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 that require coordinated legal, regulatory, and public policy strategies.

Through more than 19 years of experience in private practice and positions within the FDA and on Capitol Hill, Wade…

Wade Ackerman advises companies and trade associations on complex and novel FDA regulatory issues that require coordinated legal, regulatory, and public policy strategies.

Through more than 19 years of experience in private practice and positions within the FDA and on Capitol Hill, Wade has acquired unique insights into the evolving legal and regulatory landscape facing companies marketing FDA-regulated products. He co-leads Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable global resources to advise life sciences and health technology clients harnessing the power of information technology and data to create new and cutting-edge innovations to improve health and achieve better outcomes for patients.

Until June 2016, Wade served as Senior FDA Counsel to the U.S. Senate Health Education, Labor & Pensions (HELP) Committee Ranking Member Patty Murray (D-WA) and, prior to that, Chairman Tom Harkin (D-IA). While at the HELP Committee, Wade was involved in all major FDA legislative initiatives, oversight hearings, and other Senate HELP Committee activities concerning the FDA and the Federal Food, Drug, and Cosmetic Act. From January 2015 through June 2016, he helped negotiate many of the FDA-related provisions in the 21st Century Cures Act, which included reforms to FDA’s review and approval of new drugs, devices, combination products, and digital health software. He also worked closely with the FDA and other stakeholders as Congress examined legislative reforms in other key areas, including diagnostics and laboratory developed tests, cosmetics, and over-the-counter drugs.

Before taking his Senate role, Wade served for more than five years as Associate Chief Counsel within the FDA’s Office of Chief Counsel. He was responsible for providing legal advice to the FDA’s Center for Drug Evaluation and Research (CDER) and the Office of Commissioner (OC) on a wide range of issues. While at FDA, he also helped to develop and implement the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and the Drug Quality and Security Act (DQSA) of 2013—both significant reforms to FDA’s regulatory authorities.

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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 2024 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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