HHS, ONC, OCR, FDA, and Your Smart Devices

Smart phones are, well, smart. They are little hand held supercomputers. They have more computing power than my first home built computer; I think they can do more than my first two or three “store bought” computers as well. Indeed, NASA engineers would have loved to have something so powerful back when they used pencil, paper, and the slide rule to put a man on the moon.  (If you are like my kids, scratching your head and muttering “Slide rule? What is a slide rule?” click here for a well done piece by Elissa Nadworny at NPR.)

Phones are not the only thing getting smarter. Today we are confronted with a variety of smart devices. We can wear watches that communicate with our phones (after all, they are smart!) to track our heart rate, blood oxygen saturation, activity level, blood glucose, and sleep patterns, to name but a very few of the possibilities.  We can wear other monitors that communicate with our phones, sending even more information to the cloud – and from there we can share information with fitness rivals, friends, neighbors, and, yes, even providers. These devices can serve as motivators, trainers, record keepers, and more – all in a small package that is convenient and simple to use.

It seems only logical that we try to develop these devices to their fullest. Imagine having a device that will allow you to assess your health and well-being in your jacket pocket? That would be the epitome of personalized medicine, right? What risks are there? Aren’t we talking about something that will make medical care cheaper, faster, and more convenient? We have so many choices, surely it is a simple matter for each of us to pick the right one for our needs.

The solution is not quite as complex as the inner workings of my phone, but it is not as simple as we might think.  We have a myriad choices of apps that do a variety of incredible things. But there lies the issue; it is not the quantity of offerings, it is the quality of the offerings that is concerning.

Just as, shocking to some, everything found on the internet is not true, not every app delivers the same quality. And some have crossed a threshold that will have implications for the entire industry. Anytime we discuss quality, the conversation will invariably segue to regulation, and the opportunity for regulation gets regulators all excited. This is where we find ourselves these days; regulators ready to reach into your pocket to decide what apps you can use on your phone.

What does this mean? It could be trouble for medical app developers who have grown accustomed to little or no regulation. The industry has known this day would come. FDA, for example, has spent the better part of five years contemplating what to do in this sector.  Part of the challenge is that mobile health apps are subject to various existing laws written back in the day of the slide rule. Federal agencies have been wrestling with how to apply these laws to current technology. The US Department of Health and Human Services (HHS), the Office of the National Coordinator for Health Information Technology (ONC), the Office for Civil Rights (OCR), and the Food and Drug Administration (FDA) have produced an interactive tool that aims to allow app developers to determine what laws might apply to mobile health apps.  The tool is not perfect, but it does give some general guidance. It is a good place to start before you wade through this FDA guidance regarding mobile medical applications, this FDA portal regarding medical apps, and the OCR’s web portal addressing questions relevant to HIPAA – and the list goes on.