USA Law and Practice Contributed by: Nadia de la Houssaye, Andy Lee, Jason Loring and Graham Ryan, Jones Walker LLP
8.3 Therapeutic and Treatment Planning AI systems used in treatment planning or therapeutic decision-making face regulatory oversight based on their risk classification and potential impact on patient care. Higher-risk applications may require extensive clinical validation, PMA processes and meaning - ful human oversight to ensure appropriate clinical judgment and professional accountability, as well as robust safety monitoring programmes. Therapeutic AI systems should demonstrate clinical benefits through appropriate evidence generation. 8.4 Remote Monitoring and Telemedicine Although in use for decades, telemedicine dem - onstrated its value most clearly during the recent COVID-19 pandemic. In this context, healthcare AI applications used in remote patient monitoring and telemedicine must comply with both AI-specific regu - lations and broader telemedicine legal frameworks. AI systems functioning in home or non-clinical settings face unique regulatory challenges related to device performance, user training and clinical oversight, as well as data privacy and security requirements for data collected outside traditional healthcare settings. At-home and remote-monitoring AI also requires inte - gration with clinical workflows that enable healthcare providers to review data, respond to alerts and co- ordinate care for remote patients. Finally, AI-enabled remote monitoring services must navigate complex reimbursement landscapes that vary by payer, service type and clinical application. 8.5 Drug Discovery and Development AI tools used in drug discovery and development receive regulatory oversight through established phar - maceutical development pathways, but are also sub - ject to a number of challenges posed by algorithmic approaches to drug design and clinical trial optimisa - tion, including: • clinical trial design – AI applications must meet good clinical practice standards while demonstrat - ing advantages over traditional trial approaches; • validation requirements – AI-driven drug discov - ery tools must undergo appropriate validation to
ensure reliability and accuracy for their intended uses in pharmaceutical development; and • intellectual property considerations – drug discov - ery raises complex intellectual property questions regarding the ownership of AI-generated insights, novel compound designs and therapeutic targets. 9. Future Trends and Regulatory Developments in Healthcare AI 9.1 Pending Legislation and Regulation The second Trump administration has taken great pains to change the role of the federal government with respect to technology, medical research and much, much more. In this environment, it is difficult to predict with certainty how the healthcare AI land - scape will develop over the next year or two. With that in mind, however, certain questions remain. • Will Executive Order 14110 on Safe, Secure, and Trustworthy Artificial Intelligence, which was rescinded by President Trump, be revived in some other form, particularly those provisions addressing AI use in healthcare? • Will the FDA’s Draft Guidance: Artificial Intelli - gence-Enabled Device Software Functions: Life - cycle Management and Marketing Submission Recommendations, which includes specific recom - mendations to support marketing submissions for AI-enabled medical devices, come into force? • Will the regulations proposed by the Department of HHS in January 2025, specifying that covered enti - ties must conduct vulnerability scanning at least every six months and penetration testing at least annually, be reversed? • Given the current paralysis of the US Congress, will proposals addressing healthcare AI, including AI governance, data privacy and healthcare-specific applications, see the light of day? 9.2 Regulatory Sandboxes and Innovation Programmes Given current executive-branch disruptions and uncertainties, existing innovation programmes and regulatory sandboxes may soon see their expira - tion dates. The following programmes may be under threat.
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