Brad Thompson counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues.
Brad serves as Chairman of the Board and Chief Data Scientist of EBG Advisors, a Washington, DC-based consultancy that takes a multidisciplinary approach to helping health care and life sciences companies navigate the many obstacles that they face. 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 artificial intelligence (AI)-driven medical products to market, Brad collaborates with other attorneys and consultants in such diverse areas as antitrust, employment law, and health care reimbursement, where data analysis plays a key role in successfully serving the client’s needs.
Machine Learning and Artificial Intelligence Practice
Brad loves math and enjoys tinkering with algorithms. To develop a deeper understanding of machine learning algorithms, Brad earned a Master of Applied Data Science in February 2022 from the University of Michigan’s School of Information. As a part of that curriculum, Brad studied the math, statistics, and computer science (Python), which serve as the basis for AI. Specific coursework included 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.
At the law firm Epstein Becker Green, Brad leads an initiative to 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.
Digital Health Practice
Brad focuses on the federal regulatory requirements—FDA, reimbursement, privacy, and others—that impact remote monitoring, mobile health, health information technology (HIT), and device interoperability. EBG Advisors and Epstein Becker Green bring together a multidisciplinary team of consultants and attorneys trained and experienced in Medicare and private insurance payment, FDA regulatory, scientific, software, clinical, and cybersecurity disciplines. In addition to coordinating the team’s services, Brad advises developers of new digital health 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. He has experience with a wide range of digital health technologies, including:
- clinical decision support software
- digital therapeutics
- clinical prediction or prognosis software
- behavioral health apps
- telemedicine technology
- digital image analysis
- mhealth apps
- personalized medicine software
- HIT/electronic health records (EHR)
- combination products that includes software used in tandem with drugs, such as dosage calculators
- software as a medical device (SaMD)/software in a medical device (SiMD)
- virtual/augmented reality
- medical Internet of things
- public health surveillance software
- medical autonomous decision-making software for such use cases as triage
- wellness assistants
- traditional medical devices that generate data to be analyzed
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 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 HIT, 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.
FDA Counseling, Investigations, and Defense Practice
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.
Coalition and Trade Association 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.
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 sought 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)
For a full list of Brad’s publications, please click here.
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.
Data Science Research & Development Projects
- Served as principal investigator on a University of Michigan-sponsored study, overseen by the University of Michigan Health Sciences and Behavioral Sciences Institutional Review Board, that quantitatively assessed the effectiveness of the Child Sexual Abuse (CSA) educational laws identified in a report prepared by nonprofit advocates. In June 2021, the Massachusetts Citizens for Children published a comprehensive review of state laws entitled “A Call to Action for Policymakers and Advocates: Child Sexual Abuse Prevention Legislation in the States.” From 2005 through June 2019, 31 states enacted laws that required or encouraged schools to teach children and sometimes adults to recognize and report CSA. To assess the effect of those laws, Brad and his team used the National Child Abuse and Neglect Data System (NCANDS), a voluntary data collection system that gathers information from all 50 states about reports of child abuse and neglect. NCANDS was established by the Children’s Bureau of the U.S. Department of Health and Human Services in response to the Child Abuse Prevention and Treatment Act of 1988. By comparing the number of CSA cases in the states with and without the educational laws through a difference-in-differences calculation (using a multivariate regression to estimate the two-way fixed effects as well as newer methodologies), and controlling for changes in population, wages, employment, and other relevant CSA laws, Brad and his team concluded that most likely such laws (1) increased the number of CSA reports made to state departments of child services each year, and (2) decreased the number of CSA cases that those departments were able to substantiate from the reported cases. Brad and his team had hypothesized, however, that effective educational content would cause more reported cases to be substantiated as people learn what to report, but implementation of the new laws surprisingly instead increased the proportion of unsubstantiated reports of CSA. Brad and his team published their analysis to help state legislators chart a path forward in combating CSA.
