More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was re-evaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities ...
New rules will apply to disability benefit claims and appeals under certain plans that are subject to the Employee Retirement Income Security Act of 1974 (ERISA), effective for claims made after April 1, 2018. According to the Department of Labor (DOL), the new rules are intended to provide greater protection to claimants, and are modeled on the enhanced claims and appeals procedures that apply to health benefit claims under the Affordable Care Act (ACA) ...
On March 1, 2018, at the American Bar Association’s National Institute on White Collar Crime, top Department of Justice (DOJ) officials signaled expansion of DOJ’s self-disclosure policy to non-Foreign Corrupt Practices Act (FCPA) cases ...
Last week, United States Attorney General Sessions announced the creation of the Department of Justice Prescription Interdiction & Litigation (PIL) Task Force to combat the prescription opioid crisis. According to the Department of Justice (Justice), the PIL Task Force will rely on “all available criminal and civil enforcement tools” to hold those at “at every level of the [opioid] distribution system” accountable for unlawful conduct ...
In West Virginia, we are approaching another Personnel Season (for Personnel Season deadlines for the 2017-2018 school year, click here). We are often asked about the listing of individual employee names on county board of education agendas ...
Earlier this year the European Commission published a draft Withdrawal Brexit Agreement. It is a draft treaty to embody the key principles from the Joint Report of the Commission and the UK on the first three elements of the Brexit negotiations (i.e., People, Ireland and Money - the "PIM" Phase). The draft Agreement sets out a roadmap for the EU's vision of the withdrawal process.This is a negotiating move by the EU - it is not an agreed draft. It is a move by the EU in the Brexit chess match ...
With the Paradise papers leak in 2017 and the infamous Panama papers leak the year before, it has become increasingly more important to choose the right destination for offshore investment. It will require careful consideration, planning and skilful professional advice. It will also no doubt require a jurisdiction with a politically and economically stable environment, sound legislation, low tax (or zero tax), a solid banking framework and a discreet environment ...
Best-known for its stunning natural beauty—jewel-colored waters, soft sandy beaches, and lush mountain ridges—the British Virgin Islands also excels among her peers in the international financial services industry. Notably, the Territory is relentless in its pursuit of refining and advancing its financial services legal structures and complying with worldwide regulatory regimes ...
On 7 February 2018, a new specialist International Chamber within the Paris Court of Appeal was launched by the French Ministry of Justice together with the Paris Bar Association. The chamber is intended to deal with international commercial matters governed by French as well as foreign law, and the use of English as well as certain common law procedures will be permitted ...
Yesterday, the U.S. Supreme Court significantly narrowed the scope of the Dodd-Frank Act's anti-retaliation measures. The decision resolved a split in authority by excluding from Dodd-Frank's whistleblower protections those persons reporting suspected violations only within their companies. In reversing the Ninth Circuit, the Court held that "Dodd-Frank's anti-retaliation provision does not extend to an individual who has not reported a violation of the securities laws to the SEC ...
READ: SEC Enforcement Division Announcement On February 12, 2018, the SEC Division of Enforcement announced the Share Class Selection Disclosure Initiative self-reporting initiative (the SCSD Initiative) ...
Earlier this year the enhanced Nurse Licensure Compact (eNLC) was implemented in all 29 participating states including Colorado, West Virginia and Kentucky. Illinois[1] and Michigan[2] are among the states with current legislation pending to adopt the eNLC, while Indiana, Ohio, Pennsylvania, California and a handful of other states do not yet have pending legislation ...
The State Medical Board of Ohio (Medical Board) recently released proposed rules that will create a non-disciplinary, confidential monitoring program for licensees with mental or physical illnesses. Historically, licensees with a mental or physical illness could not only be subject to formal disciplinary action pursuant to the Medical Board’s rules, but the licensee’s mental or physical illness became public information as a result of the disciplinary process ...
The Securities and Exchange Commission’s Office of Compliance Inspections and Examinations (“OCIE”) has announced its 2018 examination priorities. The 2018 priorities provide insight into what activities OCIE believes present the highest risks to investors and, as such, what the examiners will be highlighting during their examinations of registered entities this year ...
As the new year started, two Department of Justice memoranda began circulating that may bring a change in the way the United States focuses its efforts in the FCA arena. The first, entitled, “Factors for Evaluating Dismissal Pursuant to 31 U.S.C ...
On February 7, 2018 the SEC Office of Compliance Inspections and Examinations (OCIE) issued the 2018 National Exam Program Examination Priorities. In introducing the examination priorities for 2018, OCIE describes the four pillars upon which the work of OCIE is based: promoting compliance; preventing fraud; identifying and monitoring risk; and informing policy. OCIE includes in the examination priorities factual data relating to the increase in examinations of investment advisers ...
IN THIS ISSUE: SEC Releases Update to 2018 Agenda of Regulatory Priorities The SEC Enforcement Division’s Initiatives Regarding Retail Investor Protection and Cybersecurity ENFORCEMENT ACTIONS: F-Squared Investment, Inc ...
Municipal Advisor Exam Results On November 7, the SEC’s National Examination Program issued a Risk Alert providing the SEC staff’s observations after conducting over 110 examinations of municipal advisors during the Municipal Advisor Examination Initiative ...
Last year the Colombian Congress issued Law 1841, which incorporated the Free Trade Agreement (“FTA”) between Colombia and Israel into the Colombian legal system. Currently, the law approving the Treaty is under review by the Colombian Constitutional Court for its definitive entry into force ...
Fresenius Medical Care North America (FMCNA), a provider of products and services for people with chronic kidney failure, has agreed to pay $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopt a comprehensive corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules ...
The State Medical Board of Ohio recently proposed amendments to the existing regulations governing light-based medical devices (lasers), which will significantly impact the provision of laser services in Ohio. While the proposal adds a new category to existing delegation authority, it also imposes new regulatory requirements to existing delegation authority which will impact Ohio physicians providing laser services ...
Country overview 1. Give an overview of the country’s economy, its structure and main characteristics, and prevailing government economic policy, particularly as regards foreign investment. The Philippines is an archipelago composed of more than 7,000 islands with 82 provinces divided in 18 regions. Rich in natural resources, it has a total land area of about 300,000 square kilometres. It is divided into three major island groups: Luzon, Visayas and Mindanao ...
We previously reported on oral arguments before the Supreme Court regarding which court has original jurisdiction to hear challenges to the Clean Water Act’s “waters of the United States” (“WOTUS”) definition. On January 22, 2018, the Supreme Court issued a unanimous decision in National Association of Manufacturers v. Department of Defense that only district courts have original jurisdiction to hear such challenges ...
Personnel Season is fast approaching for county boards of education. Personnel offices are busy ensuring proper notices are sent to impacted employees, employees are afforded hearings before a reduction or transfer is acted upon by the board, and board of education agendas are legally compliant. At the same time, personnel offices are receiving early notice of year-end retirements from classroom teachers. W. V a ...
