Following the controversial consultation exercise that ran earlier this year the Permitted Development right authorising conversions from uses falling within Use Class E to residential uses will be added to the statute books this week. What is coming into force is significantly pared down from what was proposed in the consultation exercise and David Mathias sets out some of the headlines below. The Town and Country Planning (General Permitted Development etc ...
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 ...
As aresult of the parliament’s intervention, mutual obligations of parties to lease agreements in shopping centres are deemed to have “expired.” Does that mean that the lease agreements have expired? The parliament has introduced into the Polish legal system aspecial regulation directly intervening in lease relationships in commercial facilities with asales area of over 2,000 m2. It is included in Art ...
A. INTRODUCTIONThe development of transportation infrastructure in the Lower Mainland depends on expropriation of private property ...
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 ...
In recent months, the need to conclude the procedures to adapt/amend/revise the municipal and inter‑municipal plans for spatial planning has been widely discussed by the municipalities, the Government, economic agents and civil society. This discussion has focused on: i) The integration into in those plans of the rules contained in special plans concerning the arrangements to safeguard territorial resources and natural values that directly bind private individuals ...
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 ...
Regarding its functions, the UPME has been monitoring the demand for electrical energy and natural gas on a daily basis, in order to identify the impact of the measures taken to mitigate the effects of COVID-19 on the consumption of these energies. The following conclusions have been reached from this monitoring: Energy demand fell in April by 16.92% compared to the average scenario projected by the UPME and by 11.10% so far in May ...
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 ...
Hand sanitiser production is just one aspect of business that's altered for £5bn industry, writes George Frier of Shepherd and Wedderburn The whisky industry continues to captivate consumers and entrepreneurs. Record exports continue and, within the sector, the emergence of new brands and the rejuvenation of existing brands demonstrate a vibrant sub-set of the Scottish food & drink economy ...
After three days of historic oral arguments before the U.S. Supreme Court, the fate of the Affordable Care Act (ACA), the momentous 2010 health reform law, is uncertain, given robust questioning of the ability of Congress to force individuals to purchase health insurance ...
Late last month, the U.S. Drug Enforcement Administration (DEA) issued a final order placing FDA-approved drugs that contain cannabidiol (CBD) derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in Schedule V of the Controlled Substances Act of 1970 (CSA). Schedule V of the CSA includes drugs such as Robitussin and Lyrica ...
On April 30, 2021, the U.S. Food and Drug Administration (FDA) announced it was revoking a policy related to new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The FDA stated that the previous policy announced by the Department of Health and Human Services (HHS) on Jan. 15, 2021, was being rescinded because the new policy would have required the FDA to publish redundant information about new applications of NDAs and ANDAs ...
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 ...
FDA Takes Action to Increase U.S. Supplies in Response to COVID-19. The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices. The FDA is engaging the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S ...
The FDA issued immediately-in-effect guidance to accelerate the development of certain laboratory tests for the urgent need caused by SARS-CoV-2. The FDA provides recommendations, among others, for serological tests, puts forth a policy for states to take responsibility for tests, and announces enforcement discretion for commercial manufacturers using new commercially developed tests prior to the FDA granting an emergency use authorization, under certain circumstances ...
On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that are subject to current good manufacturing practice (cGMP) requirements ...
