USA Law and Practice Contributed by: Nadia de la Houssaye, Allison Bell, Emily Degan Vorhoff and Keiana Palmer, Jones Walker LLP
The Centers for Disease Control and Prevention (CDC)
The Federal Communications Commission (FCC) This regulates telecommunications aspects of telehealth, including broadband infrastructure essential for remote care delivery. The FCC’s Connected Care Pilot Program supports tel- ehealth for low-income patients and veterans. The Department of Justice (DOJ) This enforces antitrust laws in healthcare mar- kets, increasingly scrutinising mergers and acquisitions in digital health. The DOJ also pros- ecutes criminal violations of HIPAA and fraud in telehealth billing. State Attorneys General These enforce state consumer protection, data privacy and antitrust laws that affect digital health companies. State attorneys general are increasingly active in addressing health data privacy concerns, exemplified by Washington State’s My Health, My Data Act. State Medical and Professional Licensing Boards These establish and enforce standards for tel- ehealth practice, remote prescribing and profes- sional conduct in virtual care environments. These entities exercise jurisdiction over digi- tal healthcare because many aspects extend beyond traditional healthcare regulation into areas such as consumer protection, telecommu- nications, securities regulation and professional licensure. Their involvement reflects the increas- ingly complex regulatory landscape as health- care adopts digital technologies that intersect with multiple domains of economic and social activity.
This provides leadership in disease prevention and public health emergency response, utilising digital health tools for population health moni- toring. These agencies frequently collaborate on digi- tal health initiatives but may sometimes apply differing standards or priorities based on their specific missions. Their collective oversight aims to ensure that digital healthcare technologies are safe, effective and accessible, and protect patient privacy while enabling innovation. 3.2 Non-Healthcare Regulatory Bodies Several non-healthcare regulatory bodies play important roles in overseeing aspects of digital healthcare. The Federal Trade Commission (FTC) As the primary consumer protection agency, the FTC regulates health-related product advertising claims, privacy practices of non-HIPAA covered entities, and competition in digital health mar- kets. For example, the FTC monitors health apps and devices to ensure that they do not make unsubstantiated medical claims and that devel- opers, manufacturers and retailers follow truth- in-advertising principles. The Securities and Exchange Commission (SEC) This oversees publicly traded digital health com- panies, ensuring accurate disclosure of business operations, risks and financial performance to investors. Digital health start-ups seeking invest- ment must comply with securities regulations.
156 CHAMBERS.COM
Powered by FlippingBook