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Shoosmiths LLP | May 2023

The Chartered Institute of Personnel and Development (CIPD) has issued a report which provides guidance on supporting employees who are experiencing fertility issues. The report surveyed 300 workers who experienced difficulties with fertility while in employment within the last five years, as well as over 2,000 senior HR professionals and decision makers ...

Han Kun Law Offices | May 2023

In recent years, China is continuously exploring the regulations of LDT (Laboratory Developed Tests, as defined below). With the introduction of a series of new regulations, many outstanding multinational and local companies have participated in the research of LDT. At this stage, general provisions can no longer meet the demand of the practice of LDT industry ...

Shoosmiths LLP | May 2023

As highlighted in our previous article, the Infected Blood Inquiry’s first interim report established considerable liabilities in relatively short order, recommending that £100,000 be paid “without delay” to victims and partners bereaved by infections transmitted by blood transfusions and blood products. Sir Brian Langstaff, former High Court judge and current Chair of the Infected Blood Inquiry, released his second interim report on 5 April 2023 ...

Buchalter | May 2023

May 15, 2023 By: Meghna Parikh The expiration of the COVID-19 Public Health Emergency (“PHE”) on May 11, 2023 could have created a “prescription cliff” leaving patients without access to controlled substances. During the PHE, telemedicine flexibilities allowed patients to have access to Schedule II and narcotic controlled substances via telemedicine without a prior in-person medical evaluation ...

The end of the COVID-19 public health emergency on May 11, 2023 has left many healthcare facilities confused about whether the vaccination mandate for Centers of Medicare and Medicaid Services (“CMS”) certified healthcare facilities still stands ...

ALTIUS/Tiberghien | May 2023

The EU regulator has harmonized the maximum levels for tetrahydrocannabinol (THC) in hemp seeds throughout the Union within the food contaminants framework. This EU harmonization puts pressure on conservative national food laws such as the Belgian Royal Decree of 31 August 2021, which treats hemp seeds as a prohibited food.The situation in Belgium, however, is changing to better align it with EU law ...

Shoosmiths LLP | May 2023

The Pensions Regulator's General Code could be published any day now, but what is it, and why has it been so delayed? Back in March Charles Counsell, then CEO of the Pensions Regulator (TPR) confirmed in an interview with Pensions Age Magazine that the long anticipated consolidated code of practice would be published in the spring, under the new title of the “General Code” ...

Carey | May 2023

On April 21st, 2023, the Public Health Institute ("ISP") issued Exempt Resolution No. 1020, which approves the "Technical Guidelines on recommendations for the labeling of cosmetic products" (the "Guide”) ...

Ohio lawmakers are considering a bill – House Bill 89 – that would bar medical, nursing, and other medical-professional students from performing pelvic, prostate, or rectal exams on anesthetized or otherwise unconscious patients without prior approval.[1] Intimate exams are used in clinical rotations as an opportunity for training, but opposition to the practice involving unconscious and uninformed patients has grown in recent years ...

Following the passage of House Bill 122 last year, the State Medical Board of Ohio (“Ohio Board”) has released final administrative rules governing the provision of telehealth services by Ohio physicians and certain other provider types.[i]  The final rules, which became effective February 28, 2023, continue the recent trend of regulators, such as the Drug Enforcement Agency,[ii] largely reverting back to pre-pandemic telehealth restrictions ...

Dinsmore & Shohl LLP | April 2023

The U.S. Department of Health and Human Service’s Office of Civil Rights (“OCR”) has announced that several notifications of enforcement discretion issued during the COVID-19 public health emergency (“PHE”) will expire concurrently with the expiration of the PHE on May 11, 2023 at 11:59 PM ...

Dinsmore & Shohl LLP | April 2023

Ohio legislators are once again attempting to transform the state’s medical marijuana control program after a similar effort stalled out last year. Proponents of the proposed legislation, Senate Bill 9, seek to expand medical marijuana access to Ohioans and revamp the structure of the current program. The proposal would establish the Division of Marijuana Control (“DMC”) under the Department of Commerce ...

Shoosmiths LLP | April 2023

Part of the fall-out of the COVID-19 pandemic is the condition labelled ‘long-covid’. This is still a relatively new condition that remains under study, but symptoms include extreme tiredness, shortness of breath, loss of smell and muscle aches. Some people experience further complications and suffer memory problems known as ‘brain fog,’ difficulty sleeping, dizziness, depression and anxiety ...

With the COVID-19 Public Health Emergency (PHE) set to end on May 11, 2023, federal agencies have published FAQs explaining how the end of the PHE will affect previously extended deadlines relating to COBRA, HIPAA special enrollment, and claims and appeals under group health plans. This article provides (i) a recap of the deadlines, (ii) rules of thumb for determining the deadlines, and (iii) tables more specifically addressing some of the most common deadlines that arise ...

Buchalter | April 2023

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 ...

Dinsmore & Shohl LLP | April 2023

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 ...

Dinsmore & Shohl LLP | April 2023

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 ...

Shoosmiths LLP | April 2023

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 ...

Dinsmore & Shohl LLP | March 2023

The Department of Health and Human Resources (“DHHR”) was West Virginia’s largest executive agency until the Legislature passed House Bill 2006 earlier this month. For several years now, West Virginia lawmakers have been looking into how to handle the enormous agency, improve its function and oversight, and improve the management of the wide range of health and social programs administered by the DHHR. With an annual budget topping $7 ...

On March 8, 2023, the Oregon Senate passed Senate Bill 592, which, if passed by the House and signed by the governor, would significantly increase the penalty amounts that the Oregon Occupational Safety and Health Division (Oregon OSHA) could impose on an employer for workplace safety violations. In addition, SB 592 would require Oregon OSHA to conduct comprehensive inspections of a workplace under specific circumstances, greatly expanding the number of inspections that an employer could face ...

Dinsmore & Shohl LLP | March 2023

Prepare for another big shift in health care operations. On January 30, 2023, President Joe Biden announced he would not extend the COVID-19 Public Health Emergency (PHE) beyond its current expiration date of May 11. The PHE was declared by former President Donald Trump in March of 2020 as COVID-19 began to spread around the nation. The waivers and other regulatory changes instituted in its wake have impacted nearly every facet of health care services ...

Carey | March 2023

Chapter 8: Technical Barriers to Trade This chapter provides rules to facilitate trade by eliminating unnecessary technical barriers, improving transparency, and promoting greater regulatory cooperation. It applies to the elaboration, approval and application of technical regulations, standards, conformity assessment procedures and trade authorization for pharmaceuticals, cosmetics and medical devices ...

ALRUD Law Firm | March 2023

Dear Readers, ALRUD Regulatory practice has prepared a new version of our regulatory Guides. This Guide is devoted to an overview of key changes and trends that took place in 2022. The review was published with the participation of ALRUD experts - Maxim Alekseev, Senior Partner and Head of ALRUD Regulatory practice,Dina Kravchenko, Senior Associate, andBoris Pribylov, Senior Associate. Follow the link below to learn more ...

Nearly 106,000 Americans are currently on waiting lists for donor organs and 17 die each day while waiting. The holy grail for rising to meet this demand and end this suffering will be the ability to “print” the organs, muscles, and tissues from individually grown cells, lowering the need for human donors and the complicated and sometimes unbearable stress that goes along with donor wait lines ...

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