Digital Home Health During the COVID-19 Pandemic: Challenges to Safety, Liability, and Informed Consent, and the Way to Move Forward

We argue that changing how postmarket studies are conducted and who evaluates them might mitigate some concerns over the agency’s increasing reliance upon RWE. Distributing the responsibility for designing, conducting, and assessing real world studies of medical devices and drugs beyond industry sponsors and the FDA is critical to producing – and acting upon – more clinically useful information. We explore how the DESI program provides a useful model for the governance of RWE today. We explain why the FDA’s Center for Devices and Radiological Health is the most promising site for a new DESI initiative inspired by the challenges of regulating drugs in the past.