Safety-Enhanced Design Evaluation for ONC Certification

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

CMS Changes Name of the EHR Incentive Programs and Advancing Care Information to “Promoting Interoperability”

Summative Usability testing for safety enhanced design (§170.314.g.3) involves recruiting targeted users as test participants (Doctors, Nurses, and other medical practitioners) and asking these users to complete a set of pre-defined tasks. An expert test facilitator conducts the testing via an established test protocol while the test sessions are recorded and later analyzed.

Usability testing cannot happen overnight, and it is important that you reach out early so that the required testing can be completed in time for your appointment with an ONC-ACB.

We recommend that you allow at least 4-6 weeks in your submission timeline for the preparation, conducting and reporting of a summative usability test for the EHR 2015 Certification.

In a public comment on the 2014 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 (is) essentially one of the most difficult criteria to complete."

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

We recommend that EHR vendors 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).

Summative testing

Summative usability testing is an industry standard usability methodology (see ) 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.

How should the Results Presented?

Results from the summative study should be created and presented to the ONC using the Customized Common Industry Format (CCIF) Template for EHR Usability Testing (NISTIR 7742 see ) These reports typically include an executive summary, an introduction, a method section, discussion of the results and any appendices

For the 2014 Edition Certification, the following are required for submission to the ONC:

  • Name and version of the product 
  • Date and location of the test 
  • Test environment 
  • Description of the intended users 
  • Total number of participants 
  • Description of participants: their experience and demographic characteristics 
  • Description of the user tasks that were tested 
  • List of the specific metrics captured during the testing for effectiveness, efficiency and satisfaction 
  • Data scoring 
  • Results of the test and data analysis 
  • Major test findings 
  • Identified area(s) of improvement(s)

 Our Chief Experience Officer, Bennett Lauber is a member of the ONC Health IT Policy Committee Implementation, Usability, and Safety Workgroup.  He shares his experiences working with EHR vendors with Federal regulators to influence public policy on the usability of health IT.

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