After nine years of deliberation, the Pennsylvania Board of Pharmacy (Board) issued final regulations (effective June 22, 2019) setting new standards for pharmacist compounding of drug products. While the final regulations are substantially less onerous than as originally proposed, the regulations represent the Board’s commitment to ensuring compounding is performed in a safe and reliable manner in Pennsylvania ...
Numerous corporate governance scandals over the past 15 years involving S-chips have tarred these mainland-operating, Singapore-listed companies with the same brush. But do all S-chips deserve their bad reputation?It was meant to be one of the Singapore Exchange’s (SGX) success stories. One of our biggest skincare companies, Best World International saw its profits grow almost 40 fold between 2013 and 2017. It was valued at S$1.8 billion at its peak in February 2019 ...
Beginning July 1, 2019, the Ohio Department of Medicaid (ODM) is requiring all Ohio managed care plans to make room and board payments directly to hospice providers when hospice services are provided to individuals residing at skilled nursing facilities (SNF) ...
Beginning next month, used car dealers in West Virginia may sell vehicles directly to consumers without a single warranty that the vehicles are operational or safe to drive. The so-called “As Is” bill – approved last March by the West Virginia Legislature – will allow merchants to make sales on an “as is” basis, effectively eliminating any implied warranties about a vehicle’s merchantability or fitness for a particular purpose ...
Overruling 38 years of precedent, the NLRB has determined employers have no duty to permit union organizers to use “public space” to solicit union support on their property. UPMC and SEIU, 368 NLRB No. 2 (June 14, 2019). UPMC is a hospital system based in western Pennsylvania. SEIU organizers visited the hospital cafeteria and distributed organizing materials to employees over lunch discussing union organizing activity ...
On June 13, 2019, the Mine Safety and Health Administration (MSHA) announced it had completed its upgrade of its Mine Data Retrieval System (MDRS). Under the new system, mine operators will have new tools to help review compliance with MSHA regulations as well as assessing employment and production records. The upgraded system will also enable mine operators to track accidents, inspections, violation history, and health sampling data ...
While appealing a $4 million verdict on the basis of willful trade dress infringement, a manufacturer admitted to copying the design of a French coffee press. When asked by an appellate judge to confirm that admission, the manufacturer’s attorney confirmed the copying, adding, “So what? It doesn’t matter.” Bodum USA has accused A Top New Casting of infringing its rights in the design of its Chambord coffee press. A jury in the U.S ...
On June 11, 2019, the United States Court of Appeals for the District of Columbia Circuit overturned the 2018 version of MSHA’s workplace examination final rule and ordered the agency to implement the text of the 2017 proposed standard. In United Steel, Paper, and Forestry et al. v. Mine Safety and Health Administration et al., No ...
The Ohio Bureau of Workers’ Compensation will no longer offer coverage for OxyContin by the end of 2019. The agency announced this change, given the drug’s potential for abuse, misuse, addiction, and dependence. The BWC will no longer pay for OxyContin or generic forms of the medication for workers who suffer an industrial injury on or after June 1, 2019. Injured workers who are currently on OxyContin will have until Dec ...
In a short, unpublished opinion, the Ninth Circuit Court of Appeals ruled that an ERISA pension plan administrator should have treated a deceased participant's registered domestic partner as a surviving spouse and granted his claim for survivor benefits ...
The topic of “joint controllers” according to Art. 26 GDPR continues to gain momentum. The State Commissioner for Data Protection and Freedom of Information in Baden-Württemberg (LfDI) has now, for the first time, published a sample of an agreement for joint controllers under Art. 26(1) s. 2 GDPR as well as a sample relating to the fulfillment of obligations to inform the data subjects pursuant to Art. 26(2) s. 2 GDPR ...
The European Commission consistently emphasises the citizens’ rights and status in its hard Brexit preparations and contingency works. It appealed to EU Member Stats to take a generous approach towards the rights of UK citizens in the EU, given that the UK reciprocates such an approach ...
There are hardly any companies that do not use video surveillance systems (CCTV). Such systems record areas such as plant and work facilities or entrance areas. Oftentimes, the video images are not only displayed live on a monitor (“camera-to-monitor system”), but are also recorded automatically for a certain period of time ...
On April 2, 2019, the United States Environmental Protection Agency (EPA) published its proposed “Modernizing Ignitable Liquids Determinations” rule in the Federal Register.[1] Ostensibly, the rule is, as described in its title, an effort to “modernize” – i.e., update – certain aspects of the regulations relating to determining whether a waste is a hazardous waste based on the characteristic of ignitability, which are found in 40 C.F.R. 261 ...
On May 9, 2019, the U.S ...
Brenna K. Legaard is a registered patent attorney with Schwabe, Williamson & Wyatt. Legaard wrote the following op-ed on the use of blockchain technology in health care. When health care professionals and consumers think of blockchain, their minds very likely go to famous cryptocurrencies like Bitcoin. But blockchain technology can be applied to so much more, including to the field of health care ...
On April 23, 2019, the San Francisco Board of Supervisors unanimously approved the Community Opportunity to Purchase Act (COPA), a policy designed to stabilize communities by preventing displacement and preserving affordable housing. The Mayor signed the legislation on May 3, 2019 and it went into effect on June 2, 2019 ...
A few years ago artificial intelligence was a concept applied to nothing else but science fiction films, nowadays, it has become a reality for many companies and industries in the development of their commercial, corporate and industrial activities. Before we start to understand the strengths or weaknesses of artificial intelligence and its perspective from the right of intellectual property, it is considered convenient to conceptualize it ...
On May 24, 2019, the U.S. Department of Health and Human Services (HHS) proposed revisions to regulations issued under Section 1557 of the Affordable Care Act (ACA) (the Proposed Rule). The Proposed Rule would revise certain provisions of the current Section 1557 rule that federal courts have ruled as likely unlawful, and eliminate the requirement that covered entities publish non-discrimination notices and include taglines in foreign languages on all significant publications ...
On May 24, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a new fact sheet providing a compilation of all provisions through which a business associate may be held directly liable with the HIPAA Privacy, Security, Breach Notification, and Enforcement regulations (collectively the HIPAA Rules) ...
Environmental Protection Agency (EPA) has issued a new rule that will impact the operations of a wide-range of health care facilities and the manner in which those facilities manage hazardous waste pharmaceuticals ...
There have been two recent developments regarding the False Claims Act (FCA) which will impact health care organizations that could be subject to a whistleblower lawsuit or FCA investigation. First, on May 7, 2019, the Department of Justice (DOJ) issued formal guidance regarding the manner in which the DOJ would award credits to defendants that cooperate with the DOJ during an FCA investigation (the Policy) ...
On May 10, 2019, the Centers for Medicare & Medicaid Services (CMS) published its final rule, 42 CFR 403, requiring drug manufacturers to disclose the price of prescription drugs in direct to consumer (DTC) advertisements. Publication of the final rule was preceded by a lively comment period that commenced on October 18, 2018 ...
On Monday, the United States Supreme Court held Title VII’s requirement that an employee-plaintiff file an administrative charge with the Equal Employment Opportunity Commission (EEOC) before filing in court is a procedural, not a jurisdictional, requirement. Thus, if a defendant does not timely raise the issue, it can be forfeited. Justice Ruth Bader Ginsburg authored the unanimous opinion of the Court ...
Dinsmore’s Government Relations team was involved in several significant legislative initiatives affecting the health care sector during the 2019 regular session of the West Virginia legislature. Most notably, Dinsmore was involved in the passage of HB 2010, relating to foster care ...
