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Pharmacy Owner Sentenced for Paying Illegal Kickbacks and Engaging in a Money Laundering Conspiracy

Summary of press release from United States Department of Justice:

A Texas pharmacy owner was sentenced today to four years and four months in prison and ordered to pay over $59 million in restitution for paying illegal kickbacks and engaging in a money laundering conspiracy. According to court documents and evidence presented at trial, Richard Hall, 53, of Fort Worth, worked with others to create and market expensive compounded medications, which are intended to be custom-tailored to individual patient needs. Hall paid marketers to recruit area doctors to write prescriptions for these expensive compounded medications, including by creating so-called “investment opportunities” so that doctors who wrote prescriptions to the pharmacy could profit from the pharmacy operations. Hall paid illegal kickbacks to these marketers and engaged in a conspiracy to launder the unlawful proceeds. A federal jury in the Northern District of Texas convicted Hall in July 2023 of four counts of paying and receiving unlawful kickbacks and one count of conspiring to launder money.

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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.

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Health Law Highlights

As Healthcare AI Advances, How Do We Balance the Benefits With Privacy Concerns?

Summary of article from HackerNoon, by Emmanuel Akin-Ademola:

AI advancements are transforming the healthcare industry, with companies like GE Healthcare and Siemens Healthineers developing technologies for accurate scans and automating routine tasks. However, these innovations raise significant concerns about data privacy and potential breaches. To address these issues, technical approaches such as anonymizing, encryption, and privacy-oriented algorithms can be adopted, alongside robust legal frameworks to protect individuals’ medical records. Additionally, patient education on privacy practices and ongoing research into data privacy and automation algorithms are crucial. While AI holds great promise for healthcare, ensuring best security practices, regulatory compliance, and continuous research is essential for a secure and effective implementation.

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Health Law Highlights

How AI Is Enhancing Health Care

Summary of article from Dallas Morning News, by James B. Milliken:

The University of Texas System is embracing the potential of artificial intelligence (AI) in healthcare, despite concerns about job losses and bias. The inaugural UT System AI Symposium in Health Care will bring together AI experts from eight institutions to discuss the responsible integration of AI into healthcare. AI is proving beneficial in various areas like administrative tasks, cancer detection, and treatment planning. The UT System is also integrating AI into degree programs across its seven medical schools, and is working with Microsoft and other academic centers to set standards for AI deployment in healthcare. State legislators are focusing on AI’s responsible deployment, with the Texas Senate prioritizing AI in its 2024 interim legislative charges.