Nan Bonifant Halstead is a health care regulatory attorney. Her practice lies at the convergence of health care and technology, where she provides comprehensive guidance to global medical device and technology companies on fraud and abuse, privacy, and reimbursement risks specific to digital health and innovative medical technologies that often challenge existing regulatory and reimbursement frameworks. Nan is recognized for her creative and practical risk management solutions, grounded in her extensive knowledge of the health care industry and her understanding of her clients’ businesses, operations, and objectives.
Leveraging her considerable experience with Medicare and Medicaid billing and reimbursement, Nan offers tailored advice under federal and state anti-kickback statutes and other fraud and abuse authorities, while considering the unique aspects of her clients’ digital health technologies. She has extensive experience advising medical device manufacturers, independent diagnostic testing facilities, telehealth providers, electronic health record companies, and other health technology entities on collaboration and development agreements, value-based arrangements, strategic data partnerships, and commercial strategies for mobile health solutions, applications, and connected devices.
Nan translates this regulatory experience into effective and efficient defensive strategies, advising health care and life sciences firms in responding to civil, criminal, and administrative enforcement actions, including False Claims Act investigations, Civil Monetary Penalties Law inquiries, and third-party payer audits.
Additionally, Nan advises clients on HIPAA, health information privacy, and interoperability issues, including compliance with the Interoperability, Information Blocking, and Patient Access final rules, which collectively establish new data-sharing principles for the health care sector that extend existing HIPAA requirements. She collaborates with all relevant stakeholders – including health IT companies, health care providers, and health plans – to design compliant processes that maintain essential investments in health IT while enabling appropriate access, exchange, and use of electronic health information.
