USA Law and Practice Contributed by: Nadia de la Houssaye, Allison Bell, Emily Degan Vorhoff and Keiana Palmer, Jones Walker LLP
telehealth provisions permanent, while others remain temporary through September 2025. This phased approach creates both opportuni- ties and compliance challenges as organisations adapt to evolving reimbursement requirements. Digital Therapeutics Classification Regulatory agencies are developing frameworks to address prescription digital therapeutics (PDTs) – software-based interventions that pre- vent, manage or treat medical conditions. These novel products challenge traditional regulatory categories, prompting discussions about appro- priate oversight mechanisms and reimburse- ment pathways. Cybersecurity Requirements The Consolidated Appropriations Act of 2023 amended the FFDCA to require cybersecu- rity information in pre-market submissions for “cyber devices”. This marks a shift towards more explicit regulatory attention to security vulner- abilities in connected health technologies. Non-Traditional Healthcare Entrants The entrance of major retailers and technol- ogy companies into healthcare delivery raises questions about corporate practice of medicine restrictions, data privacy protections and regu- latory oversight. Companies such as Amazon, CVS and Walgreens are expanding primary care, pharmacy and telehealth services, challenging traditional healthcare models. Interoperability Mandates The CMS Interoperability and Prior Authoriza- tion Final Rule, issued in January 2024, requires implementation of FHIR-based APIs to stream- line health information exchange. These require- ments represent significant regulatory efforts to address fragmentation in health information systems.
These emerging issues reflect the increasing complexity of digital healthcare regulation as technologies evolve and cross traditional bound- aries between healthcare, consumer products and information services. 5.2 Recent or Imminent Reform Several significant legislative and regulatory reforms are reshaping the digital healthcare landscape, driven by policy objectives includ- ing expanded access, enhanced privacy protec- tions, improved interoperability and appropriate oversight of emerging technologies. Telehealth expansion initiatives include the fol- lowing: • recent federal guidance has extended certain Medicare telehealth flexibilities through Sep- tember 2025, providing temporary continuity while permanent policies are developed; • the proposed Telehealth Modernization Act aims to permanently remove geographic restrictions for Medicare telehealth services; and • state-level legislation continues to expand participation in interstate licensure compacts, with dozens of states passing legislation in 2024 covering various health professions. Privacy and data protection includes the follow- ing: • the American Data Privacy and Protection Act, while currently stalled in Congress, repre- sents ongoing efforts to establish a national privacy framework that would address health data outside HIPAA’s scope; • the FTC’s final Health Breach Notification Rule, which became effective in July 2024, clarifies requirements for non-HIPAA covered entities handling health information; and
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