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INTRODUCTION In a previous issue of Decoded, we discussed the alarming fact that many medical devices, including those implanted in patients' bodies, are leaving the manufacturers with known cybersecurity flaws. Due to these known flaws, these devices are vulnerable to being hacked, and patients’ personal/protected health information ("PHI") stolen; or worse, the device being held hostage in a ransomware attack ...

Shoosmiths LLP | June 2022

Using evidence given at the UK COVID-19 Inquiry in later criminal or other proceedings The Chair of the UK COVID-19 Inquiry, the Rt Hon Baroness Heather Hallett DBE ...

Shoosmiths LLP | May 2022

Recent reports indicate that mental health and well-being have dropped back down the business agenda, despite levels of workplace stress remaining high in the wake of the pandemic. A recent report by the Chartered Institute of Personnel and Development (CIPD) found that many employers are failing to keep mental health and well-being at the forefront of their business agenda despite the lingering impact of the pandemic ...

PLMJ | May 2022

Regulation (EC) 2017/746 of 5 April came into force on 26 May 2022 and it establishes the regulatory framework for in vitro diagnostic medical devices (IVDs). In doing so, it replaces the previous regulations in Directive 98/79/EC of 27 October 1998 ...

Governor Mike DeWine signed Ohio House Bill 81 on June 16, 2021, codifying a significant change regarding eligibility for temporary total disability benefits (TTD) under Ohio Revised Code §4123.56(F). By enacting R.C. §4123.56(F), the legislature intended to leave behind decades of case law concerning the doctrine of voluntary abandonment ...

On May 16, 2022, the Colorado Supreme Court issued an opinion that serves as a cautionary tale for health care providers hoping to bill patients at chargemaster rates. The court’s decision in French v. Centura Health turned on the meaning of the phrase “all charges of the Hospital,” as set forth in the hospital service agreement (HSA) signed by Ms. French. Centura argued that the phrase “unambiguously refers to a hospital’s chargemaster rates.” Ms ...

Shoosmiths LLP | May 2022

Aaron Harlow and Ian Hardman examine the tough new measures that are being taken to force the real estate industry to pay to remove cladding - protecting leaseholders from costs. The Department for Levelling Up, Housing and Communities (DLUHC) has requested that residential property developers fund and undertake all necessary remediation of buildings over 11m that they have had a role in developing. This includes buildings both 11-18m and 18m+ ...

Shoosmiths LLP | May 2022

Charles Arrand considers the Regulatory Reform (Fire Safety) Order 2005, with a focus on both the potential business and human costs of failing to discharge obligations under the Order. Fire safety is regulated by the Regulatory Reform (Fire Safety) Order 2005 (the Order), which applies to almost all buildings, places and structures other than individual private homes ...

AELEX | May 2022

INTRODUCTION On 10 March, 2022, the Federal High Court sitting in Abuja in Suits No: FHC/ABJ/CS/791/2020: Fan Milk International A/S v. Mandarin Oriental Services BV and The Registrar of Trademarks and FHC/ABJ/CS/792/2020: Fan Milk International A/S v. Mandarin Oriental Services BV and The Registrar of Trademarks, delivered two landmark judgements and established certain principles on the determination of trademark infringement ...

On May 23, 2022, the Oregon Medical Board (OMB) is hosting a public hearing on rules that propose major changes to the way physician assistants (PAs) practice in Oregon. The rules were written in response to House Bill 3036, which supporters have dubbed the “Physician Assistant Modernization Bill.” More broadly, the rules were written in response to mounting concerns about health care access and equity, especially for rural and minority populations ...

ALRUD Law Firm | May 2022

In the light of the current geopolitical situation, including severe counter sanctions and restrictions imposed by the Russian Government, we would like to provide you with an update on the current IP regulation in Russia. Partial legalization of parallel imports On 29th March, the Russian government issued a Decree No ...

Han Kun Law Offices | May 2022

On May 9, 2022, National Medical Products Administration (NMPA) issued for public comments a draft revision (the “Draft Revision”) to the Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China (the “Regulations”). The public comment period ends on June 6, 2022. The Regulations were last revised and became effective in March 2019 ...

