Must read
CMS
Establishes new requirements for healthcare data exchange and prior authorization processes under the Interoperability and Patient Access final rule. The Centers for Medicare & Medicaid Services (CMS) has issued the Interoperability and Prior Authorization Final Rule (CMS-0057-F), establishing...
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CMS
Amazon, Google, Meta, Oracle and other large employers support CMS efforts to extend electronic prior authorization requirements to self-funded health plans. Amazon, Axon Enterprise, Google, Meta and Oracle have publicly backed the Centers for Medicare & Medicaid Services' initiative to expand...
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FDA
Clarifies regulatory boundaries for digital health apps that interact with prescription drugs, aiming to reduce uncertainty for developers. The FDA has finalized its guidance on prescription drug use-related software (PDURS), defining which digital health applications that interact with...
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HHS
NIST
Critical vulnerability in InterSystems IRIS for Health allows attackers to view and reuse transmitted healthcare data due to TLS/SSL encryption being disabled by default. CISA has issued an advisory (ICSMA-26-295-01) identifying a critical vulnerability in InterSystems IRIS for Health where...
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HHS
HHS-adjusted civil monetary penalties for HIPAA violations now range from $145 to $2,190,294 per violation, reflecting annual inflation updates that impact healthcare organizations' compliance risk calculations. The U.S.
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HL7
FHIR
HHS
ONC/ASTP
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...
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FDA
The AMA calls for FDA to establish a risk-based framework for generative AI oversight to clarify accountability and support responsible innovation in healthcare. The American Medical Association (AMA) is urging the U.S.
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HHS
CMS
New federal Medicaid work requirements and eligibility restrictions from the 2025 reconciliation law will affect millions of enrollees starting in 2026. Major federal changes to Medicaid eligibility and financing enacted in the 2025 reconciliation law are now taking effect, introducing work...
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FDA
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...
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CMS
💬 Comments close in 43 days (Dec 15)
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...
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FDA
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)
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 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 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...