EHR Usability Evaluations

Summative testing for your EHR:

The Usability People conduct and report summative usability evaluations using the NISTIR 7742 Customized Common Industry Format Template for EHR Usability Testing—suitable for satisfying the Safety-enhanced Design criteria portion of your ONC certification.

EHR Safety-enhanced design (§170.315.g.3) (aka Usability) Testing for ONC Certification

The Office of the National Coordinator for Health Information Technology has made several enhancements to the Safety-enhanced (aka usability) testing portion of the certification criteria.

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established a Merit-based Incentive Payment System (MIPS) that, in part, is based upon compliance with certain rules. The following describes what is required to obtain the ONC Certification for Safety-enhanced Design (§170.315.g.3) for an EHR.

Developers have been developing health IT products, including EHRs, which they intend to have certified to the ONC certification criteria requirements. .

User-centered Design

User-Centered Design: Helping users become Effective, Efficient, and Satisfied

ONC states that a User-centered design processes must be applied to each capability an EHR technology includes that is specified in the following certification criteria: §170.315(a)(1); § 170.315(a)(2); § 170.315(a)(6); § 170.315(a)(7); § 170.315(a)(8); § 170.315(a)(16); §170.315(b)(3); and § 170.315(b)(4). Health IT developers must select an industry standard User-Centered design process because compliance with this certification criterion requires submission of the name, description, and citation (URL and/or publication citation) of the process that was selected. Examples of method(s) that could be employed for UCD, including ISO 9241-11, ISO 13407, ISO 16982, ISO/IEC 62366, ISO 9241-210 and NISTIR 7741.

We recommend that EHR vendors examine NIST 7741 and follow the ISO 9241-11 standard. ISO-9241 Part 11: (1998) pertains to the extent to which a product can be used by specified users to achieve specified goals with: 

Effectiveness (Task completion by users),

Efficiency (Task on time) and

Satisfaction (responded by user in term of experience) in a specified context of use (users, tasks, equipment & environments).

Latest news: The ONC 21st Century Cures Act Final Rule had been published as of March 11, 2024. This new rule makes several significant changes of the ONC certification criteria requirements.

"EHR technology certified to the standards and criteria established by the Office of the National Coordinator of Health Information Technology (ONC) can support you in all four performance categories of the Centers for Medicare & Medicaid Services (CMS) Merit-based Incentive Payment System (MIPS)"