On January 25, 2022, Senators Patty Murray and Richard Burr (Chair and Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, respectively) released a “discussion draft” of bipartisan legislation—the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (“PREVENT Pandemics Act”)—which contains notable provisions related to digital health.
A.J. Carvalho is an associate in the Washington office, where he practices in the Patent Litigation, False Claims Act, and White Collar Defense and Investigations Practice Groups, and also maintains an active pro bono practice.
Prior to attending law school, A.J. worked at Walter Reed National Military Medical Center coordinating exploratory clinical research studies related to blast injuries, particularly amputation, and concomitant conditions.
Spurred by the realities of the COVID-19 pandemic, FDA has taken a number of regulatory actions to advance the use of digital health technologies (“DHTs”) in clinical trials. DHTs provide sponsors with opportunities to capture a broader array of information from study subjects than is typically available through traditional study designs. This includes information from…