(I would like to thank Tim Gee of Medical Connectivity Consulting and Mike Robkin for their comments on a draft. The views expressed, right or wrong, are only the author’s and should not be attributed to anyone else.)
At mHealth meetings, I keep hearing representatives from hospitals and other healthcare caregivers say they don’t believe FDA regulations extend to them. They seem to believe that an institution must have a smokestack and an assembly line before it needs to worry about FDA regulation beyond clinical research. But that's just not true. FDA can regulate even those engaged in the practice of medicine, if they are also engaged in FDA-regulated activities.
FDA regulation covers making “devices,” regardless of who engages in that activity. In this series of articles, I've described the types of hardware and software FDA might regulate as “devices,” and provided some background on what the regulatory framework looks like. In my last article, I noted that recent activity at FDA suggests the agency is preparing to expand its scope to most areas of HIT, and by implication into both the patient-end and the caregiver-end of mHealth. In fact, as revealed by the Huffington Post, in February of this year, FDA sent a letter to 350 hospitals inviting them to voluntarily report problems with HIT systems (including EHRs and hand-held devices), as a part of FDA’s MedSun program.
In this article, I review examples of where FDA has regulated caregivers to identify the factors that lead the agency in that direction, and provide a high-level overview of the relevant law. With that as background, I also examine some mHealth care provider practices that might end up FDA-regulated, and offer suggestions for how care providers can avoid FDA regulation if that prospect doesn't excite them.
FDA Care Provider Regulation Examples
If, as an example, a large hospital were to buy a medical device company, FDA would not all of a sudden lose authority over the products the medical device company sells. In fact, it's actually somewhat common for FDA to regulate activities of healthcare providers and professionals who tread into product waters. I'll give four examples.
First, over the last couple of decades, in FDA's view some pharmacies went beyond the traditional practice of pharmacy services into the production of new drugs. Pharmacies have always compounded drugs, which can include mixing various ingredients to make them taste better or easier to digest. But according to FDA, in some cases pharmacies started to basically make their own versions of commercially-available drugs. Apparently some of those pharmacies also did so in advance of receiving a prescription, and in large quantities unrelated to any one patient. So FDA adopted an enforcement policy declaring those activities to be regulated drug manufacturing.
Second, some clinical laboratories develop their own chemical reagents and software for conducting tests on blood and other specimens. FDA declared it has the right to regulate those chemical products just as if they were made by commercial manufacturers. Indeed, FDA has proposed to regulate a subset of laboratory-developed tests that combine multiple variables (e.g. gender, age, and weight) using an interpretation function (i.e. algorithm) to generate a patient specific result.
Third, physicians and other clinicians sometimes directly sell drugs to, or use medical devices on, patients. When they do so, these clinicians also might promote their services. If they promote uses the FDA has not approved for the products, FDA may enforce its regulatory requirement on the caregivers. In the 1960s and 70s, FDA took several clinics to court that were hawking various remedies for cancer and all sorts of other maladies. As recently as last year, FDA went after a clinic that was offering hyperbaric chambers to treat conditions like stroke, coma, and multiple sclerosis. When the clinicians stand to directly gain financially and use aggressive promotion beyond the cleared label, FDA tends to get involved.
Fourth, and perhaps most analogous to mHealth, FDA regulates the hospital reprocessing and reusing of “single use devices.” Manufacturers of disposable products do not validate cleaning and re-sterilization of their products. So when hospitals decide, as a matter of saving money, to reuse devices intended to be thrown away, FDA says in industry guidance that the reuse is a new use beyond what the original clearance contemplated. As the promoter of the new use, the hospital needs to satisfy FDA regulatory requirements just as any other manufacturer, securing approval and following good manufacturing practices.
The point of these examples is FDA has shown no reluctance to impose its requirements on any type of healthcare organization that engages in what the agency believes to be manufacturing. Smokestacks are not required.