Telehealth, Digital Health, and Health Information Technology

• Structured health technology business models to comply with health care laws and regulations, including strategic guidance on the provision of professional services across the United States and compliance with state corporate practice of medicine prohibitions.
• Represented several telehealth management service organizations in responding to California Medical Board information requests and investigations.
• Managed regulatory due diligence on for buyers and sellers in connection with a variety of telehealth and health technology transactions.
• Negotiated and provided regulatory counsel for wide range of digital health and health information technology agreements.
• Provided ongoing health care regulatory advice to a wide range of digital health and health information technology companies.

Hospitals, Health Systems, and Other Health Care Providers

• Assisted health care providers in developing and implementing new technologies. For example, assisted in navigating the regulatory issues posed by the development of a patient screening health app co-developed by a physician and a hospital.
• Regularly assisted a broad range of health care providers in monitoring and navigating California health care regulatory requirements and enforcement, including but not limited to corporate practice of medicine prohibitions and other provider licensing laws, Physician Ownership and Referral Act and other state fraud and abuse laws, state health information privacy and security laws such as the California Consumer Privacy Act of 2018 as amended by the California Privacy Rights Act, Genetic Information Privacy Act, Confidentiality of Medical Information Act, Patient Access to Health Records Act, Lanterman Petris Short Act, and state breach reporting laws.
• Represented clients across the health care industry (health plans, publicly traded companies, nonprofit hospitals, private equity backed health care providers) in performing/responding to health care regulatory due diligence on a variety of health care providers and addressing regulatory issues and requirements that arose in the context of the transaction. Regularly assisted a wide range of clients in responding to breach investigations, health information privacy and security audits and requests for information. Represented a client in responding to a wide scale California County information privacy and security audit which involved a forensic system assessment and onsite inspection, twenty employee interviews, multiple sets of questionnaire responses, and the production of hundreds of documents.
• Developed a wide range of health care operational tools, for example toolkits for managing business associate relationships and managing patients who are refusing discharge or are otherwise difficult to place in an appropriate level of care.
• Regularly conducted a wide range of regulatory compliance audits and investigations (e.g. HIPAA, fraud, waste, and abuse) for a variety of health care providers and assisted with process improvement and risk mitigation strategies.

Life Sciences and Medical Devices

• Assisted a variety of clients with licensing requirements related to device distribution, for example negotiated settlement of disciplinary action with the California Board of Pharmacy for a medical device wholesaler and developed a 50-state, post-acquisition regulatory filing plan for a large diagnostics company.
• Evaluated medical device and biotechnology company marketing campaigns for compliance with the federal Anti-Kickback Statute and other fraud and abuse laws.
• Evaluated FDA regulatory implications for a variety of cellular and tissue based products and analyzed proposed product marketing materials for FDA and FTC regulatory implications.

Health Plans

• Regularly advised on health information privacy and security law compliance issues. For example, advised health plans regarding the collection, use, and sharing of data for product development and marketing initiatives.
• Advised California health plans regarding issues related to medical practice, for example California requirements for prescribing birth control pills using telehealth and California health care provider licensing and supervision requirements relevant to the quality assurance program.
• Advised health plans regarding health care regulatory considerations related to vertical integration efforts, including transactional regulatory due diligence, fraud and abuse compliance advise, and risk management.