Safety-Enhanced Design (SED) Testing Services

Stay Compliant, Confident, and Ahead of the Curve with Expert SED Testing

Is your organization prepared for the new ONC Health IT Certification requirements? With the transition from §170.315(a)(9) Clinical Decision Support (CDS) to the new §170.315(b)(11) Decision Support Interventions (DSI) criterion effective January 1, 2025, it's critical to ensure your Health IT products meet the latest Safety-Enhanced Design (SED) testing standards.

Let Us Help You Navigate SED Compliance

Our experienced team has helped dozens of Health IT vendors and healthcare organizations successfully meet ONC's evolving SED requirements. Whether you need to update an existing report or create a new one, we'll guide you every step of the way. Don't wait—reach out now to ensure your software is ready for certification and real-world use.

What is Safety-Enhanced Design (SED)?

Safety-Enhanced Design is a rigorous usability testing process required by ONC for certified Health IT modules. SED testing ensures your software is not only compliant with federal regulations but also safe, intuitive, and effective for real-world users. This process involves:

Usability testing with real users on all certified functionalities
Measurement of key metrics: task success/failure rates, time on task, user satisfaction, and more
Comprehensive reporting following NIST and ONC guidelines
Continuous improvement: updating SED documentation as new functionalities or regulatory changes arise

Why Choose Us for SED Testing?

Experience You Can Trust

We have extensive experience helping Health IT vendors, developers, and healthcare organizations successfully meet ONC's evolving SED requirements. Our team is deeply familiar with the evolving ONC standards and the practical challenges of SED documentation and usability testing.

Up-to-Date with the Latest Changes

We are fully versed in the transition to the new (b)(11) DSI criterion and can help you:

Update your existing SED report (supplemental SED) or create an entirely new one
Identify and address user-facing functionality gaps between (a)(9) and (b)(11)

Comprehensive, Personalized Support

Whether you need a one-time SED test or ongoing support, we tailor our services to your workflow, certification goals, and timeline. Our process is transparent, collaborative, and designed to minimize disruption while maximizing compliance and usability outcomes.

SED Testing for All Relevant Certification Criteria

We support SED testing for all ONC-mandated criteria, including:

§170.315(a)(1) CPOE – Medications
§170.315(a)(2) CPOE – Laboratory
§170.315(a)(3) CPOE – Diagnostic Imaging
§170.315(a)(4) Drug-Drug, Drug-Allergy Interaction Checks
§170.315(a)(5) Demographics

§170.315(a)(9) Clinical Decision Support (expired Jan 1, 2025)
§170.315(a)(14) Implantable Device List
§170.315(b)(2) Clinical Information Reconciliation
§170.315(b)(3) Electronic Prescribing
§170.315(b)(11) Decision Support Interventions

Common Terms and Search Phrases

We help with:

Safety-Enhanced Design (SED) Usability Testing
ONC Health IT Certification
(b)(11) DSI Criterion Compliance
Supplemental SED Reports
Usability Testing for Health IT
ONC-ACB SED Requirements
ONC Testing

Ready to Get Started?

Don't risk delays or non-compliance. Let our experts guide you through every step of the SED testing process—whether you need to update your existing report for the new (b)(11) requirements or start from scratch. We're here to make certification easier, safer, and more reliable for your organization.