According to the Food and Drug Administration, a medical device is "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."
Also, the agency has issued a guidance document differentiating a mobile medical app from a medical device. Electronic medical records, at least in their present form, are unlikely to be interpreted to be medical devices. But, what about the future? What if next-generation EMRs have deep intelligence and decision support, advising treatment using DIY medical apps? What would be the regulatory implications, given that:
1. They are not safe now. They contribute to significant medical errors and might require a black box warning.
2. They are not secure.
3. They are not effective.
4. They would probably require a 510 (k) approval. New applications might be so new they require a PMA process for approval.
5. They are not user friendly.
6. The do not achieve their intended use.
7. They have not been demonstrated to be cost effective.
8. They do not come with proper labeling or a product insert.
9. There are no instruction manuals.
10. It is hard to find replacement parts.
CEOs of companies that make electronic medical records as medical devices would be getting cease and desist letters from the FDA. Maybe it's time to call a preventive moratorium on their use before we get to that point.
Arlen Meyers, MD, MBA is the President and CEO of the Society of Physician Entrepreneurs at www.sopenet.org