April 17, 2023 By: Meghna Parikh ALERT: Recent guidance from the Food and Drug Administration (“FDA”) clarifies a procedural issue for premarket submissions related to cybersecurity of medical devices and emphasizes the importance of collaboration between the FDA and medical device manufacturers. Providers using medical devices in their practice should pay attention to these rulings because they impacts the providers’ ability to educate and engage their patients ...
Contents Please click on the links below to jump to the relevant section: Overview FAQ 1: Are SPV trustees in scope? FAQ 2: What about SPVs that aren’t trustees? Do you need to have a “customer” or “third party” to be in scope? FAQ 3: I do have “customers” or “third parties” ...
On March 31, 2023, Governor Andy Beshear signed Senate Bill 47 making medical marijuana use and sale legal in Kentucky, effective January 1, 2025. [i] Kentucky now joins at least 37 other states that have legalized medical marijuana. The newest piece of legislation comes on the heels of Governor Beshear signing two executive orders related to cannabis in November of 2022 ...
On March 22, 2023, the Centers for Medicare & Medicaid Services (“CMS”) updated its guidance and survey process for home dialysis services in nursing homes.[1] The updated guidance is based on comments, questions, and feedback received from state survey agencies, the dialysis community and other stakeholders since CMS initially issued guidance in 2018 ...
On the 2nd of February 2023, the European Insurance and Occupational Pensions Authority (hereinafter referred to as “EIOPA”) published a Supervisory Statement on the use of governance arrangements in third countries to perform functions or activities (hereinafter referred to as the “Statement”) ...
Americans have increasingly accepted meat and dairy alternatives as staples in their daily diets. For example, recent market research shows that two out of every five U.S. consumers plan to purchase plant-based meat products in 2023. The prevalence of these forms of alternative protein has set the stage for a semantic — and potentially paradigm-shifting — dispute over the very meaning of the terms "meat," "milk" and "dairy ...
Earlier this year, the government announced its support for the passing of the Workers (Predictable Terms and Conditions) Bill. Should it become law, the Bill is set to bring huge change for tens of millions of employees in the UK who do not currently have a statutory right to request a predictable working pattern ...
Shoosmiths’ Public Inquiries team is delighted to present a series of podcasts in respect of reflections and experiences of the COVID-19 pandemic. Hosted by Hayley Saunders and Alex Friston, we are delighted to be joined by a variety of speakers, each bringing something different to the table in relation to impacts, views and then thoughts towards the Public Inquiry, which is set to commence its first public hearings on 13 June ...
As schools and institutions of higher education anticipate the release of new Title IX regulations this May, on Thursday, April 6, the U.S. Department of Education (the “Department”) released a new notice of proposed rulemaking relating to athletic eligibility under Title IX (the “Athletics NPRM”). The Athletics NPRM was forecast by the Department in its proposed Title IX regulations published in July 2022 ...
A summary of the key takeaways from a recent webinar on 2023 Changes to the Immigration Rules. The webinar was hosted by Pavan Sumal and Rachel Harvey and a recording of the webinar can be found below along with a summary of the key takeaways ...
To mark the launch of EG's latest UK Cities Investor Guide at MIPIM 2023, Shoosmiths real estate partner Patrick Duffy joined a panel discussion on public-private partnerships. The session explored the opportunities and challenges that will affect the growth of UK cities, as well as what more can be done to attract innovation and investment ...
Previously, the Government issued Decree No. 03/2023/ND-CP dated 10 February 2023 on the functions, tasks, powers and organizational structure of the Vietnam Competition Commission (“VCC”) (“Decree 03”). The Prime Minister has now issued Decision No. 310/QD-TTg dated 29 March 2023 appointing Mr. Le Trieu Dung to hold the position of Chairman of the VCC (“Decision 310”). Before being appointed as the Chairman of VCC, Mr ...
The development of Bermuda's insurance regime is a result of prevailing market conditions and considerations. Recent enhancements to Bermuda's insurance regime have focused on commercial insurers (particularly in the life sector) and this trend looks to continue through and beyond 2023. That said, the BMA recently updated the Insurance Code of Conduct (the Code) in September 2022 ...
The first hearings for the official UK Covid-19 Inquiry are fast approaching – though less quickly than originally anticipated, with the start date now delayed to Tuesday 13 June. Although public hearings are yet to get under way, the Inquiry has nonetheless had a busy February and March, with preliminary hearings for Modules 1 (pandemic preparedness and resilience), 2 (political and administrative decision-making) and 3 (impact on the healthcare sector) all taking place ...
Facilitating whistleblowing and supporting those who do raise concerns is a very important health check for charities, who are judged not just on the basis of what they do, but also how they do it, and who need to remain mindful of “walking the talk ...
The Directorate of Investments and Company Administration (“DICA“) announced on 1st April 2023 (“Announcement“) regarding the additional requirements when the annual return (“AR“) is submitted by the companies to DICA within two months after registering their company under the Myanmar Companies Law (“MCL“) ...
The Law on Food Safety which was promulgated on 8 June 2022 obliges food business operators (such as food business owners or manufacturers, processors, packagers, wholesalers, retailers, and distributers) (“Operators”) to immediately notify the competent authorities of problems with the food products and cooperate with the authorities to implement measures to avoid or minimize risks caused by the food, as well as to trace, recall, and withdraw unsafe food products from the market ...
March 31, 2023 By: Michael Flynn and Brett Voets On March 30, 2023, the Consumer Financial Protection Bureau (CFPB) issued the long-awaited final version of its rules on Small Business Lending under the Equal Credit Opportunity Act.[1] The new rule imposes significant burdens and risks on lenders, and will likely result in significant amounts of loan-related data being made public, as discussed below ...
Time is running out for developers that have not yet signed the Developer Remediation Contract. The Secretary of State for Levelling Up, Housing and Communities, Michael Gove, delivered a clear message last week: “The Responsible Actors Scheme is coming. Only developers who behave responsibly will be trusted to build the homes of the future. Any eligible developers who fail to do the right thing will need to find a new line of work” ...
Biometric identifiers are unique to every individual. They include your fingerprints, facial structure, and even how you walk. There is the Illinois Biometric Information Protection Act (“BIPA”), and biometric protection bills are currently working their ways through the legislatures in Maryland and Mississippi ...
