Gina Bertolini advises health care clients on health care privacy and security, fraud and abuse, digital health, and complex commercial health care contracting matters. Gina frequently advises on the complex interplay between privacy, technology, and health care. In the digital health space, she assists health care providers and technology companies in navigating federal and state regulations related to the provision of care via telemedicine, including corporate practice of medicine (CPOM), state licensure, privacy, reimbursement, and state and federal laws for treating and prescribing via remote modalities. In the data privacy and security space, she advises on federal and state privacy laws, structures health care data transactions in the commercial and research spaces, and has managed multiple health system data breaches, from initial mitigation and investigation to interfacing with government regulators and developing notice and response initiatives. Gina develops policies and trainings to address HIPAA, Information Blocking, and Confidentiality of Substance Use Disorder Records compliance, and has advised multiple health systems on the development of their electronic health record systems (including patient portals) and their Information Blocking compliance efforts. Gina also assists health care providers with significant commercial contracting initiatives, including developing comprehensive suites of supply chain contracts and contract playbooks, structuring health system group purchasing organizations (GPOs) and purchasing collaboratives, and negotiating multi-million dollar commercial contract initiatives.
As a former academic medical center in-house attorney, Gina advises on the intersection of complex federal and state policies and the provision of health care, such as EMTALA, 501(r) and state law charity care requirements, the Anti-kickback Statute and Inducements to Beneficiaries laws, and credentialing and peer review. Gina also has experience structuring hospital-third party arrangements, negotiating joint venture and affiliation contracts, and assisting with health care mergers and acquisitions, and advises on physician contracting, including structuring compliant physician compensation arrangements.
Gina has a particular interest in issues related to the facilitation of patient care, including risk management, informed consent, medical ethics, treatment of minors, substance use disorders, and end-of-life decision-making.
Gina is an active author and speaker on critical issues affecting the health care industry.
Prior to joining the firm, Gina worked for The University of Michigan as an associate vice president and deputy general counsel for the University of Michigan Health System. She also worked for The University of North Carolina Health Care System as an assistant general counsel. In her role as assistant general counsel, Gina also served as legal director for UNC Physicians Network, LLC, a community-based physician organization owned by UNC Health Care System. Before joining UNC Health Care System, Gina was an associate attorney for six years with the firm’s Research Triangle Park office, focusing on health law issues. She also served as a law clerk to the Honorable Elizabeth A. Jenkins, United States District Court for the Middle District of Florida.
- Treating Behavioral Health Issues and Substance Use Disorders Confidentiality of Substance Use Disorders Records at 42 C.F.R. Part 2: “Areas of Turbulence”, presentation to the NC Bar Health Law Section Annual Meeting, March 8, 2019
- 340B Mega-Guidance, presentation to the NC Bar Health Law Section Annual Meeting, April 29, 2016
- Where the Wild Things Are: Health Care Reform & What’s In Store for 2016, K&L Gates “Under the Wire” CLE Seminar, 2016
- BioEthics and the Lawyer (Exploring the Intersection of Bioethics and the Law and the Impact on the Delivery of Health Care), NC Bar Association, Health Law Section Annual Meeting, 2013
- Appropriate Decisionmakers in Patient Care, Ethics Grand Rounds, UNC Hospitals; 2012
- Errors That Grow Into Lawsuits: Minimizing Risk While Providing Quality Patient Care in a Changing Environment; Legal Issues and Risk Management for Nurses (conference), UNC Center for Leadership Development, 2012
- The UNC Health Care System and Blue Cross Blue Shield of North Carolina Model Medical Practice: A Blueprint for Success; AHLA Academic Medical Center conference, 2012 (Washington, D.C.)
- Making Decisions for Pediatric Patients: Insights from Law and Ethics, Ethics Grand Rounds, UNC Hospitals, 2011
- How Informed Does Consent Need to Be? Surgical Ground Rounds, UNC Hospitals, 2011
- Informed Consent, Medical Records, and Authorized Representatives, Oh My! Legal and Risk Management Issues in the PACU and Ambulatory Care Centers; PACU Conference, UNC Center for Leadership Development, 2011
- Back to the Future: Hospital Acquisition of Physician Practices, North Carolina Bar Association, 2010
- “Privacy of Health Information After Dobbs: OCR Guidance on Disclosures of PHI and The Privacy of Personal Information on Devices,” Employee Relations Law Journal, Winter 2022
- “Ransomware Attacks Target Health Care Industry,” Reuters Westlaw Today, 31 October 2022
- “5 Steps For Counsel Managing Health Care Data Breaches,” Law360, 18 March 2022
- 340B Program Omnibus Guidance: Mega-Changes on the Horizon?, American Health Lawyers Association Rap Sheet, November 2015
- Interviewed and quoted, “OFAC Fines Add to Ransomware Peril; 'It's a Between-a-Rock-and-a-Hard-Place Thing,'” Report on Medicare Compliance, Volume 30, Number 9, 8 March 2021