Safety-enhanced Design

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

Click Here For more information about our Safety-enhanced Design Evaluation Services.

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, as of March 11, 2024, what is required to obtain the ONC Certification for Safety-enhanced Design (§170.315.g.3) for an EHR.

An ounce of prevention -- is worth a pound of cure

Residents in the commonwealth of Virginia must take their car for a “safety inspection” each year. The test criteria is published by the state and it is fairly easy to determine in advance if your car is going to pass the inspection. Before you take your car for inspection, first you make sure that all lights are functional, the tires all have proper tread, the windshield wipers are working, etc. If you find anything, you make a small fix BEFORE going to the inspection station and will save the hassle of dealing with a failed test. An ounce of prevention.

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.

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