This is the fourth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process.  Today’s video explores the question: what data will be needed to substantiate the offering?

Tags: Data Security, FDA, Health data, Medical Devices, Mobile Medical Apps
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Photo of Wade Ackerman 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…

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 nearly 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.

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Photo of Libbie Canter Libbie Canter

Libbie Canter represents a wide variety of multinational companies on managing privacy, cyber security, and artificial intelligence risks, including helping clients with their most complex privacy challenges and the development of governance frameworks and processes to comply with U.S. and global privacy laws.

Libbie Canter represents a wide variety of multinational companies on managing privacy, cyber security, and artificial intelligence risks, including helping clients with their most complex privacy challenges and the development of governance frameworks and processes to comply with U.S. and global privacy laws. She routinely supports clients on their efforts to launch new products and services involving emerging technologies, and she has assisted dozens of clients with their efforts to prepare for and comply with federal and state laws, including the California Consumer Privacy Act, the Colorado AI Act, and other state laws. As part of her practice, she also regularly represents clients in strategic transactions involving personal data, cybersecurity, and artificial intelligence risk and represents clients in enforcement and litigation postures.

Libbie represents clients across industries, but she also has deep expertise in advising clients in highly-regulated sectors, including financial services and digital health companies. She counsels these companies — and their technology and advertising partners — on how to address legacy regulatory issues and the cutting edge issues that have emerged with industry innovations and data collaborations.

Chambers USA 2025 ranks Libbie in Band 3 Nationwide for both Privacy & Data Security: Privacy and Privacy & Data Security: Healthcare. Chambers USA notes, Libbie is “incredibly sharp and really thorough. She can do the nitty-gritty, in-the-weeds legal work incredibly well but she also can think of a bigger-picture business context and help to think through practical solutions.”

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