Machine Learning in Healthcare: Regulatory Requirements, Reimbursement Challenges, Privacy and Security Risks

Ms. Metnick is a partner in the Corporate Practice Group in the firm's Chicago office and a member of the Healthcare and Privacy & Cybersecurity Teams. She represents a range of healthcare industry clients, including hospitals and health systems, physician organizations and digital health companies. Ms. Metnick advises on healthcare regulatory and transactional matters with a focus on health information privacy and security. She is the founder and leader of Sheppard Mullin Healthy AI, which is an initiative focused on legal issues relates to the use of AI in healthcare. Ms. Metnick counsels healthcare clients on issues relating to AI, including governance, contractual matters, and data related issues. She advises clients on a range of privacy and security laws, including HIPAA and other federal and state privacy laws. Ms. Metnick also counsels businesses in data breach investigations and compliance with federal and state breach notification laws. She is a Certified Information Privacy Professional/United States (CIPP/ US) and a Certified Information Privacy Professional/Europe (CIPP/E).

Mr. Thompson counsels medical device, drug, and combination product companies on a wide range of FDA and FTC regulatory, reimbursement, and clinical trial issues. He is a quantitative thinker by nature, who enjoys tinkering with algorithms. To develop a deeper understanding of machine learning algorithms, Mr. Thompson 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, he studied the math, statistics, and computer science (Python), which serve as the basis for artificial intelligence (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 Epstein Becker Green, Mr. Thompson 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.

Ms. Godes advises clients on reimbursement and policy strategy for medical devices, diagnostics, biologics and health services by public and private payers. With more than 25 years of health industry experience, she leverages her deep knowledge and strong industry relationships to deliver strategic, operational and policy consultative services to companies of all sizes, from start-ups to Fortune 100 companies. For the past decade, Ms. Godes has worked alongside healthcare innovators to advance their market access goals, including: navigating the complex Centers for Medicare and Medicaid Services landscape; addressing the challenges and opportunities of bringing e-products to market; and providing insight on the U.S. healthcare system and the health industry. She also collaborates with clients pursuing Medicare coding, coverage and payment of their groundbreaking, digitally-enabled healthcare solutions and services, including diagnostic tests and medical devices, artificial intelligence-powered technologies, remote monitoring tools, and other innovative health services.