As the American press focuses on the dismantling of the Affordable Care Act, the wheels have been set in motion to implement new health care legislation that enjoys strong bipartisan support. The 21st Century Cures Act (the “Act”), signed by President Obama on December 13, addresses a broad range of health care priorities, including drug innovation, biomedical research, and mental health reform ...
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. Employers also must provide copies of the reports to their full-time employees ...
Near the tail-end of 2016, the Serbian Competition Commission initiated an investigation for an alleged competition infringement that took place in June of the same year. The infringement involved a failure to notify a merger for mandatory clearance. The transaction in question concerned an unreported acquisition of sole control on the IT market ...
Karanovic & Nikolic provided complete legal support to Affidea, a largest European medical service provider with respect to opening the first foreign hospital located in Belgrade. Our services consisted of extensive regulatory and corporate advice related to formation and start of operations of Affidea&s first hospital in Serbia. Affidea is one of the largest healthcare investors and operates over 180 Diagnostic and Cancer Treatment Centers in 15 countries across Europe ...
The world stands at the threshold of a new age. Self-driving cars have hit the streets and created the knock-on collision of technology and the law. Autonomous transportation presents a network of complex problems that have to be addressed before we can safely strap ourselves into a vehicle without a driver. August 2016 saw the implementation of the world’s first self-driving taxis in Singapore ...
To the untrained eye, technology and the judiciary sector may seem rather far apart. IT is ever changing and dynamic, while courts are by design deliberate and slow. However, even the most resistant institutions are not immune to change; Serbian courts now appear to be further steps towards incorporating new technology for the ultimate goal of greater efficiency ...
Yesterday Moscow court of appeal approved the decision of the court of the 1st instance referring to restricting access to LinkedIn website. The main reason for this decision was the fact that LinkedIn did not transfer the databases processing Russian nationals’ personal data in Russia. The Russian Localization Law which is in force as of September 1, 2015, requires that certain types of processing of Russian nationals personal data are performed in the databases located in Russia ...
Whether you are a garage tinkerer or an engineer at a technology company, you probably have considered obtaining a patent to protect one of your ideas or innovations. There is an allure to a government issued document declaring that you are the inventor of a patent that grants you exclusive right to your innovation. However, the next time that light bulb goes off above your head, here are five things you should consider before calling your patent lawyer. 1 ...
The United States Patent and Trademark Office has published its first major update to the rules for trademark trials and appeals in nearly a decade. The final changes to the Trademark Trial and Appeal Board (“TTAB”) Rules of Practice appear in the October 7, 2016 Federal Register (81 Fed. Reg. 69950) and are scheduled to go into effect on January 14, 2017 ...
Recent media reports have informed us that the European Commission has issued an official charge sheet accusing Google of an abuse of dominance concerning its Android mobile operating system and contracts with smartphone producers and telecom operators. The European Commission considers Google dominant in the markets for general internet search services, licensable smart mobile operating systems and app stores for the Android mobile operating system ...
Bayer AG, a German chemical company, and Monsanto Co., an American agrochemical corporation recently announced they have signed a definitive merger agreement under which Bayer plans to acquire Monsanto to create “a Global Leader in Agriculture ...
Regulation 2016/679 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC ("Regulation") will replace Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data ("Directive"). The Regulation will be enforced after 25 May 2018, thus, entities are required to prepare for compliance by then ...
Despite being in existence for years, many have only recently become familiar with encryption. This follows heightened publicity around its use on popular social media platforms purportedly offering end-to-end encryption. Encryption (or cryptography) has been described as a mathematical formula or algorithm that encodes and decodes information, with only authorised persons having access to such information through a key ...
1. Pharmaceutical market players mostly deal with two regulators These are the Ministry of Healthcare of Ukraine (MOH) and the State Administration of Ukraine on Medicinal Products and Narcotic Drugs Control (SAUMP). The MOH is responsible for state registration of medicines, while the SAUMP deals with licensing, evaluation of good manufacturing practice (GMP) compliance, control over quality of medicines, and regulation of medical devices. 2 ...
On October 3rd ALRUD Law Firm Partner Anton Dzhuplin joined a workshop of international Conference “What is happening in pharmaceutical market?”, which took place at “PHARMASTRATEGIES-2017” summit. The conference annually brings together Country managers, CEOs, top-managers of pharmaceutical manufacturers, distributors and retailers, heads of associations, representatives of regulatory authorities, professional and business media ...
Last June 16, the Superior Court of Québec1 rendered a safeguard order in an injunction proceeding in favour of a health-care institution the purpose of which was to set conditions for the visits of the daughter of a user of the institution who was an incapable person lodged there, as well as her interactions with the user and the staff ...
In the last several years, Texas has generated significant news stories related to the disagreements between the Texas Medical Board (“TMB”) and Teladoc, a telehealth medical provider. The original dispute centered around the right of telemedicine providers to treat Texas residents without an initial in-person visit, which some would argue circumvents the establishment of the practitioner-patient relationship ...
Financial technologies need specific legal solutions and an open approach to the law. There are lots of indications that financial technology, or FinTech, is one of the next chapters in the digital revolution unrolling before our eyes. The role of finance in the economic life of the society was laid bare by the last financial crisis. The tragic consequences of errors committed on Wall Street, i.e ...
Consent to End-of-Life Care Article 11 of the Civil Code of Québec1 states that no one can be made to undergo care without his consent. The Act respecting end-of-life care2 ("the Act"), passed by the National Assembly of Québec, came into force on December 15, 2015. Since that date, a person can give or refuse consent to specific forms of end-of-life care, provided he has given advance medical directives ("AMDs") for that purpose ...
Earlier this year, we released our inaugural cyber survey report, Perspectives on Cyber Risk (the Report), intended to provide insight into Australian organisations' cyber risk posture and cyber resilience capability.Perhaps one of the more surprising findings in the Report was that surveyed organisations did not appear to be overly concerned about the risk of regulatory action flowing from a cyber breach ...
Zoetis, the animal health company, has acquired Danish biotech company Scandinavian Micro Biodevices for USD 80 million (approximately DKK 533 million). Plesner assisted Zoetis with the transaction. Zoetis Inc. has acquired Scandinavian Micro Biodevices ApS for the purpose of extending its pipeline of veterinary diagonistics products ...
On July 25, 2016, China Food and Drug Administration (“CFDA”) published the latest "Measures for the Administration of Drug Registration (revised draft)” (“Latest Revised Draft”) for public comments1 ...
On July 1st, 2016 the Pilot Patent Prosecution Highway agreement (PPH) executed by the member states of the Pacific Alliance (Chile, Mexico, Colombia and Peru1) came into force.The PPH Pilot Program is an agreement executed by the patent offices of said countries, which allows applicants to request an accelerated examination process of a patent application ...
On June 23rd the United Kingdom (UK)1 decided, by means of a referendum, to exit from the European Union. This decision is known as “Brexit”. According to Art. 50 of the Treaty on European Union, the UK must notify the European Council – which for this purpose represents the EU – of its intention to exit, after which the parties will negotiate an agreement setting out the arrangements of that withdrawal and of the future relationship between the UK and the EU ...
The US Second Circuit Court of Appeals, overturning an earlier court ruling from a lower court, has held that the US Government cannot compel Microsoft to hand over emails stored on a server in Dublin in a narcotics case. The decision is a milestone victory for privacy rights and will be greatly welcomed by US technology companies storing data abroad ...
