Safety-enhanced Design

EHR Safety-enhanced design (§170.315.g.3) (aka Usability) 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.

Safe HealthIT SAVES LIVES!

Many EHRs really do suck, as ZDoggMD described in his very popular parody video 'EHR state of Mind'. But without some nudge towards an improved user experience many of the "less than optimal" EHRs will only get worse as they grow and Engineering-centric developers add more and more features on top of a poorly designed information architecture.

Vehicles are not allowed to be sold in the USA unless they have meet strict safety standards, why isn't this the same for EHRs?

Don't like 30 clicks to order Ambien? How about 50!

EHR usability Gap - Specified Context of Use

The efficient and effective use of Electronic Health Records are essential, as these systems are increasingly becoming a central tool for patient care.

The Health Information Technology for Economic and Clinical Health (HITECH) Act provided providers with a significant financial incentive to increase the adoption and use of EHRs. EHR vendors were required to conduct and report on a summative usability evaluation of their system as part of the Stage 2 Meaningful Use program (The ONC 2014 Edition Certification) and beyond. However, a recent report funded by the Agency for Healthcare Research and Quality (AHRQ), identified several “issues” with the certified EHR vendors in the processes, practices and use of standards and best practices with regard to usability and human factors.

Auto bumpers and HealthIT Interoperability

Ralph Nadar's book Unsafe At Any Speed raised public awareness of some of the safety problems associated with the Chevrolet Corvair.  Nadar’s book, however, was also an indictment of the auto industry as a whole and served as a lightning rod for legislation establishing what would eventually become the National Highway Transportation Safety Administration (NHTSA). 

These two industries, HealthIT and automobiles have quite a lot in common including that they are both highly regulated.  These regulations exist because in both industries poor design can lead to safety issues and the possible death of their user’s.

ONC has posted the final 2015 Edition Test Method

The 2015 Edition Final Test Method has been posted and additional test procedure tools have been added. It can be accessed on the ONC Health IT Certification Program webpage.

The test procedures offer objective guidance to Accredited Testing Laboratories (ATLs) as they conduct Health IT module testing in the ONC Health IT Certification Program, to provide traceability from the certification criterion or criteria to testing activities, and to ensure consistency throughout the certification process.

The new Test Procedures format includes a grid of testing components that the ATLs would use as the test approach for that particular criterion.

The Final Test Method outlines the requirements for evaluating conformance of health IT Modules to the certification criteria defined in the ONC 2015 Edition Final Rule (45 CFR Part 170 Subpart II) published in the Federal Register on October 16, 2015.

Here is a direct link to the Safety-Enhanced Design (aka Usability) portion of the 2015 edition certification:

https://www.healthit.gov/sites/default/files/170_315_g3_safety_enhanced_...


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

For Usability evaluations of your EHR: contact The Usability People

The Usability People

Together we may save a life! #SafeHealthIT

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