Category: Health Law Highlights

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Health Law Highlights

No Surprises Act Implementation Faces Challenges

Summary of article from Proskauer Rose LLP, by D. Austin Rettew, Vinay Kohli:

Two district courts have issued conflicting rulings on the enforceability of arbitration awards under the No Surprises Act (NSA), highlighting ongoing challenges in its implementation. The NSA, enacted in 2020, aims to protect patients from unexpected medical bills by capping out-of-network charges at median in-network rates and establishing a mandatory dispute resolution process. The New Jersey District Court ruled that the Federal Arbitration Act (FAA) applies to enforce NSA awards, while the Texas District Court concluded that the FAA does not provide such a mechanism. The Texas ruling is being appealed, and additional NSA-related regulations and legal challenges are pending. Health care providers should seek expert legal advice to navigate this complex and evolving regulatory landscape.

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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

HHS and FBI Release Joint Cybersecurity Advisory Statement for Healthcare Providers

Summary of article from Morgan Lewis, by Amy M. Magnano, Michael J. Madderra, Roshni Edalur:

The Department of Health and Human Services (HHS) and the Federal Bureau of Investigation (FBI) released a joint cybersecurity advisory (CSA) to alert healthcare providers about phishing attacks and the associated tactics used by threat actors. The advisory emphasizes the importance of updating security measures, including the implementation of multi-factor authentication and enhanced IT Help Desk training to combat social engineering attacks. It also recommends securing remote access tools and testing security programs against outlined threat behaviors. The CSA provides specific indicators of compromise and suggests proactive steps to mitigate risks. Morgan Lewis offers guidance and best practices to help healthcare entities navigate these cybersecurity challenges.

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Health Law Highlights

Pharmacies and Pharmacists in the Crosshairs: DOJ’s $408 million Settlement with Rite Aid

Summary of article from Woods Rogers, by Justin Lugar:

The Department of Justice (DOJ) announced a $408 million settlement with Rite Aid and its affiliates over allegations of violating the Controlled Substances Act (CSA) and the False Claims Act (FCA) by filling unnecessary opioid prescriptions. This settlement underscores the DOJ’s commitment to enforcing pharmacists’ responsibilities to ensure prescriptions are issued for legitimate medical purposes. Recent enforcement actions, including significant penalties against various pharmacies and individuals, highlight the increasing scrutiny and accountability faced by pharmacists and pharmacies. The DOJ, alongside the DEA, is utilizing predictive analytics and state monitoring programs to intensify these actions. Pharmacies must now be more vigilant in adhering to CSA regulations to avoid severe penalties and legal consequences.

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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

Data Privacy in Healthcare: Balancing Innovation with Patient Security

Summary of article from Healthcare IT Today, by Ganesh Nathella:

The integration of digital technologies in healthcare has improved patient care but also raised significant data privacy concerns. Healthcare organizations are investing in robust data protection measures as they adopt tools like telemedicine and remote monitoring. Emerging technologies such as blockchain, AI, and IoT offer solutions but also introduce new security challenges. Compliance with regulations like HIPAA and GDPR is critical, though fragmented global standards complicate this. Balancing innovation with patient security is essential for maintaining trust and advancing healthcare.

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Health Law Highlights

The Overturning of Chevron Deference: Implications for AI in Medical Research

Summary of article from Husch Blackwell, by Ragini A. Acharya. Matthew Deutsch:

The Supreme Court’s recent decision to overturn Chevron deference marks a significant shift in administrative law, transferring interpretive authority from federal agencies to the courts. This ruling, driven by concerns over judicial abdication and regulatory inconsistency, is expected to slow the pace of agency regulations, particularly impacting healthcare agencies like the FDA and HHS. The change poses challenges for the adoption of AI in medical research, potentially delaying innovations in clinical trials and safety monitoring due to increased legal scrutiny. While proponents argue that Congress should oversee emerging technologies such as AI, the decision raises concerns about the responsiveness and adaptability of agencies in addressing public health emergencies and technological advancements. Overall, the healthcare sector must now navigate a more cautious and litigious regulatory environment.

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Health Law Highlights

Navigating the Legal Boundaries of Telehealth

Summary of article from Womble Bond Dickinson, by Melissa Ratliff:

Telehealth, which has evolved significantly over centuries, has revolutionized modern healthcare by providing patients with remote access to medical services. However, this advancement brings complex legal challenges, including state-specific licensure requirements, standards of care, privacy and confidentiality under HIPAA, informed consent, online prescribing regulations, reimbursement and billing policies, and technology platform compliance. Healthcare providers must navigate these issues to ensure legal and ethical telehealth practices. Understanding these legal nuances is essential for maintaining compliance and delivering quality 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.