Nothing hinders business growth more than regulatory uncertainty or burden. Health care has its share of those issues. While the mobile and wireless health craze has moderated in recent months, if history is a guide, the kernel of value in these devices and applications will continue to grow and some significant products and services will evolve. A major barrier to that evolution has been uncertainty about how the Food & Drug Administration will regulate these devices and applications. The total communications and information systems around mobile health are amazingly complex. The FDA has now issued proposed guidance for mobile health applications. The mHealth Regulatory Coalition, an industry group, had earlier proposed draft guidances for the FDA to consider. (FDA Guidance) (Proposed Guidance 1) (Proposed Guidance 2) (Proposed Guidance 3)
The primary difficulty is that the FDA has long viewed software that is intended to diagnosis, prevent or treat human health issues as a medical device and its regulation of software and the associated hardware has been patchy, inconsistent and has not kept up with technology developments. To its credit, and because industry has pressed hard, the FDA is trying to address this leading-edge mobile health area relatively early on. The guidance focuses on what it views as the highest risk items to patients, which includes products that have attachments like glucose sensors or EEG electrodes that make a product more like a traditional medical device; decision support apps; or software that controls the function of a medical device. All this kind of functionality will face stricter scrutiny, including the potential need for trials.
On the other hand certain uses were identified that will need little or no review, including online medical references, general fitness and wellness apps, electronic health record or personal health record apps, billing and other administrative software and generic tools or apps that aren’t specific to health care. Software that just stores, sorts or transmits data is considered low risk. Software that helps physicians and other care providers decide how to diagnosis and treat disease will need more scrutiny. People who just provide software for one-time downloads won’t have to worry; they aren’t considered manufacturers. But hospitals and other providers or payers who develop home-grown software with mobile uses may be considered a manufacturer and subject to regulation. There are obviously still some areas to be sorted out and it is a very complex subject; but the guidance may give some certainty to manufacturers and as importantly, investors.