AI in Health Care: Adapting to World-Changing Technology – A Health Law Institute CLE Event

Agenda

8:30-8:35 – Welcome and Introductions with Health Law Institute Director, Professor Barbara Colombo and MHSL student Molly VandeVoort

8:35-9am – Overview of AI –  Mark Gardner

• Description: The evolution of AI in healthcare including common terms and definitions.

9-9:30am – AI in Health Care Regulatory Considerations – Nathan Downing

• Description: Current FDA landscape on the regulation of AI regarding market authorization and beyond including strategies for effective industry compliance with FDA laws and regulations.

9:30-10am – Privacy and Consumer Considerations with Data Usage in AI – Paul Rothermel

• Description: Privacy law considerations for using AI/ML in health care and how state and federal law are beginning to address this topic.

10-10:30am – AI and Scope of Practice Considerations – Kelly Henderson and Brita Hansen, MD

• Description: Overview and examples of how AI is being utilized and developed within the clinical space, including a discussion of the broader implications of AI in legal discovery, and the challenges posed by the law’s lag in adapting to these rapidly advancing technologies.

10:30-11:15am – Panel and Q&A – Moderated by Molly VandeVoort

• Panelists: Nathan Downing, Kelly Henderson, Brita Hansen, MD and Christopher Tignanelli, MD

Speaker Details

Barbara Colombo, MHSL Professor of Law, Health Law Institute Director

• Barbara Colombo is a professor and director of the Health Law Institute and Health Care Compliance Certification Program at Mitchell Hamline, where her responsibilities include the ongoing management and strategic growth and development of this nationally recognized program. Prior to her affiliation with the law school, Barbara served as the assistant commissioner and principal regulator of Minnesota nursing homes, hospitals, health plans, emergency medical services, and health occupations. She also practiced with Robins, Kaplan, Miller and Ciresi in the areas of product liability and personal injury. Barbara started her career as a critical care registered nurse, working at several of Minnesota’s largest health care systems.

Nathan Downing, Managing Attorney, Gardner Law

• Nathan focuses his practice on FDA-regulated clients. His industry experience allows him to provide actionable legal advice on a variety of health law matters. Nathan regularly advises FDA-regulated clients on regulatory and compliance matters. He advises clients on their advertising and promotion programs, represents clients in front of the FDA on a variety of matters, and assesses industry initiatives for compliance concerns. Nathan’s extensive regulatory experience allows him to advise clients regarding a variety of medical products, including pharmaceuticals, medical devices, medical foods, and nutritional supplements.
• Education: Juris Doctor, Sturm College of Law, University of Denver / Bachelor of Science, Neuroscience, University of Minnesota

Mark Gardner, Founder and Managing Partner, Gardner Law

• Mark founded Gardner Law, an FDA law firm that specializes in regulatory, compliance, and privacy matters. Using his real-world in-house experience, combined with extensive private practice experience, which includes secondments with some of the largest healthcare companies in the world, Mark solves multifaceted legal challenges for clients in a practical fashion. His unique background in healthcare, which spans back to 1999, is used to evaluate industry practices against regulatory requirements, helping companies achieve business goals in a compliant fashion. His specialties include guiding clients through complex FDA matters, performing due diligence for buyers and sellers, assessing sales and marketing programs and commercial transactions, designing and implementing compliant ways to interact with healthcare providers, facilitating government transparency reporting, and auditing and investigating company activities for compliance with the law. Mark works with regulators at the FDA, CMS, and OCR, and with law enforcement at the DOJ and OIG. Mark teaches at Mitchell Hamline School of Law, University of Minnesota Law School, and University of Minnesota, Carlson School of Management.

Brita Hansen, MD

• Dr. Hansen is a board-certified physician in internal medicine and clinical informatics who practices as a primary care internist and serves as the Medical Director of Analytics and Digital Innovation for Allina Health. She has previously held leadership roles in provider, industry, and payer organizations. Areas of focus include clinical decision making, technology-enabled clinical process improvement, population health data management, and digital transformation, including responsible use of artificial intelligence in care delivery settings. She received her MD from the University of Minnesota; completed Internal Medicine residency and chief residency at Hennepin County Medical Center in Minneapolis; and received her MBA at University of St. Thomas and additional training in public health practice at University of Minnesota School of Public Health.

Kelly Henderson, Vice President for Risk Services and Deputy Chief Legal Officer, Allina Heath

• Kelly Henderson is the Vice President for Risk Services and Deputy Chief Legal Officer at Allina Heath. She leads the Risk Services team which includes Risk Management, Insurance and Worker’s Compensation as well as overseeing all litigation at Allina Health. Prior to coming to Allina Health in 2008 she was an Assistant County Attorney in Kanabec County where she handled a wide variety of trial matters including criminal prosecution and civil commitments. Kelly began her career at Faegre & Benson where she was in the corporate health care law practice.  Kelly graduated summa cum laude from the College of St. Benedict and earned her law degree summa cum laude from Hamline University.

Paul Rothermel, Senior Attorney, Gardner Law

• Paul’s practice is focused on interpreting and applying privacy and cybersecurity laws, regulations, and standards, as well as general health care compliance matters. He gives clients confidence through his practical experience and deep knowledge of privacy laws including HIPAA, GDPR, and CCPA, among other state and federal laws. Paul advises clients routinely on data privacy, technology, and cybersecurity issues impacting device and drug manufacturers. He is experienced in counseling on innovative health care technologies, clinical research, cybersecurity, contracting, and third-party risk management. He works regularly with clients to assess and implement privacy and data protection programs. Paul is also deployed as a contracted privacy and data protection officer for a variety of clients.

Christopher Tignanelli, MD MBA MS FACS FAMIA

• Tignanelli is a tenured Associate Professor of Surgery in the Division of Acute Care Surgery at the University of Minnesota. Within the University of Minnesota, Dr. Tignanelli is also the Associate Dean for Data Science, co-Director for UMN’s Program for Clinical Artificial Intelligence, and co-Director for UMN’s Quality Outcomes, Discovery and Evaluation Core, which oversees the UMN’s clinical data repository. He has published over 125 papers, and his research program focuses on the implementation of an evaluation of AI-enabled and non-AI-based clinical decision support systems into practice with the goal of improving the delivery of evidence-based care. His research program has received $29 million in direct funding from the Gates Foundation, NIH, AHRQ, and the Henry M Jackson Foundation for the Advancement of Military Medicine at the principal investigator or director level.

Molly VandeVoort, MPH

• Molly VandeVoort is a healthcare policy expert specializing in statutorily required reporting, regulatory compliance, and data-driven decision-making. With extensive experience at the Centers for Medicare & Medicaid Services (CMS) and in the private sector, she has led initiatives on Medicaid drug programs, the No Surprises Act and Transparency Rules the federal dispute resolution processes, and medical policies in managed care. Currently a Senior Principal at Coforma, Molly translates complex healthcare regulations into actionable business strategies. She is also pursuing her Juris Doctor at Mitchell Hamline School of Law, focusing on health law and compliance.