Brad Thompson counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues.
Machine Learning and Artificial Intelligence Practice
Brad is a quantitative thinker by nature, who enjoys tinkering with algorithms. To develop a deeper understanding of machine learning algorithms, Brad has returned to the University of Michigan, part time and using distance learning avenues, to pursue a Master in Applied Data Science from the School of Information. As a part of that curriculum, Brad is studying the math, statistics, and computer science (Python), which serve as the basis for artificial intelligence (AI). Specific coursework includes SQL & Databases, SQL Architectures & Technologies, Efficient Data Processing, Scalable Data Processing, Math Methods for Data Science, Data Mining, Supervised Learning, Unsupervised Learning, Deep Learning, Machine Learning Pipelines, Natural Language Processing, and Network Analysis. Brad expects to graduate in 2021.
At Epstein Becker Green, Brad leads an initiative to comprehensively serve the legal needs of those clients that either develop or use AI tools. That initiative cuts across the firm’s practice areas to include both health and labor.
In his own practice, Brad regularly advises developers of new “software as a medical device” (or “SaMD”) products seeking FDA approval through the de novo process, the 510(k) process, and even in tandem with drug products. In this regard, he has been deeply involved in some of the most innovative technologies in this space both in the United States and internationally. Throughout 2019, Brad visited eight of the leading engineering schools across the country to meet with students and alumni to teach them about the FDA requirements associated with bringing new AI-based medical device products to market. Over a thousand entrepreneurs signed up. Building on that momentum, Brad founded the AI Startups in Health Coalition (AISHC) to help ensure that startup companies addressing clinical needs have a voice in FDA’s future plans to regulate AI, including FDA’s policymaking on its software precertification program as well as its good machine learning practices initiative. Brad has published and spoken widely on these topics.
Brad serves as Chairman of the Board and Chief Data Scientist of EBG Advisors, Inc. Affiliated with the law firm, EBG Advisors is a Washington, D.C., based consultancy that takes a multidisciplinary approach to helping health care and life sciences companies navigate the many obstacles that they face. EBG Advisors is a network of international attorneys, regulatory affairs professionals, reimbursement experts, engineers, clinicians, quality systems advisors, and other professionals who specialize in providing coordinated guidance and solutions across various segments of the health care industry. In his role with EBG Advisors, Brad leads multidisciplinary teams delivering those integrated services. As Chief Data Scientist, in addition to working with clients bringing AI-driven medical products to market, Brad collaborates with other attorneys and consultants in such diverse areas as antitrust, employment law, and healthcare reimbursement, where data analysis plays a key role in successfully serving the client’s needs.
Digital Health Practice
In the Digital Health Initiative at the firm, Brad focuses on the federal regulatory requirements—FDA, reimbursement, privacy, and others—that impact remote monitoring, mobile health, HIT, and device interoperability. The firm’s Initiative brings together a multidisciplinary team of attorneys and consultants trained and experienced in Medicare and private insurance payment, FDA regulatory, scientific, IT, clinical, and security disciplines. Brad served on a workgroup created by the U.S. Department of Health and Human Services (HHS) and the Federal Communications Commission (FCC), charged with identifying key considerations to improve patient safety and promote innovation in health information technology, including mobile medical applications. He co-chaired the workgroup’s Regulations Subcommittee, which focused on identifying regulatory best practices for such technologies. Brad regularly conducts educational programs on digital health regulation and blogs for Mobihealthnews.com.
Counseling, Investigations, and Defense
Brad regularly defends companies receiving FDA warning letters, on a wide gamut of subjects including good manufacturing practice compliance and off label promotion. He frequently counsels companies on premarket clearance and approval strategies and on marketing strategies. When medical device companies become concerned that perhaps their employees have not followed FDA requirements, they often engage Brad to investigate. With a special focus on drug delivery companies, Brad also advises such companies on the unique aspects of combination product development and manufacturing.
