Category: Health Law Highlights

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Health Law Highlights

AI and Digital Governance: Exploring Platform Liability

Summary of article from IAPP, by Uzma Chaudhry:

The modern internet, integrating AI, IoT, and advanced cybersecurity, is a rapidly evolving ecosystem with significant societal impact, accessible to 5.35 billion people globally. This digital landscape has increased the influence of intermediaries like search engines and social media, raising concerns about privacy, misinformation, and intermediary liability under laws such as Section 230 of the Communications Decency Act, Section 512 of the : Digital Millennium Copyright Act, and the EU e-Commerce Directive. The rise of generative AI adds complexity, challenging existing legal frameworks and prompting discussions on whether current immunities should extend to AI-generated content. Recent cases like Gonzalez v. Google highlight ambiguities in intermediary liability, particularly as AI technologies evolve. Future legal interpretations will need to address the nuances of AI and its role in content creation and dissemination.

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Health Law Highlights

Wave of the Future: Are AI and Data Mining the Next Generation of “Professional Whistleblowers”?

Summary of article from Arnall Golden Gregory LLP, by Kara Gordon Silverman:

The integration of AI and data mining in False Claims Act (FCA) litigation presents both opportunities and challenges, enabling whistleblowers to analyze vast datasets and detect potential fraud without insider knowledge. However, these technologies must navigate legal hurdles such as the public disclosure bar and the requirement for specificity in allegations as per Rule 9(b) of the Federal Rules of Civil Procedure. Despite these challenges, professional whistleblowers, exemplified by entities like Integra Med Analytics, continue to leverage AI-driven data to bring FCA cases, sometimes securing significant settlements. This trend necessitates vigilant defense strategies to scrutinize the standing and validity of such claims. The ongoing evolution underscores the need for balancing technological advancements with legal safeguards to ensure fair and substantiated whistleblowing.

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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

Post-Chevron Health Care Regulations: The Dawn of a New Day

Summary of article from ArentFox Schiff, by Douglas a. Grimm, Lowell C. Brown, David S. Greenberg, Pascal Naples:

The Supreme Court’s decision in Loper Bright Enterprises v. Raimondo overturns the Chevron deference, requiring courts to independently interpret ambiguous statutory provisions rather than deferring to federal agencies. This shift, particularly impacting the health care industry, reinstates the more limited Skidmore deference, where courts only defer to agency interpretations found persuasive. Additionally, the decision in Corner Post v. Federal Reserve extends the statute of limitations for challenging agency actions, potentially increasing litigation against agency regulations. Health care organizations may face greater regulatory uncertainty and variability across jurisdictions as courts independently interpret complex statutes and regulations. Consequently, HHS may adopt more cautious regulatory approaches and increased reliance on guidance over formal rulemaking.

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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

False Claims Act Settlements to Know from Q2 2024

Summary of article from Bass, Berry & Sims PLC, by Latazia Carter, Scott Gallisdorfer:

In Q2 2024, the Department of Justice announced significant False Claims Act settlements, highlighting ongoing enforcement in areas such as unlawful kickbacks, improper billing, and subcontracting violations. Notable settlements included a $27.9 million agreement with a laboratory owner for fraudulent cancer genomic tests and a $12 million settlement with Innovasis Inc. for paying kickbacks to spine surgeons. Cape Cod Hospital and a chronic disease management provider, facing Medicare billing violations, each entered into Corporate Integrity Agreements (CIAs) and paid $24.3 million and $14.9 million, respectively. Additionally, CityMD resolved COVID-19 testing fraud allegations with a $12 million settlement, and Sikorsky Services Inc. and Derco Aerospace Inc. paid $70 million for unlawful subcontracting practices in Navy procurement. These cases underscore the importance of compliance for entities engaged in government contracts and healthcare services.

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Health Law Highlights

OCR Settles Alleged HIPAA Violations for $950,000 Following 2017 Ransomware Attack

Summary of article from King & Spalding, by Elizabeth Kimball Key:

On July 1, 2024, the HHS Office of Civil Rights (OCR) announced that Heritage Valley Health System agreed to pay $950,000 to settle alleged HIPAA violations following a 2017 ransomware attack. The settlement includes a corrective action plan (CAP) to address compliance gaps, marking the third HIPAA enforcement action involving ransomware. The OCR’s investigation revealed several potential HIPAA violations, including inadequate risk analysis, lack of a contingency plan, and insufficient access controls for electronic protected health information (ePHI). As part of the CAP, Heritage Valley will conduct a comprehensive risk analysis, implement a risk management plan, update its policies and procedures, and train its workforce on HIPAA compliance. OCR highlighted a significant increase in ransomware-related breaches, underscoring its enforcement priority.

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Health Law Highlights

CMS’ First No Surprises Audit Targets Aetna, Finds Some Noncompliance

Summary of article from Healthcare Dive, by Rebecca Pifer:

The CMS’ first audit under the No Surprises Act found Aetna in Texas noncompliant with several key requirements, particularly in its calculation of qualifying payment amounts (QPAs) for air ambulance services. Aetna used incorrect methodologies, leading to both overestimations and underestimations of QPAs, and failed to provide necessary disclosures to providers. This lack of compliance could hinder the arbitration process, already burdened with backlogs. Aetna has since corrected its practices and must self-audit QPA calculations from 2022 onwards. The audit highlights ongoing disputes over QPA methodologies, which have led to legal challenges and delays in the arbitration process.

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Health Law Highlights

Addressing Patient Transportation Needs

Summary of article from Dentons, by Susan Freed:

A significant barrier to accessing healthcare services is the lack of transportation, with one in five patients forgoing needed care due to this issue, particularly in rural areas lacking public transport and ride-share options. Hospitals are increasingly offering free transportation to ensure patients, especially the most vulnerable, do not miss critical services. However, these programs must comply with the Anti-Kickback Statute and the Civil Monetary Penalty Law. This article references a podcast that explores these compliance issues and provides guidance on structuring compliant transportation programs, along with a sample transportation policy.