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Health Law Highlights

Wade’s Healthcare Privacy Advisor for November 6, 2024

Access & Privacy

AI Governance

AI Risk Management

Corporate Compliance

Cybersecurity

Growth & Innovation

Legislation

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Health Law Highlights

Wade’s Health Law Highlights for November 5, 2024

Access & Privacy

Cryotheraphy

Fraud & Abuse

Gender-Affirming Care

HIPAA

Ransomware

Reimbursement

Telehealth

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Health Law Highlights

Wade’s Healthcare Privacy Advisor for October 30, 2024

Navigating AI: A Quick Start Guide for Healthcare Professionals

To get started with AI in healthcare, clinicians should set clear goals, create a personalized learning roadmap, and identify essential resources. Understanding AI fundamentals, including programming skills, is crucial for effective collaboration and decision-making. Clinicians can enhance their knowledge and skills through formal education, online courses, and hands-on experience.

Clinician involvement in AI development is crucial, yet often inconsistent, necessitating a multidisciplinary approach to ensure trust and usability in clinical settings. Effective AI integration requires clinicians to understand AI basics, set learning goals, and engage in continuous education, including programming skills and AI model development. A structured learning approach, incorporating formal AI education into medical curricula, can enhance clinicians’ ability to innovate and apply AI tools effectively. Practical resources such as online courses, textbooks, and professional networks are essential for clinicians to gain AI proficiency.

Success in AI adoption involves setting clear milestones, leveraging low-code platforms for ease of use, and fostering collaboration with AI experts. Overall, AI offers significant opportunities for healthcare professionals to improve patient care and drive innovation through informed engagement and structured learning.

AI

Blockchain

  • The global “Blockchain Technology in Healthcare” market is projected to grow significantly, driven by its potential to enhance security, efficiency, and transparency in healthcare services. Blockchain technology offers secure storage of electronic health records, streamlines data management, and improves drug traceability. Recent developments highlight the ongoing integration of blockchain in healthcare, with companies like IBM and Patientory Inc. making strides in the field.

Data Breaches

Data Privacy

Cybersecurity

Health Data

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Health Law Highlights

Wade’s Health Law Highlights for October 29, 2024

Eli Lilly Targets Compounding Kits

Eli Lilly has filed a lawsuit against Pivotal Peptides, a drug vendor in Washington state, accusing them of selling do-it-yourself kits for making knockoff versions of their weight-loss and diabetes drugs, Zepbound and Mounjaro.

Pivotal Peptides allegedly sold these kits without requiring a prescription or medical consultation, labeling the ingredients as “research chemicals” not intended for human use. The company ignored a cease-and-desist letter from Lilly and continued operations under a guise, using coded language to sell their products.

The lawsuit alleges serious safety issues, as these untested and non-pharmaceutical-grade drugs could be ordered by anyone.

Lilly’s legal actions are part of a broader effort to address the sale of illicit tirzepatide versions amid ongoing legal debates over compounded drug formulations.

The FDA had previously declared a shortage of tirzepatide, allowing licensed pharmacies to legally compound the drug, but is now reconsidering this decision following lawsuits from compounding pharmacies. Eli Lilly emphasizes the significant risks posed to patient safety by the sale of these unapproved and potentially harmful drugs.

Anti-Discrimination

  • The Department of Health and Human Services’ final rule implementing Section 1557 of the Affordable Care Act prohibits discrimination in healthcare and requires covered entities to appoint coordinators, post nondiscrimination notices, and implement policies and procedures by specific deadlines. Covered entities must also ensure patient care decision support tools are used non-discriminatorily and provide language assistance and auxiliary aids by May 1, 2025.

Blockchain

  • The global “Blockchain Technology in Healthcare” market is projected to grow significantly, driven by its potential to enhance security, efficiency, and transparency in healthcare services. Blockchain technology offers secure storage of electronic health records, streamlines data management, and improves drug traceability. Recent developments highlight the ongoing integration of blockchain in healthcare, with companies like IBM and Patientory Inc. making strides in the field.

