ONC/ASTP

ONC certification, USCDI & information sharing

Follow ONC/ASTP health-IT certification criteria, USCDI data classes and the information-sharing rules your roadmap is built on — concise, fully-sourced, and tracked across their lifecycle.

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Latest briefs

Notable Industry ONC/ASTP CMS

AMA Launches Interoperability Initiative to Add Structured Clinical Terminology to CPT Codes, Starting with Prior Auth

By embedding structured clinical terminology directly into CPT codes, AMA aims to accelerate electronic prior authorization and cut administrative burden at the point of care. The American Medical Association has launched a new interoperability initiative focused on mapping structured clinical...

High HHS ONC/ASTP

ONC Proposes HTI-5 Rule to Streamline Health IT Certification and Advance Interoperability

HHS/ONC's fifth Health Data, Technology, and Interoperability rulemaking targets certification program efficiency and continued information-blocking enforcement improvements. HHS and ONC have proposed the HTI-5 rule, the latest in the Health Data, Technology, and Interoperability rulemaking...

High ONC/ASTP HHS TEFCA

ONC Adds Audit Layer to TEFCA as Network Surpasses 1 Billion Records Exchanged

New federal oversight measures — including third-party audits of TEFCA participants — signal ONC is shifting from network-building to network-accountability mode. ONC has announced a package of oversight measures designed to strengthen governance of the Trusted Exchange Framework and Common...

High ONC/ASTP CMS

ONC Publishes HTI-4 Final Rule, Completing Its 2024–2025 Health IT Certification Rulemaking Cycle

With HTI-4 finalized on August 4, 2025, ONC has now closed out four major rulemakings that together reshape certification criteria, information blocking, TEFCA, and prescription workflows. ONC's certification program regulations page now reflects a completed four-rule cycle stretching from early...

Notable ONC/ASTP

ONC Health IT Certification Program: How It Works and What's New in 2025

ONC's certification framework — the gatekeeper for federally recognized health IT — is updating criteria, surveillance rules, and standards versioning processes that every EHR and API developer must track. The ONC Health IT Certification Program is the federal mechanism through which health...

Notable CMS ONC/ASTP

Post-Acute Visibility Emerges as a Core Competency for ACOs Under CMS's LEAD Model

As CMS's LEAD model extends value-based care timelines, health systems that lack real-time post-acute data will find themselves structurally disadvantaged on cost and quality performance. CMS's LEAD (Longitudinal Episode-based Alternative Payment) model reshapes how accountable care organizations...

Must read CMS

CMS-0057-F Final Rule Mandates FHIR-Based Prior Authorization and Data-Sharing APIs by 2026–2027

The 2024 CMS Interoperability and Prior Authorization final rule sets hard compliance deadlines for payers to implement FHIR APIs that streamline prior authorization and cross-payer data exchange — with a key HIPAA carve-out clearing the path. CMS released the 2024 Interoperability and Prior...

Notable CMS

CMS Final Rule Tightens Oversight of Hospital Accrediting Organizations, Bars Fee-Based Consulting

New conflict-of-interest protections and updated performance-review requirements will reshape how the nine CMS-recognized accrediting organizations survey more than 9,000 Medicare-participating providers. CMS has issued a final rule updating the regulatory framework governing the organizations...

High CMS

CMS Stands Up New Health Tech Office to Drive Interoperability and Digital Product Strategy

The agency is formalizing its ambitions in health-IT modernization by creating a dedicated organizational unit to lead interoperability initiatives and digital product development. The Centers for Medicare & Medicaid Services (CMS) has established a new health technology office designed to...

High HL7 FHIR

FAST Releases Computable Consent IG for Standards-Based Privacy Enforcement

The new HL7 FHIR Implementation Guide enables scalable, interoperable consent management across healthcare data exchange networks. The HL7 FHIR at Scale Taskforce (FAST) has released the Scalable Consent Management Implementation Guide to address growing challenges in consent enforcement across...

Notable HHS 💬 Comments close in 49 days (Sep 25)

HHS/ACF Proposes 3-Year Extension with Revisions to Mental Health and Onsite Health Forms for Refugee Children

The proposal merges two public health forms into a single Onsite Health Intervention Form and adds limited sharing of health data with DHS to ensure continuity of care for unaccompanied refugee minors. The Administration for Children and Families (ACF), through its Office of Refugee Resettlement...

Must read HL7 FHIR 💬 Comments close in 10 days (Aug 17)

FHIR R6 Ballot 4 Opens for Normative Comment — Final Shape of the Next Major Release Takes Form

HL7's fourth normative ballot of FHIR R6 is the consensus gate that will define the stable, binding specification healthcare-IT teams must eventually certify against. HL7 International has opened an out-of-cycle Normative ballot for FHIR Release 6 (v6.0.0-ballot4), with voting and comments...

High CMS 💬 Comments close in 38 days (Sep 14)

CMS Proposes CY 2027 Physician Fee Schedule: Interoperability, Quality, and Payment Updates Open for Comment

The sweeping annual PFS proposed rule touches Medicare payment rates, the Promoting Interoperability Program, Quality Payment Program, Medicare Shared Savings Program, and new IRA drug-rebate codifications — with a September 14 comment deadline. CMS published its CY 2027 Physician Fee Schedule...

