The European Commission has presented its Proposal for a Regulation on the European Health Data Space (the “Proposal”). While it aims to strengthen the rights of individuals and unlock data’s potential for research purposes, it also adds complexity to an already extensive legal framework. Here is what you need to know: In its 2020 Data Strategy, the European Commission outlined a plan to unlock the untapped potential of the EU data economy ...
Judgments of the European Court of Justice in Merk, Sharp & Dohme BV v. Etat Belge (C-245/03) and Glaxosmithkline SA v. Etat Belge (C-296/03) of 20 January 2005 Directive 89/105, on the transparency of medicines pricing and reimbursement rules (hereinafter the “Directive”) was first interpreted in 2001 and 2002, when the European Court of Justice (hereinafter the “ECJ”) rendered two decisions regarding the implementation of the Directive in Austria and in Finland ...
Introduction An EU Regulation on the making available on the Union market as well as export from the Union of certain commodities and products associated with deforestation and forest degradation (“Deforestation Regulation”) was agreed upon by the EU legislators in December 2022. The European Parliament has now green-lighted the Provisional Agreement at this month’s plenary session ...
Regulation (EC) 2017/746 of 5 April came into force on 26 May 2022 and it establishes the regulatory framework for in vitro diagnostic medical devices (IVDs). In doing so, it replaces the previous regulations in Directive 98/79/EC of 27 October 1998 ...
Introduction The rapid spread of COVID-19 pandemic has led to a significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), masks for social use (textile articles) and other products destined to prevent the spread of the disease. As a result, it became clear that there was insufficient supply to meet existing needs during the state of emergency and the subsequent period ...
The International Trade Commission (ITC) sits in a nondescript office building about a block farther south of the National Mall than tourists usually care to venture. Patent owners come from around the country to this tree-lined street in Washington, D.C., to seek a powerful remedy to protect their patented products: an exclusion order. An exclusion order directs U.S. Customs and Border Protection to block infringing imports at the United States border ...
As of March 19, 2020, the requirement to receive a certificate of need (CON) prior to increasing bed capacity has been temporarily suspended byTennessee Executive Order No. 15(the “Order”) ...
Months into the United States’ trade dispute with China, and there is no end in sight to the dispute. There are three significant deadlines for U.S. importers to consider involving the tariffs the U.S ...
The Ohio Department of Commerce (Department) recently announced licensed medical marijuana cultivators who are maxing out their grow area capacity will be permitted to apply for an expansion. Presently, there are 20 Level I cultivators capable of growing up to 25,000 square feet of medicinal marijuana, and 15 Level II cultivator licensees that are smaller in scale and permitted up to 3,000 square feet of grow capacity ...
The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”)[1] was enacted on October 24, 2018. Among other things, the SUPPORT Act amended the Physician Payments Sunshine Act (“Sunshine Act”)[2] to expand the definition of “covered recipients”[3] for payment tracking and reporting purposes ...
We would like to inform you that the Russian President has signed amendments to Article 1360 the Civil Code of the Russian Federation ('Russian Civil Code'), in terms of providing compulsory licenses to use an invention, utility model or industrial design ('patent rights') on 30 April, 2021. The amendments came into force on 11 May, 2021 ...
In the midst of the coronavirus outbreak, the Centers for Medicare & Medicaid Services (CMS) has taken steps to make healthcare services more accessible through telehealth, particularly for those who are at high-risk of complications from the virus. CMS and commercial payors have opened a viable path for healthcare providers to continue to provide care to high risk patients and other patients and receive reimbursement for services to current and new patients ...
A recent report published by the White House Council of Economic Advisers (“CEA”) on drug pricing in the United States of America has put the cost of medicine and the access thereto by the poor, firmly back in the spotlight. And on a global scale. In the CEA report, President Donald Trump’s administration argues that the USA pays higher prices for pharmaceuticals because other developed countries have systems in place to actively force down drug pricing ...
It’s no surprise that the National Cybersecurity Center of Excellence (NCCOE) has extended the public comment period for one of its newest guides, “Securing Electronic Health Records on Mobile Devices ...
The Costa Rica´s General Directorate of Customs issued the statement DGA-010-2020, which expands the list of products for surgical use that have export and re-export restrictions, which they had initially established through directive DGA-003-2020. The products added are as follows: Mono-glasses: Mono-glasses with indirect ventilation, transparent lens, foam covered frame and adjustable headband. Ergonomic and panoramic design. HSC: 9004.90.10.00 ...
Effective on April 6, 2020, an Order was published to establish the technical guidelines (the “Technical Guidelines”) for the activities described in Article 1, Section II, sub-sections (c) and (e) of the order that adopted extraordinary measures to deal with the health emergency caused by the SARS-CoV2 virus” (the “Order”). (We published an article on the Order, which may be foundhere ...
Six months on from the implementation of sections 20 and 21 of the Road Safety Act 2006, and occupational road safety remains a significant cause for concern for employers. The Act introduced two new offences of causing death by careless driving and causing death whilst unlicensed, disqualified or uninsured, with offenders finding themselves facing up to five years’ imprisonment for what could be a momentary lapse of concentration ...
This paper will address the varying requirements for fair market value in transactions involving physicians and hospitals and other health care providers. The paper will first examine the Stark law and how and when transactions may satisfy Stark’s requirements for fair market value. Second, the use of fair market value for compliance with the federal Anti-Kickback statute will be addressed ...
In response to the economic impact of the COVID-19 pandemic, the federal government has passed several new laws to provide trillions of dollars of funding to affected businesses and individuals. But this also means there are new compliance considerations for entities receiving federal funds, especially as it relates to the False Claims Act’s “false certification” theory of liability ...
The U.S. Attorney’s Office in Nashville, Tennessee, arguably the capital of the investor-owned healthcare industry, is taking on healthcare providers and winning. In a series of summary judgment rulings over the past year, the federal district court has assessed tens of millions of dollars in damages and penalties under the federal False Claims Act (FCA). In these cases, the court found that the defendants flagrantly violated clearly written provisions of Medicare rules ...
The controversial issue of whether employers can check their employees' temperatures has been much debated. Both the Employment Ministry and the Data Protection Authority (DPA) have recently changed their positions in this respect ...
