EHR Usability Evaluations

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EHR Safety-enhanced design (§170.315.g.3) testing for ONC 2015 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 can now begin developing health IT products, including EHRs, which they intend to have certified to the 2015 Edition certification criteria requirements. Any modifications that CMS considers for the EHR Incentive Programs or MIPS would be proposed in future rulemaking and would take into account the certification criteria available through the ONC Health IT Certification Program and the 2015 Edition final rule, as well as the time needed for product development and certification.

Summative testing requirements for the 2015 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 certification needs to test the following 12 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)(6) Problem list
  • Section 170.315(a)(7) Medication list
  • Section 170.315(a)(8) Medication allergy list
  • 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).

Latest news: MACRA FINAL RULE rule has been published by HHS, streamlining federal programs including meaningful use.

"The new Advancing Care Information program would replace MU for Medicare physicians, aiming for 'simpler, more connected, less burdensome technology."