Health Care & Life Sciences

The health care and life sciences industry is driven by a diverse mix of analytical scientists, empathetic caregivers, and precision-driven technologists with deep professional expertise devoted to advancing human health and understanding living systems. Attaining these goals, however, requires simultaneous navigation of the frequent regulatory changes, increasing enforcement activity, technological innovations, workforce challenges, evolving reimbursement models, and accelerating consolidation which are constantly reshaping the landscape for providers, suppliers, operators, manufacturers, investors, and emerging healthcare platforms.

Few other industries face the breadth and intensity of the legal, regulatory, and operational pressures found in health care and life sciences. Success in this industry requires counsel that understands not only the rules, but how they intersect with clients’ real‑world goals and operational, transactional, and investment decisions.

At Smith Gambrell & Russell, we help health care and life sciences clients navigate complexity with confidence. SGR’s Health Care and Life Sciences practice counsels health care and life sciences businesses at every stage of growth, including providers and suppliers of all sizes, industry stakeholders in digital health, pharmaceuticals, biotechnology, and medical devices, as well as private equity sponsors, portfolio companies, management service organizations, and other investors active in the healthcare space. By integrating deep experience across regulatory, corporate, tax, financing, employment, antitrust, white collar, and other litigation, real estate, intellectual property, and international disciplines, our team delivers practical, comprehensive, strategic advice that is tailored to each client’s unique objectives, supports compliance, promotes efficient operations, facilitates transactions, enables growth, and positions organizations for long‑term success in an increasingly sophisticated and rapidly evolving industry.

Health care and life sciences businesses are businesses with many of the same needs as other businesses, and we routinely assist our clients with matters such as corporate governance documents; real estate purchases and leasing; employment agreements, employee policies and procedures, and disciplinary matters; and tax matters. We also work closely with SGR’s Real Estate team on more complex real estate transactions involving health care and life sciences clients as sellers, buyers, and major lessees.

SGR’s Health Care and Life Sciences attorneys also regularly advise providers, founders, management companies, and investors in connection with healthcare mergers and acquisitions, private equity-backed acquisitions and recapitalizations, platform growth initiatives, recapitalizations, joint ventures, MSO and friendly physician and dentist structures, physician alignment strategies, and other complex affiliations and restructurings. Our team has substantial experience navigating the unique regulatory and operational issues that arise in healthcare transactions, including corporate practice of medicine concerns, Stark and Anti-Kickback compliance, reimbursement and provider enrollment matters, licensure and accreditation issues, management services arrangements, change of ownership considerations, and compliance with state-specific requirements such as those for certificates of need, agency notices and reporting, and specialized licenses and permits.

We also regularly counsel on regulatory matters which impact our clients’ routine operations, including requirements for human subjects research; marketing of drugs and devices; HIPAA policies and procedures and other data privacy and security issues; compliance program development and implementation; government and internal investigations; private and governmental payor issues, including contracting, compliance with reimbursement policies, and administrative appeals of claim denials and audit results; certificate of need requirements (including DET requests); 340B program compliance; federal grant compliance; and other state and federal enforcement matters.

Our team also regularly advises organizations which provide support services within the health care and life sciences industry. Our services to these organizations include advising on complex commercial arrangements, regulatory compliance, healthcare transactions, strategic affiliations, and private equity and sponsor-backed growth initiatives, including the unique operational and regulatory challenges that arise when supporting highly regulated entities.

Whether serving as day-to-day counsel, guiding transformative transactions, or managing strategy for responding to challenges, we work closely with clients to deliver practical solutions that align legal strategy with operational and business objectives.

Our Capabilities

We advise a broad and sophisticated client base, including:

• Providers, Operators, and Healthcare Platforms: Hospitals and health systems, physician groups and multi-specialty practices, individual practitioners, ambulatory surgery centers, telehealth providers, behavioral health organizations, imaging centers, laboratories, retail and specialty pharmacies, long-term care providers, CCRCs and other senior living communities, specialty clinics, and other healthcare delivery organizations.
• Life Sciences Organizations: Domestic and international pharmaceutical companies, biotechnology and medical device developers and manufacturers, clinical research organizations, and leading research universities.
• Support Organizations: Management services organizations (MSOs), revenue cycle management companies, healthcare technology and telehealth companies, clinician staffing organizations, medical real estate developers and operators, healthcare analytics and data companies, pharmacy and supply chain entities, and other businesses supporting the healthcare ecosystem.