Data Breaches

Health Data

HIPAA

Reproductive Health

Weight Loss

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Health Law Highlights

Wade’s Healthcare Privacy Advisor

Legislation

Security Practices

LLMs

LItigaton

Online Tracking

Regulation

Threat Vector

Opinion

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Health Law Highlights

Wade’s Health Law Highlights

Litigation

Security Standards

Quality of Care

Fraud & Abuse

Out-of-Network

Ransomware

Telemedicine

  • The Texas Medical Board has proposed new telemedicine regulations. The new rules would require a full license to provide telemedicine services, reaffirms that telemedicine services be performed in compliance with the Texas Occupations Code and the Medical Practice Act, and establishes requirements for prescribing for chronic pain via telemedicine.
  • The DEA is expected to extend telemedicine prescribing flexibilities for controlled substances through 2025, following pressure from Congress and the White House. Without an extension, the flexibilities that have increased access to healthcare for rural and underserved communities will expire, potentially leaving thousands of patients without access to critical medications. Stakeholders are urging the DEA to extend the flexibilities and create a taskforce to provide feedback on a new proposed rule for telemedicine prescribing of controlled substances.

CMS

M&A

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Health Law Highlights

Online Tracking Technologies and HIPAA Misconceptions

Summary of article from IAPP, by John Haskell:

Misconceptions persist about the use of online tracking technologies (OTTs) for marketing under HIPAA compliance. HIPAA mandates that covered entities must obtain explicit authorization from individuals before using or disclosing their personal health information (PHI) for marketing purposes. Simply signing a Business Associate Agreement (BAA) does not ensure compliance, particularly when PHI is involved. The U.S. Department of Health and Human Services (HHS) has clarified that disclosures of PHI to tracking technology vendors without proper authorizations are impermissible. Additionally, business associates are prohibited from using PHI for their own purposes, such as marketing campaigns. Compliance with HIPAA requires obtaining valid authorizations and adhering to specific guidelines, rather than relying solely on BAAs. Understanding these requirements is crucial to avoid regulatory issues.

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Health Law Highlights

People Are Overdosing on Off-Brand Weight-Loss Drugs, FDA Warns

Summary of article from Ars Technica, by Beth Mole:

The FDA has issued a warning about overdoses related to off-brand versions of the weight-loss drug semaglutide, commonly known as Wegovy and Ozempic. Due to high costs and supply shortages, patients are turning to compounded versions, which lack standardized dosing and safety assurances. These compounded drugs often come with unclear instructions and improper syringe sizes, leading to significant dosing errors—sometimes up to 20 times the intended amount. Such overdoses have resulted in severe health issues, including nausea, vomiting, and pancreatitis. The FDA emphasizes that compounded drugs carry higher risks and should only be used when absolutely necessary. The agency also noted that healthcare providers have made dosage calculation errors, further exacerbating the problem.

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Health Law Highlights

P-R-I-V-A-C-Y is Priceless to Me: The 2024 Privacy Rule

Summary of article from Holland & Hart, by Leslie Thomson:

The Department of Health and Human Services has issued the 2024 Privacy Rule, amending HIPAA privacy regulations to restrict the use or disclosure of an individual’s Protected Health Information (PHI) related to reproductive healthcare for certain non-healthcare purposes. This rule aims to protect individual privacy and trust in healthcare providers by prohibiting the use of PHI for criminal, civil, or administrative investigations or liabilities concerning lawful reproductive healthcare activities. Covered entities must update workforce training, HIPAA policies, procedures, and business associate agreements by December 23, 2024. Additionally, the Notice of Privacy Practices must be revised by February 16, 2026, to reflect these changes and address proposals related to the Confidentiality of Substance Use Disorder (SUD) Patient Records.

Categories
Health Law Highlights

AI and Healthcare: Decoding the Latest 1557 Non-Discrimination Regulations

Summary of article from Bricker Graydon LLP, by N. Bradford Wells:

The 2024 Final Rule under Section 1557 of the Affordable Care Act reinstates and expands anti-discrimination provisions for healthcare providers and health plans receiving federal reimbursement. Notably, it extends these provisions to entities participating exclusively in Medicare Part B and introduces regulations for the use of Patient Care Decision Support Tools (PCDST), including AI and clinical algorithms. Covered Entities must now ensure these tools do not perpetuate discrimination based on protected characteristics such as race, sex, and disability. This involves understanding the training data and methodologies used in AI tools, conducting regular audits, and implementing compliance programs. The rule emphasizes the need for AI data literacy among providers to prevent biased treatment decisions. Additionally, the rule has broadened the definition of sex discrimination, although enforcement of this expansion is currently under a nationwide injunction. Compliance with these regulations will require significant vigilance and proactive risk management by healthcare entities.