§170.315(g)(3) Safety-enhanced Design

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 2015 Edition certification.

EHR Safety-enhanced design (§170.315.g.3) (aka Usability) Testing for ONC 2015 Edition 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 2015 Edition 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 2015 Edition certification criteria requirements. .

Summative testing requirements for the 2015 Cures Update Edition

Summative usability testing is an industry standard usability methodology (see http://bit.ly/13WYqTU ) During the testing a trained user experience professional works with the EHR vendor to create a series of representative tasks and then measures the amount of time it takes to complete the task (time on task), how many and what type of errors occur (error rates), and satisfaction with the task interaction (user satisfaction). The results —as measured by things like task times, assisted and un-assisted completion rates and standardized satisfaction scores --can be benchmarked against current industry standards.

Summative testing for the 2015 Cures Update certification needs to test the following 9 areas:

Section 170.315(a)(1) Computerized provider order entry – medications
Section 170.315(a)(2) Computerized provider order entry – laboratory
Section 170.315(a)(3) Computerized provider order entry – diagnostic imaging
Section 170.315(a)(4) Drug-drug, drug-allergy interaction checks
Section 170.315(a)(5) Demographics
Section 170.315(a)(9) Clinical decision support
Section 170.315(a)(14) Implantable device list
Section 170.315(b)(2) Clinical information reconciliation and incorporation
Section 170.315(b)(3) Electronic prescribing

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).