Shoosmiths LLP | May 2022

The recent COVID-19 Inquiry's public consultation on its draft terms of reference has captured a substantial amount of public engagement; balancing the representation of all affected groups and avoiding lengthy delays looks like a real challenge. Baroness Hallett’s draft terms of reference (draft terms), published on 11 March, requested the views of individuals and organisations by 7 April on the scope of the COVID-19 Inquiry ...

Shoosmiths LLP | May 2022

The COVID-19 Public Inquiry presents a key growth area for litigation in the medium to long term. Here, Matthew MacLachlan considers key litigation risks, potential parties and emerging themes ...

Buchalter | May 2022

May 12, 2022 By: Mikhail Parnes and Devan McCarty Health plans routinely assert that contracted providers must appeal underpayments or claim denials according to the health plans’ internal dispute process. The payer/provider agreement itself, or provider manuals that health plans contend are incorporated by reference, are the basis for the appeal requirement. Health plans oftentimes analogize this process to the legal principle of exhaustion of administrative remedies ...

On March 30, 2022 the Division of Examinations of the United States Securities & Exchange Commission published the 2022 Examination Priorities. As in other years, the 2022 Examination Priorities document provides certain data regarding the scope of the examination program and the growth of the investment adviser community ...

Shoosmiths LLP | May 2022

Amy Leech, employment law associate and Shoosmiths’ mental health and wellbeing champion, considers the benefits of having an employee led mental health champion network within your business. As an employer, you will have lots of opportunities to look after your employees’ mental health. However, many organisations are still just paying lip service to it ...

Companies may purchase third party technology from time to time. When acquiring patents from outside the company, or from related entities, there are important factors to be considered. Here are certain issues for buyers when preparing a patent acquisition agreement.    The buyer should first determine that all the record owners of the purchased Intellectual Property are party to the patent acquisition agreement. A particular patent may be assigned to a subsidiary of the seller ...

Shoosmiths LLP | April 2022

The government announced several new business immigration routes to be launched in 2022 which consolidate and reform existing routes. The aim is to provide more opportunities for businesses to attract talent from overseas as well as to provide opportunities for growing businesses and recent graduates from international universities. The new Global Business Mobility Visas comprise of five different categories: 1 ...

Shoosmiths LLP | April 2022

On 6 April 2022, Shoosmiths hosted the second in a series of webinars about the UK COVID-19 Public Inquiry. The webinar focussed on the current status of the inquiry and gave practical tips for potentially interested parties. Hosted by Hayley Saunders (Partner), the webinar included talks by Charles Arrand (Partner), Alex Friston (Associate) and Hannah Frost (Associate) ...

Buchalter | April 2022

April 19, 2022 By: T. Mark Tubis The U.S. Department of Health and Human Services (“HHS”) has renewed the January 31, 2020 determination that a public health emergency (“PHE”) exists nationwide. Each determination renews the PHE for 90 days, so all HHS/CMS waivers and flexibilities applicable during the PHE will continue until at least July 15, 2022, unless the PHE is terminated sooner ...

Buchalter | April 2022

April 12, 2022  By: Mary H. Rose Health care providers who received Provider Relief Funds under the CARES Act during Period 1 (April 10, 2020 to June 30, 2020) were required to use the funds by June 30, 2021 and submit a report to the Health Resources and Services Administration (HRSA) regarding use of the funds by September 30, 2021. On March 10, 2022, HRSA sent notices to approximately 10,000 providers who failed to meet the report deadline ...

On March 3, 2022, President Biden signed the long-titled Ending Forced Arbitration of Sexual Assault and Sexual Harassment Act of 2021. Seen as a result of the #MeToo movement, this fairly simple amendment to Title 9 of the United States Code prohibits private employers from mandating that employees submit to arbitration of sexual assault and sexual harassment claims ...

Hanson Bridgett LLP | April 2022

After over two years of statewide eviction moratoria in the forms of executive orders, Judicial Council rules, and legislation, California's eviction moratorium was scheduled to come to an end on March 31, 2022. However, on March 31, 2022, Lt. Gov. Eleni Kounalakis, serving as acting governor while Governor Gavin Newsom was out of state, signed Assembly Bill 2179 into law, which took effect immediately ...

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