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Carey | January 2023

On January 17, 2023, the Institute of Public Health ("ISP") –by means of Res. Ex. No. 106– approved the Good Manufacturing Practice Guideline for Medical Devices and In Vitro Diagnosis Medical Devices (the "Guideline") ...

Shoosmiths LLP | January 2023

To help further the objectives of the Women’s Health Strategy for England (published by the Department of Health and Social Care in July 2022) £1.97m has been awarded to help women in the workplace who are experiencing reproductive health issues. The grant will be shared between 16 charities which include, amongst others, Fertility Network UK, Sands, Tommy’s and Mind ...

Lavery Lawyers | January 2023

In early 2022, the Autorité des marchés financiers (the AMF) conducted specific consultations on financial products offered on the Internet. Further to these consultations, the AMF published explanations on the Regulation respecting Alternative Distribution Methods (the RADM) in late December 2022 ...

Dinsmore & Shohl LLP | January 2023

HUD-insured debt may be a narrow field within the broader realm of commercial real estate finance, but it never ceases to amaze me the variety of issues that I encounter within the relatively small HUD sandbox.  Dinsmore’s work as lender’s counsel on a recent multifamily 223(f) loan had me grappling with issues related to sovereign immunity, a legal concept that had barely entered my consciousness since graduating from law school ...

Mamo TCV Advocates | January 2023

  The MFSA issued a Circular on the 22nd of December 2022 in which it proposed amendments to the Companies Act (Cell Companies carrying on business of Insurance) Regulations, Subsidiary Legislation 386.10 (“the PCC Regulations”). The PCC Regulations provide for the creation and regulation of cell companies ...

Arendt & Medernach | January 2023

On 22 December 2022, the Commissariat aux Assurances (the CAA) released Circular Letter 22/22 on the takeover of intermediation in certain types of life insurance contracts (Circular 22/22).This circular provides guidelines on issues that may arise in the context of a takeover of insurance intermediation (reprise d’intermédiation). 1 ...

Shoosmiths LLP | January 2023

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 ...

Dinsmore & Shohl LLP | January 2023

The U.S. Department of Justice’s Office of Legal Counsel recently released an advisory opinion[i] regarding Section 1461 of title 18 of the U.S. Code. In it, they write the “Comstock Act”[ii] does not prohibit the mailing of certain medications used to perform abortions where the sender does not believe the medications will be used unlawfully. This opinion comes in the wake of the U.S ...

Shoosmiths LLP | January 2023

As the Covid-19 Inquiry reaches Module 2 of its timeline and it turns its attention to the political and administrative decisions made at the height of the pandemic, Shoosmiths looks at the history of public inquiries to reflect on their purpose and effectiveness in preventing future mistakes of the same kind. Reviewing previous public inquiries may inform us about the likely trajectory of the Covid-19 Inquiry ...

If your organization operates or could be sued in New York, there has been recent activity on the legal and regulatory risk landscape that risk professionals should be prepared for. New York’s newly-enacted Comprehensive Insurance Disclosure Requirements legislation opens the door for defendants to request that organizations disclose the details of their commercial insurance programs that may apply to a judgment in the case ...

Afridi & Angell | January 2023

In September 2022, the UAE introduced an insurance scheme pursuant to Federal Decree No. 13 of 2022 concerning unemployment insurance. This law was followed by Cabinet Decision No. 97 of 2022 concerning the mechanisms and controls for implementing the unemployment insurance scheme, and Ministerial Resolution No. 604 of 2022 concerning the unemployment insurance scheme (together with the Federal Decree, theUnemployment Insurance Law) ...

Dinsmore & Shohl LLP | December 2022

On December 14, 2022, the National Labor Relations Board reinstated a previous test used to determine which employees must be included in an appropriate bargaining unit. In American Steel Construction, Inc., 372 NLRB No. 23 (2022), the Board overruled the test established in PCC Structurals, 365 NLRB No. 160 (2017), and The Boeing Co., 368 NLRB No. 67 (2019), opting to return to the test set forth in Specialty Healthcare & Rehabilitation Center of Mobile, 357 NLRB 934 (2011) ...

Dinsmore & Shohl LLP | December 2022

The COVID-19 pandemic resulted in many business owners seeking business interruption and extra expense coverage for lost income sustained as a result of mandatory closures of their businesses.  At the core of such claims is the issue of whether businesses can obtain coverage for business interruption in the absence of direct physical loss to their business premises from COVID-19.  Consistent with national trends, the Supreme Court of Ohio, in Neuro-Communication Servs., Inc. v ...

Shoosmiths LLP | December 2022

As applications for Module 3 Core Participant (CP) status drew to a close on 5 December 2022, the Inquiry team have announced two key dates, as we continue to monitor progress of the UK Covid-19 Inquiry. No timescales have been given as to when applicants will be informed of the outcome of their CP applications, with the only information provided being that the Inquiry Chair (Baroness Heather Hallett) will be reviewing and determining in 'due course' ...

Buchalter | December 2022

December 2, 2022 By: Anna G. Thomas To increase transparency regarding payments to physicians by drug and medical device companies, Governor Newsom signed AB 1278, which imposes certain additional disclosure obligations on physicians.  Beginning on January 1, 2023, physicians will be required to comply with new patient notice and posting requirements. Notice to Patients Under this law, physicians must provide to patients an Open Payments database notice ...

Dinsmore & Shohl LLP | November 2022

On November 15, 2022, Governor Andy Beshear announced two executive orders related to cannabis in Kentucky. The first executive order allows certain individual Kentuckians and their caregivers to bring and use medical marijuana into the state without facing legal consequences beginning January 1, 2023, so long as they meet a set of three criteria ...

Shoosmiths LLP | November 2022

The UK Covid-19 Inquiry (“the Inquiry”) opened its third Module on 8 November 2022, along with the application process for Core Participant (“CP”) status. Module 3 will consider the impact of the Covid-19 pandemic on the healthcare sector in England, Wales, Scotland and Northern Ireland ...

Han Kun Law Offices | November 2022

As the regulation system on human genetic resources ("HGR"), biosecurity and laboratory animals is experiencing continuous improvement, enforcement actions of the Ministry of Science and Technology ("the MOST") have become more active and tight in recent years ...

Han Kun Law Offices | November 2022

Fast-growing e-commerce has changed lifestyles and invented new ways of consumption, amid which demand has rapidly increased for Internet-based medical services such as online drug sales and online medical diagnosis.  Since the regulation and promotion of "Internet-based healthcare services" was included as part of the Outline of the "Healthy China 2030" Plan, China's Internet healthcare industry has been flourishing, channeled by a series of favorable policy decisions ...

Shoosmiths LLP | November 2022

The High Court has handed down three new judgments on BI insurance claims resulting from Covid-19: Stonegate Pub Co Ltd v MS Amlin Corporate Member Ltd [2022] EWHC 2548 (Comm), Various Eateries Trading Ltd (formerly Strada Trading Ltd) v Allianz Insurance Plc [2022] EWHC 2549 (Comm) and Greggs v Zurich Insurance Plc [2022] EWHC 2545 (Comm).  These cases are another reminder of the complexities of BI insurance and the particular challenges created by Covid-19 ...

Mamo TCV Advocates | November 2022

  MamoTCV has contributed to the 10th Edition of The Insurance and Reinsurance Law Review. This edition was edited by Simon Cooper (Ince Gordon Dadds LLP) and provides an overview of the legal and regulatory regime for (re)insurance undertakings and intermediaries in 30 jurisdictions. The publication provides guidance on legal and market developments in each jurisdiction aiding comparative analysis ...

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