Today the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (NPRM) that will end HRSA’s delays in implementing a January 5, 2017 final rule concerning 340B drug price calculations and civil monetary penalties (CMPs) against manufacturers who knowingly and intentionally overcharge 340B covered entities for 340B drugs (the Final Rule) ...
Article PDF On October 19, 2018, the Treasury Department released proposed regulations regarding certain aspects of the new qualified opportunity funds ("QOF") and related qualified opportunity zones ...
Governor Brown signed into law a number of bills, which significantly impact employers. Unless otherwise indicated, each new law takes effect the begining of 2019. For an in-depth analysis of how each law might affect your organization, contact one of Hanson Bridgett's experienced labor and employment lawyers ...
Recently, California legislators passed SB 954 creating a new pre-mediation requirement – the prospective Mediation Disclosure. "As soon as reasonably possible" before agreeing to mediate, attorneys are to present to clients a Mediation Disclosure affirmatively explaining mediation's confidentiality restrictions, execution of which acknowledges the client's understanding of the restriction's impact ...
In a rare bipartisan and bicameral compromise, Congress has passed the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,” shortened to the “SUPPORT Act.” The bill was signed by President Trump on October 24, 2018 ...
Information is critical to the conduct of health and medical research. Much of the time the information relates to individuals. Higher education institutions regularly collect, use, disclose and hold information, including health information, for research purposes ...
To coincide with its 250th anniversary, Shepherd and Wedderburn commissioned the University of Strathclyde’s Fraser of Allander Institute to consider the future challenges and, more importantly, opportunities for Scotland’s economy ...
Impact of Trump Administration, Midterm Elections and the Rise of Automotive M&ARespondents to Dykema’s 14th Annual M&A Outlook Survey expressed the highest level of optimism for the M&A market in the 14-year history of the firm’s survey. Sixty-five percent of respondents expect the M&A market to strengthen over the next 12 months, significantly up from the mid- to high 30s where it has remained for the past several years ...
On October 3, 2018, the IRS issued guidance for employers on how to claim tax deductions for business meals this year. Under the Tax Cuts and Jobs Act, ("TCJA") business expenses for "entertainment" are no longer deductible, effective for 2018. However, the TCJA did not modify the separate 50% deduction for expenses for business meals, which left employers wondering how to distinguish a business meal from entertainment ...
Many companies are currently facing challenges in relation to the GDPR compliance of their video surveillance. Main issues in this respect are questions related to transparency requirements and information notices, the need for a data protection impact assessment as well as questions concerning retention requirements and retention periods. The German Federal Labor Court (BAG) has recently commented on the admissible storage duration of lawful video recordings ...
In response to questions regarding the legality of Cannabidiol (CBD) oil products, the State of Ohio Board of Pharmacy (Board) announced that only licensed and operating Medical Marijuana Control Program dispensaries may sell CBD oil products. In June, the Board announced the award of 56 provisional medical marijuana dispensary licenses. All of those provisional licensees will have six months to comply with operational requirements in order to obtain a certification of operation (COO) ...
On September 20, 2018, the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced settlements with three Boston hospitals for disclosing Protected Health Information (PHI) to ABC News documentary filmcrews.[i] In total, the hospitals paid OCR $999,000 to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule ...
In its green paper on corporate governance reform, the Government sought views on measures designed to address "a widespread perception that executive pay has become increasingly disconnected from both the pay of ordinary working people and the underlying long-term performance of companies" ...
On September 11, 2018, the Securities and Exchange Commission (“SEC”) announced its first enforcement actions alleging that entities offering certain investments in cryptocurrencies should be registered as an investment adviser or broker-dealer ...
Lawyers are often criticised for using overly complex legal and technical wording in contracts. The purpose of a contract is, amongst other things, to clearly set out the rights and obligations of the contracting parties, and to limit uncertainty during the particular project. To this end, it is important to use plain English in contract drafting and as a general rule, to use short sentences, defined terms and a clear and logical structure ...
Months into the United States’ trade dispute with China, and there is no end in sight to the dispute. There are three significant deadlines for U.S. importers to consider involving the tariffs the U.S ...
Background The legal and philosophical aspects relating to the concept of “ownership” with respect to human biological material of various kinds has been hotly debated ...
As we reported in our May 31, 2018 Alert, the California Legislature has been considering legislation to prevent joint powers authority (JPA) member agencies from contracting out of liability for the JPA's pension obligations ...
Earlier this year, in Kim v. Toyota Motor Corp., the California Supreme Court delivered a significant win to product manufacturers concerning the admissibility of industry custom and practice evidence in a strict product liability design defect action. Haynes and Boone, LLP Partner M.C ...
On August 31, 2018 California’s legislature passed Senate Bill 1402. Unless vetoed by Governor Brown on or before September 30, SB 1402 will allow shippers to be held jointly liable for state labor and employment law violations by port trucking companies. The bill, which was authored by Senator Lara (D-Bell Gardens), is aimed at ending the purported “exploitation of truck drivers who haul cargo from California’s ports ...
Earlier this year, the Supreme Court issued its opinion in the matter of Lucia v. SEC, 585 U.S. (2018), which held that administrative law judges of the U.S. Securities and Exchange Commission (SEC) are considered Inferior Officers of the United States, therefore subject to the Appointments Clause (Article II, Sec. 2) of the U.S. Constitution. The Supreme Court ruled in favor of Mr ...
Following the enactment of the Economic Growth, Regulatory Relief, and Consumer Protection Act, the Securities and Exchange Commission (SEC) has adopted an amendment to Rule 701(e) increasing the threshold amount of securities that can be sold during a 12-month period from $5 million to $10 million. Securities sold in excess of the threshold trigger enhanced disclosure obligations for the issuer ...
As a business owner in the Pacific Northwest, you likely have heard of the changes to California’s regulations regarding warning labels on consumer products, Proposition 65, which takes effect August 30, 2018. Your business may be affected by the changes if your business conducts any consumer product-related business in California ...
