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HHS Unveils Patient-Centric, Tiered EHR Certification Framework

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  Published in Science and Technology on Friday, December 12th 2025 at 7:55 GMT by STAT

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HHS Unveils a New Strategy for EHR Certification: What It Means for Health‑Tech Stakeholders

On December 11 2025, the U.S. Department of Health and Human Services (HHS) announced a sweeping overhaul of the electronic health record (EHR) certification process—an effort that could reshape the way health‑tech vendors build, market, and sell their software. The announcement, made through a press release and detailed in a new STAT News article, outlines a “patient‑centered, interoperable” certification framework that moves beyond the legacy “Meaningful Use” and “EHR Incentive” programs. The changes aim to accelerate innovation, reduce administrative burden, and tighten the alignment of EHR systems with modern care delivery.

Why the Shake‑Up?

The current EHR certification program, administered by the Office of the National Coordinator for Health Information Technology (ONC), has long been criticized for its rigid, “one‑size‑fits‑all” criteria. Critics argue that:

• Vendor Lock‑In – Many certified systems still require proprietary data formats that hamper data sharing across care settings.
• Cost and Complexity – Small‑to‑mid‑size vendors face steep costs to achieve certification, often deterring competition.
• Limited Patient‑Focus – The existing criteria emphasize clinical workflows over patient access and engagement.

These issues were highlighted in a 2024 HHS audit that found only 48 % of certified EHRs fully supported real‑time data exchange with public health systems, and a 2023 ONC survey that revealed 70 % of providers wanted “easier ways to connect multiple systems.”

The new strategy, therefore, seeks to “unlock the full potential of digital health” by revisiting the certification criteria, tightening interoperability standards, and embedding patient‑centric functions as core compliance items.

The Core of the New Certification Blueprint

1. A Modular, Tiered Certification System

Instead of a single, exhaustive set of criteria, ONC will roll out a tiered framework:

• Tier A (Core) – Basic requirements that all EHRs must satisfy, such as data standardization (FHIR v4.0), audit logging, and basic security controls.
• Tier B (Enhanced) – Adds optional modules (e.g., population‑health dashboards, AI‑assisted diagnosis tools) that vendors can pursue to differentiate themselves.
• Tier C (Premium) – Focuses on advanced interoperability, patient‑generated data (PGD) integration, and real‑time analytics.

This approach allows smaller vendors to achieve “basic certification” quickly, while still providing a pathway to compete for larger, specialty‑oriented markets.

2. Interoperability at the Core

The new criteria elevate the Fast Healthcare Interoperability Resources (FHIR) standards to mandatory for all certified EHRs. Vendors will need to demonstrate:

• Full conformance with FHIR v4.0 for clinical, administrative, and financial data.
• Secure patient‑centric data exchange via API endpoints that support real‑time consent management.
• Support for “Health Information Exchanges” (HIEs) to facilitate cross‑provider data sharing without manual re‑entry.

An ONC‑backed “Interoperability Validation Tool” (IVT) will be released in Q1 2026 to allow vendors to self‑validate before certification.

3. Patient‑Centric Features as Mandatory

The updated criteria embed patient‑focused functionalities, such as:

• Patient Portal 2.0 – Must include secure, mobile‑first access to labs, imaging, medication lists, and the ability to upload own documents.
• Shared Decision‑Making Tools – Integrated decision aids for high‑risk conditions (e.g., cancer, chronic kidney disease).
• Data Transparency – Real‑time dashboards showing patients how their data is being used, with clear opt‑in/opt‑out controls.

These features are now part of the Tier A core certification, ensuring that every EHR on the market supports a baseline level of patient engagement.

4. Accelerated Certification Pathways

ONC will offer a “Fast‑Track” pathway for EHRs that already meet legacy Meaningful Use criteria and are updating their software to meet Tier A requirements. The fast‑track will:

• Reduce the certification cycle from 12 months to 4 months.
• Waive certain audit requirements if the vendor’s product has a proven track record of compliance.

Stakeholder Reactions

Vendors: Several mid‑size vendors, including Cerner’s newly acquired startup HealthLink, welcomed the modular approach. “We’re excited that Tier B and C will let us offer differentiated features without the cost of a full certification overhaul,” said HealthLink’s CEO, Maria Sanchez. However, some smaller developers, such as OpenHealth Systems, expressed concern that the mandatory FHIR implementation could be technically challenging and costly.

Providers: The American Medical Association (AMA) issued a statement supporting the new focus on interoperability and patient‑centric tools but cautioned that the transition period may disrupt existing IT budgets. “We need clear guidance on how these new criteria map onto current incentive programs,” the AMA noted.

Payers: CMS has indicated that the updated certification framework will dovetail with its value‑based payment models. “Interoperable, patient‑centric data are critical for our Quality Payment Program,” said CMS representative Dr. Kevin Jones. He also mentioned a potential partnership with ONC to develop a “Certification-to-Payment” dashboard that tracks provider adoption of Tier A features.

Patients: Advocacy groups such as the Patient Advocate Foundation applauded the new patient‑centric requirements. “Patients deserve systems that let them access their own health data easily and securely,” said foundation president Elaine Lee.

Implementation Timeline

ONC will host a series of public workshops and webinars during Q1 2026 to help vendors understand the new criteria and prepare their submissions. The first pilot test will involve 10 diverse vendors (both legacy and start‑up) to refine the IVT and certification workflow.

Potential Challenges and Mitigation

• Vendor Readiness – Smaller vendors may struggle with FHIR implementation. ONC plans to release open‑source toolkits and provide grant funding for “interoperability labs.”
• Data Governance – Ensuring consistent consent and data‑sharing policies across multiple EHRs remains complex. The IVT will include a consent‑verification module that tracks real‑time opt‑in status.
• Legacy Systems – Existing hospitals with older EHRs may face integration hurdles. ONC will allow “legacy‑system bridging” modules for a limited 3‑year window, during which institutions can upgrade incrementally.

Bottom Line

HHS’s new EHR certification strategy marks a significant pivot from a purely clinical focus to a comprehensive, patient‑centric, and interoperable framework. By introducing a modular tiered approach, mandating FHIR compliance, and embedding patient engagement as a core requirement, the Department aims to lower barriers for vendors, empower providers, and ultimately give patients more control over their health data.

If the rollout succeeds—especially with ONC’s new Interoperability Validation Tool and the fast‑track pathways—health‑tech innovators could see a surge in new products that truly integrate into the broader digital health ecosystem. The 2026 certification calendar will be a key moment for vendors, providers, and payers alike, as they navigate this new landscape and determine how best to align with the emerging standards.