On March 3, 2020, Attorney General William Barr announced the National Nursing Home Initiative—a new U.S. Department of Justice (“DOJ”) taskforce organized to push criminal and civil enforcement action against nursing homes across the country. The initiative will help coordinate DOJ enforcement actions against nursing homes that provide “grossly substandard care ...
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 ...
In 2016, West Virginia had the highest death rate in the country from drug overdoses—primarily caused by opioids—at 52.0 for every 100,000 people.[1] The state was on track to exceed that number in 2017.[2] Seeking to enact policies that not only curb but reverse this upward trend, the West Virginia Legislature introduced a number of bills during the 2018 Regular Legislative Session that sought to address this disturbing epidemic. One of these, S.B ...
Few medical issues are as significant to an employee and an employer as major back surgery. The procedure incapacitates the injured worker for months and leaves the employer short staffed while the employee recovers. Additionally, these surgeries often do not result in the expected outcome, which leads to further impairment and expense ...
On April 18, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued revised guidance regarding exclusions imposed under section 1128(b)(7) of the Social Security Act ...
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 ...
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 ...
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 ...
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 ...
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 ...
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) ...
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 ...
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 ...
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 ...
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”) ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Individuals who participated in the Centers for Medicare and Medicaid (“CMS”) Quality Payment Program Merit-based Incentive Payment System (“MIPS”) in 2019 may request a Targeted Review of their performance feedback, including their MIPS final score and payment adjustment factor at the Quality Payment Program website. In July, CMS released the MIPS Performance Feedback and scores for eligible providers ...
Medical Cannabis approvals in the City have been the subject of intense negotiations, hearings, and appeals in the last two months. First, our law firm assisted the Apothecarium - Sunset (an additional location in the Sunset District for the medical cannabis dispensary called The Apothecarium currently near the Castro), in obtaining an approval at the Planning Commission ...