For many years, in vitro diagnostic tests has been an area of substantial focus for Brad. He has:
- Served for approximately 10 years as chief outside counsel to one of the world’s largest IVD makers, handling essentially all FDA and Medicare reimbursement issues
- Represented, over time, four of the five largest IVD manufacturers, as well as many others
- Represented trade associations on special projects involving FDA and laboratory developed tests, as well as CLIA and Medicare reimbursement for IVDs
- Represented a coalition seeking the movement of regulatory responsibility for CLIA waiver determinations from CDC to FDA, and then seeking improvements in the way FDA administered the process
- Lectured on FDA’s rules for ASRs and RUOs and the regulation of IVDs and LDTs
- Written a substantial number of diagnostics-related publications, including two book chapters, and has contributed regularly to IVD Technology magazine.
Policy and Industry Advocacy
For trade associations, Brad has served as regulatory counsel for Continua Health Alliance; as counsel to AdvaMed for payment issues; as General Counsel to the Combination Products Coalition, the mHealth Regulatory Coalition, the CDS Coalition (focusing on clinical decision support software), and the AI Startups in Health Coalition (AISHC); and for 17 years, as General Counsel and Secretary for the Indiana Medical Device Manufacturers Council (the “IMDMC”).
For over 30 years, Brad has focused on administrative law issues, particularly on the best ways for agencies and the public to work together in defining new regulatory policy and guidance. In the mid-1990s, on behalf of the IMDMC and about a dozen large trade associations representing virtually every industry the FDA regulates, Brad advocated that FDA should improve its guidance development process to enhance the quality and reliability of guidance as well as to better ensure public participation. Brad’s advocacy resulted in the so-called FDA Good Guidance Practices, now embraced by other federal agencies, as well. In the late 1990s, Brad successfully advocated that what is now called the Centers for Medicare & Medicaid Services should conduct its coverage decision-making process more openly, and in particular should permit public attendance at its advisory committee meetings.
Brad has also served as Co-Chair of the Food & Drug Law Committee of the Administrative Law Section of the American Bar Association, and of the Medical Device Committee of the Food & Drug Law Institute.
Learn more about Brad’s Coalition Advocacy efforts.
In legislative matters, Brad has over the years actively worked to ensure that health care economic information can be appropriately shared without running afoul of FDA requirements, and seeking to secure stakeholders a reasonable avenue of appeal when Medicare contractors deny claims. In both cases, Congress enacted responsive legislation.
Brad has also testified before congressional subcommittees:
- Before the Subcommittee on Communications and Technology, House Committee on Energy and Commerce, March 19, 2013, on FDA regulation of mobile medical applications and devices under its medical device authority.
- Before a Joint Hearing of the Subcommittee on National Economic Growth, Natural Resources & Regulatory Affairs and the Subcommittee on Human Resources and Intergovernmental Relations, both of the House Committee on Government Reform and Oversight, September 14, 1995, on FDA’s Use of Guidance Documents and Rulemaking.
Academia and Publishing
Brad has taught food and drug law at Indiana University School of Law—Indianapolis and Columbia Law School, and has guest lectured at Cornell Tech, on clinical decision support software and algorithms.
Brad’s publications include:
- FDA Regulation of mHealth (Second Edition) (MobiHealthNews, November 2013)
- Off-Label Communications: A Guide to Sales and Marketing Compliance, FDLI (2008, 2010, 2012, and 2014 – fourth edition) (Co-Authored One Chapter)
- Chapter 5, “In Vitro Diagnostic Devices,” in Medical Devices Law and Regulation Answer Book 2011-12 (PLI, Sept. 2011)
- In Vitro Diagnostics: The Complete Regulatory Guide (FDLI, April 2010) (Authored One Chapter, Chapter 5)
- Guide to Medicare Coverage Decision-Making and Appeals (ABA, 2002) (Authored Two Chapters)
- FDA Regulation of Medical Devices (Interpharm Press, 1995)
Whenever Brad gets free time, he loves to meet and photograph people who serve others. Over the last few years, he has been focused on the “Gospel Justice Story Project,” through which he collects and reports stories on what Christian legal aid attorneys do. He has also contributed to the Gospel Justice Initiative blog, “Do Likewise.” Brad released his first multimedia film in July 2013, entitled “Gospel Justice: The Guardian,” and wrote and photographed Christians at work serving others for a book called Macedonia, Indiana. Learn more about these projects.