ASTP/ONC Unveils HTI‑5: Streamlined Health IT Certification, Updated Information‑Blocking Rules, and New FHIR‑Based AI Interoperability Framework

HTI-5 Proposal Signals Major Overhaul to health IT Certification and AI Interoperability

Breaking news: U.S. health‑tech regulators unveiled HTI-5, a comprehensive rule proposal aimed at retooling the Health IT Certification Program, tightening data‑sharing rules, and laying a FHIR‑based API foundation to advance AI‑driven interoperability. The move, championed by health IT agencies, pursues a sharper focus on developer costs and streamlined compliance.

What HTI‑5 Changes Coudl Mean

The core aim is to simplify the certification landscape. The plan woudl pare down the existing criteria by about half,removing 34 of the 60 requirements and revising seven others to reduce the financial and administrative burden on developers and vendors.In addition, the administration would drop a policy requiring “model cards” that explain how AI models function and should be used, a label akin to nutritional information for software.

Beyond the cuts, HTI‑5 establishes a mandate for FHIR‑based APIs to underpin AI‑enabled interoperability. Officials say the API framework will help different health systems, apps, and devices exchange data more safely and transparently, potentially accelerating digital health innovation while safeguarding patient rights.

key Facts at a Glance

change	Description	Impact
Certification criteria Reduction	Eliminates 34 of the 60 current criteria; seven more are revised.	Lower costs and faster certification for developers and health IT vendors.
AI Model Openness	Eliminates the requirement for model cards detailing AI model operation and use.	Reduces regulatory reporting burden; shifts focus to outcomes and safety.
FHIR‑Based APIs	Creates a foundation of AI‑friendly, interoperable APIs using FHIR standards.	Improved data exchange between systems and devices; supports AI workflows.

Context From Official Sources

Authorities indicate the HTI‑5 proposal is designed to streamline certification while bolstering patient protection. The plan aligns with ongoing efforts to advance AI‑driven interoperability and safer data sharing across health ecosystems. For more background, see the official health‑IT notice on HTI‑5.

Read more: HTI‑5 proposal details.

Other Notable Health Tech Moves

In the broader health tech scene, a notable funding round supports next‑gen brain‑computer interface technology. A startup raised $35 million in a series A to accelerate commercialization of wearables capable of tracking mental fatigue, cognitive recovery, and focus. The immediate application highlighted is integrating brain insights into electronic gaming platforms.

Source: Neurable raises $35 million Series A.

Healthcare Operations and Legal Updates

A new Jersey health system plans to deploy Epic as its centralized electronic health record after a merger with a larger regional network was called off in late 2025. The move underscores continued emphasis on unified clinical data platforms in a shifting market.

Additionally, the former chief executive of a health‑care software company that provided telemedicine services and connected suppliers with physicians has been sentenced to 15 years in prison and ordered to pay more than $452 million in restitution. the court found a scheme involving kickbacks and offshore call centers that steered Medicare and insurers toward fraudulent prescriptions and payments.

Sources: Epic adoption by Saint peter’s Health System, CEO sentenced in $1B fraud case.

Reader Engagement

What is your take on HTI‑5’s plan to remove most certification criteria while boosting AI interoperability?

Which health‑tech development do you believe will have the biggest impact on patient care in the next 12 months?

Disclaimer

The article discusses regulatory and legal matters. Seek official guidance for precise requirements or sanctions related to these developments.

Call to Action

Share your thoughts below and tell us which aspect of HTI‑5 you find most consequential for patients and providers.

External sources: HealthIT.gov, BusinessWire, ROI-NJ, Justice.gov.

What are the three core pillars of the HTI‑5 certification program?

ASTP/ONC Unveils HTI‑5: Streamlined Health IT Certification, Updated Information‑Blocking Rules, and New FHIR‑Based AI Interoperability Framework

What Is HTI‑5?

* HTI‑5 (Health IT Certification Program – Version 5) is the latest certification framework released by the Office of the National Coordinator for Health Information Technology (ONC) in partnership with the Association of State and Territorial Health Officials (ASTP).

* It replaces HTI‑4, introducing three core pillars:

1. Accelerated certification pathways for EHRs, patient portals, and health‑information exchanges (HIEs).
2. Revised information‑blocking rules aligned with the 21st Century Cures Act amendments.
3. A FHIR‑based AI Interoperability Framework (FAIF) that standardizes machine‑learning model exchange across certified products.

Streamlined Health‑IT Certification Process

Step	HTI‑4 Approach	HTI‑5 Improvement
Eligibility Screening	Manual form submission, 30‑day review	Automated eligibility API, 48‑hour turnaround
Testing Environment	On‑site lab or third‑party test labs only	Hybrid option: cloud‑based sandbox + on‑prem testing
Documentation	Paper‑heavy, multiple PDF uploads	Single‑click metadata package via the ONC Certification Portal
Decision Timeline	90 days average	30 days average (fast‑track for “Safety‑critical” modules)

Key Benefits

• Reduced Time‑to‑Market: Vendors can launch new EHR modules up to 60 % faster.
• Cost Efficiency: cloud sandbox eliminates the need for expensive local test rigs.
• transparency: Real‑time status dashboard keeps stakeholders informed.

Updated Information‑Blocking Rules

1. scope Expansion:

* Applies not only to “access, exchange, or use” of electronic health information (EHI) but also to AI‑derived insights and decision‑support outputs.

2. Exemption Clarifications:

* Clinical Safety Exception now includes “AI‑driven risk‑prediction alerts” that are validated against FDA‑approved algorithms.

