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 ...
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 ...
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 ...
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) ...
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 ...
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 ...
With the government’s widely publicised plan to end the sale of new petrol and diesel cars in the UK by the end of the decade comes a secondary issue – the need for an extensive electric vehicle (EV) charging infrastructure to support an exponential increase in the number of EV cars on the road. Rollout of EV chargepoints is significantly behind what is needed to meet the predicted demand from 2030 ...
That’s the question Shoosmiths and Cornwall Insight’s recent report sought to answer, investigating the role the Battery-as-a-Service (BaaS) model could play as part of the UK’s electric vehicle charging network. In a new video, Jonathan Smart, partner and head of mobility at Shoosmiths, discusses the BaaS model, which enables electric vehicle owners and business fleets to swap out depleted batteries for fully charged ones at a service station via a subscription service ...
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
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
“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 ...
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 ...
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 ...
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 ...
Proposal for a regulation of the European Parliament and of the Council on standards of quality and safety Current regulatory framework and scope of application The EU regulatory framework on substances of human origin (“SoHO”) is reflected in Directives 2002/98/EC for blood and 2004/23/EC for tissues and cells ...
On 21st July 2022, the COVID-19 Inquiry was opened. Module 1 will consider the extent to which the risk of a Coronavirus pandemic was properly identified and planned for and whether the UK was ready for that eventuality. In broad terms, the module will look at the UK’s preparedness for whole-system civil emergencies, including resourcing, the system of risk management and pandemic readiness ...
Ohio’s “Heartbeat” Bill became law in Ohio when the U.S. District Court, Southern District of Ohio lifted its long pending injunction after the Supreme Court overturned Roe v. Wade ...
On July 19, 2022, the Court of Claims ordered that the current Improved Workforce Opportunity Wage Act (minimum wage) and Michigan Paid Medical Leave Act (paid leave) are void and reinstated the original ballot initiatives. However, employers do not need to overhaul their policies just yet because the ruling is stayed until February 19, 2023. Pending the outcome of appeal, these changes may not go into effect at all ...
As we discussed in a prior update, on July 13, 2022, Plaintiff Christian Buckner filed a lawsuit in the Federal District Court in Tampa, Florida, seeking to enjoin the Infrastructure Investment and Jobs Act’s set-aside of 10% (around $37 billion) of transportation funding for “small business concerns” owned and controlled by “socially and economically disadvantaged individuals ...
