Mobile Health: The Evolving Industry and Regulatory Landscape

This interactive course provides a landscape of the evolving mobile health technology sector with an explanation of the equally dynamic framework created by U.S. regulatory authorities that oversee this transforming area. Emerging mobile health needs are met with the development of technological solutions enabling new models of delivery of care services and information. The new technologies span the entire lifecycle of care from wellness to chronic disease management and end-of-life care. In less than ten years, the movement has given rise to an entirely new health technology sector known as “mobile health.”

The new healthcare environment has been accelerated by macroeconomic shifts accompanied by the proliferation of new information technologies, which have accelerated the pace of change in unprecedented ways. These new information technologies are enabling new models of delivery of care services and information. Opportunities for revenue models and commercialization strategies previously not possible are now beginning to emerge for mobile health innovators. These new potentially sustainable businesses are built around mobile technologies, and reach their users and organizations in novel ways, continuing to give momentum to the growth of this industry sector.

Topics Include:

  • Framework established by the FDA on past positions, current strategy and recommendations, and emerging regulatory issues, with several examples drawn from industry news

  • A regulatory outlook will be discussed with actionable advice to help navigate upcoming changes and implementation of current regulatory strategies

  • Broader issues surrounding the governance of mobile health, specifically on privacy, confidentiality, and security will be presented.


Prerequisites :

Offering code Offering title
REGL.X404 Regulation of Medical Devices and Diagnostics
MEDD.X407 Quality Systems for Medical Devices: FDA QSR and ISO 13485
MEDD.X400 Design Control for Medical Devices