At a news conference on April 20, Governor Wolf announced he is extending his stay-at-home order until May 8, 2020. But in a nod to a construction industry that has been particularly hard-hit by the Governor’s shutdown and stay-at-home orders, Governor Wolf said he also will permit construction (both residential and non-residential construction) to resume throughout the Commonwealth on May 8, 2020 ...
On December 11, 2018, Pennsylvania Auditor General Eugene A. Depasquale released a long-awaited report discussing the role of pharmacy benefit managers (PBMs) in Pennsylvania’s health care system ...
Several years ago the U.S. Centers for Medicare and Medicaid Services (CMS) required skilled nursing facilities (SNFs) to report nurse staffing levels using the SNF’s payroll records, in an effort to obtain more accurate information about actual daily nurse presence in SNFs. CMS has collected this Payroll Based Journal (PBJ) information for a few quarters now ...
The U.S. Centers for Medicare and Medicaid Services (CMS) issued a final rule redesigning the Medicare Accountable Care Organization (ACO) program via a new Pathways to Success ACO model. [1]See83 FR 67816 (Dec. 31, 2018). CMS stated five goals for this redesign: ACO Accountability, Competition, Engagement, Integrity, and Quality ...
Patents offer useful services. With them, the holder can prevent competitors from offering products using the patented technology. In addition to the rights that a patent holder has had up until now (injunction, disclosure, indemnification), now a fourth right is joining in on the action and is continuously gaining in significance. This right involves the right to inspection. It is especially important in the case of process patents and at trade shows ...
Resolution number 217/2018 was published in the Brazilian PTO’s Official Bulletin number 2470, and amends Resolution number 80/2013, which refers to the fast-track examination for patent applications related to products, pharmaceutical processes, equipment and materials related to public health, aiming to accelerate patent applications considered strategic to the Brazilian Public Healthcare System ...
The impact on human health of the global pandemic of the SARS-CoV-2 virus and the resulting disease termed COVID-19 cannot be overstated. Not since the influenza pandemic of 1918 have so many regions of the world been so acutely impacted by a single pathogen. Society in 2020 has the advantage of a more sophisticated biotechnology industry. Testing is considered crucial in controlling (or at least mitigating) the pandemic, and tests from several companies have become widely available ...
The world is in an upheaval now with the pandemic raging for over a year. The discussions and decisions that probably would never have been made a few years ago are being made today in the interest of the greater good and the public at large. When Bill Gates expressed his reservations against lifting IP protection on vaccine patents, it left the world reeling and his comments understandably criticised by experts and laymen alike ...
There were two recent decisions – one in the USA and one in the UK – which dealt with the important but seldom-discussed concept of patent exhaustion. Patent exhaustion in essence means this: the initial authorised sale of a patented item terminates all patent rights to that item, for the reason that the owner of the patent (the patentee) has been rewarded for its ingenuity by that sale ...
Packaging and packaging waste has been regulated by the European Union (“EU”) since 1994. As consumers, we all know that most goods are sold in packaging, and that there may be various packaging at the several stages of the product’s life. Packaging comes in a diversity of material (glass, paper, cardboard, metal, plastics, wood, corks, textile, ceramics or porcelain…) and items (cans, tubes, boxes, films and bags) ...
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 ...
There was a bit of a stir in the British press recently, with certain companies complaining that the major UK supermarket chains are now using get-ups for their own-label products that are so similar to the get-ups used by the major brand owners that consumer confusion is inevitable. An industry spokesman said this: ‘Our research shows that consumers are more likely to buy own-label products if they look like brands ...
Supreme Court resolves Circuit split by setting forth standard that owners of famous trademarks must prove “actual dilution” as opposed to “likelihood of dilution” in order to prevail on a Federal Trademark Dilution Act (FTDA) claim.The Supreme Court handed down its decision in the Moseley dba Victor’s Little Secret v ...
Introduction: On March 4, 2003, the United States Supreme Court issued its unanimous decision, written by Justice John Paul Stevens, regarding the Federal Trademark Dilution Act (“FTDA”) ...
China's National Medical Products Administration (NMPA) released the 2023 Drug Review Annual Report on its official website on February 4, 2024, closely followed by the 2023 Medical Device Registration Annual Report on February 5. According to the public information, more than 60 innovative drugs have been approved by NMPA from 2022 to 2023, and a total of 61 innovative medical devices have been approved in 2023 ...
Introduction By: David Balfour The Medical Board of California investigates physicians for potential violations of the Medical Practice Act. If an investigation results in findings of violations, the Board will refer the case to the Attorney General’s Office recommending the filing of an Accusation seeking disciplinary action against the physician’s license ...
Since 2013, the National Medical Products Administration ("NMPA")Center for Drug Evaluation("CDE")has been releasing a Drug Review Annual Report ("Report")each year, which summarizes its work on drug review of the previous year ...
The Occupational Safety and Health Administration (“OSHA”) issued a final rule to “Improve Tracking of Workplace Injuries and Illnesses, “ which requires employers to electronically submit their injury and illness records to OSHA. Specifically, establishments with 250 or more employees must annually submit their Forms 300, 300A, and 301. And, establishments with 20 to 249 employees must annually submit their Form 300A ...
Last week, the Occupational Safety and Health Administration (OSHA) issued a COVID-19 Emergency Temporary Standard (ETS) for employers only in the health care sector in response to President Joe Biden’s January Executive Order on Protecting Worker Health and Safety. The ETS becomes effective on the date it is published in the Federal Register, which is yet to be determined. In addition, OSHA promulgated new non-binding guidance for employers in all other sectors ...
Dubai is the fastest growing healthcare market within the GCC and is becoming an increasingly attractive sector for investors. In this inBrief article we explain the key drivers behind this growth and set out the options available to investors wishing to enter the Dubai healthcare market ...
Summary Proposed FASTER Act defines sesame as a major allergen under the Federal Food, Drug and Cosmetic Act; FDA Draft Guidance recommends the declaration of sesame as an ingredient in flavors and spices. Although non-binding, these actions foreshadow the regulation of sesame as a major food allergen in the future. Two recent legislative actions and an FDA publication address emerging concerns about sesame as an allergen. 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 ...
