Charles Arrand considers the Regulatory Reform (Fire Safety) Order 2005, with a focus on both the potential business and human costs of failing to discharge obligations under the Order. Fire safety is regulated by the Regulatory Reform (Fire Safety) Order 2005 (the Order), which applies to almost all buildings, places and structures other than individual private homes ...
On August 6, 2020, the U.S. Court of Appeals for the First Circuit affirmed the conviction of Massachusetts gynecologist Rita Luthra for criminal HIPAA violations and obstructing a health care investigation. Although such HIPAA prosecutions are uncommon, the case underscores the risks health care providers and others run when handling protected patient information and when speaking with government investigators ...
The Health Care Arbitral Tribunal (Arbitral Tribunal) has pronounced a decision on a dispute between an independent medical specialist and a Medical Specialist Company (MSC) for the first time since the introduction of the comprehensive rates on 1 January 2015. Although neither party has terminated the existing (membership) agreement between them, the Arbitral Tribunal is of the opinion that termination of membership and deregistration of the specialist from the members' register are justified ...
While the pandemic and subsequent economic downturn are creating unprecedented challenges for health systems across the country, opportunities for collaboration remain as strong as they had been pre-COVID, and large health systems are well positioned to take advantage of new opportunities. In light of this, Waller has partnered with Kaufman Hall to develop a guide for health system leaders, The Health System Growth Imperative: Charting Opportunities During the Pandemic and Beyond ...
Legislators filed bills before the official start date of the 83rd Texas Legislative Session; many of the bills already filed address healthcare issues. 1. The Budget. Texas legislative leaders recently approved a self-imposed budget cap for the 2014-2015 biennium based on a conservative estimate of growth in the state’s economy, holding lawmakers to not more than a 10 ...
Several listed companies recently bought the music rights of world famous stars such as Bob Dylan and Taylor Swift. The payoff of investing in music mainly comes from streams revenues. But the benefits do not seem to be that bad: for instance, since Sony bought Michael Jackson's music portfolio in 2016, its stock price has quadrupled (1) ...
Several listed companies recently bought the music rights of world famous stars such as Bob Dylan and Taylor Swift. The payoff of investing in music mainly comes from streams revenues. But the benefits do not seem to be that bad: for instance, since Sony bought Michael Jackson's music portfolio in 2016, its stock price has quadrupled (1) ...
Earlier this week, the U.S. Supreme Court issued a split decision and failed to resolve whether copyrighted materials legally made abroad can be imported into the U.S. and sold without the express permission of the copyright owner. See Costco Wholesale Corp. v. Omega S.A., 562 U.S. __ (2010). In other words, it is still up to the nation’s circuit courts to decide whether the first sale doctrine extinguishes the rights of a copyright holder when the goods are made outside of the U.S ...
“Government efforts to manipulate markets and prices on consumer goods never work as intended, and in this case, would be counterproductive.” The waning days of summer signal the approaching midterm election season. Amid inflation, recession and voter discontent, it’s understandable that a group of congress members are anxious to put points on the board with a price-control scheme that they wrongly believe will lower prescription drug prices ...
The Florida Agency for Health Care Administration (“AHCA”) earlier this month fined Humana $3.4 million for failing to promptly report suspected cases of Medicaid fraud and abuse by others, as required by statute and Humana’s Medicaid HMO contract. Though many states have similar laws or regulations, this appears to be the first enforcement action of its kind in the nation ...
On April 14, 2015, the White House announced that President Obama intends to remove Cuba from the government’s list of nations that sponsor terrorism. This decision follows a series of important changes to US policies and regulations affecting business and commercial transactions between the United States and Cuba ...
IN OUR JUNE 2005 “FDA WATCH” column, we provided an overview of the regulatory, political, and scientific landscape for follow-on biological products in the U.S. As reported a year ago, the biogenerics debate centers around whether generic biologics are scientifically possible (i.e ...
On Capitol Hill, U.S. lawmakers are considering legislation that would authorize the U.S. Food and Drug Administration (FDA) to approve generic versions of biological products. Representative Henry Waxman (D, CA), of “Hatch-Waxman” fame, has introduced the “Access to Life Saving Medicine Act” (H.R. 1038) to advance this change to U.S. law. In introducing the legislation, Rep ...
Hospitals and health systems are on the frontlines fighting the COVID-19 pandemic. But, behind the scenes, they are grappling to sustain operations and finances significantly impacted by the state of the economy. In the latest version of our PointbyPoint podcast, Waller’s Ken Marlow and Eb LeMaster, managing director at Ponder, discuss the various factors impacting hospitals and health systems today ...
As Hurricane Harvey continues to cause far-reaching disruptions, it is important to understand how to effectively assert or respond to assertions of force majeure. This summary outlines the steps to take to assert force majeure, and initial considerations for those who have received several notices of force majeure from counterparties ...
On 23 September 2018 Federal Decree-Law 19 of 2018 regarding Foreign Direct Investment (the FDI Law) was issued. Through the FDI Law the foundations were laid for the relaxation of the 51 per cent UAE national ownership requirement for companies incorporated onshore in the UAE ...
It's a quiet Friday afternoon edging uneventfully toward the end of the day when a client calls: they’re interested in acquiring a U.S.-based widget maker. After your internal conflict check clears, reality hits – what do you do now? Whether your client is a foreign (non-U.S.) business targeting a U.S.-based company, or the U.S. target of a foreign purchaser, your deal may have Committee on Foreign Investment in the United States (CFIUS) implications ...
The Canadian government, concerned about the impact of COVID-19 on corporate valuations, has issued guidance that it will pay particular attention to foreign direct investments of any value (meaning, even investments that are not subject to review under the Investment Canada Act (the “ICA”)). The government’s announcement does not amend the ICA, nor any thresholds for review ...
The Covid-19 pandemic situation has emerged as more than just a healthcare crisis. Accordingly, the focus is to address and anticipate at the same time the economic and social implications which are still at an early stage. What we are rapidly starting to acknowledge is that the circumstances created by the pandemic have revealed legislative gaps and vulnerabilities, which need to be addressed in order to avoid further negative impacts to the extent possible ...
Broad scope of application The FSR targets any undertaking engaged in an economic activity in the internal market that has received a foreign subsidy distorting the internal market. A foreign subsidy is any financial contribution provided by a third country (non-EU Member State) which confers a benefit on an undertaking engaging in an economic activity in the internal market and which is limited to one or more undertakings or industries ...
Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...
Between 22 May 2012 and 4 June 2012, staff teams from the European Commission, European Central Bank and International Monetary Fund (“IMF”) visited Lisbon to conduct the fourth review (the “Review”) of Portugal’s economic programme (the “Programme”). A copy of the initial statement can be downloaded here:http://ec.europa.eu/economy_finance/articles/financial_operations/2012-06-04-portugal_en.htm And a copy of the full report can be downloaded here: http://ec.europa ...
After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
Judgement of the European Court of Justice in case C-212/03 – Commission v. France, dated 26 May 2005 The Commission acted against France on the grounds that certain French rules on the importation of medicines are contrary to Article 28 of EC Treaty on the free movement of goods. The relevant national rules and administrative practice required a licence for the importation of medicines for personal use in France ...
