§170.315(g)(3) Safety Enhanced Design and Meaningful Use (and the ONC 2015 Certification)

§170.315(g)(3) Safety-enhanced design

As providers of usability testing and user experience services we know that one of the major advantages of electronic health records (EHRs) are their potential to increase patient safety by preventing, detecting and aiding in the recovery from human errors. ONC has set certification standards for safety-enhanced design (SED), making patient safety a primary focus in the design of an EHR.

Select this link for information on the final rule and ONC 2015 certification (required for the MIPS/MACRA incentives)

Safety-Enhanced Design Certification requires that EHR vendors follow two major steps:

1. Use a formal User Centered Design (UCD) process during development.
2. Perform Summative Usability Testing on specific areas of the product.

UCD Process:

UCD procedures have been specified in detail in several ISO standards. We recommend that EHR vendors follow the ISO 9241-11 standard as the guidance for their formal UCD process. 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).

Summative Testing:

Summative usability testing is described in detail in “Test Procedure for §170.314(g)(3) Safety-enhanced design.” http://www.healthit.gov/sites/default/files/170.314g3safetyenhanceddesig...

In the test procedure, real users run the EHR with a series of fundamental tasks. The goal is to measure the usability and safety of the EHR by documenting

(1) Its effectiveness in performing each task
(2) Its efficiency in performing that task, and
(3) The user’s satisfaction from performing the task.

Each task is a fundamental EHR capability, and each must be tested and reported within the usability evaluation report. For the 2014 certification, the required tasks focus on the following issues:

1. Computerized Provider Order Entry System (CPOE) (§ 170.314(a)(1));
2. Drug- drug, drug-allergy interaction checks (§ 170.314(a)(2));
3. Medication list (§ 170.314(a)(6));
4. Medication allergy list (§ 170.314(a)(7));
5. Clinical decision support (§ 170.314(a)(8));
6. Electronic medication administration record (§ 170.314(a)(16));
7. Electronic prescribing (§ 170.314(b)(3));
8. Clinical information reconciliation (§ 170.314(b)(4)).

In a public comment on the certification process, Drummond (one of the ONC ATCB's) stated that

"...the usability test effort is not a small undertaking for EHR vendors. In fact, it was essentially one of the most difficult criteria to complete."



Usability testing cannot happen overnight, and it is important that you reach out to your usability partner (or internal UX team) early so that the required testing can be completed in time for your appointment with the ONC-ACB (such as Drummond, Infoguard,etc.) . We recommend that you allow at least 3-4 weeks in your submission timeline for the preparation, conducting and reporting of a summative usability test for EHR 2014 Certification.

Information about the ONC 2015 edition certification is available via The Usability People.

Usability reports produced by The Usability People adhere to the NISTIR 7742 CCIF format suitable for submission to an ONC-ACB. We can also provide a set of prioritized, detailed, and actionable feedback that you can take directly to your design and development teams for implementation.


The Usability People would welcome the opportunity to work with you on improving the Usability of Healthcare IT.

For expert Safety-enhanced Design (aka Usability) evaluation of your EHR: contact The Usability People

The Usability People

Together we may save a life! #SafeHealthIT