State efforts to address the 340B Drug Program[1] continue to ramp up in 2024. Early this January, Kentucky Senator Stephen Meredith introduced Senate Bill 27 ("SB-27"), which intends to address a number of purchasing restrictions drug manufacturers unilaterally imposed on health care providers participating in the 340B Program ...
Social determinants (or drivers) of health (SDOH) can create substantial barriers to an individual’s overall health and wellbeing. For example, several factors associated with economic hardship—lack of transportation, safe housing, or access to nutritious food, etc.—are highly correlated with poor health outcomes ...
In the fourth quarter of 2023, Sen. Raphael Warnock, D-Ga., made industry news, important banking and financial rule changes were implemented, and Georgia's Department of Banking and Finance quietly issued important new regulatory guidance on a handful of topics. Warnock Addresses Banking Committee, Introduces Legislation First, during a three-plus hour U.S ...
Insurance contracts, like any other type of contract, require informed consent by all signatories. This concept is especially relevant considering that an insurance contract is an example of uberrimae fidei, i.e. an agreement requiring the utmost and the most absolute good faith when one party is disclosing facts that could influence the other party?s decision. In other words, policyholders are held to a high degree of honesty when providing their insurers with information ...
Can a patent be infringed even if the patented product is not manufactured, assembled, or even used? Indeed, such infringement is possible. In fact, this is known as the theory of inducement of infringement. Naturally, acts of ?inducement? must meet certain conditions before inducement of infringement can be found. The Federal Court of Appeal recently clarified these conditions ...
In recent years, the job market has changed considerably, especially further to the pandemic and the impacts it has had. Employers and employees in Quebec faced unprecedented situations, and these appear to have led to a significant increase in claims for recognition of psychological occupational injuries, such as adjustment disorders and depression ...
Driven by the passion and belief, and fraught with various risks and challenges, the research and development of innovative drugs and medical devices is a journey that's never easy. Along the journey, an individual may stride resolutely, yet with companionship, two can traverse faster and farther ...
In June of 2022, the Supreme Court of the United States unanimously held in American Hospital Association v. Becerra that the United States Department of Health and Human Services (“HHS”) and the Centers for Medicare and Medicaid Services (“CMS”) overstepped their statutory authority when cutting 340B-related reimbursements to hospitals from 2018 through 2022 ...
By: Daniel Silva, Sanjay Bhandari, and Manisha Malhotra The Paycheck Protection Program (“PPP”) emerged as a lifeline for small businesses grappling with the unprecedented challenges of the COVID-19 pandemic. Lenders navigated a landscape of regulations that Congress quickly drafted in response to the pandemic. These regulations and obligations evolved, subtly yet materially, from the first and second rounds of PPP “draws ...
Employment Tribunals have a duty to make reasonable adjustments where a participant is disadvantaged, for example due to disability, to ensure fairness in proceedings. We share our recent experiences of how the Tribunals apply this duty in practice ...
Updated on 8 January 2024.Food law is extensively harmonized throughout the EU, but national law still has a role to play. In this short article, we look at three developments in Belgian food law that have taken place in 2023: the amendments to the Food Safety Agency’s administrative fining regime, the introduction of nutrivigilance, and the announced revision of the food hygiene legislation.1 ...
Both the Belgian legislator and government have played an active role in 2023 when it comes to pharma legislation, which has led to a number of changes in the legal framework. In this article, we look back and discuss five noteworthy developments in Belgian pharma law. 1 ...
Recent changes to Ohio law have licensed health care professionals asking themselves when was the last time they confirmed or updated their email address, and other contact information, with agencies like the State Medical Board of Ohio, the Ohio Board of Nursing or the Board of Pharmacy? The impetus for such reflection is that Ohio licensing agencies may now serve significant legal documents exclusively through email, or a last-known fax number, as opposed to registered or certified mail thro
Module 6 of the UK’s Covid-19 Public Inquiry opened on 12 December 2023, with public hearings set to begin in Spring 2025. This article explores what Module 6 will examine and explains how and why members of the Care Sector may want to become involved ...
There was considerable anticipation regarding whether the negotiations would be successfully concluded during this meeting. Without an agreement, there was a risk of significant delays in the adoption of the framework. This was undesirable for EU institutions that have invested considerable prestige in leading the regulation of AI globally. Read more about the most contentious issues leading up to the last negotiation meeting in this article ...
We’re entering the season of giving. Over the coming weeks, Americans across the nation will gather with family and friends to celebrate the holidays and give selflessly to the people and causes they love. Unfortunately, the Biden administration might be embracing the giving spirit a little too much. Federal officials may soon decide to give away key domestic assets — American intellectual property (IP) — to our rivals ...
