USA Trends and Developments Contributed by: Nadia de la Houssaye, Allison Bell, Emily Degan Vorhoff and Keiana Palmer, Jones Walker LLP
rithmic decision-making in healthcare, including bias in training data and the challenge of validat- ing continuously learning systems. Healthcare providers utilising AI tools for clinical documen- tation, such as automated note-taking during patient encounters, face potential Health Insur- ance Portability and Accountability Act (HIPAA) violations if proper safeguards are not in place. Health systems and hospitals are establishing stricter governance frameworks to mitigate these risks, but the rapid pace of innovation often out- strips the development of internal policies. The integration of AI into medical practice also raises questions about training, credentialling and liability. Medical schools and residency pro- grammes are beginning to incorporate AI literacy into their curricula, while professional societies are developing guidelines for the responsible use of these tools in clinical practice. For digital health developers, these shifts under- score the importance of designing AI systems that complement clinical workflows and support physician decision-making rather than attempt- ing to automate complex clinical judgements. Solutions that enhance efficiency while preserv- ing the physician’s role as the ultimate decision- maker are likely to see the strongest adoption in the coming years. Regulatory Oversight and Cybersecurity: Shifting Priorities As the HHS Office for Civil Rights (OCR) faces potential budget cuts under the new administra- tion, its capacity to conduct oversight regarding compliance with HIPAA, the ADA and related leg- islation is likely to be constrained. This reduced federal oversight comes at a time when cyberse- curity threats to healthcare entities are reaching unprecedented levels.
According to The HIPAA Journal , data breach- es involving 500 or more healthcare records reached near-record numbers in 2024 (second only to 2023), continuing an alarming upward trend. Healthcare data remains a prime target for hackers due to its high value on black mar- kets and the critical nature of healthcare opera- tions that makes organisations more likely to pay ransoms. A significant concern is the lack of a private right of action for individuals affected by healthcare data breaches, leaving many patients with lim- ited recourse when their sensitive information is compromised. While many states have enacted laws more stringent than federal legislation, enforcement resources may be stretched thin. The expected new HIPAA regulations under the Trump administration regarding cybersecurity will likely establish clearer standards for health- care entities, but questions remain about imple- mentation timelines and enforcement mecha- nisms in light of resource constraints. For healthcare providers, researchers and ven- dors, cybersecurity has emerged as one of the most significant operational and compliance risks. The integration of AI systems, which often require access to vast amounts of patient data, further complicates the security landscape. Organisations must implement robust security frameworks that address not only technical vul- nerabilities but also the human factors that often contribute to breaches. Corporate Practice of Medicine: Outdated Laws Continue to Stymie Growth Although many private equity investments in digital health offer distinct advantages – includ- ing expanded geographic reach, economies of scale and access to management expertise –
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