AI & Digital Health

1) Clinical Practice & Professional Regulation

We provide practical, strategic guidance on navigating the complex state and federal laws governing the practice of medicine, including licensure requirements, corporate practice of medicine restrictions, telemedicine regulations, and laws related to diagnosis and treatment. The application of these frameworks to clinical AI raises novel regulatory questions, such as the level of physician or clinician oversight required and how states will regulate AI tools that provide medical advice, generate diagnoses, or otherwise engage in activities deemed the “practice of medicine.”

In addition to deep subject-matter expertise, we maintain strong, on-the-ground relationships with key regulators and professional associations (including FSMB, NCSBN, and AMA) and have extensive experience representing technology companies and provider organizations before the bodies that develop and enforce these rules.

2) Risk Management & Liability

We design and implement multi-layered strategies to prevent and mitigate malpractice and liability risks arising from the use of clinical AI. Effective risk management typically requires coordinated, proactive measures across multiple domains, including clinician oversight, product design, AI governance, clinical and escalation protocols, customer service and complaint handling, user terms and conditions, advertising and marketing practices, insurance coverage, corporate structure, and compliance with applicable regulatory frameworks such as FDA requirements and state medical practice laws.

3) Reimbursement & Coverage

We develop and execute strategies to secure coverage and reimbursement under existing payment codes. The integration of AI into clinical practice presents unique challenges within the predominantly fee-for-service reimbursement system. To support client goals, we collaborate with experienced consultants who have successfully worked with the AMA and CMS on the development of CPT and HCPCS code sets.

We also advise on alternative commercialization pathways, including participation in value-based care programs, direct-to-consumer telemedicine offerings, direct primary care and concierge medicine models, and direct contracting with self-funded employers.

4) Privacy & Data

We advise clients on protecting and securing rights in health data while ensuring compliance with applicable privacy and data protection frameworks, including HIPAA (where applicable), the FTC Act, and state medical confidentiality and consumer health privacy laws. While many privacy rules applicable to AI mirror those governing other health data, AI introduces new and evolving use cases that often require updated approaches to data governance. These include issues related to permitted uses and disclosures, deidentification standards, user consent, and data ownership.

Our work spans both strategic guidance, such as developing privacy and data-use strategies, and tactical execution, including drafting and reviewing policies, notices, consents, product specifications, and data-use agreements.

5) FDA Medical Device Regulation

We advise clients on the application of the FD&C Act to AI-enabled products and closely track FDA guidance related to clinical AI. We work with leading FDA experts and consultants on issues such as jurisdictional analyses, device classification pathways, marketing requirements, and ongoing compliance obligations.

We also counsel clients on the interplay between FDA regulation of software as a medical device, state laws governing the practice of medicine, and CMS rules related to reimbursement. When appropriate, we supplement our core team with specialized FDA subject matter expertise, including top FDA attorneys and consultants.

6) Additional Considerations

We monitor and advise on evolving state and federal laws and agency guidance specific to AI in healthcare, as well as other legal frameworks that may be implicated depending on the nature of a client’s services. These may include anti-discrimination laws (such as the ADA and Affordable Care Act), intellectual property protection (copyright, trademark, and patent), healthcare fraud and abuse laws (including anti-kickback statutes and the False Claims Act), and child and consumer protection laws enforced by the FTC and state agencies, among others.

Much of our depth in these areas stems from our focused work within the digital health sector, including telehealth and AI-driven healthcare solutions. While each client’s products and challenges are unique, digital health companies often face a common set of legal and operational issues. Our experience navigating these industry-wide patterns has allowed us to develop highly specialized expertise that is directly relevant and valuable to organizations building, expanding, and operating digital health programs.