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 ...
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 ...
This article discusses the recent Insight Paper on Web3 (“Paper”) which was published by the Digital Regulation Cooperation Forum (“DRCF”) on 3 February 2023. It explores the regulatory perspective on the future vision of the internet and what the next steps are for the regulators and interested stakeholders ...
The Digital Markets Act (DMA) – which is underpinned by competition law - allows access to third parties to data previously held only by ‘Gatekeepers’, namely, large digital platforms, such as Google or Facebook ...
17 February, 2023, marks the deadline for providers of online platforms to publish information on the average monthly active recipients of their services in the European Union (EU), as required by the Digital Services Act (Regulation (EU) 2022/2065) (DSA). The DSA defines online platforms as providers of hosting services that publicly disseminate users’ information ...
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 ...
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 ...
The UK government’s 2022 Policy Paper on AI Regulation made no specific reference to generative AI models such as ChatGPT, the chatbot that has been taking the world by storm. Considering the speed at which such AI models are developing, however, and the interest they are attracting, the government may look to consider regulating them more explicitly. In such case, it is unclear whether the government will stick to the principles set out by Liz Truss’s administration ...
The UK’s advertising regulator, the Advertising Standards Authority (ASA), has recently issued a warning to advertisers to ensure that their marketing does not mislead or take advantage of consumers when advertising products as saving money in the cost-of-living crisis ...
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 ...
On April 27, 2022,Republic Act No. 11712, or thePublic Health Emergency Benefits and Allowances for Health Care Workers Act(“RA 11712”), was signed into law in recognition of the critical role of health care workers in providing quality health care and ensuring disease prevention in the general population, especially during the pandemic. It seeks to promote the welfare of health care workers through the grant of mandatory benefits and allowances with utmost efficiency ...
With the decreasing number of positive COVID-19 cases, more employees are now returning to on-site work and new COVID-19 testing protocols are in place. The Inter-Agency Task Force for the Management of Emerging Infectious Diseases (“IATF”) provided guidelines for COVID-19 testing requirements for unvaccinated and partially vaccinated employees through its Resolutions No. 148-B and 149. Also, the National COVID-19 Immunization Program opened to the general public nationwide ...
On September 16, 2022, the DOLE issuedDepartment Order No. 237, series of 2022, or the Revised Implementing Rules and Regulations of Republic Act No. 11165or the Telecommuting Act (“Revised Telecommuting Rules”). New Definitions The Revised Telecommuting Rules clarified the definition of an “alternative workplace” and a “regular workplace” ...
On January 5, 2023, the Federal Trade Commission (“FTC”) issued a Proposed Rule that would prohibit employers from enforcing non-compete agreements against former employees, contractors, and other workers. Dinsmore & Shohl’s Labor and Employment Group’s legal alert on January 5, provides general information about the changes envisaged in the Proposed Rule ...
BigTech has kept information about advertising (who is seeing the adverts, who is clicking on the adverts...) largely in a safe under lock and key. This is about to change and advertising agencies could be a major beneficiary. Advertising agencies likely need to invest in capabilities to analyse huge volumes of data, or engage external advisors to do this work ...
