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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 ...

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 ...

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") ...

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 ...

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 ...

Haynes and Boone, LLP | April 2016

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 ...

Dinsmore & Shohl LLP | August 2017

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 ...

Dinsmore & Shohl LLP | June 2018

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 ...

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 ...

Dykema | March 2020

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 ...

ENSafrica | July 2013

Myriad Genetics is known as a leader in the market for diagnostic testing of BRCA1 and BRCA2 gene mutations that have been linked to breast and ovarian cancer.  These same diagnostic tests were recently in the celebrity press, as Angelina Jolie announced she had been tested positive for the mutations, resulting in her electing to have a preventative double mastectomy ...

Social determinants (or drivers) of health (SDOH) can create substantial barriers to an individual’s overall health and wellbeing. For example, several factors associated with economic hardship—lack of transportation, safe housing, or access to nutritious food, etc.—are highly correlated with poor health outcomes ...

Deacons | August 2020

Did you know? The new Trade Marks (Amendment) Ordinance 2020 which came into effect on 19 June 2020 empowers the Registrar of Trade Marks to make the rules for implementing the long-awaited Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks (the “Madrid Protocol”) in Hong Kong ...

Dinsmore & Shohl LLP | August 2023

In its second tranche of major standards reduction, The Joint Commission will eliminate or consolidate 210 accreditation standards across many of its programs. The modification to the affected standards will be effective August 27, 2023. The reduction is part of a major review effort of Joint Commission requirements announced in September of 2022 ...

As we get ready to turn the page to 2022, one hesitates to continue to discuss the COVID-19 pandemic. However, the fallout continues, with fresh ramifications for the long-term care industry. The industry continues to receive heightened scrutiny following the pandemic, and New York's legislative answer to the concerns are set to hit nursing home businesses in New York as of Jan. 1, 2022, with a cap on allowable profits. The impact on capital outlays and acquisitions remains to be seen ...

Shoosmiths LLP | May 2021

The negative impact of COVID-19 across the social and economic spectrum is undeniable. We reflect on the findings from the Social Mobility Commission and consider how employers can help give a much-needed boost to social mobility moving forwards. Research recently published by the Social Mobility Commission has given a snapshot of public perceptions of where and whom the pandemic has impacted most ...

Shoosmiths LLP | June 2021

Our latest article in the series looking at the impact of the pandemic on different groups focuses on how COVID-19 has affected those within ethnic minorities, what this has meant for the BLM movement and what employers can do to better support employees. Impact of COVID-19 The latest statistics all point to the fact that the COVID-19 pandemic has disproportionately affected those within ethnic minorities ...

Governor Mike DeWine signed Ohio House Bill 81 on June 16, 2021, codifying a significant change regarding eligibility for temporary total disability benefits (TTD) under Ohio Revised Code §4123.56(F). By enacting R.C. §4123.56(F), the legislature intended to leave behind decades of case law concerning the doctrine of voluntary abandonment ...

Waller | January 2019

While buzzwords like consolidation and price transparency continue to dominate headlines, major players throughout the healthcare ecosystem are working tirelessly behind the scenes to deploy creative and complex service methods that leverage a smarter, more holistic approach to care. The goal? Control escalating costs and deliver tangible value to patients – all while maintaining a healthy balance sheet ...

Waller | August 2020

Executive summary The COVID-19 pandemic has created significant challenges for smaller hospitals and health systems. It has presented significant challenges to smaller, less capitalized and otherwise distressed healthcare providers. In terms of operating performance, half of our country’s hospitals reported negative margins as Q1 of 2020 ...

Simonsen Vogt Wiig AS | September 2017

Norway has biobanks and health registers that from a world perspective are practically unique. We frequently use metaphors like "silver heirlooms" and "the new oil". The test nevertheless consists in whether the Norwegian research environments are successful in commercializing their research, and the commodities require a correct processing. The Lifandis StoryLifandis AS (former Hunt Biosciences) managed Norway's most valuable biobank and its data; the so-called HUNT collection ...

Shoosmiths LLP | April 2009

A campaign that ran throughout March has been extended into April, and will focus on refurbishment, repair and maintenance works. Statistics show that more than half of workers who died on construction sites in recent years were working on refurbishment projects ...

Waller | December 2020

The Paycheck Protection Program (the “PPP”) was passed into law by Congress as part of the CARES Act earlier this year in response to the COVID-19 pandemic. While considered a relative success at its intended goal of temporarily preserving jobs during the pendency of the pandemic, the PPP ended its initial run with tens of billions of dollars left on the table and frustrated borrowers and lenders because of opaque and frequently changing rules and regulations ...

Dinsmore & Shohl LLP | February 2023

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 ...

As the United States and countries all over the world continue to grapple with the Covid-19 pandemic, the race is on for Covid-19 treatments and vaccines.  There is currently no FDA-approved therapy or vaccine for Covid-19.  Given the profound urgency, life sciences companies and other researchers are prioritizing research and development of potential therapies and vaccines ...

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