Telehealth Emerging Legal and Regulatory Issues: Adopting and Implementing Innovative Solutions

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.

Widely recognized as a digital health thought leader, Mr. Sherer counsels health care providers and suppliers – including hospital systems, national telehealth platforms, investors and digital health startups – on issues involving regulatory compliance, transactions and innovative business arrangements. He advises clients on the full range of regulatory health care issues facing digital health stakeholders. His telehealth experience includes advising on compliance with state licensure requirements for physicians and non-physician practitioners, corporate practice of medicine issues, remote prescribing (including controlled substances), patient consent and Medicare, Medicaid and commercial reimbursement. Mr. Sher advises clients on compliance with laws against fraud and abuse, including federal and state anti-kickback and self-referral laws, as well as privacy issues arising under HIPAA and its state-level counterparts. He has substantial experience pertaining to structuring, operationalizing and scaling “PC-MSO” arrangements across all 50 states. Mr. Sherer also advises venture capital and private equity firms conducting regulatory diligence associated with investments in digital health and health care technology ventures, from seed stage funding to nine-figure raises.

Ms. Joseph counsels health systems, academic medical centers, teaching hospitals, and other providers on a broad spectrum of regulatory and business matters. While her expansive practice helps providers address countless challenges, a particular focus is regulatory compliance, including physician self-referral, anti-kickback, and other fraud and abuse law matters. Ms. Joseph spends much of her time working closely with legal and compliance departments in health systems across the country, often advising on establishing innovative programs while navigating complex federal and state regulatory laws, and regularly counseling on protocols and best practices that can reduce the likelihood of government investigations or actions. She also regularly assists with internal investigations and assessing and responding to the results of such investigations, including assisting with development of corrective action recommendations and self-disclosures. A sought-after speaker and prolific writer on some of the most complex and critical healthcare law issues, Ms. Josephy regularly shares her insights in publications and presentations across the country. 

Mr. Tjoe is a partner in the firm’s Technology and Life Sciences groups and a member of the firm’s Life Sciences Regulatory & Compliance practice. He focuses his practice on product development strategies and FDA regulatory counseling, in particular as related to medical devices, digital health products, in vitro diagnostics, laboratory developed tests, compounded drugs, cell and gene therapies, biosimilars, and other drugs and biologics. Mr. Tjoe advises clients in analyzing premarket pathways, product adverse event risk profiles, product communications and marketing, and GMP compliance. He also advises on exclusivity issues, is a contributor to Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S., and regularly conducts risk analyses for offerings and transactions involving FDA-regulated entities across the medical device, drug, and biologic industries.