Category: Health Law Highlights

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Health Law Highlights

Credentialing Is Burdening Small Hospitals—and Underserved Communities Pay the Price

Summary of article from HealthExec, by Chad Van Alstin:

The credentialing process in healthcare, which verifies a provider’s education, training, licenses, and professional experience, is a time-consuming manual task, especially burdensome for small hospitals and independent practices. The lack of a centralized data repository and varying state regulations complicate the process, with no current way to automate it due to the need for data from hundreds of disparate sources. This process can delay the hiring of healthcare providers, impacting patient care, especially in underserved communities. Solutions like blockchain have been explored but are met with skepticism due to issues of data reliability and technical limitations. Until a more efficient system is found, the credentialing process remains largely manual, leading to increased time and labor costs, particularly affecting rural and underserved areas.

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Health Law Highlights

Importance of Negotiating Holdover Provisions in Health Care Leases

Summary of article from Epstein Becker & Green, by Zlata Fayer, Allison Zangrilli:

Negotiating holdover provisions, clauses that account for situations when a tenant remains in the property after lease expiration, is crucial in health care leases. Tenants who fail to vacate on time face holdover rental rates which can be up to double the agreed monthly rent. Therefore, tenants should negotiate these provisions to ensure a reasonable holdover rental rate. They may also aim for a grace period with an unchanged base rental before the holdover rate comes into effect. This negotiation can help tenants limit their liability in unforeseen circumstances that prevent them from vacating the premises on time.

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Health Law Highlights

As Federal Healthcare AI Regs Stall, States Take Matters Into Own Hands

Summary of article from Medical Marketing & Media, by Lecia Bushak:

States such as Colorado and California are introducing legislation to regulate the use of Artificial Intelligence (AI) in various sectors, including healthcare, in response to the lack of federal regulation. Colorado’s Governor signed SB 205, the first comprehensive AI bias law in the nation, which aims to regulate the use of AI in high-stake decisions and prevent discriminatory use based on genetic information or other data. California is pushing forward approximately 30 regulatory measures to establish boundaries around AI technology, building upon its 2020 data privacy law. Across the US, around 400 new laws on AI have been proposed this year, reflecting the growing legislative interest in the area. Despite some draft legislation at the federal level, experts do not anticipate federal regulation on AI to be established in the near future.

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Health Law Highlights

Can ChatGPT Be Trusted to Provide Medication Information to Patients?

Summary of article from Drug Topics, by Lauren Massaro:

A study published in the Journal of the American Pharmacists Association has found that while AI chatbot, ChatGPT, can provide correct answers to common medication questions, it may not always provide complete information. The study evaluated ChatGPT’s responses to questions about the top 20 drugs, and found that 92.5% of responses were completely correct, but only 80.8% were complete. The study also found inconsistencies in the chatbot’s responses when the same questions were asked again after two weeks. Despite these limitations, the authors believe AI chatbots have potential as healthcare tools, but stress the importance of patients validating information with healthcare professionals. They also highlight the need for robust regulatory frameworks, fact-checking mechanisms, and increased public education about health literacy and responsible use of AI.

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Health Law Highlights

Tips to Shorten Healthcare’s Cybersecurity Learning Curve

Summary of article from Healthcare IT News, by Andrea Fox:

Healthcare organizations are struggling with cybersecurity, especially as threats become more sophisticated. Traditional endpoint detection and response systems are proving inadequate, with many able to be bypassed without triggering alerts. Healthcare organizations have unique blind spots due to reliance on basic security measures and a complex digital infrastructure. Artificial intelligence can aid in identifying and responding to threats in real-time, but AI is a tool, not a magic solution. Healthcare organizations and third-party vendors need to adopt advanced threat detection and response technologies, and act as a united front to better resist cyberattacks.

