You may have heard something about GDPR lately and thought "Why should I care? It probably won't affect me or my business.” In reality, the implications of GDPR are far-reaching. The European Union’s General Data Protection Regulation (GDPR) is a set of regulations strengthening data privacy and protection laws for residents of the EU. The regulations take effect in just two months: May 25, to be exact ...
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(FDA) announced that it was re-evaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities ...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) ...
Alvarado v. Dart Container Corporation, Case No. S232607 (Cal. Sup. Ct, March 5, 2018) On March 5, 2018, the California Supreme Court issued its long awaited overtime calculation decision in Alvarado v. Dart Container Corporation, Case No. S232607 (March 5, 2018). The specific question before the Court was "how an employee’s overtime pay rate should be calculated when the employee has earned a flat sum bonus during a single pay period ...
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 ...
Insolvency that stems from the obligations assumed by a joint venture may concern any of the associates. Such proceeding, especially when it has an international dimension, requires a broader perspective on some of the requirements set forth by law with respect to the initiation and application of the proceeding. Through its effects on the debtor, creditors and on the socioeconomic environment in general, insolvency is more than a mere legal procedure ...
Hidden in the details of the Bipartisan Budget Act of 2018 are some key telehealth provisions that are receiving praise from many industry groups and could mark a significant development for Medicare telehealth policy. The new legislation promotes telehealth in several ways. Tele-stroke. Medicare currently only covers tele-stroke services for patients located in rural health professional shortage areas and counties not classified as a metropolitan statistical area ...
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 ...
1.1 What type of legal system has your jurisdiction got? Are there any rules that govern civil procedure in your jurisdiction? The Philippine legal system is primarily a civil law system, although it may be considered a mixed regime consisting of both civil andcommon law traditions. Civil procedure is governed primarily bythe 1997 Rules of Civil Procedure, or Rules 1 to 71 of the Rules of Court (“ROC”), and various issuances promulgated by the Supreme Court. 1 ...
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 ...
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 ...
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 ...
In vacating a jury’s award of almost $54 million based on a finding of willful trademark and trade dress infringement, an Illinois federal district court granted the defendants’ motion for a new trial, finding the trial “fundamentally unfair due to the admission of unreliable and prejudicial expert testimony.” The Black & Decker Corporation et al v. Positec USA Inc.,No. 1:2011cv05426 (N.D. Ill. Sept. 11, 2017) ...
This week we learned that Amazon, Berkshire Hathaway and J.P. Morgan Chase have joined forces to tackle employee healthcare costs. This announcement marks yet another chapter in some employers' frustration with our nation’s healthcare system. Employees are equally tired of the increasing cost of healthcare eating away what should be their wage increases even as employers pay for ever increasing health insurance premiums ...
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 ...
Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year using IRS Form 1095-C. The IRS uses the forms to assess whether an employer "shared responsibility" penalty applies. Employers also must provide copies of the forms to their full-time employees ...
On January 8, 2018, the U.S. Court of Appeals for the Federal Circuit issued itsen bancdecision inWi-Fi One, LLC v. Broadcom Corp., Appeal 2015-1944 (Fed. Cir. Jan. 8, 2018) (en banc) holding that Patent Trial and Appeal Board (“PTAB”) time-bar determinations under 35 U.S.C. § 315(b) in aninter partesreview (“IPR”) proceeding are appealable. Theen bancdecision overrules a panel’s earlier decision inAchates Reference Publishing Inc. v. Apple Inc.803 F ...
Last week, the U.S. Department of Labor (DOL) issued proposed rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer association to provide health coverage for their employees ...
As part of a now-infamous 1972 monologue, comedian George Carlin listed the “Seven Words You Can Never Say on Television,” colorfully repeating each throughout his routine. While many of those words remain unacceptable for the airwaves, they may now be suitable for federal trademark registration, thanks to a recent decision from the Federal Circuit Court of Appeals ...
1. Treaties Is your country party to any bilateral or multilateral treaties for the reciprocal recognition and enforcement of foreign judgments? What is the country’s approach to entering into these treaties and what, if any, amendments or reservations has your country made to such treaties? The Philippines is not a party to any bilateral or multilateral treaty for the recognition and enforcement of foreign judgments ...
The Construction Industry Arbitration Commission of the Philippines (“CIAC”) has original and exclusive jurisdiction over disputes arising from, or connected with, contracts entered into by parties involved in construction in the Philippines. Construction disputes may range from contractual money claims to disputes over the execution of the construction work. Construction disputes may involve government or private contracts ...
After two long years of analysing and debating, the Serbian Parliament adopted changes to the Bankruptcy Law and they have entered into force. The idea was to improve the position of secured creditors and to provide clarity to certain provisions that caused conflicting interpretations in practice. Changes will apply only to bankruptcies initiated after the changes entered into force ...
Ever since the latest Law on Enforcement and Security entered into force on the 1stof July, 2016, an issue arose over the wording and scope of Article 48, dealing with how creditors acquiring claims can initiate enforcement. The main idea behind this new law was to make it easier for creditors to collect claims ...
Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. The Federal Circuit’s first decision under the Biologics Price Competition and Innovation Act (BPCIA) involved Zarxio, Sandoz’s Neupogen biosimilar product. Amgen v. Sandoz, 794 F.3d 1347 (Fed Cir. 2015) ...
