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
The July 2017 issue of the Asian Legal Business (ALB) includes a Philippine regional update by SyCipLaw partner Hiyasmin H. Lapitan and associate Jo Margarette W. Remollo entitled, “Guidelines on Related Party Transactions for Insurers in the Philippines”. The article summarizes the Insurance Commission’s compliance guidelines on related party transactions, as set out in Insurance Circular Letter No. 2017-29 ...
Barry Buchman, Adrian Azer and Greg Van Houten have joined Haynes and Boone, LLP’s Washington, D.C. office in the Insurance Recovery Practice, expanding the group’s presence coast-to-coast. Partner Barry Buchman brings more than 20 years of experience and looks forward to helping the practice flourish in Washington, D.C., and the East Coast ...
Should States Embrace Telehealth Parity? Parity in telehealth is the notion that health services provided via telehealth technology should be treated equally as health services provided face-to-face. This is consistent with coverage parity, which requires payors to provide the same level of insurance coverage for patient encounters and services, while payment parity (a.k.a ...
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was reevaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities.The bills reawakened a debate about the pros and cons of POHs ...
Regulators Expand Opportunities for Telehealth Services Under COVID-19 Shadow By: Phil Kim, Kayla Cristales, and Jennifer Kreick As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services ...
In this report, you will find a summary of two important decrees published yesterday in the Official Gazette. Regulatory Decree of Law No. 27,350 of medical and scientific research on the medicinal use of the cannabis plant and its derivatives By means of Executive Branch’s Decree No ...
The U.S ...
On November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...
On Friday, March 13, 2020, the Department of Health and Human Services (HHS) announced several waivers of existing Centers for Medicare and Medicaid (CMS) regulations pursuant to Section 1135(b) of the Social Security Act, including the waiver of certain Emergency Medical Treatment and Active Labor Act (EMTALA) obligations and Medicare conditions of participation during the COVID-19 pandemic ...
The Quebec Court of Appeal confirmed the Superior Court’s decision, which dismissed the insured’s action in warranty against his liability insurer under his home owner’s policy. The insured alleged that the purchasers’ claim for reducing the purchase price due to a hidden defect was covered under the liability insurance policy. The Facts In April 2005, Plaintiffs, Bérubé and Marcil, purchased Johnston’s residence ...
On June 2, 2010, the Quebec Court of Appeal confirmed the Superior Court’s decision (per Justice Gill es Hébert), which dismissed the insured’s action in warranty against his liability insurer under his home owner’s policy. The insured all eged that the purchasers’ cl aim for reducing the purchase price due to a hidden defect was covered under the liability insurance policy.(1)THE FACTSIn April 2005, Plaintiffs, Bérubé and Marcil, purchased Johnston’s residence ...
On June 1, 2023, China's Ministry of Science and Technology ("MOST") officially released the Implementation Rules for the Regulation of Human Genetic Resources Administration ("Implementation Rules"), which will come into effect on July 1, 2023 ...
China began legislating the protection of human genetic resources in 1998, at which time the Ministry of Science and Technology (MOST) and the Ministry of Health jointly formulated the Interim Measures for Administration of Human Genetic Resources; however, there had been no corresponding implementing rules to implement it in practice ...
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 ...
Amidst continuing COVID-19 concerns, regulators issued certain waivers of HIPAA requirements and penalties as well as additional guidance applicable during this public health emergency. HIPAA Enforcement Discretion for Telehealth ...
With the Universal Community Testing Programme for COVID-19 detection by the Hong Kong Government and temperature screening in the workplace, the collection and use of biometric data (such as DNA samples, fingerprints and facial images) have raised concerns among the public. In August 2020, the Privacy Commissioner (PC) has updated its guidance note on how data users should collect and use biometric data in compliance with the Personal Data (Privacy) Ordinance (Guidance Note) ...
IN FEBRUARY AND MARCH 2010, THE SUPERIOR COURT RENDERED TWO INTERESTING DECISIONS IN CASES INVOLVING FIRES. WE WILL REVIEW THESE DECISIONS , WHICH HAVE A NUMBER OF FEATURES IN COMMON, INCLUDING THE CONSIDERABLE SUMS OF MONEY AT STAKE, THE LENGTHY TIME PERIOD BETWEEN THE LOSS AND THE TRIAL, AND THE NUMBER OF PERSONS INVOLVED IN THE CONDUCT OF EACH CASE.THE GOODFELLOW CASE: “THE DORMANT FIRE ”On August 22, 1998, a major fire broke out in Goodfellow Inc ...
An increasing number of captives have been looking at writing business interruption coverage for their owners. They should tread carefully, as doing so without following the correct procedures could have adverse tax implications. The outbreak of COVID-19 has caught many businesses off guard and in need of cash. Some hope their business interruption insurance policies will provide coverage for a loss of income suffered from a slowdown or suspension of operations ...
Commentators and lawyers continue to make blanket statements regarding lack of business interruption coverage for losses caused by the novel coronavirus (COVID-19). They contend that coronavirus-related losses cannot satisfy the “direct physical loss of or damage to [covered] property” language contained in many policies to trigger coverage in the first place ...
Although Hurricane Lane’s substantial weakening from a Category 5 storm as it approached land likely spared Hawaii a disaster, the storm still caused much harm. Areas of the Big Island got inundated with well over three feet of rain, causing landslides and major road closures, and high winds stoked brush fires on Maui, burning 2,300 acres of land, damaging multiple homes, and forcing hundreds of evacuations ...
In Haberdashers’ Aske’s Federation Trust Ltd v Lakehouse Contracts Ltd [2018] EWHC 558 (TCC), England’s Technology and Construction Court had to decide on the extent of coverage (or inclusion) of a project insurance policy for a construction project and how that coverage was affected by a sub-contractor having its own insurance cover ...
The deadline for meeting the previously issued nursing home compliance mandate is approaching. The Centers for Medicare & Medicaid Services (CMS) issued the mandate in 2016 and gave facilities three years to become compliant. On November 28, 2019, skilled nursing facilities (SNF) and nursing homes will be required to adopt and implement a compliance program as a condition for participation in Medicare and Medicaid ...
