On June 5, 2025, the FDA issued draft guidance addressing frequently asked questions regarding the transfer or sale of a 510(k) clearance from one 510(k) holder to another. As transfer of 510(k)s is a common issue during transactions involving medical devices, this guidance, if finalized as written, will provide helpful insight regarding the FDA’s position … Continue Reading
Squire Patton Boggs has launched its US Executive Actions Monitor, a site dedicated to tracking executive actions issued by President Donald Trump since taking office. We offer an overview of all executive orders, providing summaries and analysis of their potential impacts, covering issues from economic and foreign policy to government reform and taxation. Our lawyers and … Continue Reading
The Office of the Attorney General of Texas (“OAG”) announced a “first-of-its-kind healthcare generative AI” settlement with Pieces Technology, Inc. (“Pieces”). The settlement related to the Texas OAG allegations that Piece’s advertising and marketing claims about the accuracy of its generative artificial intelligence (GenAI) products in violation of the Texas Deceptive Trade Practices – Consumer Protection Act … Continue Reading
On August 20, 2024, a Texas federal judge permanently barred the implementation of a controversial Federal Trade Commission (FTC) regulation that would have invalidated tens of millions of existing non-compete agreements and precluded the adoption of new covenants. We discussed the FTC’s non-compete regulation earlier this year. The decision comes as a relief to employers … Continue Reading
On July 15, 2024, Singapore’s Personal Data Protection Commission Singapore (PDPC) released a Proposed Guide on Synthetic Data Generation (Guide). The Guide is a resource within the Privacy Enhancing Technology (PET) Sandbox which aims to assist organisations in understanding the techniques and potential applications of Synthetic Data generation, particularly in the context of artificial intelligence (AI) without … Continue Reading
As a digital technologies hub in the Asia Pacific region, Singapore is making a big push to advance Artificial Intelligence (AI) technologies across various sectors, including healthcare. The promise of AI in managing Singapore’s ageing population and enhancing patient care and treatment more broadly cannot be overstated. This spans the ability to better predict and … Continue Reading
On June 27, 2024, the Supreme Court ruled in a 5-4 decision that a bankruptcy court does not have the statutory authority to discharge creditors’ claims against a non-debtor without the creditors’ consent (except in asbestos cases). The decision in Harrington v. Purdue Pharma settles a long-standing dispute in the bankruptcy world that will have significant impact on Purdue … Continue Reading
On June 6, 2024, Reps. Diana DeGette (D-CO) and Larry Bucshon, MD (R-IN) released a letter requesting information from stakeholders on their 21st Century Cures initiative, a policy effort focused on medical research and health care transformation and reforms. With this opportunity to comment, the lawmakers have renewed their commitment to developing the initiative with … Continue Reading
On 5 June 2024, the Australian Information Commissioner commenced civil penalty proceedings in the Australian Federal Court against Medibank Private Limited (an Australian health insurance provider) in relation to an October 2022 data breach. On 25 October 2022, Medibank notified the Office of the Australian Information Commissioner (OAIC) of a data breach concerning sensitive personal … Continue Reading
Washington’s My Health My Data Act (“MHMDA”) and Nevada’s SB 370 (“NV CHD Law”) (collectively, “CHD Laws”) went into effect at the end of last month, on March 31, 2024 (as many know, MHMDA’s geofencing prohibition went into effect last summer). Unlike the Health Insurance Portability and Accountability Act (“HIPAA”), a federal law which governs privacy and security … Continue Reading
On February 28, 2024, President Biden issued a groundbreaking executive order (EO) establishing the framework for new restrictions on transactions involving US persons’ sensitive personal data and “countries of concern,” including China, or related parties.… Continue Reading
Members of our Government Investigations & White Collar team recently presented a timely webinar on the new Foreign Extortion Prevention Act (FEPA). The Act, which has been referred to as “the most consequential anti-foreign-bribery law passed in almost 50 years,” allows the DOJ to prosecute foreign officials who demand or accept a bribe from a … Continue Reading
