The September 23, 2013 deadline for covered entities, business associates and their subcontractors to implement the new HIPAA rules is approaching quickly. In case you missed it, on January 25, 2013, the U.S. Department of Health and Human Services issued an omnibus final rule modifying the Health Insurance Portability and Accountability Act of 1996 ...
Late yesterday afternoon, the West Virginia Department of Environmental Protection (“DEP”) published on its website what it characterizes as a “rough draft” of its forthcoming emergency[1] rule (the “Draft Rule”), which is 79 pages in length. This Draft Rule comes nine days after the agency’s release of an Interpretive Rule implementing, in part, the new Aboveground Storage Tank Act (the “AST Act”), a summary of which is available here ...
On February 3, 2015, House Bill 2574 (“HB 2574”) was introduced in the West Virginia Legislature. HB 2574 proposes to remedy the unintended consequences to businesses created by the passage of the Aboveground Storage Tank Act (the “AST Act”) during the 2014 regular session of the Legislature immediately following the contamination of the Elk River from Freedom Industries, Inc ...
By the time you are reading this, the October 1 deadline to register all aboveground storage tanks (“ASTs”) in West Virginia has passed, and the world is still turning. If you have not yet registered your ASTs, it is still a good idea to register any tanks that qualify as ASTs as soon as you can. However, the West Virginia Department of Environmental Protection (“WVDEP”) is proceeding with implementation of the Aboveground Storage Tank Act, W. Va ...
by Eric E. Kinder President Bush signed the ADA Amendments Act into law. The ADAAA significantly increases the scope of the Americans with Disabilities Act of 1990 as it has been interpreted by federal courts by overturning several United States Supreme Court decisions regarding the Act. According to the Congressional Committees that oversaw the passage of the ADAAA, these amendments will restore the original Congressional intent behind the ADA ...
On August 7, 2012, the United States Court of Appeals for the Sixth Circuit in Summit Petroleum Corp. v. United States EPA, et al., Case Nos. 09-4348/10-4572, dealt the United States Environmental Protection Agency ("EPA") a major setback in its efforts to aggregate multiple, often disperse, emitting units in the oil and natural gas industry as a single stationary source - thus subjecting them to more stringent controls under the Clean Air Act ("CAA") ...
2016 was the driest year in South Africa since rainfall records began in 1904‚ with the current drought predicted to continue well into 2017. Climate variables resulting in such devastating droughts are giving rise to increased competition for dwindling water resources in parts of South Africa. When water is critical to the ongoing operation of a business, it is important to establish precisely what right a business has to water and how to protect this right ...
The Trump Administration has signaled its intent to roll back the scope of federal jurisdiction under the Clean Water Act in an Executive Order issued on February 28. The Executive Order directs U.S. EPA and the Corps of Engineers to consider rescinding or revising the "Clean Water Rule," which defines when the Clean Water Act applies to wetlands, ponds, intermittent streams, and other water bodies that have a "significant nexus" to "navigable waters ...
On February 21, 2017 the Ninth Circuit Court of Appeals in the case San Luis and Delta-Mendota Water Authority v. Haugrud found that water releases under California Fish and Game Code Section 5937 to keep fish in "good condition" creates an exception to the requirement to obtain a water right permit change from the State Water Resources Control Board (SWRCB). The Haugrud case addresses the Bureau of Reclamation (BOR) 2013 release of Trinity River water from the Lewiston Dam ...
View the February 2017 Health Law Vitals Newsletter PDF. Final Guidance Sheds Light on Medical Device Reporting Requirements In November 2016, the U.S. Food and Drug Administration issued a final guidance on medical device reporting for manufacturers ("Final MDR Guidance") ...
Just weeks into the new Administration, perhaps the only certain thing is that there will be uncertainty as the Administration makes its mark and works to fulfill campaign promises. Meanwhile, restaurant chains and food companies are trying to allocate resources to best address business priorities and hot legal issues ...
The current EU regulations for medical devices and in vitro diagnostics are from the 1990s. The rapid technical developments in the health care system in recent years as well as the increased cross-border trade urgently require a modernization of the current legal framework. Now the adoption of new EU legislation is imminent. This article provides a brief overview of the planned content and the likely entry into force of the Regulations ...
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 ...
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 ...
For about two years now, most renewable energy projects, particularly wind farm projects, have been financed using a so-called “hybrid” model, i.e. a combination of medium-term bank debt and long-term financing or private placements. The term “hybrid” is derived from the vocabulary of the Public-Private Partnerships industry, particularly projects involving an operational and maintenance component as part of a long-term concession ...
A federal appeals court has rejected two challenges to the environmental review of the Los Angeles County Metropolitan Transportation Authority's (Metro's) planned subway expansion in Downtown Los Angeles. The "Regional Connector" project, approved in 2012, will create a three-station, underground link through Downtown that will allow passengers to travel from points on the Metro Gold Line to the Blue and Expo lines without having to transfer trains ...
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 ...
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 ...
For far too long, Africa has been plagued by the demon of conflict minerals, which have played a key role in fuelling conflict and extensive human rights violations. The terrible scenes in Sierra Leone, Liberia and the Democratic Republic of Congo (DRC) remain vivid in the mind. In the history of conflict minerals, diamonds occupy the highest spot. They are valuable, portable and easily tradeable ...
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 ...
