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 ...
The Republic of the Union of Myanmar intends to promote foreign investments in the electric vehicle sector in Myanmar by means of a mix of legal and policy initiatives aimed at incentivizing such investments. For the purpose of this article we have considered the year 2022 as the most critical year for legal regulations on electric vehicles (“EVs“) and have pivoted our discussion on legal developments prior to, during and after 2022” ...
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 ...
Recent months have seen sustained industrial action in the rail sector. On 20 February 2023, the government launched a 12-week consultation on setting minimum service levels for passenger rail. Unlike in many European countries, there are currently no limits in the UK on the number of employees who are able to take part in strike action together ...
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") ...
There are so many things to celebrate following the news announcement earlier this week that GWR had purchased Vivarail’s assets following it having sadly entered into administration at the end of last year. Naturally the saving of a number of jobs is great to hear but in addition the protection of the highly innovative technology which will ultimately help to support the introduction of battery powered trains onto our network has to be a good thing ...
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 ...
On the occasion of Children’s Day on January 12, 2023, Kudun and Partners launched an internal donation drive on January 12 to rally firm members to support children’s centers in Bangkok and Hat Yai. The donation drive was initiated as part of the firm’s continuous aspiration to contribute back the society ...
Buoyed by consumer demand and legislative support, respondents to Dykema’s 2023 Automotive Trends survey enter the year in a period of cautious innovation. After analyzing survey responses, the firm's 2023 Automotive Trends Report compiles insights from key decision-makers to understand what trends will have the greatest impact on the automotive industry in the following year and beyond ...
On December 2, 2022, President Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act (“Marijuana Research Act” or “Act”) into law. The Act aims to help facilitate research on marijuana, directs the Drug Enforcement Administration (DEA) to follow new procedures to register practitioners to conduct marijuana research, and improves the supply of marijuana for research ...
Texas is increasingly a purple political state. The motto of the state's capital city implores its citizens to keep it weird.[1] Recent polling shows that Texans overwhelmingly support medical cannabis.[2] Every one of Texas' neighboring states has a real medical cannabis program ...
The recently published project of the National Development Plan (“PND”) 2022-2026 “Colombia World Power of Life” embodies the objectives, goals and priorities of the National Government for the next four years. In the PND, the National Government introduces rules or regulations that would make it easier to achieve the objectives pursued ...
On February 1, the Federal Trade Commission (“FTC”) announced enforcement action for the first time under its Health Breach Notification Rule[1]. The complaint against telehealth and prescription drug discount provider GoodRx Holdings Inc. (“GoodRx”), alleges its failure to notify consumers and others of its unauthorized disclosures of consumers’ personal health information to Facebook, Google and other companies ...
On Tuesday 7 February 2023, the Transport Secretary, Rt Hon Mark Harper, laid out his commitment to the rail industry for the first time during the George Bradshaw address. As it stands it was a huge night for rail, with the sector desperate for some clarity over what the next steps are in relation to a number of things ranging from the establishment of Great British Railways (GBR) through to where it will be based and visibility of work pipelines ...
The Department of Justice (“DOJ”) withdrew three longstanding healthcare antitrust enforcement policy statements on the afternoon of Friday, February 3, 2023. The move follows a series of White House antitrust initiatives ...
At the end of 2022, the Centers for Medicare and Medicaid (“CMS”) issued a proposed rule that would amend the standard imposed on Medicare providers to report and return overpayments. If finalized, the proposed rule would replace the 60-day overpayment rule’s current “reasonable diligence” standard with the False Claims Act “knowingly” standard ...
As reported by various news outlets, the State Medical Board of Ohio (“Board”) has, and will continue, to ramp up investigations and enforcement actions related to alleged violations of ethical and professional guidelines. In particular, professional boundaries and sexual misconduct issues will be a primary focus for the Board, as it has been since the revelations of the Dr. Richard Strauss case became public ...
This week marks Children's Mental Health Week (6-12 February 2023). The focus on mental health has been increasing in recent years, with one in six children aged between five and 16 likely to have experienced mental health challenges. As a result, there are a growing number of workdays lost by parents, guardians, carers, and those with childcare responsibilities, to support and manage such challenges ...
On January 1, 2023, the Ohio Board of Nursing joined the multi-state Nurse Licensure Compact (“NLC”), allowing nurses who hold an Ohio nursing license to apply for a multi-state license. Ohio has joined at least 37 other states that participate in the multi-state license ...
As previously discussed in our January 5, 2023 legal alert, the Pennsylvania Department of Human Services (“Pennsylvania DHS”) issued a Medical Assistance Bulletin (the “Bulletin”) in late December, 2022 that had the potential to put 340B savings at risk in Pennsylvania ...
