EHRs and the FDA



File this under your definition of irony:  an iPhone app that turns your phone into a breathalizer with the addition of a small accessory can’t get on the market without FDA approval while the software that medical professionals rely on everyday to check interactions between medications and communicate patient medical information barely has to make it through beta testing.


To be quite honest, I still have mixed feelings as to whether or not EHRs should be regulated by the FDA as medical devices or not.  On one hand the approval process is lengthy and stifling to innovation.  Let’s say a diabetic insulin or cardiac monitor manufacturer wants to change their software so the data can be easily accessed and exported by the patient.  FDA approval is required.  This causes the manufacturer to carefully bundle all of their enhancements together since there really is no turning back after a version release comes out.  No quick, incremental improvements can happen, which is, you know, how the rest of technology works.  On the other hand, people’s lives are at stake.  Some check to make sure a product isn’t snake oil is beneficial to society.  This is like saving a drowning person with a fleet of turtles.  They’ll get there…eventually. Of course, the person may have drowned by then.

How does the FDA define what a medical device is anyway?

“An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

Perfectly vague on purpose and all it would take for an EHR to be considered a medical device would be an internal decision by the FDA or someone suing the FDA to make it so.  I would hazard a guess to say that EHRs will be regulated in the future by something more than a “certification”.  The “Meaningful Use” definition after all doesn’t include “Safely use”.  Whether that will be beneficial to the healthcare industry or not remains to be seen.





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