defined regulatory pathway for simple in vitro diagnostic devices detecting Bacillus species secreted proteins in human clinical samples, potentially accelerating market access. The FDA has issued a final order classifying the simple in vitro diagnostic (IVD)...
Blue Cross Blue Shield Association's approach to centralizing and digitizing reference medical policies into reusable FHIR Questionnaires offers a concrete playbook for payers and vendors scaling prior authorization under Da Vinci DTR. The HL7 Da Vinci Project's June 2026 Community Roundtable...
A new designated expert role for information blocking enforcement has arrived with no clear definition of qualifications, scope, or process — including from the expert themselves. ONC has established a formal "Information Blocking Expert" designation under the information blocking framework, but...
A new analysis in npj Digital Medicine traces the growth and evolving patterns of FDA clearances and approvals for digital medical devices over 20 years, offering a data-driven baseline for the field. A peer-reviewed study published in npj Digital Medicine on June 17, 2026 examines two decades of...
A new integrative review maps the legal, technical, and governance barriers to deploying granular, revocable patient consent for secondary health data use across Europe — and proposes a three-stage architecture to address them. Secondary use of health data — for research, innovation, and public...
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...
A new CMS organizational unit consolidates the agency's health-IT standards agenda under a chief product officer, ending the fragmented command structure that long complicated interoperability policy execution. CMS has established the Office of Health Technology and Products (OHTP) , a structural...
DirectTrust's submission signals the health-IT trust community's stake in how CMS shapes FHIR-based prior authorization and interoperability standards for drugs. DirectTrust submitted formal comments to HHS and CMS on the Interoperability Standards and Prior Authorization for Drugs Proposed Rule...
As AI systems consume clinical data across organizations, syntactic interoperability alone fails to preserve meaning — a shared semantic layer is now a prerequisite, not a nice-to-have. In a MedCity News opinion piece, Hamid Tabatabaie argues that the healthcare industry's hard-won...
HHS/ONC is soliciting public feedback on a proposed data collection, as required by the Paperwork Reduction Act, with comments due July 10, 2026. The Office of the National Coordinator for Health IT (ONC), within HHS's Office of the Secretary, has published a 60-day public comment notice in the...
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