Category: Health Law Highlights

Categories
Health Law Highlights

FDA Finalizes Rule Regulating Laboratory Developed Tests

Summary of article from Polsinelli, by Suzanne Bassett, Michael Gaba:

The FDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) was published on May 6, 2024, and is expected to take effect in 60 days. The rule expands the definition of in vitro diagnostics (IVDs) to include LDTs and will significantly alter the regulatory landscape for LDTs, impacting manufacturers, patients, and healthcare providers. Despite over 6,500 comments, no substantial changes were made from the Proposed Rule to the Final Rule, but there were significant adjustments to enforcement discretion policies. The rule is expected to face legal challenges and potential legislative action from Congress. The Final Rule applies to all IVDs offered as LDTs, regardless of whether the test meets the traditional definition.

Categories
Health Law Highlights

How HHS OCR Is Boosting HIPAA Enforcement; Here Come Audits

Summary of article from BankInfo Security, by Marianne Kolbasuk McGee:

The Department of Health and Human Services (HHS) is working on a proposed update to the HIPAA Security Rule and intensifying enforcement efforts, including resuming HITECH Act HIPAA audits. The focus is on the requirement for risk analysis, a significant weakness among regulated organizations, contributing to many breaches. HHS plans to update the HIPAA Security Rule by the end of the year to reflect technological and healthcare delivery changes over the last two decades. Despite its scalability and technology-neutral nature, the rule’s 20-year-old framework doesn’t reflect current healthcare practices, necessitating the integration of practices like end-to-end encryption. Additionally, the HHS has reopened HITECH audits and is proactively conducting them.

Categories
Health Law Highlights

Do Cosmetic Injections Involve The Practice Of Medicine?

Summary of article from Hendershot & Cowart, by Keith Lefkowitz:

Cosmetic injections, such as Botox and dermal fillers, are considered the practice of medicine in Texas and can only be performed under the authority of a physician. Texas law has seen a series of criminal cases involving unlicensed practice of medicine and cosmetic injections, resulting in serious consequences. Practicing medicine without a license is a crime in Texas, with penalties ranging from state jail felonies to third degree felonies, depending on the harm caused. The Texas Medical Board and Attorney General can also impose civil penalties and issue cease-and-desist orders. Therefore, healthcare providers and med spa owners are advised to consult with a healthcare attorney to ensure regulatory compliance and patient safety.

Categories
Health Law Highlights

A Comprehensive Guide to Creating a Sustainable Cookie Program

Summary of article from IAPP, by Jodi Daniels, CIPP/US:

Managing cookies is essential for compliance with privacy and data protection laws worldwide. Establishing a cookie governance program involves designating roles for program leadership, creating a comprehensive policy for cookie use and removal, and implementing systems to manage user consent. Regular audits and privacy impact assessments for new cookie use are necessary to ensure ongoing compliance. Employees should be trained on the cookie program and privacy practices, and privacy notices must accurately reflect the company’s cookie practices. As technologies and privacy laws evolve, businesses should regularly review and update their cookie governance program to maintain compliance.

Categories
Health Law Highlights

UnitedHealth Paid Hackers $22 Million Ransom

Summary of article from CNBC, by Ashley Capoot:

UnitedHealth Group confirmed the company paid a $22 million ransom after hackers breached its subsidiary, Change Healthcare, affecting the healthcare sector broadly. The breach left many doctors unable to fill prescriptions or get paid for their services temporarily. Witty revealed that the cybercriminals accessed Change Healthcare through a server that lacked multi-factor authentication, a security measure now implemented across all UnitedHealth’s external-facing systems. The breach compromised files containing protected health information and personally identifiable information, with a data review ongoing. UnitedHealth is working with regulators to assess the breach and notify affected individuals, while also implementing measures to prevent future cyberattacks.

Categories
Health Law Highlights

Rehab Hospital Chain Hack Affects 101,000; Facing 6 Lawsuits

Summary of article from GovInfo Security, by Marianne Kolbasuk McGee:

Ernest Health, a Texas-based operator of rehabilitation hospitals, is facing multiple federal proposed class action lawsuits following a ransomware attack that potentially compromised the sensitive information of over 101,000 individuals across several states. The company reported 33 separate breaches involving a network server and a HIPAA business associate at rehabilitation and long-term care hospitals in 12 states. The lawsuits allege that Ernest Health’s negligence in failing to protect sensitive personal information puts the plaintiffs at risk of identity theft and other crimes. The compromised information includes names, addresses, birthdates, medical record numbers, health insurance plan member IDs, claims data, diagnosis, and prescription information, with some Social Security numbers and driver’s license numbers also affected. In response to the incident, Ernest Health has implemented additional safeguards and technical security measures to further protect and monitor its systems.

Categories
Health Law Highlights

How ACOs Can Harness AI’s Transformative Potential

Summary of article from MedCity News, by Theresa Hush:

Artificial intelligence (AI) is revolutionizing various sectors, including healthcare, by improving diagnoses, personalizing medicine, and developing less-invasive procedures. However, its application in accountable care organizations (ACOs) remains limited, mainly to patient-checking bots and robotic assistants, without fully exploring AI’s potential for predictive healthcare and cost reduction. ACOs face challenges in data aggregation and utilization, often relying on retrospective claims data rather than forward-thinking clinical data insights, hindering significant improvements in patient outcomes and cost savings. To leverage AI effectively, ACOs need to aggregate comprehensive data from all provider EHRs, build clinically rich data substrates, and share data with providers. Thus, integrating AI with electronic health records can offer ACOs opportunities to improve patient health outcomes and reduce costs.

Categories
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.

Categories
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.

Categories
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.