Key Regulatory Issues for Digital Health Companies

Goodwin Procter, LLP partners Roger Cohen (Healthcare) and Steven Tjoe (FDA) and associate Anne Brendel (Healthcare) discuss the key regulatory issues facing digital health, telemedicine, and healthcare IT companies.  This presentation will cover the FDA's regulation of devices, applicable exclusions, and enforcement discretion. The presenters will also dive into the ever-changing healthcare regulatory guidelines, including the corporate practice of medicine; fraud, waste, and abuse laws; and HIPAA. They'll describe the latest developments in website tracking technology restrictions and the extension of COVID-19 flexibilities in prescribing controlled substances via telemedicine.

Learning Objectives:

1. Evaluate when digital health products are subject to FDA regulation
2. Review how CPOM restrictions, fraud and abuse laws, and HIPAA apply to digital health companies and how digital health companies can comply
3. Identify the current status of prescribing controlled substances via telehealth
4. Discuss the limitations on the use of tracking technologies by digital health companies