Innovative Health Care Delivery: The Scientific and Regulatory Challenges in Designing mHealth Interventions.

Scientists looking for innovative ways to deliver health care have long searched for mechanisms that can enable the right intervention to be delivered at the right time. Traditional delivery mechanisms have been limited both to the availability of a provider (e.g., a physician) and the location of care (e.g., a hospital or outpatient clinic). In recent years, however, numerous technological advancements—including wearable devices, mobile technologies, and the widespread development and use of user-friendly smartphone applications—have resulted in signifi cant changes in how care is delivered. For example, mobile Health (mHealth) technologies are now commonly used to deliver interventions in a self-service and personalized manner, reducing the demands on providers and lifting limitations on the locations in which care can be delivered. Successful examples of mHealth interventions include programs to: 1. maintain adherence to HIV medication and to smoking cessation eff orts, which have shown suffi cient eff ectiveness for adoption by health services [1]; 2. assist caregivers in managing veteran post-traumatic stress disorder (PTSD) and provide support with health care-related tasks within the Veterans Aff airs (VA) system [2]; 3. continuously monitor chronic medical conditions, collect and share relevant data, and use this data to develop more eff ective treatment or disease management plans [1,3]; 4. encourage physical activity and weight loss in a more cost-eff ective, scalable manner than oneto-one approaches [1,4]; and 5. reduce excessive alcohol use [1,4].