The HTI-4 Final Rule, finalized by the Office of the National Coordinator for Health IT (ONC) in August 2025 and effective October 1, 2025, brings critical updates to the certification criteria for electronic health record (EHR) systems. These changes notably affect electronic prescribing, real-time prescription benefit checks, and electronic prior authorization workflows. Understanding the impact of HTI-4 on usability testing—particularly Safety Enhanced Design (SED)—is essential for EHR developers and healthcare organizations aiming to maintain compliance in the 2026 certification cycle and beyond.
What is Safety Enhanced Design (SED)?
SED is an ONC-mandated usability assurance process defined under 45 CFR §170.315(g)(3), requiring health IT developers to implement user-centered design (UCD) principles and perform summative usability testing addressing patient safety risks. Specifically, SED entails:
- Documenting the entire UCD process, aligned with ISO 9241-210 and ASTM E2624 standards for human factors engineering.
- Conducting summative usability testing involving at least 10 representative clinicians performing realistic clinical scenarios to evaluate effectiveness, efficiency, and satisfaction.
- Measuring and mitigating use-related hazards potentially contributing to medical errors.
- Reporting results using the NISTIR 7742 Common Industry Format (CIF) for ONC-Authorized Certification Bodies (ONC-ACBs).
How the HTI-4 Rule Impacts Usability and SED Testing
HTI-4 introduces new certification criteria that modify existing and add new workflows affecting medication-related processes and API integrations in EHRs. The main usability impacts related to SED testing include:
1. New and Altered Workflows
HTI-4 mandates implementation of:
- Updated electronic prescribing standards (NCPDP SCRIPT, latest RxNorm) with integrated electronic prior authorization as a required feature.
- Real-time prescription benefit (RTPB) checks, providing instant patient-specific cost and coverage information at the point of prescribing.
These changes alter the prescribing workflow, increasing complexity and introducing additional decision points. Any modifications in user workflows or safety-critical tasks require updated or new SED usability validation to confirm continued safety and effectiveness.
2. API-Driven Features and Decision Support
HTI-4 expands API criteria for:
- Prior authorization streamlined through HL7 FHIR Da Vinci Project standards.
- Workflow Triggers for Decision Support Interventions (CDS Hooks).
- Real-time subscription notifications that alert users to events like hospital admission or discharge.
These new interactive elements introduce novel user interface components and decision support integrations that must be included in usability testing to evaluate user performance and error potential.
3. Optional Prior Authorization Modules with Future SED Implications
While some prior authorization features are optional for now, their adoption triggers full SED requirements for the involved workflows and system interfaces.
Practical Guidance for Meeting HTI-4 Usability and SED Requirements
EHR developers with existing ONC-certified products should consider these steps:
- Conduct a Gap Analysis: Identify EHR modules affected by HTI-4 and assess which workflows and interfaces require SED testing updates.
- Update User-Centered Design Documentation: Revise task analyses, user research, and design history matching HTI-4’s new workflows to maintain compliance with ISO 9241-210 and ASTM E2624.
- Plan and Perform Summative Usability Testing: Develop clinical scenarios reflecting HTI-4 workflows—electronic prescribing with RTPB, electronic prior authorization, and API-based decision support. Recruit at least 10 representative clinical users, and measure success rates, error frequency, and satisfaction per NISTIR 7742 CIF protocols.
- Test API-Integrated Features Thoroughly: Simulate real-world interactions with APIs for prior authorization, RTPB, and CDS triggers, focusing on user comprehension and error mitigation in integrated workflows.
- Engage Early with ONC-Authorized Certification Bodies: Collaborate proactively with ONC-ACBs to clarify expectations on HTI-4’s SED testing, gain insights on test approach optimizations, and address ambiguities.
- Clinician and Staff Training: Ensure end users are supported with training on the new workflows and system functionalities to reduce use errors post-deployment.
Why Partner with Us?
Navigating HTI-4’s new SED usability testing requirements can be challenging — but that’s where our expertise comes in. At Brainstorm Ergonomics, we specialize in human-centered design and usability consulting specifically tailored for healthcare IT. We help health IT developers and healthcare organizations:
- Perform comprehensive gap analyses of evolving ONC certification criteria.
- Apply rigorous user-centered design processes aligned with industry standards.
- Design and conduct summative usability testing that meets regulatory expectations.
- Develop clear, compliant SED documentation to streamline certifications.
Our proven approach reduces risk, accelerates certification timelines, and improves clinical usability — ensuring your EHR solutions not only comply with HTI-4 but also deliver safer, more user-friendly healthcare experiences.
Stay Ahead with Brainstorm Ergonomics
Don’t wait for certification deadlines to catch you off guard. Contact us today to schedule a consultation and learn how we can support your team in meeting HTI-4 usability and SED requirements with confidence and clarity. Together, we can design safer, smarter electronic health records—built with users, for users.
Schedule a Discovery CallReferences
- HealthIT.gov. HTI-4 Final Rule Overview. Link (2025).
- Drummond Group. What You Need to Know About the HTI-4 Final Rule. Link (2025).
- Rural Health Info Center. Policy Update: HTI-4 Final Rule Effective October 1, 2025. Link (2025).
- Healthcare IT Today. Buckle Up: HTI-4 Accelerates Mandatory RTPB and EPA Integration for EHRs. Link (2025).
- Dynamic Health IT. HTI-4 Final Rule: ePrescribing, Prior Authorization, and Real-Time Benefit. Link (2025).
- HealthIT.gov. Safety Enhanced Design Testing. Link (2024).
- HealthIT.gov. Test Procedure for §170.314(g)(3) Safety-enhanced design. PDF (2013).
- NIST. Technical Evaluation, Testing, and Validation of the Usability of Health IT. PDF (2013).
- SafetyEnhancedDesign.com. Safety-Enhanced Design - ONC Certification. Link (2004).
- Drummond Group. ONC Authorized Testing & Certification Body. Link (2025).