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INTRODUCTION In a previous issue of Decoded, we discussed the alarming fact that many medical devices, including those implanted in patients' bodies, are leaving the manufacturers with known cybersecurity flaws. Due to these known flaws, these devices are vulnerable to being hacked, and patients’ personal/protected health information ("PHI") stolen; or worse, the device being held hostage in a ransomware attack ...

Asters | August 2022

In July, the Antimonopoly Committee asked the Ministry of Strategic Industries to update the conditions for providing state aid to companies that develop, manufacture, repair, and service aviation equipment and engines. What to update and how, the committee wrote in recently adopted  recommendations .  Asters lawyer  Olena Gadomska told Mind what the latter envisage, why AMCU is resorting to such changes and who they will affect   ...

Heuking | January 2017

The current EU regulations for medical devices and in vitro diagnostics are from the 1990s. The rapid technical developments in the health care system in recent years as well as the increased cross-border trade urgently require a modernization of the current legal framework. Now the adoption of new EU legislation is imminent. This article provides a brief overview of the planned content and the likely entry into force of the Regulations ...

Dykema | March 2020

Introduction The supply chain effects from the global spread of the novel coronavirus have been building for nearly two months, and are expected to reach a peak in the near future (if not necessarily then to recede).[1] The effects have centered on China to date, but the epidemic has spread to other centers of production and the duration of its threat to public health and of the governmental and social measures taken to address its spread remains unknown ...

Carey | January 2023

On January 17, 2023, the Institute of Public Health ("ISP") –by means of Res. Ex. No. 106– approved the Good Manufacturing Practice Guideline for Medical Devices and In Vitro Diagnosis Medical Devices (the "Guideline") ...

Kudun and Partners | June 2021

The rapid spread of Covid-19 has placed the healthcare system in Thailand under severe pressure. Following the outbreak of the pandemic, new startups focusing on telemedicine have sprung up to take on the challenge of innovating the way healthcare services can be provided to patients ...

A trend is emerging with recently filed litigation involving the COVID-19 pandemic. Spilman attorneys are committed to providing information that allows businesses to react as quickly as possible to avert civil litigation threats or to protect your interests through litigation. Monitoring these litigation trends will allow organizations to prepare to defend against such threats in the future or to identify and pursue civil remedies when needed ...

It took thirteen years, four months, and five days of heated debates and passionate protests before the country’s first reproductive health law was passed. Four days shy of Christmas last year, President Aquino finally signed the 24-page bill into law. It is now Republic Act No. 10354 or The Responsible Parenthood and Reproductive Health Act of 2012 (RH Law). The passing of the RH Law, however, does by no means close this chapter of Philippine history ...

Mamo TCV Advocates | September 2022

  While their advent was initially hailed as a revolution for the creative industries, non-fungible tokens (“NFTs”) appear to have lost significant steam over the past months with the Wall Street Journal reporting that NFT sales have dropped by 92% over September 2021 figures ...

Dinsmore & Shohl LLP | December 2023

We’re entering the season of giving. Over the coming weeks, Americans across the nation will gather with family and friends to celebrate the holidays and give selflessly to the people and causes they love. Unfortunately, the Biden administra­tion might be embracing the giving spirit a little too much. Federal officials may soon decide to give away key domestic assets — American intellectual property (IP) — to our rivals ...

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) ...

Shoosmiths LLP | March 2024

Episode 8 of the Journey Through a Contract series highlights the key considerations when a business is entering into a contract with a consumer. This podcast examines the key considerations parties should give to contractual rights and obligations as they flow through a supply chain. A supply chain can consist of a number of different contracts, including those with raw material suppliers and manufacturers at the start, to distributors and customers at the end ...

Dinsmore & Shohl LLP | February 2023

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 ...

For those of us in the dispute resolution world in construction, one cultural trait that is seen with nearly all contractors is a strong sense to do the job right. Most businesses are small, and closely held. And most contractors carry significant pride in their work product and in keeping their clients happy. That character extends not only to work in progress, but also to resolution of issues related to the work after it is complete ...

Two articles (Newsweek and Fierce Biotech) describe the new lawsuit by the Henrietta Lacks Estate surrounding the HeLa cell line. The claim is "unjust enrichment," a difficult claim to win, but one that seems to fit this case, if any does. If you don't know this story, I recommend The Immortal Life of Henrietta Lacks, by Rebecca Skloot. It is the true story of an apparently wonderful woman, Ms ...

Lavery Lawyers | April 2014

On April 1, 2014, the Superior Court issued an interesting decision respecting consent to care1. The Quebec City CHU petitioned the Superior Court in order to be authorized to provide care for a 60‑day period to a patient despite the refusal of her parents. On March 14, the 22 years old patient suffered cardiac arrest following an intravenous drug overdose ...

Haynes and Boone, LLP | June 2017

In recent months, in a unanimous decision authored by Justice Thomas, the Supreme Court issued its much-awaited decision in Sandoz Inc. v. Amgen Inc. et al., No 15-1039, considering two critical questions in the biosimilar approval mechanisms adopted in the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...

Simonsen Vogt Wiig AS | November 2022

On appeal, the trademark infringement was no longer in dispute. Still, the decision has a fundamental interest in the intellectual property legal space. The judgement deals with principal issues related to compensation claims for trademark infringement where the infringement and alleged damage merely relates to a subpart of the infringer’s ads and turnover. Norgesgjerde and Vindex (the original plaintiffs) claimed total damages and compensation in excess of NOK 10 million ...

Haynes and Boone, LLP | March 2015

In an opinion that will certainly cause Texas hospitals, physicians, nursing home operators and other healthcare providers to consider whether they should insert standard arbitration clauses into their pre-treatment agreements, the Texas Supreme Court held last week that the Federal Arbitration Act (“FAA”) preempts the more stringent arbitration requirements set forth in the Texas Medical Liability Act (“TMLA”).The Fredericksburg Care Co., L.P. v. Juanita Perez et al, No. 13-0573, 2015 Tex ...

Since March 2020, the United States and Canada have agreed upon mutually reciprocal COVID-19 related travel restrictions. U.S. and Canadian officials mutually determined that “non-essential” travel between the U.S. and Canada “poses additional risk of transmission and spread of the virus associated with COVID-19 and places the populace of both nations at increased risk of contracting the virus associated with COVID-19 ...

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 ...

Shoosmiths LLP | February 2024

From Dominic Cummings to Nicola Sturgeon, 2023 was a noisy, headline-grabbing year for the UK’s public inquiry into the Covid-19 pandemic. What’s coming in 2024? And what does it mean for businesses? In terms of media exposure, the first full year in the life of the UK’s official Covid-19 Inquiry was a resounding success ...

Shoosmiths LLP | December 2021

On 12 May 2021, Prime Minister Boris Johnson committed to holding a Public Inquiry into COVID-19 that will place "the state's actions under the microscope". Demonstrating that it is independent, objective and fair is fundamental to an Inquiry’s purpose. We take a look at the extent to which the State can effectively examine itself in a Public Inquiry when it has ultimate responsibility for determining the remit, and therefore inevitably the scope of any conclusions ...

Shoosmiths LLP | May 2022

The COVID-19 Public Inquiry presents a key growth area for litigation in the medium to long term. Here, Matthew MacLachlan considers key litigation risks, potential parties and emerging themes ...

Dinsmore & Shohl LLP | October 2018

On September 20, 2018, the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced settlements with three Boston hospitals for disclosing Protected Health Information (PHI) to ABC News documentary filmcrews.[i] In total, the hospitals paid OCR $999,000 to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule ...

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