Physicians and healthcare institutions are accustomed to adapting as new technologies and methods are introduced. In particular, emerging technologies often introduce uncertainty as to the applicable knowledge base and their appropriate deployment or use. Mobile health and wearables may prove particularly challenging because of their hybrid existence, sometimes inside and sometimes outside, the traditional provider-patient relationship and its relatively tightly regulated domain. In this context the private liability model, or regulation by litigation, is particularly troublesome. A case-by-case liability decision-making model will tend to exhibit particular indeterminacy when faced with novel issues. As with any other treatment innovation, the customary-practice standard of care for malpractice can chill or accelerate adoption of new approaches. Doing things “the old way” can appear safer from a liability standpoint. But that is true only up to an ill-defined tipping point at which the innovation becomes the prevailing standard of care. Malpractice liability for healthcare providers who participate in the design of, rely on, or recommend and prescribe mobile health products does not raise novel legal issues. However, existing legal doctrines will likely influence the development and adoption of mobile health products by healthcare professionals. The FDA has decided on a very “light” approach to the regulation of mobile health apps and wearables, in all probability based on a determination that any perception of over-regulation would stifle innovation. An alternative argument is that regulatory certainty would reduce market anxiety and spur development.255 When it comes to the more dignitary losses that occur when privacy or security are breached, traditional regulatory systems such as HIPAA do not provide remedies for individuals. Here too, relatively underdeveloped common law analogs will be applied, bringing with them another set of indeterminacies. What is clear is that regulation by litigation currently does apply to the mobile health space. However, the applicable common law doctrines are by nature fact-intensive and, at least in the early days of application to novel fact patterns, tend to exhibit high levels of indeterminacy.
255. Cortez, supra note 13, at 1179.