USA Trends and Developments Contributed by: Nadia de la Houssaye, Allison Bell, Emily Degan Vorhoff and Keiana Palmer, Jones Walker LLP
Expanding Influence of AI on Medical Specialties and Workforce Dynamics The rapid advancement of AI in healthcare is reshaping certain medical specialties, particular- ly those that rely heavily on image interpretation such as radiology, pathology and dermatology. As AI systems demonstrate increasing accura- cy in reading X-rays, MRIs and other diagnostic images, some medical students and physicians are reconsidering their specialisation choices. This trend reflects broader concerns about the potential for AI to displace certain aspects of physician work, though most experts emphasise that AI tools should augment rather than replace clinical judgement. Highlighting the continued importance of holistic clinical reasoning and patient interaction that extends beyond algo- rithmic interpretation, it is important to note that physicians do not treat films, they treat human patients. The Food and Drug Administration (FDA) has stepped up its oversight of AI-enabled medi- cal devices, requiring more rigorous validation and clearance processes. On 6 January 2025, the FDA published the Draft Guidance: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submis- sion Recommendations . This draft guidance proposes life cycle considerations and offers specific recommendations to support market- ing submissions for AI-enabled medical devices. The draft guidance also highlights recommenda- tions from previous guidance (in order to assist manufacturers with applying those recommen- dations to AI-enabled devices) and provides additional recommendations on topics of spe- cific relevance for AI. This heightened scrutiny reflects growing aware- ness of the potential risks associated with algo-
and regulatory compliance. In early 2025, the American Hospital Association (AHA) published a summary of a recent survey which suggested that a rebound may be in store this year: of 103 senior leaders whose companies sell digital health products, 81% have a positive outlook or are cautiously optimistic about investment pros- pects for 2025; 79% said that their organisations would pursue new investment capital over the next 12 months. Clinical workflow optimisation solutions, value- based care enablement platforms, and revenue cycle management technologies have attract- ed significant funding. A notable trend is the increasing integration of artificial intelligence (AI) into digital health solutions, which brings both opportunities and challenges. While AI offers the potential to improve diagnostic accuracy, streamline administrative tasks and personalise treatment plans, it also raises concerns about data privacy, regulatory compliance and clinical validity (see below). The changing regulatory environment under the new administration has also raised concerns about potential limitations on research that examines differential treatment outcomes based on demographic factors such as gender, race, ethnicity and age. This could hamper efforts to address healthcare disparities and develop more personalised treatment protocols. Additionally, reduced federal funding for clinical trials and research, including digital healthcare solutions, is creating gaps that private invest- ment alone may struggle to fill. The lack of fully integrated platforms for clinical trial manage- ment remains a significant challenge, highlight- ing the need for enterprise-level solutions in this critical area of healthcare innovation.
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