We also serve as general counsel to an AMA National Medical Specialty Society and its certifying Board, represent national and regional coordinating centers for the HRSA/CDC National Hemophilia Program, and maintain specialized experience advising Catholic health systems. We have also been engaged as Specially Appointed Attorneys General to work on special projects for the Georgia Department of Community Health.

Our practice spans the full lifecycle of health care and life sciences operations, including:

• Regulatory counsel on state and federal laws related to the finance and delivery of healthcare services
• Compliance and governance issues for both for-profit and nonprofit organizations
• Health care mergers and acquisitions, joint ventures, and restructurings
• Formation, acquisition, and scaling of healthcare platforms, including MSO-led models, equity rollovers, and physician alignment frameworks and the regulatory issues inherent in such transactions
• FDA law
• Data privacy and security
• HIPAA, Stark Law, Anti-Kickback Statute (AKS), False Claims Act (FCA), EMTALA,
• Medicare and Medicaid
• Provider licensure, enrollment and credentialing
• Managed care contracting
• Certificate of Need (CON) matters, including extensive experience obtaining determination letters for physician-owned single specialty ambulatory surgery centers in Georgia
• Payor contracting, billing, and appeals
• Health care real estate, construction, and physician joint ventures
• Technology, cybersecurity, digital health and telehealth
• Intellectual property, including patent prosecution, tech transfer, and licensing for drugs and devices
• HRSA/CDC grant compliance, 340B program matters, and subaward contracting
• Human subjects research and clinical trial agreements
• Manufacturing, supply chain, and international expansion: SGR’s global reach supports inbound international health care and life sciences clients with U.S. market entry, facility site selection, and supply/distribution arrangements, with SGR’s Health Care and Life Sciences team advising on regulatory requirements for their U.S. manufacturing operations, product marketing, and communications with federal and state agencies.

Our Approach

Health care and life sciences clients operate under constant pressure to balance regulatory compliance, patient care, innovation, and financial performance. We focus on helping clients manage risk without losing momentum.

Our attorneys bring first-hand industry experience, having served as in-house counsel, compliance officers, risk managers, IRB members, board chairs, and university faculty. This perspective enables us to anticipate challenges and provide guidance that is both legally sound and operationally practical.

We collaborate closely with leadership, investors, administrators, clinicians, and in-house counsel to align legal strategy with business realities. Whether advising on day-to-day compliance, structuring transformative transactions, or navigating regulatory scrutiny, our goal is to keep clients moving forward while protecting their mission and reputation.

Life Sciences, Innovation, and Growth

For life sciences companies, innovation must be protected, financed, manufactured, and commercialized within a demanding regulatory framework. We support clients at every stage—from research and clinical trials to commercialization and global distribution.

Our experience includes advising on clinical study agreements, collaborative research with pharmaceutical companies, nationwide research databanks, and partnerships with academic and independent researchers. We combine regulatory insight with IP, financing, and international capabilities to help transform scientific advancement into sustainable success.

Investigations, Disputes, and Enforcement

Clients facing disputes benefit from our deep bench of litigators, including former federal prosecutors, who represent organizations in:

• Qui tam and False Claims Act litigation
• Civil and criminal investigations by state and federal agencies
• AKS, Stark, and Medicare/Medicaid enforcement actions
• Antitrust matters and complex commercial disputes
• Multi-district and class action litigation
• Licensing board proceedings and administrative hearings
• Hospital peer review proceedings and provider disputes

A Long‑Term Partner to the Industry

We are not just regulatory advisors or deal lawyers—we are long-term partners to organizations that deliver care, develop life-saving technologies, and invest in the future of health care and life sciences. By connecting legal strategy to operational, financial, and human considerations, we help clients make informed decisions that stand up to scrutiny today—and tomorrow.