Lindsay P. Holmes

Digital Health and Technology-Enabled Health Care

Lindsay counsels digital health companies, virtual care providers, AI-enabled health care platforms, health care technology vendors, and pharmacy-adjacent businesses on the legal and regulatory issues that arise in delivering innovative health care services.

As well as advising on AI use in health care delivery, she guides clients on the corporate practice of medicine and professional corporation (PC)-friendly structures, telehealth and telepharmacy compliance, controlled substance prescribing, provider supervision and scope of practice requirements, billing compliance, and federal program reimbursement. She also helps digital health companies develop and implement compliance programs, assess regulatory risk, respond to investigations, and address the evolving legal requirements affecting technology-enabled care models.

Pharmaceuticals, Medical Devices, and Life Sciences

Lindsay advises pharmaceutical, medical device, food, dietary supplement, cosmetic, and life science companies on a wide range of Food and Drug Administration (FDA) regulatory matters, from product launches and labeling and advertising review to conducting mock compliance audits and inspection-readiness assessments. She guides clients in responding to FDA administrative and enforcement actions such as Form 483 observations, warning letters, untitled letters, recalls, product seizures, and requests to cease production. Lindsay also supports regulatory diligence for transactions, and advises on the impact of new legislation, regulations, and agency guidance.

For pharma clients, Lindsay counsels on drug pricing, Medicare Part D, and authorized distributor agreements. For medical device companies, she advises on software-as-a-medical-device initiatives, 510(k) submissions, and Emergency Use Authorizations. Her FDA practice also extends to advising 503B outsourcing facilities operating under the Drug Quality and Security Act (DQSA), as well as drug manufacturers, wholesalers, and other entities subject to the Drug Supply Chain Security Act (DSCSA).

Health Care Providers and Pharmacies

Lindsay provides ongoing operational and compliance counseling to health care providers, pharmacies, management service organizations (MSOs), and other health care businesses. She guides clients on compliance with federal and state laws including the Anti-Kickback Statute (AKS), Stark Law, Civil Monetary Penalties Law (CMPL), and the False Claims Act (FCA), as well as Medicare and Medicaid reimbursement, billing compliance, overpayment exposure, licensing and practice laws, and operational compliance challenges.

She has supported clients in matters involving the Office of Inspector General (OIG), US Department of Justice (DOJ), Drug Enforcement Administration (DEA), and state boards of pharmacy — navigating investigations, enforcement actions, and compliance remediation efforts.

For pharmacy clients, Lindsay negotiates group purchasing organization (GPO), pharmacy benefit management (PBM), and pharmacy participation agreements. She also counsels on controlled substance compliance and assesses anti-kickback and fraud-and-abuse risks associated with pharmacy services and management arrangements.

In-House Experience

For five years, Lindsay was in-house at Amazon Health Services (AHS). During this time, she served as senior corporate counsel and lead legal adviser to One Medical's operations and revenue cycle teams, guiding regulatory compliance, reimbursement, health care operations, and enterprise risk management. Lindsay also served as senior corporate counsel for Amazon Pharmacy and the AHS Compliance Program.

Personal Interests

In her free time, Lindsay enjoys spending time with her family and playing tennis.