Key Points Governor Newsom vetoed AB 339. AB 361 will continue to operate as currently construed. On October 7, 2021, Governor Newsom vetoed Assembly Bill (AB) 339 (Lee), a bill aimed at addressing Brown Act teleconferencing requirements for large public entities. AB 339 sought to add special rules for meetings of city councils or county board of supervisors that govern jurisdictions containing at least 250,000 people ...
The U.S. Department of Health and Human Services, the U.S. Department of Labor and the U.S. Department of Treasury have released another set of interim final regulations (the “IFR”) regarding the coverage of preventive care without cost sharing. As with all guidance, the IFR cannot be considered in isolation ...
Trademark owners with registrations in EU where the UK is designated should soon receive notification for treatment of registrations and applications following the Brexit transition period. The Brexit transitional period, during which EU laws and rights have continued in force in the UK, will end on December 31, 2020. Thereafter, EU Trade Mark and Design applications and registrations (and designations of the EU) will only cover the remaining 27 EU member states ...
This is the first in our series of articles in which we will look at how Brexit and the EU-UK trade deal impacts research and development. In July 2020, the Government published its Research and Development Roadmap, which sets out the UK’s ambitious long-term objectives for investment in science and research to deliver economic growth and societal benefits across the UK ...
On July 7, 2016, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule intended to prohibit hospitals operating certain off-campus provider-based departments (PBDs) from billing under the Outpatient Prospective Payment System (OPPS). In an effort to implement Section 603 of the Bipartisan Budget Act of 2015, CMS says the proposed rule will save about $500 million a year by refocusing payments on the patient rather than the clinical setting ...
On the occasion of Breast Cancer Awareness Month 2022, our firm organized a photo-taking session on Friday, October 21 at 3 pm. This session is a part of a global effort to raise awareness about breast cancer, one of the world’s most prevalent types of cancer. Often times, the disease has been overlooked by males. However, breast cancer can affect both men and women ...
In Greek mythology, Prometheus stole fire from Zeus to give to mankind. It seems that Zeus is now reclaiming some of that fire in the guise of Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150 (U.S. Mar. 20, 2012), the Supreme Court’s latest decision addressing patent-eligible subject matter. But a practical analysis of Prometheus reveals strategies one can use in drafting patent claims to keep those claims burning ...
The second HIPAA settlement of 2021 is the first traditional enforcement action of the year. And, it’s a big one. Traditionally, OCR enforcement has been triggered by breaches. In 2020, however, we saw a significant increase in a sub-set of Privacy Rule enforcement arising out of the U.S. Department of Health and Human Services’ Office for Civil Rights’ (OCR) patient “Right of Access” initiative ...
It's that time of year again – CLE Compliance season! With the impact of COVID-19, we know many of our clients have found it challenging to meet their annual CLE requirements. Bradley is pleased to offer you a complimentary, online CLE addressing key topics with thought-leading speakers from inside and outside of Bradley. This CLE program includes 1 ethics hour and 2 general hours ...
California’s cannabis-related businesses will face a dual battle in complying with Proposition 65 requiring businesses to warn the public about cancer-causing chemicals present in products they purchase, writes Buchalter’s Anne Marie Ellis. Businesses are going to have to change their labeling and packaging to list marijuana smoke as a reproductive toxicant and cancer causing agent ...
Kindly note that Decree No. 221, of the Ministry of the Interior and Public Security, was published today, extending the validity of Supreme Decree No. 102, of 2020, of the Ministry of the Interior and Public Security, which provides for the temporary closure of places authorized for the entry and exit of foreigners, due to public health emergency of international importance given the outbreak of the new Coronavirus (2019-NCOV) , until September 30, 2021 ...
Bona Fide Relationship Requirement Law. Public Act 247 of 2107, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance (“CS”) ...
During the COVID-19 pandemic, questions about employee health-privacy-related symptoms, testing, and vaccination became prevalent in discussions about the workplace at all levels—from “the water cooler” to national news ...
On September 18th, 2020, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) adopted a new Order approving the criteria for blocking the websites with the content infringing the healthcare regulations. The document establishes criteria for identifying and blocking websites that illegally sale or distribute content that forms a positive image of persons engaged in prohibited retail trade of medicines ...
Last week, 49 state attorneys general announced a $49.5 million settlement with Blackbaud, Inc. (Blackbaud) over the software company’s data-security practices and its response to a breach in 2020 that exposed the personal information of millions of individuals. Blackbaud provides software solutions to nonprofit organizations, including charities, schools and healthcare agencies, to help them connect with donors and manage data about their constituencies ...
As the poultry farming crisis looms and countries are on the lookout for outbreaks of infection, scientists are closely following the evolution of the virus, which is moving to new sources of infection.Before a crisis is on our doorstep, businesses should prepare themselves for the consequences of a high rate of absenteeism. Without exaggerating the risks, they should adopt preventive strategies and become aware of the legal ins and outs of their actions ...
Scope of this treatiseThe purpose of this discussion is to address those cases which are most likely to have a significant effect for those practicing in the chemical, pharmaceutical and biotech areas ...
The new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Patient Protection and Affordable Care Act of 2010. The details about the use of this pathway were left for further development through Food & Drug Administration (“FDA”) action ...
Interdisciplinary collaborations and partnering across the medical research and life sciences sectors are becoming increasingly common. Large corporations with good industry reputations and large research budgets are seeking to collaborate with smaller companies developing next-generation products. Equally, smaller companies are coming together to share complementary know-how and technologies and to work together in the global marketplace ...
Currently a large part of politicians, economists and lawyers are working hard to ensure that a recent Lithuania’s bank bankruptcy story would not repeat itself. Sometimes people still associate the term “bank” with instability, possibility to lose something or lack of transparent governing. Maybe this is the reason why there are no biobanks in Lithuanian which are widespread in the EU and other countries of the world ...
In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13 ...
2023 By Jarom B. Phipps, Esq. INTRODUCTION "Does it matter when an attorney completes the certificate of independent review for a gift to a care custodian in relation to when the dependent adult executes the transfer document? Getting the answer correct is important because a certificate that fails to comply with Probate Code section 21384 makes the donative transfer to the care custodian presumptively invalid ...
A number of events have occurred recently involving the Federal Trade Commission and healthcare entities. First, garnering the lead spotlight, the FTC began presenting its case in the U.S. District Court for Northern Illinois to enjoin a merger between Advocate Health and NorthShore University HealthSystem, two large Chicago-area health systems ...
Following up on the passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the Department of Health and Human Services (HHS) recently issued a proposed rule to replace the Medicare sustainable growth rate (SGR) methodology which was repealed by MACRA. The proposed rule would implement the Merit-based Incentive Payment System (MIPS) to replace SGR and establish incentives for participation in Advanced Alternative Payment Models (Advanced APMs) ...
