AI and Telehealth: Addressing Licensing, Informed Consent, Privacy, Liability, and Other Legal Challenges

Mr. Cohen practices in the firm’s nationally recognized Life Sciences practice. He counsels healthcare services, life sciences, and healthcare IT clients concerning compliance with the myriad laws and regulations governing the delivery of healthcare services such as the Anti-Kickback Statute, the Physician Self-Referral Law (the Stark Law), the False Claims Act, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Medicare and Medicaid rules and regulations, and laws governing reimbursement, licensure and certification. Mr. Cohen’s experience also includes extensive work on healthcare transactions, with deep experience assisting clients in transactions involving and providing counsel to health IT companies such as telemedicine providers and electronic health record, mobile health (mHealth), and digital health companies. In addition to his transactional work, Mr. Cohen has a long track record of successfully representing healthcare and life science clients in government investigations and litigation. Mr. Cohen is a Visiting Instructor at the Weill Cornell Graduate School of Medical Sciences where he teaches a class on healthcare law and is a frequent speaker at healthcare industry events and regularly publishes articles about healthcare law.

Ms. Otenaike counsels investors, hospitals and healthcare systems, digital health companies, mobile health companies, and biotechnology and pharmaceutical companies on how to navigate the maze of healthcare laws and address operational, regulatory, transactional, and compliance concerns. She also advises FDA-regulated companies in the food and beverage, dietary supplement, pharmaceutical and medical device, and technology industries on regulatory and compliance issues. On the transactional side, Ms. Otenaike handles regulatory due diligence review and agreement drafting and negotiation for acquisitions and financings involving a wide variety of healthcare providers and FDA-regulated entities.