This week, Congress is holding hearings on FDA's plan to oversee and regulate medical apps for smartphones as medical devices. As I wrote back in my Medical Apps, FDA and Patient Data Integrity posting, the regulation of medical apps is a perilous road for FDA to take given the agency's track record when it comes to technology and innovation.
Congress is using the device tax as the leitmotif, but in reality, this three-day hearing is really about whether FDA should even be tackling medical apps right now. Today, the agency can barely get a handle on its current responsibilities to oversee approximately 25% of the entire US economy. Adding the ultra fast-paced landscape of medical apps to FDA's regulatory plate seems to lie somewhere between a foolhardy power grab and a tragically noble safety effort.
According to Clinical Innovation & Technology, there are already 27,000 medical app products on the marketplace today, most of which are either free or less than a few dollars in cost. An additional 500 new medical apps are launched each day. Even if every FDA employee, from Commissioner Hamburg all the way down to the agency's latest summer intern, were to instantly (*poof*) turn into expert "FDA medical app reviewers," the agency does not have enough human beings to review all the apps on the market today much less keep pace with all the new, daily medical app product launches and nor the countless updated revisions to earlier released apps.
For a medical app to go through the FDA 510(k) process takes 3-18 months of FDA review and costs a company hundreds of thousands of dollars. So far, only 80 apps have gone through the approval process.
And to what end? What known, quantifiable, tangible public health and safety risks are being eliminated or mitigated?
What are the Public Health Risks?
For the vast majority of these apps - at least 90-95% - there are no public-wide health or safety risks not already covered under other rules such as false advertising (FTC) or market mechanics (bug-ridden apps tend not to get used very much). These are the apps geared toward you and me (i.e., the general public).
For the tiny sliver of apps for whom intended users are professional, trained medical personnel - doctors, nurses, clinicians, etc. - the risk is not direct harm to the patient; the risk is that the data within the app will become corrupted somewhow and not allow an accurate reading, an accurate diagnoses, an accurate display of trends, etc.
And its these professional, clinical apps that pose a risk - not to public health and safety - but to the ability of healthcare professionals to rely upon medical apps as helpful tools, just as the healthcare professional relies upon an office computer or Microsoft Word or the fax machine or a sharps disposal bin. FDA does not regulate these as devices...does it?
Oh wait, FDA does regulate sharps trash bins as medical devices (we'll save that for a future post).
A Simple, Common Sense Regulatory Approach to Medical Apps
Last year, Sweden's Medical Products Agency (Sweden's "FDA") published a very reasonable, balanced regulatory view with their guide on how medical software falls under the EU health regulations such as the EU GMPs and EU Annex 11. Sweden clarifies that smartphone medical apps do not - and will not ever - fall under the category of actual medical devices unless the smartphone or tablet is specifically converted into a medical device to be used largely for the detection, diagnoses and/or treatment of medical conditions (such as a smartphone specifically into a patient monitoring device).
Under that rubric, only apps strictly designed for healthcare professionals, clinical settings and/or dedicated to patient monitoring and reporting (to healthcare professionals) would fall into FDA's purview. You can download an English translation of Sweden's simple, common sense approach to regulating medical apps here.
Congress and FDA would best serve the public by adopting such a common sense approach, at least for now until actual risks materialize enough to justify heavier regulatory oversight.
Implementing heavy FDA oversight of medical apps as medical devices in the US today will only verify Winston Churchill's wry observation, "Americans can always be counted on to do the right thing...after they have exhausted all other possibilities."