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Digital health companies are subject to a complex web of healthcare regulations. Both seasoned health-tech stakeholders and newcomers must be able to spot potential regulatory issues impacting their business and develop a forward-thinking and nuanced legal strategy that considers enforcement risks alongside the company’s stage, goals, and risk tolerance.

The first session in this webinar series will guide digital health founders, executives, innovators, and general counsel through an overview of the laws that apply to digital health companies, including:

• The corporate practice of medicine ("CPOM") and other corporate practice prohibitions;

• Fraud and abuse laws, including the Anti-Kickback Statute ("AKS"), the Stark Law, and fee-splitting;

• Federal and state laws applicable to the delivery of digital health, including billing third-party payors, online prescribing, state licensure, and provider-patient relationships;

• The Health Insurance Portability and Accountability Act ("HIPAA"), the Federal Trade Commission ("FTC") Health Breach Notification Rule, and state data privacy rules; and

• Regulation by the U.S. Food and Drug Administration ("FDA"), including the Federal Food, Drug, and Cosmetic Act ("FD&C Act").