ONC's HTI-1 final rule implements provisions of the 21st Century Cures Act and makes updates to the ONC Health IT Certification Program with new and updated standards, implementation specifications, and certification criteria. Provisions in the HTI-1 final rule advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information The application of user-centered design (UCD) during development and summative usability testing (aka Safety-enhanced Design evaluation) is limited to only those nine certification criteria specified in this certification criterion and only for which certification is sought, namely [80 FR 62670]:

§ 170.315 (a)(1) Computerized provider order entry (CPOE) – medications
§ 170.315 (a)(2) Computerized provider order entry (CPOE) – laboratory
§ 170.315 (a)(3) Computerized provider order entry (CPOE) – diagnostic imaging
§ 170.315 (a)(4) Drug-drug, drug-allergy interaction checks for CPOE
§ 170.315 (a)(5) Demographics
§ 170.315 (a)(9) Clinical decision support (expires on January 1, 2025)
§ 170.315 (a)(14) Implantable device list
§ 170.315 (b)(2) Clinical information reconciliation and incorporation
§ 170.315 (b)(3) Electronic prescribing
§ 170.315 (b)(11) Decision support interventions

(note: that (b)(11) is to replace (a)(9) on 1/1/25)

Unlock the potential of your EHR software with expert assistance in meeting the rigorous certification criteria. At The Usability People, we specialize in guiding EHR software companies through the intricate process of user-centered design (UCD) application, particularly for the specified certification criteria, including Computerized Provider Order Entry (CPOE), clinical decision support, electronic prescribing, and more.

Our tailored approach ensures that your software not only meets but exceeds the standards set forth by these criteria, enhancing usability, functionality, and overall user experience.

Let us help you navigate the complexities of certification requirements and elevate your EHR software to new heights of excellence.

Ready to take your EHR software to the next level? Contact us today to learn more about our specialized services and how we can support your journey towards certification success.

For more information see:

https://www.healthit.gov/test-method/safety-enhanced-design