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Buchalter | December 2022

December 2, 2022 By: Anna G. Thomas To increase transparency regarding payments to physicians by drug and medical device companies, Governor Newsom signed AB 1278, which imposes certain additional disclosure obligations on physicians.  Beginning on January 1, 2023, physicians will be required to comply with new patient notice and posting requirements. Notice to Patients Under this law, physicians must provide to patients an Open Payments database notice ...

Dinsmore & Shohl LLP | November 2022

On November 15, 2022, Governor Andy Beshear announced two executive orders related to cannabis in Kentucky. The first executive order allows certain individual Kentuckians and their caregivers to bring and use medical marijuana into the state without facing legal consequences beginning January 1, 2023, so long as they meet a set of three criteria ...

Shoosmiths LLP | November 2022

The UK Covid-19 Inquiry (“the Inquiry”) opened its third Module on 8 November 2022, along with the application process for Core Participant (“CP”) status. Module 3 will consider the impact of the Covid-19 pandemic on the healthcare sector in England, Wales, Scotland and Northern Ireland ...

Han Kun Law Offices | November 2022

As the regulation system on human genetic resources ("HGR"), biosecurity and laboratory animals is experiencing continuous improvement, enforcement actions of the Ministry of Science and Technology ("the MOST") have become more active and tight in recent years ...

Han Kun Law Offices | November 2022

Fast-growing e-commerce has changed lifestyles and invented new ways of consumption, amid which demand has rapidly increased for Internet-based medical services such as online drug sales and online medical diagnosis.  Since the regulation and promotion of "Internet-based healthcare services" was included as part of the Outline of the "Healthy China 2030" Plan, China's Internet healthcare industry has been flourishing, channeled by a series of favorable policy decisions ...

Han Kun Law Offices | November 2022

Since 2013, the National Medical Products Administration ("NMPA")Center for Drug Evaluation("CDE")has been releasing a Drug Review Annual Report ("Report")each year, which summarizes its work on drug review of the previous year ...

Shoosmiths LLP | November 2022

How can an employment disciplinary investigation findings determine fitness and propriety? Senior Managers & Certification Regime (SM&CR) firms are under a duty to consider fitness and propriety on an ongoing basis ...

Makarim & Taira S. | November 2022

The Indonesian Minister of Health has issued Minister of Health Regulation No. 24 of 2022 on Medical Records (“MOH 24/2022”), under which the MOH requires all healthcare facilities to keep electronic medical records. MOH 24/2022 allows, among other things, cooperation between a healthcare facility and a third-party electronic organizer and covers who may have access to electronic medical records ...

Han Kun Law Offices | November 2022

On October 26, 2022, the National Medical Products Administration ("NMPA") issued the newly revised Measures for the Administration of Drug Recalls ("the 2022 Measures") that has just been formally adopted. The former Measures for the Administration of Drug Recalls ("the 2007 Measures") was issued and implemented on December 10, 2007 ...

Mamo TCV Advocates | October 2022

  October is Breast Cancer Awareness Month, an annual campaign to raise awareness about the impact of breast cancer and to raise funds for research into its cause, prevention, diagnosis, treatment and cure. The firm held an event last week at its offices with staff in order to raise awareness about breast cancer and to raise funds for the cause. The firm is once again making a contribution to the Action for Breast Cancer Foundation ...

Shoosmiths LLP | October 2022

On 13 October 2022, Shoosmiths hosted a webinar on the UK Covid-19 Inquiry (the ‘Inquiry’). The webinar took a closer look at the structure and progress of the Inquiry, alongside the commercial and legal considerations that any potential witness or party should be aware of, including the role of a Core Participant (‘CP’). The webinar was hosted by Paul Eccles (Partner) and included talks by Alex Friston (Associate) and Charles Arrand (Partner) ...

Dinsmore & Shohl LLP | October 2022

In February of 2022, during his State of the Union Address, President Biden announced an action plan to improve the safety and quality of care in the nation’s nursing homes.[i] On October 21, 2022, Centers for Medicare and Medicaid Services (CMS) announced new requirements to help with oversight of facilities selected to the Special Focus Facilities (SFF) Program ...

