Last week, Senators Amy Klobuchar (D-MN) and Lisa Murkowski (R-AK) introduced the Protecting Personal Health Data Act (S. 1842), which would provide new privacy and security rules from the Department of Health and Human Services (“HHS”) for technologies that collect personal health data, such as wearable fitness trackers, social-media sites focused on health data or conditions, and direct-to-consumer genetic testing services, among other technologies. Specifically, the legislation would direct the HHS Secretary to issue regulations relating to the privacy and security of health-related consumer devices, services, applications, and software. These new regulations will also cover a new category of personal health data that is otherwise not protected health information under HIPAA.
Continue Reading Legislation Seeks to Regulate Privacy and Security of Wearables and Genetic Testing Kits
Wade Ackerman
Wade Ackerman advises companies and trade associations on complex and novel FDA regulatory issues, with a particular focus on cutting-edge technologies that require coordinated legal, regulatory, and public policy strategies. He works with clients across the life sciences and technology sectors—including those developing artificial intelligence, digital health tools, and other innovative technologies—helping them anticipate and navigate rapidly evolving federal, state and global regulatory frameworks.
With more than two decades of experience in private practice and senior government roles, Wade brings deep insight into the interplay of innovation, health policy, and FDA regulation. Since 2017, he has co-led Covington’s multidisciplinary Digital Health Initiative, which draws on the firm’s global resources to advise companies harnessing data and technology to transform healthcare delivery and improve patient outcomes.
Until June 2016, Wade served as Senior FDA Counsel to the U.S. Senate Health, Education, Labor & Pensions (HELP) Committee, where he played a central role in major FDA legislative initiatives, oversight hearings, and policy development. He helped negotiate key provisions of the 21st Century Cures Act, shaping reforms to FDA’s review and approval of drugs, devices, and digital health software.
Earlier in his career, Wade served for more than five years as Associate Chief Counsel within FDA’s Office of Chief Counsel, advising the Center for Drug Evaluation and Research (CDER) and the Office of Commissioner (OC) on a wide range of drug regulatory and policy issues. He was also involved in developing and implementing significant reforms, including the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and the Drug Quality and Security Act (DQSA) of 2013.