Weekly feed
16 curated updates · reviewed against primary sources
Proposed rule would prohibit collecting race/ethnicity data on census and exclude many noncitizens from apportionment, potentially undermining health equity efforts. The U.S.
The FDA seeks input on evidence requirements for RASDs, including AI integration, cybersecurity, and clinical performance, to shape future clearance pathways. The FDA has released draft guidance outlining recommendations for premarket submissions of robotically-assisted surgical devices (RASDs),...
HHS Request for Information explores whether deceased donor islet cells should be regulated as organs under OPTN policy or as cell products, impacting transplant access and regulatory pathways for Type 1 diabetes therapies. The Department of Health and Human Services (HHS) has opened a public...
Unanimously approved SB 1120 would limit AI use in mental health treatment decisions while requiring human oversight and patient notification. The California Senate unanimously passed Senate Bill 1120, legislation designed to establish common-sense guardrails for artificial intelligence...
Healthcare remains the primary target for ransomware attacks, highlighting urgent cybersecurity risks for providers. A new analysis of ransomware activity reveals that 77% of ransomware groups are actively targeting the healthcare sector in the United States, underscoring the industry's...
The September 30 HL7 Da Vinci Community Roundtable will provide updates on ePA regulatory developments, implementation guide status, and real-world deployment progress as the industry moves beyond pilots to production. HL7 International announced that the Da Vinci Project will hold a Community...
Healthcare's reliance on single clearinghouse points creates systemic risk despite lessons from 2022 Change Healthcare cyberattack. Two years after the Change Healthcare cyberattack exposed critical vulnerabilities in healthcare claims processing infrastructure, the industry continues to lack...
A new CMS-led initiative seeks to overhaul how quality is measured across Medicaid and CHIP programs in partnership with a majority of states. The Trump administration announced a new partnership between CMS and 37 states aimed at fundamentally rethinking quality measurement approaches for...
HHS renamed the ORR system of records and adjusted routine uses to streamline information sharing for child protection while maintaining Privacy Act safeguards. The Department of Health and Human Services (HHS) is modifying its existing Privacy Act system of records for the Office of Refugee...
The draft NIH policy aims to facilitate sharing summary-level study results with clinical research participants, with public comment open until October 26, 2026. The National Institutes of Health (NIH) has released a draft policy on sharing summary-level study results with clinical research...
HHS and CMS pause new agent/broker enrollment through Federally-facilitated Exchanges for Plan Year 2027 to implement program-integrity safeguards against fraud and misuse of consumer data. The Department of Health and Human Services (HHS) issued an interim final rule with comment period that...
DirectTrust's modernized Direct implementation enables cloud-native secure messaging while maintaining compatibility with legacy healthcare workflows. DirectTrust has unveiled a modernized implementation of the Direct Project protocol designed specifically for cloud environments and...
Aligning regulatory language with updated FD&C and PHS Acts to support alternative testing methodologies and reduce animal testing emphasis. The FDA is proposing to amend its regulations by replacing references to "animal" tests or studies with "nonclinical" tests or studies, and adding...
Leveraging P2P data exchange for strategic initiatives like network development and care management transforms compliance into market differentiation. Payer-to-payer (P2P) interoperability capabilities, once viewed primarily as a regulatory requirement under TEFCA’s QHFN, are evolving into...
FDA proposes a 60-day comment period for a survey of healthcare providers to inform pregnancy exposure registry enrollment and improve maternal health safety data collection. The Food and Drug Administration (FDA) has issued a Federal Register notice announcing a proposed information collection...
A 60-day comment period begins for the FDA's information collection related to HCT/P regulations under the Paperwork Reduction Act. The U.S.