Notable CMS HHS

HHS Publishes Secretarial Comments on Battelle/CBE 2025 Annual Quality Measures Report to Congress

CMS fulfills its statutory obligation to review and publish the Consensus-Based Entity's annual activities report, a key checkpoint in the federal quality measurement governance cycle. The HHS Secretary has reviewed and published in the Federal Register Battelle Memorial Institute's 2025 Annual...

High ONC/ASTP HHS

Keeler Maps the Reemergent ONC/HHS Regulatory Roadmap: HTI-5 Rollback, HTI-6 Preview, and Dual HIPAA Access Rules

A rare moment of regulatory visibility gives health-IT teams a structured view of what's coming — and what's being undone — across interoperability and HIPAA access. Brendan Keeler's July 2026 analysis unpacks a newly visible HHS/ONC regulatory pipeline, identifying four distinct actions that...

High CMS 💬 Comments close in 24 days (Aug 31)

CMS Proposes 2027 OPPS/ASC Payment Updates, Expands Prior Auth, and Issues HPT Standardization RFI

The sweeping CY2027 outpatient payment proposed rule touches reimbursement rates, quality reporting, prior authorization expansion, and a first-of-its-kind request for input on making hospital price transparency data more machine-comparable — with comments due August 31. CMS published its...

Notable ONC/ASTP TEFCA

TEFCA Gets a Hall Monitor, and Information-Blocking Enforcement Eyes a Labor Day Debut

Brendan Keeler's holiday-week roundup covers TEFCA's new oversight posture, a rumored information-blocking action against Epic, and the state of interoperability heading into summer 2026. In his Fourth of July edition, Keeler surveys the interoperability landscape with characteristic irreverence.

High TEFCA

Sequoia Project Publishes Guidance on Computable Consent for Health Information Exchange

New operational guidance helps providers, payers, and developers implement machine-readable consent in health data exchange workflows — a long-standing friction point for nationwide interoperability. The Sequoia Project released new guidance on June 30, 2026 designed to help healthcare...

High ONC/ASTP CMS 💬 Comment window closed

ONC Releases USCDI+ Quality Draft Version 2 for Public Comment Through July 17

The second draft of the USCDI+ Quality data standard is open for stakeholder comment until July 17, 2026 — a key opportunity to shape the data element requirements underpinning future eCQMs. ONC published USCDI+ Quality Draft Version 2 on June 17, 2026, and is accepting public comments through...

High HL7 FHIR

BCBSA & Itiliti Health Share Real-World DTR Questionnaire Standardization Case Study at HL7 Da Vinci June Roundtable

Blue Cross Blue Shield Association's approach to centralizing and digitizing reference medical policies into reusable FHIR Questionnaires offers a concrete playbook for payers and vendors scaling prior authorization under Da Vinci DTR. The HL7 Da Vinci Project's June 2026 Community Roundtable...

Notable FDA

Study Maps Two Decades of FDA Digital Medical Device Authorizations

A new analysis in npj Digital Medicine traces the growth and evolving patterns of FDA clearances and approvals for digital medical devices over 20 years, offering a data-driven baseline for the field. A peer-reviewed study published in npj Digital Medicine on June 17, 2026 examines two decades of...

Notable HL7 FHIR Other

JMIR Review: Dynamic Consent for Health Data Reuse Faces Legal Fragmentation Under GDPR and Incoming EHDS Rules

A new integrative review maps the legal, technical, and governance barriers to deploying granular, revocable patient consent for secondary health data use across Europe — and proposes a three-stage architecture to address them. Secondary use of health data — for research, innovation, and public...

High CMS HHS

DirectTrust Files Formal Comment on CMS-0062-P Drug Prior Authorization Interoperability Rule

DirectTrust's submission signals the health-IT trust community's stake in how CMS shapes FHIR-based prior authorization and interoperability standards for drugs. DirectTrust submitted formal comments to HHS and CMS on the Interoperability Standards and Prior Authorization for Drugs Proposed Rule...

FYI HL7 FHIR

Commentary: FHIR-Level Data Exchange Is Insufficient for AI — Healthcare Needs Semantic Interoperability

As AI systems consume clinical data across organizations, syntactic interoperability alone fails to preserve meaning — a shared semantic layer is now a prerequisite, not a nice-to-have. In a MedCity News opinion piece, Hamid Tabatabaie argues that the healthcare industry's hard-won...

FYI ONC/ASTP HHS 💬 Comment window closed

ONC Opens 60-Day Comment Window on Proposed Information Collection Under Paperwork Reduction Act

HHS/ONC is soliciting public feedback on a proposed data collection, as required by the Paperwork Reduction Act, with comments due July 10, 2026. The Office of the National Coordinator for Health IT (ONC), within HHS's Office of the Secretary, has published a 60-day public comment notice in the...

High ONC/ASTP

ONC Proposes HTI-5 Rule: Remove 34 Certification Criteria, Tighten Info-Blocking Exceptions, and Lay FHIR-First Foundation

The sweeping deregulatory proposed rule would cut more than half of ONC's certification requirements while closing loopholes EHR vendors have used to block data access—and it explicitly brings autonomous AI systems under information-blocking rules. ONC's HTI-5 Proposed Rule ("Health Data,...

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