Is FDA's EHR Exemption Becoming Extinct?

By Brian Dolan
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Bradley Merrill ThompsonBy Bradley Merrill Thompson

FDA's exemption for EHRs seems headed the way of the dodo bird.  Nobody planned it that way, but a combination of opposing trends-- the trend toward greater and greater functionality for EHRs and the trend toward greater FDA regulation of any software functionality that can impact patients -- means there may very well be little left of the traditional EHR exemption in the future. That second trend was really brought home this past week when FDA held a hearing on the scope of its planned oversight of clinical decision support software.  More on that later.

Industry needs to start planning its response now.  And when I say industry, I’m including not only traditional software vendors, but those users that potentially cross the line of FDA jurisdiction by modifying what they purchase.  Industry’s response can include a wide range of activities from advocacy to ensure the agency understands the importance of a light touch in some areas of software development where speed and agility are essential, to preparing for FDA regulation for those types of software that clearly and directly impact patient care.

Technology Trends

I'm a liberal arts guy, so I won’t even pretend I can offer great insight into the direction of IT in hospitals.  But here's my 100,000 foot summary of what I hear is going on.

A long time ago, the concept of EHRs started as a way merely to better record the health-related information the doctor wanted to preserve in a patient's file. Basically, early EHRs automated recordkeeping.  That automation offered advantages in terms of tidying up unruly files, and at least conceptually offered a quicker route for retrieval as well as lower-cost for storage.

To state the obvious, the digitalization of healthcare, though, hardly stopped there. At least two enhancements were quickly identified:

  1. Instead of manually collecting information, some vendors and users decided to digitize the information generated by a medical device for easy import into the EHR.
  2. Once users had this enormous treasure trove of digital information, they only naturally began to identify algorithms and other ways to make better use of the digital information.  Healthcare professionals wanted to use the information to improve individual patient diagnosis, medical research and the overall quality of care.

Those two technology trends are making FDA more and more interested in regulating at least certain aspects of EHRs and associated software.