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Week of Aug 9–15, 2026

11 curated updates · reviewed against primary sources

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All Open for comment ONC/ASTP CMS HL7 FHIR HITRUST FDA
High HHS FDA ONC/ASTP

Federal regulators hold closed-door talks on clinical AI adoption

HHS, FDA, and ONC officials convene private meetings with industry to accelerate AI use in healthcare settings. Federal health officials from HHS, FDA, and ONC have initiated a series of closed-door meetings with technology companies, researchers, and lobbyists focused on accelerating the...

High HHS

CPSC Requests Hospital Emergency Room Digital Patient Data Amid Privacy Concerns

The U.S. Consumer Product Safety Commission seeks digital emergency department data from hospitals to inform injury prevention, raising questions about patient privacy safeguards and data use limitations. The United States Consumer Product Safety Commission (CPSC) is requesting digital patient...

High CMS ONC/ASTP

CMS Finalizes FY 2027 IPPS Rule with ONC Health IT Standards Updates and Quality Program Changes

The final rule updates Medicare hospital payment rates for FY 2027, adopts new health IT standards, and modifies quality reporting requirements for acute care and long-term care hospitals. The Centers for Medicare & Medicaid Services (CMS) has issued a final rule revising the Medicare hospital...

Notable FDA 💬 Comments close in 54 days (Oct 9)

FDA Proposes Reclassifying Digital Breast Tomosynthesis Systems from Class III to Class II

FDA's proposal would reduce regulatory burden for DBT systems by moving them from premarket approval to special controls with 510(k) pathway, while establishing new device classification and safety requirements. The Food and Drug Administration (FDA) is proposing to reclassify digital breast...

Notable HHS CMS 💬 Comments close in 19 days (Sep 4)

CMS re-establishes Privacy Act matching program with Department of War for ACA eligibility verification

CMS seeks public comment on renewed data matching to verify ACA minimum essential coverage eligibility via Department of War health benefits. The Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) has issued a notice in the Federal Register regarding the...

Notable FDA 💬 Comments close in 30 days (Sep 15)

FDA Seeks Comment on Medical Device Voluntary Improvement Program Information Collection

FDA requests public comment on proposed information collection for its Medical Device Voluntary Improvement Program under PRA requirements. The Food and Drug Administration is announcing a 60-day public comment period on a proposed information collection associated with the Medical Device...