Category: Health Law Highlights

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Health Law Highlights

Lessons Learned From Walmart, Amazon, and Walgreens: Healthcare’s Retail Reset

Summary of article from D Magazine, by Will Maddox:

Walmart, Amazon, and other major corporations have struggled to make a profitable venture into primary care, often citing high operating costs and reimbursement challenges. Retail healthcare has proven complex due to the transient nature of providers in these settings and the difficulty in maintaining long-term patient relationships. Further, the current fee-for-service model in healthcare is unsustainable. The ongoing shortage of physicians is a significant challenge. A new payment model could alleviate the shortage and better meet the growing demand for primary care.

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Health Law Highlights

Now is Not the Time to Relax: Record Settlements in Stark Law and False Claims Cases

Summary of article from Lathrop GPM, by Jesse A. Berg:

In May 2024, the University of Pittsburgh Medical Center (UPMC) settled a False Claims Act case for $38 million, marking one of the largest settlements in U.S. history for alleged Stark Law violations. The case emphasizes the importance of fair market value compensation in hospital-physician financial arrangements and debunked the idea that a Department of Justice (DOJ) decision not to intervene in an FCA case means the issue is resolved. The case underscores the need for healthcare organizations to ensure their physician compensation practices can withstand increased regulatory scrutiny and comply with Stark Law principles.

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Health Law Highlights

Employers Must Keep Reproductive Health Information About Their Plan Participants Private Under New HIPAA Privacy Rule

Summary of article from Akerman LLP, by Beth Alcalde, Elizabeth Hodge:

The newly updated HIPAA Privacy Rule, effective June 25, 2024, provides enhanced protection for reproductive health care records, preventing their disclosure to state law enforcement agencies except under certain conditions. The definition of “reproductive health care” is broad, encompassing a wide range of male and female health services. There are strict restrictions on using such information for investigations, and health plan administrators and associated businesses have direct responsibility for compliance. Upon receiving a request for such information, a signed written attestation is required from the requester stating the intended use or disclosure is not for a prohibited purpose. Revisions to the Notice of Privacy Practices (NOPP) must be in place by February 16, 2026, and legal challenges to the Final Rule are expected.

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Health Law Highlights

How Generative AI Will Change Jobs In Healthcare

Summary of article by Bernard Marr:

Generative AI is poised to revolutionize healthcare by assisting in diagnosis and treatment, personalizing care, and accelerating research and development. It can analyze complex datasets, like medical images, and provide personalized treatment programs, while AI chatbots can offer specialized advice and patient monitoring. It can also expedite drug discovery by generating genetic codes and simulating human physiological responses. However, ethical implications concerning data privacy, bias, and AI accountability must be addressed. Professionals will need to understand these issues, ensure secure data handling, and comprehend when human intervention is necessary.

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Health Law Highlights

What You Need To Know About Texas Consumer Data Privacy Law

Summary of article from The National Review, by Elizabeth Rogers:

The Texas Data Privacy and Security Act (TDPSA) is a comprehensive privacy law that applies broadly to individuals and businesses dealing with personal data in Texas. It introduces a strong set of consumer privacy rights, including the rights to access, correct, and delete personal data, and to opt-out of data processing for targeted advertising. The law imposes obligations on data controllers, such as data minimization, nondiscrimination, and the requirement of consent before processing sensitive data. Controllers must also conduct data protection assessments for certain types of processing that pose heightened risks to consumers. The law is enforced by the Attorney General, with civil penalties of up to $7,500 per violation, and businesses are advised to update their privacy policies and procedures to comply with the TDPSA.

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Health Law Highlights

Ethical Implications Surrounding Use of AI in Healthcare

Summary of article from BioSpectrum, by Arpita Goyal:

Algorithmic biases in AI systems, which could perpetuate historical inequalities and affect healthcare quality, need to be addressed through diversified training data and sophisticated algorithms. Ensuring clinical validity and transparency in AI deployment is essential for establishing trust and accountability, and human clinical judgment should not be supplanted by AI predictions. Balancing innovation and ethical accountability, with a focus on patient welfare and societal values, is crucial for fully leveraging the benefits of AI in healthcare.

