On June 15, 2022, the Supreme Court of the United States released its long-awaited decision in American Hospital Association v. Becerra in which it unanimously held that the United States Department of Health and Human Services (HHS) overstepped its statutory authority by cutting 340B-related reimbursement to hospitals ...
On April 1, 2019, the Health Resources and Services Administration (HRSA) launched a secure website that lists the maximum price drug manufacturers may charge 340B-covered entities for 340B-eligible drug purchases (the 340B Ceiling Price Site). Drug manufacturers and 340B-covered entities may access the 340B Ceiling Price Site through their HRSA Office of Pharmacy Affairs information system (the 340B OPAIS) account here: https://340bopais.hrsa ...
As U.S. hospitals and health clinics continue preparing for novel coronavirus (COVID-19) patient surges, federal regulatory agencies are developing resources to help health care providers comply with myriad regulatory requirements. In this context, the U.S ...
The September 23, 2013 deadline for covered entities, business associates and their subcontractors to implement the new HIPAA rules is approaching quickly. In case you missed it, on January 25, 2013, the U.S. Department of Health and Human Services issued an omnibus final rule modifying the Health Insurance Portability and Accountability Act of 1996 ...
This week, I caught up with patent attorneys Jonathan D’Silva and Bryan Walker of MacDonald Illig Jones & Britton, LLP to hear their perspectives on some key strategic intellectual property (IP) legal issues ...
The glacial pace at which the federal government has implemented cannabis policy–particularly in light of the rapid evolution of cannabis laws at the state level–is at the same time predictable and frustrating to those seeking a measure of certainty ...
The joint employer rule has been a hot topic in the last several years, mostly in the context of the Fair Labor Standards Act. Recall the drama of the Trump administration's narrower definition of a joint employer for wage purposes, followed by the Biden administration's almost immediate rescission of that rule. Gig economy workers have battled about overtime and their entitlement to it under the FLSA's definitions ...
On January 29, 2003, pursuant to the requirements of Section 307 of the Sarbanes-Oxley Act of 2002, the SEC issued a release adopting a new Rule 205 entitled “Standards of Professional Conduct for Attorneys Appearing and Practicing Before the Commission in the Representation of an Issuer” (the “Standards”) ...
Governor Wolf announced that 24 Pennsylvania counties will move from the red phase to the yellow phase of the reopening plan beginning at 12:01 a.m. Friday, May 8. The 24 counties announced today are: Bradford, Cameron, Centre, Clarion, Clearfield, Clinton, Crawford, Elk, Erie, Forest, Jefferson, Lawrence, Lycoming, McKean, Mercer, Montour, Northumberland, Potter, Snyder, Sullivan, Tioga, Union, Venango and Warren ...
As the American press focuses on the dismantling of the Affordable Care Act, the wheels have been set in motion to implement new health care legislation that enjoys strong bipartisan support. The 21st Century Cures Act (the “Act”), signed by President Obama on December 13, addresses a broad range of health care priorities, including drug innovation, biomedical research, and mental health reform ...
1. How do you foresee the evolving regulatory landscape in offshore jurisdictions impacting Asia-based clients in 2024, and what strategies is your firm considering to navigate these changes effectively? Anthony McKenzie (AM): Asia is the world's largest and most populated continent, comprised of many different economies, cultures and laws. The use of Cayman, BVI and Bermuda structures has a long track record throughout Asia and it is this familiarity which has contributed to their popularity ...
As discussed in our February 4, 2022 client alert and our December 15, 2022 client alert, certain legal entities are now subject to new reporting requirements in the United States about their beneficial ownership pursuant to the requirements of the Corporate Transparency Act (the “CTA”). As mandated by the CTA, the Financial Crimes Enforcement Network (“FinCEN”) issued a final rule (the “Final Rule”) to implement the CTA ...
Jon Bew and Wayne Gibbard, co-heads of the Financial Services Sector at Shoosmiths, comment on upcoming trends and developments to expect in 2024 for the sector. Everyone is feeling it, the rumbling of a technological storm. The immergence of generative AI, RegTech and increased fraud and cyber risk, have swept clouds of uncertainty across the Financial Services Sector… ...
