The U.S. Department of Justice (DOJ), National Security Division (NSD), recently published updated[1] policy guidance, effective immediately, for companies considering whether to voluntarily self-disclose potentially criminal violations of U.S. export control and sanctions statutes.[2] The policy, dated Dec ...
Recent enforcement actions initiated by the Bureau of Industry and Security’s (“BIS”) Office of Antiboycott Compliance (“OAC”) serve as a warning to U.S. persons (including U.S. companies) with business interests in and around the Middle East. It is easy for the complacent to run afoul of OAC’s Antiboycott Regulations when evaluating and responding to otherwise routine documents such as a letters of credit, shipping certificates, or purchase orders ...
Under a new state law that takes effect January 1, 2020, California health care facilities and other entities must report any written allegations that a physician or other healing arts licensee has sexually abused or engaged in sexual misconduct with respect to a patient. Sexual misconduct is defined as "inappropriate contact or communication of a sexual nature." SB 425 (Hill) amends the Business and Professions Code to add a new provision, Section 805.8 ...
As we approach the end of 2019, we look back on the requirement introduced by the Companies (Miscellaneous Reporting) Regulations 2018 (Regulations) for very large private companies to make a statement about their corporate governance arrangements. This statement relates to financial years beginning on or after 1 January 2019 and as we head into 2020, the new year will bring with it the start of the first actual reporting period under the Regulations ...
The DIFC has provided slightly more clarity as to how UAE Cabinet Decision 31 of 2019 (the Economic Substance Regulations, or ESR) will apply within Dubai’s financial free zone. Helpful as the guidance is, significant questions remain. The DIFC held a presentation on 17 December to discuss the Economic Substance Regulations. The first point of note was that all businesses in the DIFC must file an ESR notification by 31 March 2020 ...
The Danish Regions have proposed a new model for establishing a so-called Treatment Council which is to assess whether the price of treatments and health technology measure up to the effect for the patients. The model will now go out for consultation. The purpose and scope In their proposal, the Danish Regions want to establish a Treatment Council which is to make recommendations regarding the use of medical devices and health technology ...
Data protection in the United States is about to undergo a major change, and everyone needs to be ready. The California Consumer Privacy Act (CCPA), signed into law June 28, 2018, enters into effect Jan. 1, 2020. It creates several new obligations for many United States-based businesses with regard to the collection, treatment, and sale of personal information ...
Starting next year, California residents who don’t have health care coverage could face a state tax penalty. Under the new Minimum Essential Coverage Individual Mandate, California residents who fail to maintain minimum essential coverage for themselves and their dependents could owe a state tax penalty, unless they qualify for an exemption ...
Recently, in Amgen Inc. v. Hospira, Inc.,[1] the Federal Circuit clarified the limits of the Safe Harbor defense in cases involving patented manufacturing methods. In a case brought in the District of Delaware, Amgen alleged that Hospira infringed several patent claims over methods of manufacturing erythropoietin (EPO), a biologic drug used to treat anemia ...
For decades, patent owners who appealed refusal of their sought-after registrations with the United States Patent and Trademark Office (USPTO) were responsible for their own costs, fees and certain expenses incurred by the USPTO (e.g. travel expenses, expert fees and copying), as required by Section 145 of the Patent Act (35 U.S.C §145) ...
On Dec. 3, 2019, the Board of Governors of the Federal Reserve System, the Federal Deposit Insurance Corporation (FDIC), the Financial Crimes Enforcement Network (FinCEN) and the Office of the Comptroller of Currency (OCC) in conjunction with the Conference of State Bank Supervisors (CSBS) issued a joint statement entitled “Providing Financial Services to Customers Engaged in Hemp-Related Businesses ...
The Ohio Board of Pharmacy (“Board of Pharmacy”) recently issued a notice to all Board of Pharmacy licensees to be on alert for a scam being perpetrated against Ohio health care providers ...
The California Consumer Privacy Act (CCPA) becomes effective on January 1, 2020. As the CCPA deadline looms, businesses need to act now to be ready. In this article, we provide an overview of the CCPA, key changes to the final law, and steps businesses can take to be ready for the CCPA ...
On 7 August 2019 the Federal Administrative Court annulled a Federal Office of Public Health (FOPH) order that had limited the price increase of a medicinal product on the list of specialities to two years. The product manufacturer had requested a price increase under Article 67(2) of the Healthcare Insurance Ordinance (SR 832.102), having incurred higher costs following the loss of two suppliers ...
On November 5, 2019, the U.S. Department of Justice (DOJ) Antitrust Division announced the establishment of a Procurement Collusion Strike Force (PCSF) to deter, detect, investigate, and prosecute criminal schemes that undermine the integrity of the government procurement process. One of the highlights of the PCSF is to reprioritize prosecutions of cartel conduct after a several-year decline ...
Some are just donkeys with a horn.I will remember 2019 as the year when many unicorns were exposed as donkeys in disguise.Invoking the rarity and mystique of the mythical creature, a “unicorn” is the term the financial market coined for companies worth US$1 billion or more. The year opened with high hopes for such companies that sought an initial public offering (IPO) in the following months ...
Hackers delight in targeting U.S. companies during the holiday season triggering a year-end spike in cyber-attacks, with Carbon Black reporting a 57.5 percentincrease in attempted cyber-attacks during past holiday seasons. This year we can expect that threat actors across the globe will remain online throughout the holiday season, looking to capitalize on the distraction of the holidays and the increased internet traffic that comes with online holiday shopping ...
Beginning Dec. 1, 2019, pharmacists licensed by the State of Ohio Board of Pharmacy (“Board”) will have new reporting requirements. The Board enacted similar reporting requirements for pharmacy interns, pharmacy technician trainees, and registered and certified pharmacy technicians. These new reporting requirements add to existing compliance considerations and burdens for licensees, registrants, their employers, and owners and operators of retail and institutional pharmacies ...
