Mobile Health Technology and the Law
by John Huffman
As in most industries, the role of technology in the delivery of health services continues to evolve at a rapid pace. An example is the growing role of mobile health—or “mhealth”—technology and applications designed to help healthcare providers deliver their services from any number of remote devices. Over half of the estimated 20,000 mhealth apps are now designed for healthcare professionals, enabling them to provide innovative services in everything from iPad radiological reads to telemedicine consultations half a world away.
Unsurprisingly, this emerging technology finds itself outpacing the governmental entities that would monitor and regulate how the technology is changing the delivery of healthcare services. As a response to these changes, the FDA recently released Draft Guidance for regulation of mhealth apps. Through the Draft Guidance, the FDA conveys its current thinking on the issue of mhealth apps and, though in parts circular and convoluted, the Draft Guidance sets out guidelines on how the FDA intends to regulate mhealth apps. This article will summarize the Draft Guidance and briefly discuss its implications and effects on the market.
The Draft Guidance defines a “mobile medical app” as a software application that runs on a commercial, off-the-shelf handheld computing device (i.e. a “mobile platform”) if that software meets the definition of “device” in the Food, Drug and Cosmetic Act (FDCA) and either a) is used as an accessory to a medical device, or b) transforms a mobile platform into a regulated medical device. As with any potential medical device, the intended use of the mobile medical app will determine whether or not it is a device and thus falls under the FDA’s regulatory authority under the FDCA.
If their products qualify as a mobile medical app, manufacturers will be subject to the requirements associated with the applicable device classification. A mobile medical app, like any other device, may be classified as class I (general controls), class II (special controls as well as general controls), or class III (premarket approval). The Draft Guidance lists classifications under which existing medical devices currently fall, and mobile medical apps that are accessories to those devices or transform mobile platforms into those devices will have to meet the requirements of that classification. For example, a mobile medical app that is an accessory to an electronic stethoscope (a class II device) or transforms an iPhone into an electronic stethoscope would be subject to class II-level regulations (i.e. 510k approval).
Helpfully, the FDA provides some guidance on what apps would be regulated under the Draft Guidance. Some examples include: a) apps controlling or displaying patient-specific data gathered from an underlying medical device (like a remote smartphone display of a bedside monitor); b) apps that enable a host device with the functionality of an existing medical device (such as attaching a transducer to transform an iPhone to a stethoscope); and c) apps that analyze data for a “patient-specific” result or diagnosis. The more indistinguishable the app is from a regulated medical device, and the greater its role is in analysis of patient-specific data, the more likely it will be to fall within the regulatory framework of the FDA.
The Draft Guidance also lists some examples of apps that would NOT be regulated as mobile medical apps. These include: a) electronic copies of textbooks and references; b) apps focused on logging, tracking or evaluating general health and wellness (such as calorie counters or appointment reminders); c) apps to assist with “general office operations” such as billing or inventory; and d) electronic health records apps.
The Draft Guidance is helpful in elucidating how the FDA plans to deal with mhealth apps specifically and the role of technology in healthcare delivery broadly. Manufacturers and designers must be careful about how they design and market their apps, and their counsel must navigate the FDA regulatory framework to bring these apps to market as quickly and as safely as possible.
There are many other issues that counsel for both developers and healthcare providers in this space will need to consider as they develop, market, gain approval for, and implement mhealth apps. These issues include scope of practice, corporate practice of medicine, HIPAA and data security, telemedicine credentialing and professional liability. One fact is certain: technology will continue to change healthcare delivery at a rapid pace, and it remains to be seen how the law will keep up.
John Huffman is an Associate at Greenberg Traurig, LLP. He can be reached at firstname.lastname@example.org.