§170.315(g)(3) Safety-Enhanced Design
Expert EHR usability evaluations for ONC certification compliance. Helping Health IT developers achieve and maintain Safety-Enhanced Design certification through comprehensive testing and evaluation services.
Comprehensive ONC Certification Services
Formative Evaluations
Identify usability issues early and improve your EHR before formal testing.
Learn more →Summative Evaluations
Comprehensive usability testing for ONC certification compliance.
Learn more →Real World Testing
Stay compliant with ONC Real World Testing requirements and ensure product safety and effectiveness.
Learn more →User-Centered Design
Apply industry-standard UCD processes to maximize user satisfaction and efficiency.
Learn more →What is Safety-Enhanced Design?
Safety-Enhanced Design (SED) is a critical component of ONC Health IT certification, specifically addressed in §170.315(g)(3) of the certification criteria. This requirement ensures that EHR systems are designed with usability and safety in mind, reducing the risk of medical errors and improving healthcare outcomes.
The ONC 21st Century Cures Act Final Rule mandates that Health IT developers must demonstrate compliance with Safety-Enhanced Design requirements through formal usability testing and evaluation processes.
Key Requirements
- Formal usability testing with representative users
- NISTIR 7742 compliant reporting
- User-centered design process documentation
- Real World Testing compliance
ONC Certification Process
Formative Evaluation
Early usability testing to identify and resolve issues
Summative Testing
Formal usability evaluation for certification
Real World Testing
Ongoing compliance monitoring
Certification
ONC approval and ongoing maintenance
Why Choose Our Safety-Enhanced Design Services?
Expert Compliance
Deep understanding of ONC requirements and latest regulatory updates. We ensure your product meets all §170.315(g)(3) criteria.
Comprehensive Testing
Full range of usability evaluation services from formative testing to Real World Testing compliance.
Certification Ready
NISTIR 7742 compliant documentation and reporting that meets ONC submission requirements.
Latest Regulatory Updates
ONC 21st Century Cures Act Final Rule
The latest regulatory updates include enhanced requirements for Safety-Enhanced Design testing, Real World Testing compliance, and user-centered design processes. Our services are fully aligned with these requirements.
Key Updates
- • Enhanced Real World Testing requirements
- • Updated user-centered design criteria
- • Strengthened usability testing standards
- • Improved documentation requirements
Our Response
- • Updated testing methodologies
- • Enhanced reporting templates
- • Expanded compliance services
- • Continuous regulatory monitoring
Ready to Achieve ONC Certification?
Let our expert team help you navigate the Safety-Enhanced Design requirements and achieve successful ONC certification.