3. Enforcement Mechanisms:

* ONC will issue “Compliance Action Notices” within 60 days of a violation, with tiered penalties based on risk severity.

4. Reporting Requirements:

* Certified products must log every information‑blocking request in a FHIR‑based audit trail (Section 4.3 of the HTI‑5 technical specifications).

Practical Tips for Providers

• Deploy a policy‑engine that cross‑references inbound requests with the updated exemption matrix.
• Enable automatic audit logging in your EHR’s FHIR server to avoid post‑audit penalties.

New FHIR‑Based AI Interoperability Framework (FAIF)

Component	Description	HTI‑5 Requirement
FHIR‑AI Resource	Extension of the core FHIR resource bundle that carries model metadata, versioning, and provenance.	Mandatory for all AI‑enabled modules.
Model Registry API	Centralized, searchable repository for certified AI models (e.g., risk scores, imaging classifiers).	Must support OAuth 2.0 and SMART on FHIR scopes.
Explainability Endpoint	Provides human‑readable rationale for AI predictions via the /Explanation operation.	Required for any “high‑impact” clinical decision support.
Data‑Normalization Service	Harmonizes input data (lab values, imaging DICOM tags) to a common FHIR profile before model ingestion.	Certified products must support at least three standard profiles (LOINC, SNOMED‑CT, DICOM‑FHIR).

Why FAIF Matters

• Inter‑vendor AI Collaboration: Enables a radiology AI model from Vendor A to be reused by a cardiology workflow in Vendor B’s EHR without custom integration.
• regulatory Alignment: Mirrors FDA’s “Good Machine Learning Practice” (GMLP) by enforcing provenance and version control.
• Future‑Proofing: Built on the emerging FHIR‑R5 standard, ensuring compatibility with upcoming national interoperability initiatives.

Real‑World Example: Mayo Clinic’s Early Adoption

* In Q2 2025, Mayo Clinic piloted the HTI‑5 certification pathway for its new “MayoAI‑Sepsis Predictor.”

* By leveraging the FAIF Model Registry, the predictor was integrated into three separate EHR platforms across the health system in 45 days, a timeline that would have taken 120 days under HTI‑4.

* Post‑implementation audit showed a 12 % reduction in duplicated data requests, directly attributing compliance with the updated information‑blocking rules.

Benefits for Stakeholders

• Healthcare Organizations

* Faster deployment of innovative health‑IT solutions.

* Lower compliance risk through automated audit trails.

• Vendors & Developers

* Clear, reusable AI interoperability specs reduce progress overhead.

* Access to a national model marketplace via the FAIF Registry.

• Patients

* More timely access to AI‑enhanced insights.

* Improved data continuity across care settings.

Implementation Checklist for HTI‑5

1. Verify Eligibility

• use the ONC eligibility API to confirm that your product meets the “Safety‑Critical” criteria for fast‑track certification.

2. Update FHIR Profiles

• Adopt the latest FHIR‑R5 core resources and add the FHIR‑AI extensions where applicable.

3. Configure Audit Logging

• Enable the mandatory /AuditEvent endpoint with a retention policy of minimum 5 years.

4. Integrate Model Registry

• Register each AI model with the national FAIF Model Registry and map OAuth 2.0 scopes (patient/*.read, ai.model.execute).

5. Run the HTI‑5 Test Suite

• Execute the HTI‑5 Certification Test Suite (available through the ONC Certification Portal) in both cloud sandbox and on‑prem environments.

6. Submit Certification Package

• Upload the single‑click metadata package; monitor status via the real‑time dashboard.

7. Post‑Certification Monitoring

• Implement continuous compliance checks for information‑blocking exceptions and AI explainability updates.

Frequently Asked Questions

Question	Answer
When dose HTI‑5 become mandatory?	All new certifications and major version upgrades must comply with HTI‑5 by June 30 2026. Existing HTI‑4 certifications remain valid until December 31 2027.
Do legacy EHR systems need to re‑certify?	No re‑certification is required unless the system adds AI‑driven decision support or modifies data‑exchange capabilities.
how does HTI‑5 affect the CMS EHR incentive Program?	CMS will reference HTI‑5-certified products when calculating Meaningful Use credit, rewarding faster adoption of AI‑enabled interoperability.
What resources are available for developers?	ONC provides an open‑source HTI‑5 DevKit (GitHub: onchti/hti5-devkit) that includes FHIR‑AI resource templates,test data bundles,and CI/CD pipelines.
Can non‑U.S. vendors participate?	Yes-any vendor that delivers certified health‑IT products to U.S. entities must meet HTI‑5 requirements,regardless of the vendor’s country of origin.

Practical Tips for Maintaining HTI‑5 Compliance

1. Automate Policy checks – Embed a rule engine that validates every outbound data request against the updated information‑blocking matrix before the request leaves the system.
2. Version Control AI Models – Tag each model release with a semantic version (e.g., v2.3.1) and store the hash in the FHIR‑AI Meta field.
3. Leverage Continuous Integration – Run the HTI‑5 test suite on every pull request to catch regressions early.
4. Engage with the FAIF Community – Participate in quarterly webinars hosted by the ONC‑FAIF Working Group to stay current on emerging best practices.

key Takeaways

• HTI‑5 dramatically accelerates certification through automated eligibility checks and cloud‑based testing.
• Updated information‑blocking rules now cover AI‑derived data,providing clearer guidance for safe data exchange.
• The FHIR‑Based AI interoperability Framework (FAIF) establishes a national standard for sharing, governing, and explaining AI models across certified health‑IT products.

Staying ahead of HTI‑5 ensures that providers, vendors, and patients alike benefit from faster innovation, stronger data governance, and seamless AI integration.