John T. Vaughan
Partner
Overview
John Vaughan is a public policy and regulation attorney in Holland & Knight's Los Angeles office. Mr. Vaughan is an accomplished legal officer and strategic adviser with a robust background in regulatory affairs, corporate governance and compliance across diverse industries, including healthcare, life sciences, biotech and technology. He has in-depth experience in the application of healthcare uses for emerging technologies, such as artificial intelligence (AI) and machine learning (ML).
Mr. Vaughan has developed legal, regulatory and legislative strategy for life sciences and technology companies. Notably, he has played a pivotal role in obtaining favorable resolutions from the U.S. Department of Justice (DOJ) and U.S. Securities and Exchange Commission (SEC) in enforcement proceedings. He is adept at navigating regulatory landscapes involving the U.S. Food and Drug Administration (FDA), U.S. Federal Trade Commission (FTC), European Medicines Agency (EMA), Centers for Medicare & Medicaid Services (CMS) and legislative bodies to help clients influence pivotal policies and regulations.
Mr. Vaughan also has extensive experience working with business-to-business (B2B) and business-to-consumer (B2C) startups and established companies to help drive business growth, profitability and long-term shareholder value.
Additionally, Mr. Vaughan understands how to establish legal governance, privacy and compliance programs, including corporate restructuring, drug and device approval, worldwide commercialization strategies and corporate compliance.
Prior to joining Holland & Knight, Mr. Vaughan served as the lead attorney for the product and corporate legal teams, as well as the chief privacy officer, for a health technology company, a subsidiary of a multinational technology conglomerate. In addition, he has held various leadership roles at several healthcare, life sciences and pharmaceutical companies.
Representative Experience
- Counseled clients building generative artificial intelligence (AI), large language model (LLM) and machine learning (ML) systems on privacy, healthcare and technology laws to help ensure compliance with applicable laws and regulations
- Led a legal team effort to develop AI platforms to help healthcare professionals detect patterns of early disease progression in oncology and endocrinology patients
- Guided clients on the appropriate use of data sets for AI modeling in healthcare, with particular emphasis on compliance with U.S. and international laws, as well as regulations regarding the proper use of personal health information (PHI) for use in medical research, drug development and longitudinal studies
- Developed quality and regulatory programs to help ensure scalable support for AI and ML products
- Restructured product quality system (QS), regulatory and privacy programs for Software as a Medical Device (SaMD) and telehealth platforms
- Advised business partners on the applicability of U.S. Food and Drug Administration (FDA) regulations and guidance for diagnostics and laboratory developed tests (LDT) using novel technologies
- Counseled clients on regulations and rulemaking related to health information technology (IT) interoperability and algorithm transparency, balancing clinical and commercial insights against data privacy
- Led diligence and merger and acquisition (M&A) teams for digital health transactions and acquisitions
- Represented clients before U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Centers for Medicare & Medicaid Services (CMS) and on Capitol Hill
- Served as the lead attorney for commercialization of more than 30 international drug, biologic or biosimilar franchises, including more than 10 product launches and the launch of the world's first biosimilars
- Developed legislative, pricing and reimbursement strategies for pharmaceutical and biologics manufacturers
- Represented numerous companies during FDA and Notified Body inspections, and effectively remediating Inspection Observations/483s, major/minor findings, including findings of adulteration or misbranding
- Advised drug and biologic manufacturers on compliance with Good x Practice (GxPs)
- Developed advertising and promotion review programs to help ensure that drug and device manufacturers remain in compliance with FDA promotional rules
- Served as in-house therapeutic area or brand attorney for multiple pharmaceutical franchises, and understand the advice in-house lawyers need from outside counsel
- Instructed clients on remediation, recalls, field actions and execution of Risk Evaluation and Mitigation Strategies (REMS)
- Directed clients and healthcare stakeholders on drug shortages and supply chain disruptions
- Represented device clients in proceedings before U.S. Food and Drug Administration (FDA), Health Canada and Notified Bodies
- Represented numerous companies during FDA and Notified Body inspections, and effectively remediating Inspection Observations/483s, major/minor findings, including findings of adulteration or misbranding
- Deep experience advising clients on the development and commercialization of all types of medical devices, from Class I devices requiring General Controls to Premarket Approval (PMA) and Software as a Medical Devices (SaMD)
- Led legal teams on device recalls, field actions and remediation strategies
- Navigated the multiple overlapping regulatory authority requirements, such as FDA QS regulations and Cybersecurity and Infrastructure Security Agency's (CISA) industrial control systems (ICS) to obtain favorable resolution for client
- Served as worldwide chief compliance officer at two major healthcare companies
- Implemented governance, privacy and compliance programs at multiple pharmaceutical and technology companies, including startups
- Created compliance and monitoring programs for life sciences companies, including companies negotiating and implementing Corporate Integrity Agreements (CIA) and Deferred Prosecution Agreements (DPA)
- Negotiated favorable resolutions to the U.S. Department of Justice (DOJ) criminal investigations of a healthcare technology company
- Conducted internal investigations for major pharmaceutical and medical device companies in the United States, Latin America, Europe and Asia-Pacific
- Led internal investigations, including investigating allegations of off-label promotion, adulteration, misbranding, diversion, fraud and abuse, and anti-bribery anti-corruption (ABAC) concerns
- Counseled companies on continuous improvement efforts to remediate findings of internal investigations
Credentials
- Rutgers Law School, J.D.
- McGill University, B.A., Arts, History and Political Science
- California
- New Jersey
- New York
- Rutgers Law Review, Articles Editor, 2001-2002
- Moot Court Board, Rutgers Law School, 2000-2002
- Los Angeles Times, DEIA Visionary Award, 2023