- Participated in a project on using American Housing Survey Data and demographics contained in the 2018 census to estimate the need for pro bono legal services to address the social determinants of health throughout the country. In a published report, Brad and his team estimated that the total number of attorney hours to address only these five legal issues (substandard housing, evictions and foreclosures, guardianships for the incapacitated, and victims of domestic violence) is over 34 million hours per year. To put that in perspective, the American Bar Association estimated that in 2018, the year from which much of our data comes, the total number of practicing attorneys in the United States was 1,338,678. Thus, to provide the needed hours, every single practicing attorney in the United States would need to contribute about 26 pro bono hours a year just to cases in those five categories.
- Created an algorithm to predict whether FDA would require a clinical trial under a 510(k) submission based on an intended use statement. Upon receiving a submission or presubmission inquiry, FDA makes a subjective decision about whether to require a clinical trial for a given 510(k). A clinical trial is a major expense and often requires a substantial amount of time. The algorithm used natural language processing to understand the proposed intended use, and then compare that intended use to over 20,000 intended use statements contained in the FDA 510(k) database for which FDA had already decided whether a clinical trial would be required. The algorithm achieved approximately 95 percent accuracy on a held out test sample with regard to whether FDA would require a clinical trial for that particular intended use.
- Created a search algorithm for the 510(k) summaries that produces a visual output connecting the proximity of the search terms to each other in a given summary. The algorithm offers the advantage of allowing the user to see where search terms are co-located, therefore suggesting the discussion of a particular concept.
- Use AI and other data science techniques on a monthly basis to analyze regulatory data released by FDA on the openFDA API, as well as clinical trial data from www.clintrials.gov. Blog posts developed based on those data provide visualizations to help, for example, understand the clinical trial basis for FDA approvals, assess how quickly FDA is reviewing submissions, understand the public health implications of information submitted in adverse event reports, and gain insight into FDA’s inspectional priorities.
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.
- University of Michigan School of Information (M.A.D.S., 2022)
- University of Michigan Law School (J.D., cum laude, 1986)
- University of Illinois at Urbana-Champaign (M.B.A., 1983)
- University of Illinois at Urbana-Champaign (B.A., cum laude, 1981)
- Major: Mathematical Economics
Board of Directors
- AquaMatic DISC, Inc. (1990-97)
- AquaMatic, Inc. (1988-97)
- EBG Advisors, Inc. (Chairman, 2015-present)
- Gospel Justice Initiative (2012-2015)
- HealthNet, Inc. (1990-94)
- Indiana Health Industry Forum (Secretary and General Counsel, 1993-2007)
- Indiana Medical Device Manufacturers Council, Inc. (Secretary and General Counsel, 1991-2006)
- Indianapolis Ambassadors, Inc. (Secretary, 1988-89)
Board of Advisors
- Medical Device Committee of FDLI
- PharmaMedDevice Conference, Reed Exhibitions
Board of Editors
- BNA's Medical Device Law & Industry Report (2007-present)
- Food & Drug Law Journal (2007-2011)
- Law360's Life Sciences Editorial Advisory Board (2014-2015)
- Medical Device & Diagnostic Industry, Santa Monica, CA (1993-2017)
- Regulatory Affairs, Rockville, MD (1991-1995)
Professional & Community Involvement
- American Bar Association
- American Bar Foundation, Fellow
- American Health Lawyers Association
- Food and Drug Law Institute
- Regulatory Affairs Professional Society
- Various positions in the Crossroads of America Council, Boy Scouts of America (1986-1995)
- August 25, 2022
- FDLI: Legal and Regulatory Opportunities to Address Bias and Transparency in Artificial Intelligence/Machine Learning in Medical DevicesJune 14, 2022
- Explainable Artificial Intelligence and Transparency: Legal Risks and Remedies for the "Black Box" ProblemJune 9, 2022
- December 9, 2021
- September 30, 2021