The use of digital health applications — sometimes called mobile health applications or mHealth — has increased dramatically in recent years. However, digital health applications thus far have been subject to limited regulatory oversight, with many digital health applications receiving little to no review prior to going on the market.
The Solomon Center for Health Law and Policy at Yale Law School in partnership with Strathmore Health Strategy led an interdisciplinary study of the regulation of digital health applications in the United States. In particular, this project identified four key limitations in many currently available digital health applications that should be addressed in future digital health regulatory reform.
Research was conducted by Ryan Knox, Senior Research Fellow at the Solomon Center for Health Law and Policy at Yale Law School; Cara Tenenbaum, Principal at Strathmore Health Strategy; and 19 Solomon Center Student Fellows from Yale’s medical, business, public health, and law schools in Fall 2020 and Spring 2021. On March 18, 2021, the Solomon Center for Health Law and Policy hosted a patient-group stakeholder meeting, which was attended by representatives of eight patient advocacy organizations. The project was also presented on June 10, 2021 to scholars at the Health Law Professors Conference.
This policy paper, “A Path to Patient-Centered Digital Health Regulation,” is the result of the research and discussions with patient advocacy organizations.