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Week of Oct 25–31, 2026

14 curated updates · reviewed against primary sources

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

HL7 FHIR Genomics Reporting Proposed for Structured Genomic Data in EHRs

A JMIR research viewpoint advocates using HL7 FHIR Genomics Reporting standards to make genomic findings actionable in EHRs while keeping raw data in governed repositories. Electronic health record systems currently fail to represent genomic findings in structured, interoperable formats, instead...

High FDA

FDA’s Digital Health Center Director Says GenAI Tools Should Be Evaluated Like Physicians

FDA official Rick Abramson argues that generative AI-enabled medical devices should be assessed using standards similar to those applied to human clinicians due to their evolving, adaptive behavior. Rick Abramson, director of the FDA’s Digital Health Center of Excellence and a radiologist by...

High CMS 💬 Comments close in 43 days (Dec 15)

CMS proposes rule to implement Medicare Part D low-income cost-sharing, REAL Act, and PBM accountability provisions of 2026 Appropriations Act

Implementation of Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026 would adjust Medicare Part D cost-sharing for low-income beneficiaries, enhance provider directory accuracy, and increase pharmacy benefit manager oversight. The Centers for Medicare & Medicaid Services...

High FDA

SMART Health IT Urges FDA to Mandate FHIR-Based Data Interfaces for Generative AI Medical Devices

Standardized FHIR interfaces improve AI device evaluation, monitoring, and real-world evidence generation by ensuring consistent, auditable data inputs from EHRs. SMART Health IT has submitted formal comments to the FDA regarding its discussion paper on generative AI-enabled medical devices,...

Notable HHS 💬 Comments close in 23 days (Nov 25)

HHS Proposes Consolidating ORR Health Forms for Unaccompanied Alien Children

The Administration for Children and Families seeks OMB approval to merge the Serious Medical Procedure Request form with medical and dental assessments into a unified "ORR Unaccompanied Alien Child Health Forms" package, including limited health information sharing with DHS for continuity of...

Notable CMS HHS 💬 Comments close in 18 days (Nov 20)

CMS Announces Privacy Act Matching Program with VA to Identify Duplicate Payments

CMS and VA will match beneficiary data to recover duplicate payments and improve payment accuracy under the Privacy Act of 1974, with public comment open until November 20, 2026. The Centers for Medicare & Medicaid Services (CMS), in coordination with the Department of Veterans Affairs (VA)...

Notable HHS 💬 Comments close in 18 days (Nov 20)

SAMHSA Proposes New Data Security Requirements for Confidential Mental Health Data Access

SAMHSA seeks OMB clearance for updated security requirements governing access to confidential substance abuse and mental health data, with public comment open until November 20, 2026. The Substance Abuse and Mental Health Services Administration (SAMHSA) has submitted a proposed information...