Kudun and Partners | October 2022

On the occasion of Breast Cancer Awareness Month 2022, our firm organized a photo-taking session on Friday, October 21 at 3 pm. This session is a part of a global effort to raise awareness about breast cancer, one of the world’s most prevalent types of cancer. Often times, the disease has been overlooked by males. However, breast cancer can affect both men and women ...

On December 7, 2021, in Georgia v. Biden, Case No. 1:21-cv-163, a federal district court judge in the U.S. District Court for the Southern District of Georgia issued a preliminary injunction enjoining enforcement of the COVID-19 vaccine mandate for federal contractors and subcontractors in all covered contracts in any state or territory of the United States. This injunction was nationwide applied to all federal contractors ...

Buchalter | October 2022

October 12, 2022 By: Michael Flynn On September 27, 2022, the Consumer Financial Protection Bureau (CFPB) issued a Request for Information Regarding Mortgage Refinances and Forbearances. The Request indicates that the CFPB is considering making the COVID emergency relief foreclosure/loss mitigation requirements a permanent requirement for mortgage lenders and servicers when dealing with temporarily distressed borrowers ...

PLMJ | October 2022

In June 2022, at one of the annual meetings of the Employment, Social Policy, Health and Consumer Affairs (“EPSCO”) Council, health ministers expressed their concerns regarding the legislative transition to Regulation (EU) No 2017/745 of the European Parliament and of the European Council of 5 April 2017 on medical devices (“MDR”) and to Regulation 2017/746 of the European Parliament and of the European Council of 5 April 2017 on in vitro diagnostic medical devi

Schwabe, Williamson & Wyatt | September 2022

During the COVID-19 pandemic, questions about employee health-privacy-related symptoms, testing, and vaccination became prevalent in discussions about the workplace at all levels—from “the water cooler” to national news ...

Hanson Bridgett LLP | September 2022

Key Points AB 890 gave Nurse Practitioners who meet certain requirements authority to practice more independently. The bill created two categories of Nurse Practitioner—one that may perform delineated functions without the use of standardized procedures in certain clinical settings where physicians and surgeons practice and another that may perform these functions and more outside of such clinical settings ...

Kudun and Partners | September 2022

On September 23, Kudun and Partners were invited by TrustLaw, the charitable arm of Thomson Reuters, to be the legal experts in their Legal Health Check Workshop. The core objective of the event was to raise awareness of how law firms, like Kudun and Partners, can work with TrustLaw to provide pro bono legal services to NGOs, Civil Society Organizations (CSOs) and social enterprises (SEs). Chai Lertvittayachaikul and Emi Rowse (Igusa), partners of Kudun and Partners, presented at the event ...

PLMJ | September 2022

Acquisition of intended exclusively for the production of parenteral bags INFARMED - the Portuguese National Authority for Medicines and Healthcare Products  (“Infarmed”) has recently adopted Decision 089/CD/2022, concerning the regulatory framework for the acquisition of medicines without a national Marketing Authorisation (“AIM”), intended exclusively for the production of parenteral bags ...

PLMJ | September 2022

Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use introduced additional requirements for the labelling of investigational and auxiliary medicinal products, in particular, for unauthorised medicinal products, in order to eliminate divergences in approach among Member States ...

Dinsmore & Shohl LLP | September 2022

“Government efforts to manipulate markets and prices on consumer goods never work as intended, and in this case, would be counterproductive.” The waning days of summer signal the approaching midterm election season. Amid inflation, recession and voter discontent, it’s understandable that a group of congress members are anxious to put points on the board with a price-control scheme that they wrongly believe will lower prescription drug prices ...

Shoosmiths LLP | September 2022

On 31 August 2022, the UK COVID-19 Inquiry (“the Inquiry”) opened its second Module. Module 2 will examine the political and administrative decision making of the UK and devolved governments, with a particular focus on early 2020 ...

Shoosmiths LLP | August 2022

With regulations imposing mandatory vaccination for certain workers in the care sector being implemented to those same regulations being revoked some four months later, employers in this sector may well be confused as to what options are available to them ...

Dinsmore & Shohl LLP | August 2022

As all court cases do, the Supreme Court's landmark decision in West Virginia v. EPA last month addressed a specific question: whether the Environmental Protection Agency had the statutory authority to shut down power plants and reshape significant parts of the energy sector in its effort to reduce emissions. The answer was a plain and simple no. Equally clear was the court's argument, which has implications for administrative actions well beyond this case ...

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