The Uncertain Road Ahead for mHealth

By Scott Sheaf

This is a pretty exciting time for mHealth and personalized medicine. We are on the brink of major changes in the way we manage our own health and wellness. Apple and Samsung’s recent entrance into the health and wellness arena with their respective HealthKit and Simband platforms are the latest, albeit high profile, addition to the wealth of work going on in the quantified self and personalized health space. Both companies are taking the approach of developing a platform and allowing everyone to take place in the innovation. Yes, indeed, it’s an exciting time, but many challenges remain.
For instance, when does my mobile device become a medical device and come under the prevue of the Food and Drug Administration (FDA) to ensure safety and effectiveness? Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. Personal health monitoring apps are most likely Class I devices and probably exempt from filing requirements of the FDA, but it doesn’t free the manufacturer from implementing the proper level of control necessary to assure the safety and effectiveness of the device. mHeath developers would be wise to find a reputable partner with a deep knowledge of FDA regulations and controls.
Patient privacy is also a big concern. Developers need to address the security and integrity of personal health information, especially as Big Data aggregators begin to house more and more health information. As a medical device cybersecurity specialist, I am not convinced that any one company can or should be trusted to keep my personal health data safe.
And what about regulation beyond the FDA? For example, the Federal Trade Commission (FTC) has been the chief federal agency on privacy policy and enforcement since the 1970s, when it began enforcing one of the first federal privacy laws. Does the FTC need to be involved when we are transmitting medical information over cellular networks?
As an industry I think we can overcome these challenges. This is just the first wave. I see some really big benefits independent of the challenges above. In the near term, as more personalized health reporting becomes pervasive, I believe we’ll see a direct impact in general health and wellness independent of the accuracy of sensors or the behind-the-scenes analytics. People tend to work harder at staying healthy when they see real-time feedback, and this is amplified when we integrate the social aspect. Seeing this information and knowing it is being shared to your social network gives the user a mental boost the run that extra mile or not eat that donut.
While more products become available to help us manage our health, we must be careful safety and efficacy aren’t compromised by knowing when a product steps over the line from being a health and wellness monitor to becoming a regulated medical device.
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Scott Sheaf is a senior software engineer at Battelle.