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Health Law Highlights

How AI Is Enhancing Health Care

Summary of article from Dallas Morning News, by James B. Milliken:

The University of Texas System is embracing the potential of artificial intelligence (AI) in healthcare, despite concerns about job losses and bias. The inaugural UT System AI Symposium in Health Care will bring together AI experts from eight institutions to discuss the responsible integration of AI into healthcare. AI is proving beneficial in various areas like administrative tasks, cancer detection, and treatment planning. The UT System is also integrating AI into degree programs across its seven medical schools, and is working with Microsoft and other academic centers to set standards for AI deployment in healthcare. State legislators are focusing on AI’s responsible deployment, with the Texas Senate prioritizing AI in its 2024 interim legislative charges.

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Chief AI Officers in Healthcare: Strategy, Tactics and Evangelism

Summary of article from HealthTech Magazine, by Nathan Eddy:

The rise of artificial intelligence (AI) in healthcare has led to organizations considering hiring a Chief AI Officer (CAIO) to spearhead their AI strategies. The role of a CAIO involves accelerating AI adoption while ensuring safety and innovation, managing investments, and addressing ethical and governance issues. They also need to understand the integration of AI with existing technologies like electronic health records. The role has evolved to include more attention to governance and risk management, especially in medical tech companies. CAIOs provide strategic advantage by guiding AI initiatives, ensuring alignment with strategic objectives, and fostering a culture of exploration and experimentation.

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Health Law Highlights

AI, Health Care, and the Realities of Being Human

Summary of article from Undark, by Arjun V.K. Sharma:

The “doorknob phenomenon” in medicine refers to patients revealing their most pressing concerns just as the doctor is about to leave. This article explores the tension between this deeply human aspect of healthcare and the rise of artificial intelligence (AI) in the medical field. While AI promises efficiency and precision, it may risk depersonalizing healthcare and overlook broader social determinants of health. The author emphasizes that despite the potential advantages of AI, the uniquely human connections between doctor and patient are irreplaceable. The future of healthcare should balance technological advancements with maintaining human empathy and understanding.

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Epic Releases Open-Source AI Validation Tool for Health Systems

Summary of article from Fierce Healthcare, by Heather Landi:

Epic has launched an open-source tool to help healthcare organizations test and monitor artificial intelligence (AI) models. Available for free on GitHub, the AI validation software suite can be integrated with electronic health record (EHR) systems and used to validate AI models from various sources. The tool automates data collection and mapping, providing near real-time metrics and analysis. However, it currently does not validate generative AI models, although Epic plans to expand its capabilities in the future. The Health AI Partnership (HAIP), which includes Duke Health, Mayo Clinic, and Kaiser Permanente, intends to use the tool for local AI model validation.

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The Colorado AI Act: What You Need to Know

Summary of article from IAPP, by Cobun Zweifel-Keegan:

The Colorado AI Act, the first U.S. cross-sector AI governance law, was signed into law on May 17, 2024, with key provisions effective from Feb. 2026. The law focuses on high-risk AI systems, defined as those making consequential decisions, and introduces stringent requirements to prevent algorithmic discrimination. The Act imposes responsibilities on both developers and deployers of AI systems, requiring them to use reasonable care to avoid algorithmic discrimination and mandating comprehensive documentation and impact assessments. The law also requires incident reporting, public disclosure of risk management, and direct consumer notifications. The law exempts entities covered by HIPAA if they provide AI-generated recommendations that require a health care provider to take action to implement that recommendation. Enforcement of the law, which treats violations as breaches of Colorado’s general consumer protection statute, will be carried out by the Colorado attorney general starting 1 Feb. 2026.

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Health Law Highlights

New Practical Guidance for Balancing Fairness, Privacy

Summary of article from IAPP, by Cobun Zweifel-Keegan:

The tension between achieving fairness and maintaining privacy in the operation of advanced AI and machine learning systems is a major challenge for digital governance teams. To test for bias and ensure equity, demographic data is often needed, potentially infringing on privacy rights. A report by the Center for Democracy and Technology AI Governance Lab offers best practices for navigating this issue, such as gathering data responsibly, pseudonymization, encryption, and conducting privacy impact assessments. Legislation, like the upcoming Colorado bill, may balance these issues by requiring fairness and bias testing in AI systems. Transparency and clear communication of methodologies are essential to build trust and uniform benchmarks in AI governance.

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Health Law Highlights

Implementing AI and Mitigating Compliance Risks – Part II

Summary of article from Dentons, by Susan Freed:

With the increasing role of generative AI in the healthcare industry, there is a growing need for a clear, consistent approach to its implementation. To mitigate compliance risks, organization must have an AI strategy, identify current uses of generative AI, update relevant policies, and create a process for evaluating new AI technology. It is important to training users, implement regular reporting strategies, and conduct periodic reviews of the AI technology in use. Providers should develop governance processes now and be flexible to enough to adapt to new technologies and regulations.

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Profound Medical Wins FDA Nod for AI in Prostate Cancer Procedure

Summary of article from MassDevice, by Sean Whooley:

Profound Medical has received FDA 510(k) clearance for its second AI model, the Contouring Assistant, designed to treat prostate cancer. The Contouring Assistant is part of the company’s TULSA-Pro system, which uses transurethral ultrasound ablation (TULSA) to ablate diseased tissue in patients with various stages of prostate cancer, benign prostatic hyperplasia (BPH), or those requiring salvage therapy. The TULSA procedure uses real-time magnetic resonance guidance to preserve urinary continence and sexual function while targeting cancerous tissue. The newly cleared AI module uses machine learning to segment the prostate, aiding in the delineation of the target ablation volume. Profound Medical is also developing another TULSA-AI module, TULSA BPH, with more details expected later in 2024.

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Health Law Highlights

Health Care, AI and Antitrust: Analysis and Next Steps

Summary of article from Manatt, Phelps & Phillips, LLP, by Dylan Carson, Harvey Rochman:

As artificial intelligence (AI) becomes more prevalent in the health care industry, there are growing concerns about potential anticompetitive conduct, including algorithmic price fixing. This issue was highlighted in a recent New York Times report alleging that certain health plans and administrators were using the same company’s algorithmic tools to set out-of-network rates, potentially leading to higher costs for patients. Antitrust enforcers argue that using the same AI systems to set prices could be seen as collusion and therefore a violation of antitrust laws. Health care companies are advised to closely monitor these developments and consider the potential legal risks associated with their use of AI.

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Health Law Highlights

Envisioning the Future of Health Care With OpenAI’s GPT-4o

Summary of article from KevinMD, by Harvey Castro, MD, MBA:

OpenAI’s GPT-4o promises to revolutionize health care with advanced predictive analytics, enhanced surgical assistance, personalized medicine, automated health monitoring, and virtual health assistants. It aims to improve emergency responses, offer immersive education and training, facilitate cross-border medical collaboration, enhance mental health services, streamline administrative processes, and foster community health initiatives. The system is built to eliminate dataset bias and ensure data security with HIPAA-compliant servers. GPT-4o’s potential applications range from predicting health trends to automating administrative tasks, all while ensuring patient data remains private and secure. This transformative AI technology is poised to improve patient outcomes, enhance operational efficiency, and foster a more equitable and advanced health care system.