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 ...
The GDPR contains rules on when it is mandatory for controllers and processors to designate a data protection officer. The Article 29 Data Protection Working Party (WP29) issued guidelines on the data protection officers (DPOs) interpreting the respective provisions of the GDPR (Articles 37-39 and Recitals 77 and 97). The Data Protection Officer (DPO) The GDPR contains rules on when it is mandatory for controllers and processors to designate a data protection officer ...
Since not only individual people, but also the overall project, are being presented, online presentation can be divided into two main parts. First is the management of personal social media. Avoid any disrespectful or offensive discourse, as well as any ambiguous posts and photos. Or as a minimum , do not display them publicly. Secondly, visual communication is absolutely crucial to protect the name of a reliable project ...
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 Serbian Competition Commission (the "Commission") recently finished sector inquiries concerning quite distinct industries – raspberries and the public procurement for software and hardware. The aim behind the inquiries was to perform extensive market research and analysis in order to acquire a clearer picture of the possible antitrust issues and risks in two sectors widely perceived as strategic for the development of the Serbian economy ...
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) ...
Earlier this year, Decree No. 1 of the Ministry of Health (herein, the "Decree") was published on the Official Gazette. The Decree sets forth the graphic characteristics of the message for the promotion of healthy life habits that must be included in the advertisement of foodstuff products established in Article 5 of Law No. 20,606 -those that qualify as "High in" one or more critical nutrients- made through mass communication ...
How new technologies and changing consumer expectations is signaling disruption to the health industry and the importance of finding ways to better measure and translate patient satisfaction and outcomes. Do you know if your clinician is doing a good job? What about the track record of your surgeon? Should you be entitled to know as a consumer? The industry is being disrupted – no longer is the family GP the dispenser of all health advice ...
One step closer to implementation of the reforms relating to EU data protection regulation, this article looks at some of the implications that the reforms are likely to have for SMEs. Key progress was made in the reform of EU data protection regulation on 12 March 2014 with the European Parliament voting in support of reform and the draft General Data Protection Regulation (the "Regulation"). The Regulation must now be adopted by the Council of Ministers in order to become law ...
Cloud computing, along with Big Data, social media, and mobility, is one of the current megatrends that will drive huge changes to the business ecosystem in the upcoming decade. Surveys held over the recent years unanimously confirm that organisations across the globe are rapidly and continuously moving to the cloud ...
The Nigerian Court of Appeal confirms that an Arbitral Tribunal has no Jurisdiction to determine contractual disputes, the resolution of which has tax implications for any of the parties. Recently the Nigerian Court of Appeal confirmed in part the decision of the Federal High Court Abuja delivered on 22 May 2012 in Suit No. FHC/ABJ/CS/923/2011 ...
A rash of lawsuits are being filed around the country against businesses and retailers, claiming their websites are not accessible to those with visual or hearing impairments. These lawsuits are being filed under Title III of the Americans with Disabilities Act ("ADA"). Title III of the ADA requires equal access for persons with disabilities in places of public accommodation. This is not a new provision of the ADA, but the focus on websites has been a relatively recent development ...
Ohio prescribers need to be aware of new rules for prescribing controlled substances that will take effect on December 29, 2017. First, prescribers will be required to include the first four characters of the ICD-10 diagnosis code or the full CDT procedure code on all prescriptions for opioids.[1] Similarly, beginning June 1, 2018, prescribers will need to include the ICD-10 diagnosis or CPT procedure code on prescriptions for all other controlled substances ...
The Bavarian Data Protection Authority ("BayLDA") has published an online test on its website that can be used by companies to determine how well they are prepared on key topics of the General Data Protection Regulation ("GDPR"). The GDPR will apply directly in the member states of the European Union with effect from May 25, 2018. This will result in significant changes to data protection law in many areas ...
Is a defeated patentee atInter PartesReview an embittered citizen whose private rights were taken without due process by a government agency lacking requisite Article III guarantees of impartiality? Or is the public getting a sweet deal when the Patent Trials and Appeals Board (PTAB) eliminates or revokes a public right that was wrongfully granted in the first place? The Supreme Court wrestled with the constitutionality ofInter PartesReview during oral argument on Monday morning, and the