Telehealth Emerging Legal and Regulatory Issues: Adopting and Implementing Innovative Solutions
Navigating Standard of Care, Privacy and Security, FDA Regulation, Advertising, Reimbursement, and More
Recording of a 90-minute CLE video webinar with Q&A
This CLE course will provide an in-depth discussion of emerging legal and regulatory issues in telehealth. The panel will discuss issues arising from the use of multiple technologies in the telehealth encounter such as remote monitoring devices, digital therapeutics, and AI-based algorithms. The panel will provide a deeper, more advanced understanding of current and emerging legal and regulatory issues arising from recent innovations in the telehealth industry.
Outline
- Standard of care
- Risk and liability
- Accessibility
- FDA regulation of digital health technologies
- Privacy and security
- Data issues
- Direct-to-consumer advertising
- Reimbursement
- Best practices for adopting and implementing innovative telehealth solutions
Benefits
The panel will review these and other key issues:
- Challenges in complying with evolving federal and state telemedicine requirements
- Compliance with telehealth requirements for new innovative technologies
- Best practices for adopting and implementing innovative telehealth solutions in line with data privacy requirements
Faculty
Roger A. Cohen
Partner
Goodwin Procter
Mr. Cohen practices in the firm’s nationally recognized Life Sciences practice. He counsels healthcare services,... | Read More
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.
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Amy M. Joseph
Partner, Co-Chair Academic Medical Center/Teaching Hospital Working Group
Hooper, Lundy & Bookman
Ms. Joseph counsels health systems, academic medical centers, teaching hospitals, and other providers on a broad... | Read More
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.
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Jeremy D. Sherer
Partner, Co-Chair Digital Health Task Force
Hooper Lundy & Bookman
Mr. Sherer specializes in digital health matters. He counsels healthcare providers and suppliers, including hospital... | Read More
Mr. Sherer specializes in digital health matters. He counsels healthcare providers and suppliers, including hospital systems, provider organizations, national telehealth platforms and digital health startups on issues involving regulatory compliance, transactions and innovative business arrangements. Mr. Sherer’s digital health experience includes counseling clients on state-level scope of practices issues (e.g., licensure, informed consent, practitioner-patient relationship establishment), Medicare, Medicaid and commercial reimbursement, corporate practice of medicine issues and e-prescribing (including controlled substances), as well as healthcare technology transactions. He also advises clients on compliance with fraud and abuse laws, including federal and state anti-kickback and self-referral laws, provider contracting, value-based care, and regulatory compliance issues. Mr. Sherer frequently speaks on digital health matters across the country and is a member of the Legal Resource Team at the Center for Telehealth and e-Health Law.
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Steven Tjoe
Partner
Goodwin Procter
Mr. Tjoe is a partner in the firm’s Technology and Life Sciences groups and a member of the firm’s Life... | Read More
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.
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