Shoosmiths’ Technology Sector Group comments on upcoming trends and developments to expect in 2024 for the sector. Artificial Intelligence (AI) Alex Kirkhope – IT & Tech Partner With Collins Dictionary naming “AI” its word of the year, there is no disputing that artificial intelligence has been the world’s most talked about technology of 2023 ...
By: Sarah Andrzejczak With a new year comes new employment laws, and Colorado is no exception. The following is a brief, non-exhaustive list of key law changes employers should be aware of for the 2024 year: Colorado’s FAMLI program will begin providing paid leave benefits to employees as of January 1, 2024 ...
Fintech companies and their partners are on alert as a flurry of new state and federal cybersecurity requirements take effect. The New York Department of Financial Services (NYDFS) and the Federal Trade Commission (FTC) both recently finalized changes that will create additional compliance obligations, expand existing regulations to new entities and mandate that banks and fintech firms move quickly to update their cybersecurity policies and incident-response capabilities ...
In the world of privacy and data, after another whirlwind year, what are the safe bets and the long shots for change in 2023? Like the technology driving it, privacy and data law moves fast, and covers many territories, so it’s not always easy to keep track of developments. Long-awaited rulemaking - such as an overarching US federal data protection law – can get stuck in the weeds, while unexpected developments in technology and politics can serve up some complete surprises ...
We have recently seen reports about the unbelievable amount of pressure on the NHS, including inaccessibility to GPs; a high degree of emergency admissions; and bed-blocking within hospitals where vulnerable patients cannot be discharged safely. These factors have exacerbated the pressure on our healthcare system to almost unprecedented levels. Medical technologies or MedTech could be the way forward to ease some of the pressure ...
Having experienced unprecedented levels of M&A activity in 2021 and the first half of 2022, followed by the market uncertainty of Q3 and Q4 of 2022, what can we expect from the M&A landscape in 2023? Here are some of our key predictions ...
Looking back at last years’ predictions for 2022, which covered the potential contributions of data, AI and automation, quantum computing, digital health, VC activity and the Future of Work, it is clear to see the tech sector has advanced considerably in the last 12 months. James Klein, head of the technology sector at Shoosmiths, comments on how his previous predictions fared and outlines upcoming trends and developments to expect in 2023 ...
With climate change continuing to be a topic of concern across the international community, Canada has recently taken another step to support the development of renewable energies and technologies. In the 2023 budget tabled on March 28, 2023, the Canadian federal government unveiled new tax incentives aimed at supporting investments in both renewable energies and certain clean technologies. These incentives can be grouped into five main Investment Tax Credits (ITCs) ...
On November 17, 2023, New York State Governor Kathy Hochul signed into law Senate Bill 4516, amending General Obligation Law Section 5-336 (GOL 5-336). As set forth in our earlier alert from when the law was first enacted, Section 5-336 limited employers’ use of nondisclosure provisions in agreements releasing claims involving sexual harassment ...
In recent years, license-in/out transactions have become the most common way for innovative drugs and medical devices (including medical aesthetics) companies to collaboratively develop and commercialize medical products and related technologies. According to public information, in China, the total amount and number of investment and financing in life sciences sector have witnessed a significant decline from 2021 to 2023, with the investment amount being only a quarter of that in 2021 ...
SyCip Salazar Hernandez & Gatmaitan (SyCipLaw) has just published the SyCipLaw TMT and Data Bulletin covering significant Philippine legal and regulatory developments in the technology, media, telecommunications and data space, from late 2022 to the first quarter of 2023. It also notes links to podcasts and materials relating to TMT and dataPLUSa commentary on whether AI can replace a local counsel ...
The 2022 tax assessment of real and personal property have been determined by the local Assessor and a Notice of Assessment was issued and mailed to property owners. Property owners should make sure to check the mail for a copy of the Notice in order to determine whether an appeal of their taxable value should be filed ...
