Weekly feed
11 curated updates · reviewed against primary sources
The investigation examines whether Epic's health IT dominance and data-sharing policies violate antitrust laws, with potential implications for interoperability and EHR market competition. The U.S.
The change lowers regulatory burden for companion diagnostic ISH tests while maintaining safety and effectiveness through special controls. The FDA has issued a final order reclassifying in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic...
Voting is open through September 14, 2026, for the HL7 ballot cycle covering FHIR implementation guides and other consensus standards. HL7 International opened its September 2026 consensus ballot cycle on August 14, 2026, inviting ballot pool members to vote on proposed FHIR implementation guides...
CMS seeks public comment on a new pathway to expedite Medicare national coverage determinations for innovative medical devices using existing regulatory processes. The Centers for Medicare & Medicaid Services (CMS) has announced a proposed Regulatory Alignment for Predictable and Immediate Device...
A study found four mandatory CMS VBC programs generated substantially higher administrative expenses compared to non-participating hospitals. Researchers analyzing Medicare cost reports determined that four mandatory value-based payment programs administered by CMS were associated with more than...
FDA seeks comment on classifying certain accessories as Class I devices, where general controls alone would ensure safety and effectiveness. The Food and Drug Administration (FDA) has published a proposed list of medical device accessories that it believes should be classified as Class I devices...
HHS is requesting a three-year generic clearance from OMB to collect customer feedback on TEFCA implementation and agency service delivery. The Office of the National Coordinator for Health IT (ONC) within the Department of Health and Human Services (HHS) has submitted a request to the Office of...
Limited research and evidence barriers make securing coverage difficult for women's health innovations, requiring early reimbursement planning. A new Milken Institute report cited by MedCity News explains that women's health startups face significant reimbursement challenges due to limited...
HHS seeks to streamline health forms for unaccompanied alien children while adding provisions for limited health information sharing with DHS to ensure continuity of care. The Administration for Children and Families (ACF) Office of Refugee Resettlement (ORR) is proposing to restructure its...
FDA requests 60-day public comment on information collection for its ASCA Program supporting medical device conformity assessment under the Paperwork Reduction Act. The Food and Drug Administration (FDA) has announced a 60-day public comment period for its proposed information collection...
FDA seeks to reclassify diagnostic endoscopic light source systems for bladder cancer detection to Class II with special controls, eliminating premarket approval requirements. The FDA is proposing to reclassify diagnostic endoscopic light source systems (product code OAY) from Class III...