On March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the “DHT Framework”). This DHT Framework is on the heels of a Discussion Paper the Agency released earlier this month on the use of artificial intelligence (AI) in drug manufacturing to seek public input on issues of critical focus (the “AI Discussion Paper”). While both actions are significant, the AI Discussion Paper is one of CDER’s few policy statements related to the deployment of AI around regulated activities (though the Center did establish an AI steering committee in 2020). CDRH, on the other hand, has issued several policy documents around AI-based software potentially regulated as “software as a medical device” (SaMD), including through an April 2019 discussion paper that proposed a regulatory framework for modifications to AI-based SaMD, an AI “Action Plan” for SaMD in January 2021, and guiding principles to inform the development of Good Machine Learning Practice for AI-based medical devices in October 2021. CDER has requested public comment on the recent DHT Discussion Paper and AI Framework by May 1 and 23, respectively.Continue Reading FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development
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 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.
AI/IoT Update: The Potential Benefits of Digital Health Technology in Managing COVID-19
The COVID-19 crisis is demonstrating the potential of digital health technology to manage some of our greatest public health challenges. The White House Office of Science and Technology Policy has issued a call to action for technology companies to help the science community answer high-priority scientific questions related to COVID-19. The Centers for Disease Control and Prevention has also recognized that technology and surveillance systems can play an integral role in supporting the public health response to outbreaks.
Continue Reading AI/IoT Update: The Potential Benefits of Digital Health Technology in Managing COVID-19
IoT Update: Senators Introduce Legislation to Regulate Privacy and Security of Wearable Health Devices and Genetic Testing Kits
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 IoT Update: Senators Introduce Legislation to Regulate Privacy and Security of Wearable Health Devices and Genetic Testing Kits