Dr. Daniel B. Rubin advises healthcare, life sciences, and pharmaceutical clients on regulatory compliance and the use of health information and other forms of personal data in the research, development, and marketing of FDA-regulated products.
Dan works with clients on matters at the intersection of health and information technology. He advises on all aspects of digital health, including the integration of apps in clinical decision-making and direct-to-consumer communication of medical information. He routinely helps clients navigate complex regulatory issues in the development and marketing of Software-as-a-Medical Device (SAMD), as well as to deploy telemedicine and other internet-based health initiatives. He also helps clients navigate privacy concerns on the state, federal, and international level throughout the healthcare and life sciences sectors, particularly as they interface with other complex regulatory regimes.
Dan advises on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues, including helping clients bring new innovations in the life sciences to market. Specifically, Dan has deep knowledge of, and hands-on experience with, the regulation and operation of clinical trials. He advises clients in the pharmaceutical, medical device, and technology sectors, as well as academic medical centers and Contract Research Organizations (CROs), on all aspects of clinical research and the use of health-related data in product development, including negotiating and implementing domestic and international research collaborations and advising on their compliant operation. He also advises clients on the establishment and operation of research databases of genetic and medical information, and the anonymization of protected health information.
Prior to joining Morrison & Foerster, Dan was an associate in the privacy and cybersecurity practice group at another major international law firm, where he was secunded to a global consumer electronics company. Dan also served as in-house privacy and regulatory counsel at a leading pharmaceutical company where he advised on the research, development, and marketing of FDA-regulated products under the FDA Good Clinical Practice Regulations and Quality Systems Regulations, as well as their international analogs.
Dan served as a law clerk to the late Honorable Juan R. Torruella of the United States Court of Appeals for the First Circuit. Dan earned his Ph.D. in health policy from the University of Michigan School of Public Health. He received his J.D., magna cum laude, from the University of Michigan Law School. Dan received his M.A. in bioethics from Case Western Reserve University and his B.A., with honors, in neuroscience from Oberlin College.Show More