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Health Law Highlights

Cybersecurity Policy – Developments to Watch

Summary of article from FiscalNote, by Nicole D’Angelo:

Cybercrime costs are projected to rise from $9.22 trillion in 2024 to $13.82 trillion by 2028, with new threats emerging due to advancements in technology, particularly AI. Governments are increasingly focusing on cybersecurity, with several key legislations proposed in 2024, including the Healthcare Cybersecurity Improvement Act and the Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA) in the US, and the EU AI Act, Network and Information Security 2 Directive (NIS2), and Digital Operation Resilience Act (DORA) in the EU. The rise of AI is also leading to new cybersecurity risks, with governments focusing on ensuring AI systems are secure and ethical. The concept of “Security by Design” is gaining traction, encouraging developers to integrate security measures into new products. The Cybersecurity and Infrastructure Security Association (CISA) is offering support to high-risk sectors, such as healthcare and education, to help them mitigate sophisticated cyberattacks.

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Health Law Highlights

Wegovy Maker Novo Nordisk Sues Nine Spas, Clinics and Pharmacies Over Copycat Drugs

Summary of article from Reuters, by Patrick Wingrove:

Novo Nordisk, a Danish pharmaceutical company, has filed lawsuits against nine more U.S. entities, including medical spas, wellness clinics, and pharmacies, for selling products that allegedly contain semaglutide, the key ingredient in its weight-loss drug Wegovy. This brings the total lawsuits to 21 since June, targeting sellers of purported copycat versions of semaglutide. The recent lawsuits were filed in federal courts across six states, with some defendants accused of selling products directly to patients without medical prescriptions and others of selling products with no semaglutide or of lower strength than advertised. Novo Nordisk also found high levels of impurities in some products, posing significant health risks to patients. This legal action mirrors similar steps taken by Eli Lilly, Novo Nordisk’s main competitor in the obesity drug market, against entities selling products claiming to contain tirzepatide, the active ingredient in its weight-loss drug Zepbound.

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Health Law Highlights

FTC and DOJ Seek Public Help Identifying “Serial Acquisition Strategy” Targets

Summary of article from Seyfarth Shaw LLP, by Brandon Bigelow, Robyn Marsh:

The Federal Trade Commission (FTC) and the Department of Justice (DOJ) are expanding their investigation into businesses using “roll up” strategies to consolidate competitors and reduce competition across the U.S. economy. Previously, these agencies focused on the healthcare industry, but the new Request for Information invites the public to submit examples of companies using serial acquisition strategies in any industry. This move follows the FTC’s aggressive litigation against such strategies in the healthcare industry, as demonstrated in the case of FTC v. U.S. Anesthesia Partners, Inc. The May 23 Request for Information seeks input from a wide range of sources and invites them to identify specific examples of these strategies and their impact on competition. Public responses, due by July 22, 2024, may influence the government’s enforcement priorities and future actions across various markets and industries.

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Health Law Highlights

Is FTC’s Noncompete Rule a Concerning Development for Physicians?

Summary of article from Medical Economics, by Amanda Hill:

The Federal Trade Commission (FTC) has issued a rule prohibiting noncompete clauses, potentially impacting physicians nationwide. Critics argue this rule overreaches federal authority, creates ambiguities in exceptions, and exacerbates divisions between hospitals and physicians. While some physicians support the ban, arguing noncompetes give undue leverage to hospitals, others maintain that reasonable noncompetes can protect smaller practices. The rule introduces legal uncertainties and potential conflicts, with the U.S. Chamber of Commerce planning to challenge the decision. The FTC rule, despite its aim to protect the workforce, may instead cause confusion and legal disputes, potentially delaying its implementation.