USA Law and Practice Contributed by: Nadia de la Houssaye, Allison Bell, Emily Degan Vorhoff and Keiana Palmer, Jones Walker LLP
and more efficient resource allocation across the healthcare system.
generally fall under the broader digital healthcare framework. Without a universal definition, stakeholders often rely on context-specific understandings within relevant regulatory schemes, industry standards and international frameworks, such as those developed by the International Medical Device The legal framework governing digital healthcare in the United States encompasses multiple fed- eral and state laws and regulations addressing various aspects of technology use in healthcare settings, as follows. Health information privacy and security: • the Health Insurance Portability and Account- ability Act of 1996 (HIPAA); • the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH); and • state-level privacy laws (eg, the California Consumer Privacy Act, the Virginia Consumer Data Protection Act, and the Biometric Infor- mation Privacy Act in Illinois). Medical device and software regulation: • the Federal Food, Drug, and Cosmetic Act (FFDCA); • the Medical Device Amendments to the FFDCA; • the 21st Century Cures Act; and • Section 524B of the FFDCA (added in 2023) addressing cybersecurity of medical devices. Regulators Forum (IMDRF). 2.2 Laws and Regulations Key Regulatory Framework
2. Legal Framework 2.1 Definition of Digital Healthcare In the United States, there is no single or univer- sal definition of digital health or digital health- care. Federal and state legislation, regulations and enforcement agencies often provide specific definitions that conform to the discrete issues, services, conditions, solutions, tools and tech- nologies addressed in particular legislative or jurisdictional contexts. Generally speaking, “digital healthcare” is under- stood as a broad term covering various health- related products, tools and services distributed through technological solutions to improve men- tal and physical health and overall well-being. These range from consumer health and wellness apps not regulated by the FDA to digital treat- ments regulated as software as a medical device (SaMD). More specific terms such as “digital medicine” and “digital therapeutics” refer to narrower cat- egories of tools, solutions and processes that actively prevent, diagnose, treat or provide ther- apeutics to address specific diseases or condi- tions. These typically include products and ser- vices such as office visits, remote consultations, prescription drugs and surgical procedures that require direct involvement of providers and patients. In contrast, technology solutions supporting healthcare operations, disease prevention, com- munity health, infrastructure and administration that do not directly treat individual conditions
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