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Through more than a decade of experience in private practice and positions within the FDA and on the Hill, Wade Ackerman has acquired unique insights into the evolving legal and regulatory landscape facing companies marketing FDA-regulated products. Mr. Ackerman advises clients on FDA regulatory matters across a range of sectors, including drugs and biologics, cosmetics, medical devices and diagnostics, and digital health products and services associated with drugs and traditional devices. He serves as one of the leaders of Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and marketing of digital health technologies.

On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies.  These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device.  In parallel, FDA also updated four previously final guidance documents to ensure

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

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