Michael Ruggio

Industries

• Health Care
  • Health Care AI & Pharma

Practices

• Business & Commercial Litigation

Biography

Michael brings more than 40 years of experience advising health care organizations on regulatory, compliance, and enforcement matters. As the lead of the firm’s Health Care AI and Pharma team, his practice focuses on helping hospitals, health systems, physician groups, laboratories, pharmaceutical companies, and other health care entities navigate complex federal and state regulatory frameworks, including issues arising from emerging technologies such as artificial intelligence. 

Michael regularly advises clients on the legal and business implications of regulatory decisions affecting health care operations. His work spans matters involving the U.S. Department of Justice, Federal Trade Commission, Centers for Medicare & Medicaid Services, Food and Drug Administration, Drug Enforcement Administration, and other regulatory agencies. He is frequently called upon to assess regulatory risk, develop compliance strategies, and guide organizations through highstakes investigations and enforcement actions. 

A significant aspect of Michael’s current practice involves advising health care organizations on the governance, compliance, and risk considerations associated with AI and other advanced technologies. He counsels clients on healthcare AI issues including regulatory compliance, data privacy, oversight of AIenabled clinical and operational tools, and alignment of emerging technologies with existing healthcare compliance programs. His experience allows him to help organizations evaluate AI use cases in a manner that accounts for patient safety, reimbursement, data protection, and regulatory accountability.  

Michael has represented clients in hundreds of matters involving complex healthcare laws and regulations, including the False Claims Act, Stark Law, AntiKickback Statute, HIPAA, antitrust, reimbursement disputes, product recalls, and FDA regulatory issues. This depth of experience enables him to quickly identify intersecting regulatory risks and develop practical, defensible strategies tailored to each client’s operational environment. 

Before entering private practice, Michael served as a Department of Justice prosecutor and Assistant United States Attorney. That experience provides him with valuable insight into government enforcement priorities and informs his approach to defending clients facing civil and criminal healthcare investigations. 

In addition to his legal practice, Michael is actively engaged in the academic and professional discussion surrounding healthcare innovation. He serves as an Adjunct Professor of Law at the University of Pittsburgh School of Law, where he teaches a course focused on AI and blockchain.