In August 2012, the Office of the National Coordinator for Health Information Technology (ONC) unveiled new certification and meaningful use requirements for electronic health records (EHRs). According to these requirements, vendors’ submissions must include (a) evidence of user-centered design and (b) a user test results. While previous certification guidance focused on the functionality of EHRs, new rules require vendors to focus on usability and employ user-centered design methods during development that derive from a safety-enhanced design framework.
What is safety-enhanced design?
At its core, safety-enhanced design underpins the principles of user-centered design (UCD) – a multi-disciplinary approach where user feedback is integrated at each stage of product design and development through application of a set of user-focused activities, e.g., formative usability testing. To demonstrate compliance with eight specific certification criteria, ONC has stated submissions complying with the safety-enhanced design test procedure must 1) contain evidence of user-centered design processes, and 2) include submission of a Common Industry Format (CIF) document in accordance with the criteria specified in NISTIR 7742, Customized Common Industry Format Template for Electronic Health Record Usability Testing. The purpose of this process is to ensure a high level of quality, efficiency and (most importantly) patient safety in the user interface.
The bottom line
Now more than ever, vendors must integrate UCD principles during EHR development; furthermore, summative user testing should demonstrate a user interface ‘fit for use’. These steps are imperative in order to meet the safety-enhanced design requirements outlined by the ONC. Though providers are not required to follow the Stage 2 requirements until 2014, vendors should take steps now to position their products for success and comply with these new guidelines.
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Robert Schumacher, GfK User Centric Executive Vice President, has more than 25 years of professional experience in corporate and academic environments. He is actively involved in designing and evaluating usability criteria for electronic health records through the Human Factors and Ergonomics Society, HIMSS Usability Taskforce, and other commercial and non-profit organizations.