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Health Law Highlights

The Impact of the EU AI Act on the Healthcare Sector

Summary of article from DataGuidance, by Michael Borrelli:

The EU AI Act aims to regulate AI systems within the EU, categorizing them by risk levels and imposing stringent requirements on high-risk systems, particularly in healthcare. This legislation emphasizes transparency, accountability, and ethical considerations to ensure AI technologies are safe and trustworthy. High-risk AI systems in healthcare must meet rigorous standards for risk management, data quality, transparency, human oversight, and post-market monitoring. While compliance presents challenges, the Act fosters innovation and aims to improve healthcare outcomes and patient safety. Overall, the EU AI Act is pivotal in shaping the ethical deployment of AI in healthcare.

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Health Law Highlights

You Can’t Surf With a Ventilator. The Problems with AI in Health Care, and Some Solutions

Summary of article from California Health Report, by Jennifer McLelland:

The author tested three major AI chatbots—Google Gemini, Meta Llama 3, and ChatGPT—on medical questions to evaluate their accuracy, finding that their responses were often incorrect or misleading. This raises concerns about AI’s potential to spread harmful misinformation, especially for families seeking information on rare medical conditions. The author argues that while AI promises simple solutions, the complex needs of children with special health care requirements necessitate increased funding for human providers who can offer personalized, accurate guidance. Furthermore, the use of AI in health insurance decisions could perpetuate existing disparities and biases in the healthcare system. The author advocates for legislative oversight and more substantial investment in human resources to ensure equitable and reliable healthcare.

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Health Law Highlights

The Promise Artificial Intelligence Holds for Improving Health Care

Summary of blog post from FDA, by Troy Tazbaz:

The FDA emphasizes the importance of integrating AI responsibly, ensuring safety and effectiveness through collaboration and adherence to standards and best practices. Key strategies include adopting risk management frameworks, quality assurance practices, and maintaining transparency and accountability throughout the AI development lifecycle. Grassroots efforts and federal initiatives are contributing to the establishment of best practices for AI quality assurance in health care. The FDA’s Digital Health Center of Excellence (DHCoE) remains open to feedback and collaboration to advance AI in health care.

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Health Law Highlights

Advanced Analytics in Predicting Healthcare Billing & Coding Audits

Summary of article from VMG Health, by Frank Cohen:

In the evolving healthcare landscape, advanced analytics, including predictive analytics, AI, and machine learning, are transforming billing and coding processes by enhancing accuracy and efficiency, thereby mitigating audit risks. These technologies analyze vast amounts of data to predict potential audit triggers, automate coding, and reduce human error. Case studies demonstrate significant benefits, such as reduced audit rates and cost savings. Implementing these technologies requires a cultural shift towards data-driven decision-making and thorough staff training. As these tools advance, they will become essential for healthcare organizations aiming to improve financial stability and compliance.

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Health Law Highlights

Patenting Power Plays For AI Drug Discovery

Summary of article from Foley & Lardner LLP, by Nikhil T. Pradhan:

The analysis of patent portfolios for nine AI drug discovery companies reveals a predominant focus on conventional pharmaceutical technologies over AI/machine learning (ML) innovations, though AI/ML filings are increasing. Companies’ patent strategies generally align with their commercial targets, though AI/ML patents often lack specific target details, suggesting broad applicability. Comparisons with the overall patent landscape show these companies have fewer filings than established “big pharma,” indicating potential opportunities for strategic patent development. The findings suggest that AI drug discovery firms could enhance their competitive edge by expanding patent protections across various drug and target classes, leveraging both conventional and AI/ML technologies. This strategic expansion could be crucial given the impending patent cliff and the rapid evolution of the biotech/pharma sector.

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Health Law Highlights

Texas Medical Center Wrestles With Promise, Perils of AI

Summary of article from Houston Chronicle, by Jim Magill:

The Texas Medical Center is increasingly integrating AI into healthcare, recognizing both its potential and risks. Key concerns include maintaining patient confidentiality and trust, with institutions like Methodist Hospital developing protocols to disclose AI’s role in patient interactions. Researchers at UTHealth Houston are creating AI models that protect privacy while analyzing large datasets for medical insights. AI is being used to personalize treatment plans, improve patient experience, and identify effective drug combinations, as exemplified by MD Anderson’s Tumor Measurement Initiative. Despite the advancements, healthcare professionals emphasize the need for thoughtful and secure implementation of AI technologies.

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Health Law Highlights

An Introduction to Healthcare AI Innovation in an Evolving Regulatory Landscape

Summary of article from Benesch, by Arielle Lester, Vince Nardone, Amanda Ray, Kathrin Zaki:

The expansion of AI applications in healthcare is revolutionizing the industry, enhancing clinical diagnostics, enabling personalized medicine, and addressing workforce shortages. By 2028, the Healthcare AI market is projected to reach $102.7 billion USD. Despite its futuristic perception, AI has historical roots dating back to the 1950s with self-learning programs. Current AI applications in healthcare include disease prediction, natural language processing for medical records, deep learning for x-ray analysis, and generative AI for administrative tasks. However, the integration of AI in healthcare comes with significant risks and is governed by a patchwork of federal and state regulations, emphasizing the need for ethical use, patient safety, and transparency.

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Health Law Highlights

The Limits of AI in Healthcare: Exploring Ethical and Practical Challenges

Summary of article from Nelson Hardiman, LLP, by Harry Nelson:

The integration of AI in healthcare, exemplified by companies like RealtimeMed and initiatives such as Eureka Health’s AI doctor, raises significant ethical and practical challenges. Physicians must navigate their responsibilities when AI influences differential diagnoses and consider the risks associated with AI-induced errors. The shift towards AI-driven diagnostics and treatment recommendations questions whether standards of care will increasingly rely on these technologies. This evolution also brings legal complexities, particularly concerning billing practices and the extent of physician involvement in AI-assisted care. As AI systems enable higher patient volumes, the traditional doctor-patient dynamic is fundamentally altered, exposing healthcare to broader risks and necessitating careful oversight.

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Health Law Highlights

‘Data Is the Differentiator’: How an Integrated Data Strategy Supports Healthcare AI Success

Summary of article from HealthTech Magazine, by Jordan Scott:

At the AWS Summit in Washington, D.C., Dr. Naqi Khan emphasized the critical role of high-quality data in the successful implementation of generative AI in healthcare. He highlighted that while healthcare generates vast amounts of data, much of it remains unstructured and unused. A robust integrated data strategy is essential for leveraging AI to improve clinician workflows, patient experiences, and health outcomes. Dr. Khan also stressed the importance of data privacy and the need for federated data approaches to reduce bias and enhance data sharing. AWS offers several services, including HealthLake, HealthImaging, and SageMaker, to support healthcare organizations in achieving these goals.

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Perspectives of Oncologists on the Ethical Implications of Using Artificial Intelligence for Cancer Care

A survey conducted by Harvard Medical School, published in JAMA Network Open, reveals that oncologists agree AI tools must be explainable, patients must consent to AI use, and oncologists must protect patients from AI biases. Despite this, many oncologists lack confidence in recognizing AI biases, highlighting a need for structured AI education and ethical guidelines. The survey found that 37% of oncologists would let patients decide between their own and AI treatment recommendations, and 77% believe they should protect patients from biased AI, though only 28% feel capable of identifying such biases.