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 ...
On 29 March 2023, the Ministry of Economy and Finance (“MEF”), in cooperation with the Ministry of Commerce (“MOC”), issued a new regulation regarding the Official Fees for Issuance of Compliance Certificates for Commercial Advertisements on Goods and/or Services in Cambodia (“Prakas 167”) ...
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 ...
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 ...
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 ...
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 ...
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 ...
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”) ...
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 ...
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 ...
On January 30, 2023, the Court of Appeal of Quebec rendered a decision in Commission scolaire De La Jonquière c. Intact Compagnie d?assurance.1 The key issues in this case are the potential for conflicts arising from liability insurance policies and the obligation to disclose documents where insurers? duty to defend conflicts with their duty to indemnify insureds ...
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 ...
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 ...
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 ...
On February 20 of this year, the Public Health Institute (hereinafter "ISP"), approved through Exempt Resolution No. 401/23 the technical guide for the sanitary registration of allergens with the purpose of establishing the guidelines and requirements for the sanitary registration of these products (the "Guide") ...
On February 20 of this year, the Public Health Institute (hereinafter "ISP"), approved through Exempt Resolution No. 405/23 the technical guide on homeopathic products with the purpose of providing the guidelines and requirements for the request of the sanitary registration of these pharmaceutical products in order to provide complete and updated information that supports the quality, safety and efficacy of these products (the "Guide") ...
On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023 ...
Over the past few weeks, the investigation of sexual misconduct cases by the State Medical Board of Ohio (“Board”) has continued to make headlines across Ohio. Due to an increased public outcry as a result of the recent media attention, as well as the previous revelations of the Board’s handling of the Dr ...
