Digital Health in the Metaverse: Navigating the Interplay Between Healthcare Delivery and Healthcare Laws

Mr. Hindman focuses his practice on healthcare regulatory, data privacy, cybersecurity, corporate, and transactional matters. He represents physicians and other healthcare providers and organizations in structuring group practices, joint ventures, medical device companies, as well as physician/hospital alignment strategies and involvement in accountable care organizations (ACOs). He also assits healthcare providers and businesses with potential compliance challenges, including compliance with the Stark physician self-referral law, federal and state anti-kickback laws, and corporate practice and fee-splitting restrictions.

Ms. Compton is a trusted advisor to clients ranging from traditional health care providers to disrupter digital health platforms as they navigate the practical and regulatory challenges of health care innovation. She counsels telemedicine and other digital health clients on business plan strategy and implementation, state-specific telemedicine regulation, corporate practice of medicine, the scope of practice, fee splitting, anti-kickback, reimbursement, and other health care regulatory issues. Leveraging her prior in-house experience at two nonprofit health systems, Ms. Compton also advises health care providers on the incorporation of telehealth and other technology infrastructures, which has seen a vast uptick as a result of the COVID-19 pandemic. She advises health care providers, clinical trials companies, ancillary providers, technology start-ups, HMOs, insurance companies, and large technology companies on HIPAA and other health data privacy and security regulations, including developing and implementing HIPAA compliance programs. She has also led significant HIPAA breach investigations, advising clients on risk management and mitigation efforts.Member

Mr. Zegarelli provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. He advises health care industry clients on the federal and state laws surrounding manufacturer product development and marketing. He has experience representing medical device companies in responding to significant unfavorable inspection observations, and he participates in the coordination of diligence reviews of transactions involving large pharmaceutical and medical device manufactures. He also reviews and drafts clinical study agreements for clients.