Fishermen in the small town of Cape May, New Jersey, are at the epicenter of a legal challenge that could reshape the landscape of agency authority. The fishermen are challenging the entrenched “Chevron” doctrine, which for years has afforded deference to government agencies with respect to reasonable interpretation of ambiguous statutes. Once again, the US … Continue Reading
On December 18, 2023, the US Department of Justice (DOJ) and Federal Trade Commission (FTC) (collectively, the “government”) released the final 2023 Merger Guidelines (the “Guidelines”) which set forth factors and frameworks the government will use when assessing mergers and acquisitions. While the Guidelines are not legally binding, they provide important guidance on how the … Continue Reading
On December 11, 2023, Singapore’s Ministry of Health launched a public consultation exercise on a proposed Health Information Bill (Bill), with a draft expected to be tabled in Parliament in the first half of 2024. Whilst extensive industry consultations have been conducted on the proposed provisions of the Bill involving 39 focus groups and over … Continue Reading
Courts around the country continue to disagree on the causation standard to be applied in False Claims Act cases based on alleged Anti-Kickback Statute violations. Two recent federal district court decisions out of the District of Massachusetts, United States v. Regeneron Pharms., Inc., No. 20-11217-FDS, 2023 WL 7016900 (D. Mass. Oct. 25, 2023) and United … Continue Reading
On December 4, 2023, Singapore’s Ministry of Health (Ministry) announced that the nation’s first ever comprehensive health data law, the Health Information Bill (Bill), will be introduced in mid-2024. A set of Cyber & Data Security Guidelines for Healthcare Providers (Guidelines) was also published. Of particular importance is that these Guidelines will frame and eventually … Continue Reading
Protecting the healthcare sector from the ever-increasing cyber threat is a matter of national security. Indeed, on March 1, 2023, President Biden issued the National Cybersecurity Strategy where the President emphasized the need to defend “the systems and assets that constitute our critical infrastructure [as] vital to our national security, public safety, and economic prosperity.” … Continue Reading
It has become commonplace to talk about compliance becoming more and more of a challenge amidst the increasing complexities and fragmentation of regulations worldwide. Data protection compliance is no exception. As new requirements continue to mushroom across the globe with escalating frequency and accompanied by heightened repercussions for any failure to meet expected standards, global … Continue Reading
Nine years after its initial inception, Singapore’s data protection authority (Commission) published in September 2023 an updated set of advisory guidelines for the healthcare sector (Revised Guidelines). As with other advisory guidelines issued by the Commission, the Revised Guidelines are not intended to be legally binding, but will guide the interpretation and enforcement of Singapore’s … Continue Reading
Over the past several weeks, Congressional Republicans have indicated they are gearing up to tackle various health policy issues – and have offered health stakeholders the opportunity to provide feedback and their expertise in policy development. On August 25, Republicans on the House of Representatives’ Committee on the Budget established a “Health Care Task Force.” … Continue Reading
Demonstrating that hospital finances and billing practices continue to be of interest to federal lawmakers, on August 7, a group of bipartisan senators sent letters to the Internal Revenue Service (IRS) and the Treasury Inspector General for Tax Administration (TIGTA) questioning the oversight of nonprofit hospitals. Sens. Elizabeth Warren (D-MA), Chuck Grassley (R-IA), Raphael Warnock … Continue Reading
Singapore has open-sourced the world’s first AI governance testing framework and toolkit, called “AI Verify”. As a single integrated software toolkit operating within a user’s enterprise environment, AI Verify allows users to conduct technical tests on their AI models, and record process checks for reporting to any shareholders or regulatory bodies. Additional toolkits can be … Continue Reading
In April, we previewed two significant False Claims Act (FCA) cases before the U.S. Supreme Court, United States ex. rel. Schutte v. SuperValu, Inc., No. 21-1326 (“SuperValu”), and United States ex. Rel. Proctor v. Safeway, Inc., No. 22-111 (“Safeway”). The FCA provides that “any person who knowingly presents, or causes to be presented, a false or fraudulent claim” to the United … Continue Reading
