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Health Law Highlights

AI and Healthcare: Decoding the Latest 1557 Non-Discrimination Regulations

Summary of article from Bricker Graydon LLP, by N. Bradford Wells:

The 2024 Final Rule under Section 1557 of the Affordable Care Act reinstates and expands anti-discrimination provisions for healthcare providers and health plans receiving federal reimbursement. Notably, it extends these provisions to entities participating exclusively in Medicare Part B and introduces regulations for the use of Patient Care Decision Support Tools (PCDST), including AI and clinical algorithms. Covered Entities must now ensure these tools do not perpetuate discrimination based on protected characteristics such as race, sex, and disability. This involves understanding the training data and methodologies used in AI tools, conducting regular audits, and implementing compliance programs. The rule emphasizes the need for AI data literacy among providers to prevent biased treatment decisions. Additionally, the rule has broadened the definition of sex discrimination, although enforcement of this expansion is currently under a nationwide injunction. Compliance with these regulations will require significant vigilance and proactive risk management by healthcare entities.

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Health Law Highlights

Stakeholder Perspectives on Ethical and Trustworthy Voice AI in Health Care

Summary of article from Sage Journals, by Jean-Christophe Bélisle-Pipon, Maria Powell, Renee English, Marie-Françoise Malo, Vardit Ravitsky, Bridge2AI–Voice Consortium, Yael Bensoussan:

Voice as a health biomarker using artificial intelligence (AI) is gaining momentum in research. The noninvasiveness of voice data collection through accessible technology (such as smartphones, telehealth, and ambient recordings) or within clinical contexts means voice AI may help address health disparities and promote the inclusion of marginalized communities. However, the development of AI-ready voice datasets free from bias and discrimination is a complex task. The objective of this study is to better understand the perspectives of engaged and interested stakeholders regarding ethical and trustworthy voice AI, to inform both further ethical inquiry and technology innovation.

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Health Law Highlights

HHS Aligns AI, Tech Strategy Under its Policy Agency

Summary of article from GovCIO, by Silvia Oakland:

The Department of Health and Human Services (HHS) has restructured its technology and data strategy responsibilities, consolidating them under its policy office. This reorganization primarily affects the Office of National Coordinator for Health IT (ONC), now renamed the Assistant Secretary for Technology Policy and ONC (ASTP/ONC). A new Office of the Chief Technology Officer will be established, encompassing the Office of the Chief AI Officer, Office of the Chief Data Officer, and a new Office of Digital Services. This digital services team will oversee HHS-wide digital strategy and ethics in technology initiatives. The 405(d) cybersecurity program will transition to the Administration for Strategic Preparedness and Response (ASPR) to enhance healthcare cybersecurity. HHS Secretary Xavier Becerra emphasized the growing importance of cybersecurity, data, and AI in healthcare. Additionally, ONC has updated the Trusted Exchange Framework and Common Agreement (TEFCA) to improve the nationwide exchange of electronic health information.

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Health Law Highlights

A Lifecycle Management Approach Toward Delivering Safe, Effective AI-Enabled Health Care

Summary of blog post from FDA, by Troy Tazbaz:

AI’s continuous learning and adaptability pose risks, such as exacerbating biases, which can harm patients and underrepresented populations. Lifecycle Management (LCM), integral to reliable software since the 1960s, can address these challenges through structured frameworks. The AI Lifecycle (AILC) concept maps traditional Software Development Lifecycles to AI-specific phases, emphasizing systematic methods for data and model evaluation. This AILC model serves as a guide for assessing standards, tools, metrics, and best practices, promoting quality, interoperability, and ethical practices. The health care community is encouraged to engage with and refine these concepts to ensure AI’s safe and effective integration into health care. Feedback and involvement are welcomed to support the development of high-quality AI models.

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Health Law Highlights

Microsoft, Mass General Developing AI Models for Radiology

Summary of article from Fierce Healthcare, by Heather Landi:

Microsoft is collaborating with Mass General Brigham and the University of Wisconsin-Madison to enhance AI in medical imaging. The partnership aims to develop, test, and validate AI algorithms to improve the accuracy and consistency of medical image analysis. These AI models will be integrated into clinical workflows via Microsoft’s Azure AI platform and Nuance’s PowerScribe radiology reporting platform. The collaboration seeks to assist radiologists and clinicians in interpreting medical images, generating reports, classifying diseases, and analyzing structured data. This initiative addresses the healthcare industry’s challenges of physician burnout and staffing shortages by leveraging generative AI to enhance workflow efficiencies. Key leaders from the partner organizations emphasize the potential of generative AI to transform clinical care and improve patient outcomes. Additionally, Microsoft is working with Nvidia to advance generative AI and cloud computing in healthcare and life sciences.

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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.