Category: Health Law Highlights

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Health Law Highlights

Drugmakers Exposed to Antitrust Probes if Patent Cache Added

Summary of article from Bloomberg Law, by Annelise Gilbert:

The US Patent and Trademark Office (USPTO) has proposed a rule that would create a repository for all settlement agreements related to patent challenges, potentially exposing pharmaceutical companies to antitrust scrutiny. The proposed rule would expand the requirements for companies to file detailed reports after reaching a settlement. The new requirement could assist the FTC and DOJ in determining if antitrust laws have been violated, and may also give non-agency third parties expanded access to the agreements. The proposal has raised concerns in the pharmaceutical industry about the disclosure of confidential agreements and potential antitrust investigations. The rule aligns with an executive order from President Joe Biden encouraging federal agencies to cooperate in policing anticompetitive practices.

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Health Law Highlights

US DEA Will Reclassify Marijuana, Ease Restrictions

Summary of article from AP News, by Zeke Miller, Joshua Goodman, Jim Mustian, Lindsay Whitehurst:

The U.S. Drug Enforcement Administration (DEA) plans to reclassify marijuana as a less dangerous drug, recognizing its medical uses and lower potential for abuse. The proposal, pending review by the White House Office of Management and Budget, would move marijuana from a Schedule I to a Schedule III drug but would not legalize it for recreational use. This change follows President Biden’s call for a review of federal marijuana law and his efforts to pardon Americans convicted of simple possession. Critics argue the move could lead to harmful side effects and that marijuana should be treated like alcohol instead. Despite the change, marijuana would still be a controlled substance and subject to federal regulations.

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Health Law Highlights

US Challenges ‘Bogus’ Patents on Ozempic and Other Drugs in Effort to Spur Competition

Summary of article from AP News, by Matthew Perrone:

The Federal Trade Commission (FTC) is challenging patents on 20 brand-name drugs, including Ozempic, as part of the Biden administration’s efforts to target pharmaceutical industry practices that inflate prices. The FTC alleges that patents filed by companies such as Novo Nordisk, GlaxoSmithKline, and AstraZeneca are inaccurate or misleading. These patents, often used to prevent competition from cheaper generic medicines, are being scrutinized as they contribute to high prescription drug costs. This move follows a similar action in September when regulators challenged over 100 patents held by drug manufacturers. The companies have 30 days to withdraw or update their patent listings, or certify their legitimacy under penalty of perjury.

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Health Law Highlights

How Pharmacies Can Protect Patient Data From Cyber Threats

Summary of article from Specialty Pharmacy Continuum, by Karen Blum:

Pharmacies, both large and small, are increasingly targeted by sophisticated cyberattacks due to their databases of patient financial and health information. The breaches can lead to identity theft and drug diversion, with hackers using advanced tactics to gain access to data. To mitigate these risks, pharmacies should establish a robust cybersecurity plan, keep it updated, and conduct regular staff training. Vetting vendors for their data protection measures and having a contingency plan for data breaches are also crucial. In case of a breach, pharmacies should comply with all legal requirements, including notifying affected individuals and the Federal Trade Commission.

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Health Law Highlights

Health Care Giant Comes Clean About Recent Hack and Paid Ransom

Summary of article from Ars Technica, by Dan Goodin:

Change Healthcare, a US health care services provider, was attacked by ransomware group ALPHV or BlackCat, disrupting the US prescription market for two weeks. The breach occurred due to a compromised account that lacked multifactor authentication (MFA), allowing hackers to access and exfiltrate data. The company paid a ransom of $22 million to ALPHV and spent two weeks rebuilding its IT infrastructure. The attack resulted in a cost of $872 million in the first quarter, leading to accelerated payments and no-interest, no-fee loans of over $6.5 billion to affected providers. Currently, the company’s payment processing is at 86% of its pre-incident levels.

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Health Law Highlights

HHS Extends the Antidiscrimination Provisions of the Affordable Care Act to Patient Care Decision Support Tools, Including Algorithms

Summary of article from Epstein Becker Green, by Bradley Merrill Thompson:

The Office of Civil Rights (OCR) has published its final rule on algorithmic discrimination by payers and health care providers. The rule, based on section 1557 of the Affordable Care Act, prohibits discrimination on the basis of race, color, national origin, sex, age, or disability through the use of patient care decision support tools. Covered entities are required to identify and mitigate the risk of discrimination in these tools, with larger, more sophisticated organizations held to a higher compliance standard. The rule applies to both automated and non-automated tools and is set to become effective 300 days after its publication. OCR is also considering additional rulemaking to expand the scope of the regulation.

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Health Law Highlights

FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

Summary of article from Jones Day, by Maureen Bennett, Ryan Blaney, Alexis Gilroy, Colleen Heisey, Michael McFerran, Lauren Murtagh:

The U.S. Food and Drug Administration (FDA) has proposed an updated draft Premarket Cybersecurity Guidance on March 13, 2024, to aid in meeting cybersecurity requirements for FDA medical device submissions. This guidance, under Section 524B of the Federal Food, Drug, and Cosmetic Act, applies to any submission for a “Cyber Device”, which is defined as any device containing software, with potential internet connectivity, and susceptibility to cybersecurity threats. Manufacturers are required to provide documentation that includes plans for dealing with cybersecurity vulnerabilities, assurance of device and system security, and a detailed software bill of materials. The guidance also addresses the impact of device modifications on cybersecurity and the need for a “reasonable assurance of cybersecurity” in the device’s safety and effectiveness evaluation. The FDA will finalize the draft guidance after considering comments and suggestions submitted by May 13, 2024.

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Health Law Highlights

FDA Brings Lab Tests Under Federal Oversight

Summary of article from AP News, by Matthew Perrone:

The FDA has finalized a regulation that will gradually introduce oversight for new tests developed by laboratories. The rule mandates that these tests, including those for life-threatening diseases, must demonstrate accurate results within a timeframe of 3.5 to 4 years. However, existing tests will not require federal review and will be grandfathered into approval. All lab tests will need to register with the agency and report any issues. The move has been opposed by the testing industry, which argues it will limit access to critical tests, increase healthcare costs, and stifle innovation.

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Health Law Highlights

Healthcare Industry Sees Increased Investment in Generative AI, LLMs

Summary of article from Health IT Analytics, by Shania Kennedy:

A recent Generative AI in Healthcare Survey reveals that healthcare and life sciences organizations are increasingly investing in generative AI projects, with larger organizations and leadership roles reporting higher adoption rates. The survey found that 35% of respondents are not actively considering generative AI, while 21% are evaluating use cases and 20% are developing these tools. The majority of organizations have significantly increased their generative AI budgets, with a focus on small, task-specific language models. The most common use cases are streamlining clinical workflows and improving patient communication. Despite the increased adoption, accuracy and potential legal and reputational risks are major roadblocks, and many generative AI projects have not been thoroughly tested for bias and explainability.

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Health Law Highlights

FTC Finalizes Changes to Health Breach Notification Rule

Summary of article from Fierce Healthcare, by Heather Landi:

The Federal Trade Commission (FTC) has finalized the revised Health Breach Notification Rule (HBNR) to enhance data privacy protection for consumers using digital health apps. The rule mandates vendors managing digital health records to notify individuals, the FTC, and sometimes the media, of any breach of unsecured personally identifiable health data. The data includes traditional health information, data from fitness trackers, and “emergent health data” such as health information inferred from location data and health-related purchases. The rule also obligates third-party service providers to notify vendors of personal health records following a breach discovery. The rule will be effective 60 days after its publication in the Federal Register.