James F. Hennessy

James is a health care regulatory attorney in Reed Smith’s Life Sciences Health Industry Group, based in the San Francisco Bay Area. He represents traditional health care providers and life sciences companies alongside the emerging generation of digital health and AI-driven companies reshaping the industry, helping clients navigate the regulatory and transactional complexities of a rapidly evolving health care landscape.

James counsels companies across the full spectrum of the industry, from physician practices, hospitals, health systems, and academic medical centers to pharmacies, clinical laboratories, medical foundations, DMEPOS suppliers, independent diagnostic testing facilities (IDTFs), federally qualified health centers (FQHCs), ambulatory surgical centers (ASCs), digital health providers and companies, telehealth providers, drug and device wholesalers, and behavioral health providers. He also represents life sciences companies and health industry-focused private equity firms, with particular experience in physician practice matters across radiology, gastroenterology, pathology, and other specialties.

James' practice spans regulatory counseling, transactional work, and compliance, including the negotiation and drafting of provider agreements, acquisitions and divestitures, transactional due diligence, change of ownership matters, and the identification and resolution of regulatory concerns. He advises clients on federal and state fraud and abuse laws (Stark Law and Anti-Kickback Statute), Medicare and Medicaid participation and reimbursement, state corporate practice of medicine issues, and provider licensure and enrollment. James has particular depth in Stark Law matters, developed through years of complex physician practice representation across a wide range of specialties. He is also deeply versed in the Management Services Organization (MSO) model, having structured and implemented MSO arrangements for clients across the country, and brings market-informed guidance on structures and approaches drawn from broad experience with what leading organizations are doing in practice.

James also counsels health care and life sciences companies including digital health and AI companies handling sensitive health data, on privacy and security compliance under the Health Insurance Portability and Accountability Act (HIPAA), the California Consumer Privacy Act of 2018 (CCPA), and California’s Confidentiality of Medical Information Act (CMIA).

A longtime San Francisco Bay Area practitioner, James maintains a forward-looking practice rooted in deep industry experience. He is energized by the transformation underway in health care and life sciences, and is committed to helping the next generation of innovative companies navigate the complex regulatory landscape with the same depth and market knowledge he has brought to the industry's most established players.

Experience

Representative matters

Represented one of the largest independent outpatient medical imaging providers in the United States in the development and launch of an Artificial Intelligence (AI)-driven platform and patient engagement partnership, enabling patients to better understand imaging results and receive personalized care recommendations.

Represented a publicly traded national provider of freestanding outpatient diagnostic imaging services in the development and launch of a flagship Artificial Intelligence (AI) product designed to leverage artificial intelligence to improve the accuracy and efficiency of patient care delivery.

Led complex health care regulatory due diligence for McKesson in its acquisition of a controlling interest in Community Oncology Revitalization Enterprise Ventures, LLC, a business and administrative services organization established by Florida Cancer Specialists & Research Institute, LLC, a leading physician owned community oncology practice.

Representative Experience

Advised clients, including hospitals, providers health systems, and start-ups, on the development and deployment of telemedicine services and related platforms across the United States, involving issues including corporate practice of medicine and professional entity formation in various states, telehealth prescribing, consent, fraud and abuse, fee-splitting and anti-kickback prohibitions, licensing, privacy and security, and other state telemedicine practice standards.

Advised a medical device manufacturer and IDTF regarding legal and regulatory issues associated with providing and billing for remote patient monitoring services under Medicare and commercial health insurance, including Stark Law compliance advice.

Assisted global social media company regarding telehealth legal considerations and concerns in developing telehealth modalities and related advertising on its platform, including licensure, data privacy and security, prescribing, consent, fraud and abuse, and other legal considerations.

Advised start-up company in developing a national platform to provide medical and pharmacy services via telehealth, including corporate practice of medicine and formation issues, pharmacy relationships and legal restrictions, licensure and structuring considerations, data privacy and security, and state fee-splitting concerns.

Represented radiology groups across the United States in forming and restructuring joint ventures with hospitals and regional health systems involving the operation of outpatient imaging centers, IDTFs, and the delivery of professional services.

Assisted start-up physical therapy telehealth company create a national platform for delivering professional physical therapy services via telehealth, including advising on the corporate practice of physical therapy and the creation of a multistate professional corporation model.

Assisted school-based medical provider to create a national platform for delivering professional medical services via telehealth, including advising on the corporate practice of medicine and the creation of a multistate professional corporation model.