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Health Law Highlights

What to Learn From DOJ’s First Telehealth-Prescribed Controlled Substances Case

Summary of article from Husch Blackwell, by Jonathan Porter:

On June 13, 2024, the Justice Department arrested two executives of Done Global Inc., a digital health company, marking the first criminal case against telehealth executives for allegedly causing illegal prescriptions of controlled substances. The charges include a drug dealing conspiracy, a healthcare fraud conspiracy, and obstruction of justice. Key lessons from the case include the importance of adherence to state and federal laws when prescribing controlled substances via telehealth, the risks of restricting prescribers’ access to patients and incentivizing prescriptions without follow-up evaluations, and the potential for prosecution under a drug-dealing conspiracy rather than the Anti-Kickback Statute. The case also highlights the potential challenges of proving such charges, particularly in light of the 2022 Supreme Court Ruan case, and the illegality and risks of deleting documents during an investigation. Despite this case, telehealth remains a valuable practice, but healthcare innovators should be mindful of the risks associated with restricting the physician-patient relationship.

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Health Law Highlights

Artificial Intelligence Governance – First, Build On What You Have

Summary of article from Guidepost Solutions LLC, by Kenneth Mendelson:

As AI technology rapidly advances, organizations must prioritize AI governance to ensure responsible and compliant use. Compliance involves adhering to global, federal, and state regulations, including new laws focused on AI use. Organizations should integrate AI considerations into their existing governance, risk-management, and compliance programs, conducting comprehensive AI risk assessments, updating policies and procedures, ensuring data privacy and security, and monitoring regulatory developments. It is also recommended to establish an AI Steering Committee to oversee AI governance efforts, including transparency, explainability, and ethical considerations. Documenting all AI governance and procedural efforts is crucial for demonstrating due diligence and responsible AI practice.

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Health Law Highlights

The Rise of Fiduciary Health Plan Litigation

Summary of article from The Wagner Law Group, by Michael Schloss, Stephen Wilkes:

In 2022, US health care spending reached $4.5 trillion, with $405 billion spent on prescription drugs and $800 billion paid through employer-sponsored health plans. A class action lawsuit, Lewandowski v. Johnson and Johnson, alleges mismanagement of the company’s health plans’ prescription-drug benefits, leading to higher costs for plan participants. The complaint argues that the company breached ERISA duties of prudence and loyalty and calls for various remedies. The defendants have filed a motion to dismiss the original complaint, arguing that the plaintiff received all benefits due to her under the plans and failed to plausibly allege an imprudent process for negotiating PBM services. The case serves as a wake-up call for health plan fiduciaries to review their PBM programs and consider the role of incentives and conflicts, among other measures.

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Health Law Highlights

FTC Signals Its Intent To Pursue Nonprofit Health Care Entities With Its Non-compete Ban Whenever Possible

Summary of article from Seyfarth Shaw LLP, by Jesse Coleman, Yumna Khan:

The Federal Trade Commission’s (FTC) Final Rule banning non-competes in worker agreements may not exempt nonprofit health care entities, including most hospital systems in the US. The FTC asserts that merely claiming tax-exempt status is not enough to be beyond its jurisdiction; it will also examine whether the corporation is organized for charitable purposes and whether either the corporation or its members derive a profit. The FTC has previously exercised jurisdiction over nonprofit entities engaged in business on behalf of for-profit members. The Final Rule, set to take effect on September 4, 2024, is currently facing legal challenges questioning its constitutionality. In the interim, nonprofit health care entities should consult with legal counsel to determine potential impact from the FTC’s non-compete ban.

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Health Law Highlights

Leveraging AI In Healthcare Operations

Summary of article from Forbes, by Brian Fugere:

The application of AI and machine learning in healthcare is transforming not only clinical areas but also operational and workforce management, with the global healthcare AI market projected to reach $427.5 billion by 2032. AI/ML can address pressing challenges in healthcare, such as complex workflows and administrative tasks, which currently consume 60%-80% of healthcare professionals’ time and contribute to workforce shortages. Learning from other industries, healthcare can implement AI/ML to optimize workflows, automate tasks, and improve operational efficiency. However, unique challenges in healthcare, including strict regulations and complex decision-making processes, necessitate careful consideration when adopting these technologies. By strategically and responsibly harnessing AI/ML, healthcare organizations can innovate and improve operations, leading to enhanced patient outcomes and a more efficient healthcare ecosystem.