The wait is over. On January 17, 2013, the Department of Health and Human Services’ ("HHS’") Office for Civil Rights ("OCR") released its long-anticipated megarule ("Omnibus Rule") amending the HIPAA Privacy, Security, Breach Notification and Enforcement Rules. These amendments implement and expand on the requirements of the Health Information Technology for Economic and Clinical Health ("HITECH") Act and the Genetic Information Nondiscrimination Act of 2008 ...
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 ...
Omnibus HIPAA Rule, Including Significant Breach Notification Rule Changes, Released by HHS - The long-awaited final rule modifying the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules (the Rule) was released on January 17, 2013 by the Department of Health and Human Services (HHS) ...
A small nonprofit hospice in Idaho became the first healthcare provider to settle a potential violation of the HIPAA Security Rule affecting fewer than 500 individuals. On January 2, 2013, Hospice of North Idaho agreed to a settlement in the amount of $50,000 with the Department of Health and Human Services, Office of Civil Rights (OCR) following an investigation relating to a 2010 breach involving a stolen, unencrypted laptop containing patient information ...
The access to records clause, sometimes called the inspection or audit clause, is a common fixture in reinsurance agreements and serves an important function. It enables the reinsurer to track the performance of the agreement and maintain an accurate view of the business ceded. More specifically, it allows the reinsurer to ensure the cedent is complying with the terms and conditions of the agreement, including timely reporting of losses and calculation of premiums ...
With a law enacted on 17 December 2012, the Finnish parliament moved forward on the longstanding plan to house intellectual property rights disputes in the Market Court. This legislative reform has a significant impact for all companies operating in Finland. The Market Court will start to hear these disputes in the autumn of 2013 ...
As we embark upon the season of goodwill, those wishing to embrace the Christmas cheer may wish to consider settlement of an ongoing commercial dispute bringing peace and goodwill to all - besides saving their business time and money in the process.Should you settle? Parties settle disputes for a variety of reasons ...
The U.S. District Court for the Eastern District of Virginia recently overturned the United States Patent & Trademark Office ("USPTO") interpretation of the patent term adjustment ("PTA") statute in Exelixis, Inc. v. Kappos. Similar to Wyeth v. Kappos, where a previous USPTO interpretation of the PTA statute was overturned, the Exelixis decision promises to add months and even years to the patent term of many patents ...
The U.S. Court of Appeals for the Second Circuit, in VAM Check Cashing Corp. v. Federal Insurance Company, No. 11-2644-cv, (2d Cir. Nov. 7, 2012), found the "overt felonious act" requirement in a crime insurance policy to be ambiguous. The court held, therefore, that the insured would be entitled to coverage for a theft at the insured’s store, even though it occurred as a result of a covert scheme to defraud ...
Narrow Construction of Food & Drug Act Undermines FDA Regulation, Class Actions A divided panel of the Second Circuit Court of Appeals in New York overturned on First Amendment grounds the conviction of a pharmaceutical sales representative for conspiracy to introduce a misbranded drug into interstate commerce, an offense more commonly referred to as off-label marketing. The decision, United States v. Caronia, No. 09-5006-cr (2d Cir. Dec ...
A Polish company enters into a contract with a German company. Which country’s law will govern the contract? Monika Hartung: To start with, under Art. 3 of the Rome I Regulation (Regulation 593/2008 of 17 June 2008 on the law applicable to contractual obligations), the parties themselves may select the law governing the contract. The previous version of Poland’s Private International Law required the existence of a link, e.g ...
With the continued development of the Marcellus and Utica Shale, businesses in West Virginia, Pennsylvania and Ohio are experiencing rapid growth and facing many issues related to this growth they had not previously experienced. One important consideration is whether and how to insure these growing assets. While myriad issues may arise regarding insurance, this article will address some general types of insurance coverage growing businesses should consider ...
On November 26, 2012, the Department of Health and Human Services’ Office of Civil Rights (“OCR”) published guidance on the two methods for de-identifying protected health information (“PHI”) in accordance with the HIPAA Privacy Rule ...
We are all too familiar with stories of contaminated food and drugs that sicken and even kill consumers. Given the increasing number of product recalls and their enormous financial impact, it is not surprising the demand for recall insurance has increased exponentially in the middle market. Why has the number of recalls increased so dramatically? The answer is twofold ...
The rapid growth of the hospice industry has attracted the attention of Congress and federal and state healthcare regulatory and enforcement agencies. The Patient Protection and Affordable Care Act (the “ACA”), signed into law by President Obama on March 23, 2010, included several provisions aimed at hospice providers ...
On November 15, 2012, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) issued a report titled “Personal Care Services: Trends, Vulnerabilities, and Recommendations for Improvement,” which included a response from the Centers for Medicare and Medicaid Services (CMS) ...
Skilled nursing facilities (SNFs) billed one-quarter of all claims in error in 2009 – resulting in $1.5 billionin inappropriate Medicare payments – according to a report released by the Department of Health and Human Services’ Office of Inspector General (OIG) on November 9, 2012. The OIG noted that the majority of the inappropriate claims were upcoded, and many involved claims for so-called “ultrahigh therapy ...
Insurers are well aware of the typical bad faith scenario in third-party claims. Counsel for a claimant sends a demand for policy limits to the insurer in the hope that the insurer does not accept within a time limit specified in the demand ...
FAQ on the Belgian Pre-Contractual Information in the Framework of Commercial Co-operation Agreements Act of 19 December 2005.Belgium has a specific legal regime protecting the economically weaker party in certain commercial partnership agreements (i.e. the Pre-Contractual Information in the Framework of Commercial Co-operation Agreements Act of 19 December 2005 – “the Act”) ...
The General Medical Council has issued definitive guidance on doctors' duties when they fear a child in their care is suffering from abuse. The GMC's 2012 Guidance on Child Protection came into effect on 3 September 2012 after a two-year working group - chaired by a senior family court Judge, the Right Honourable Lord Justice Thorpe - listened to evidence given by child protection experts ...
On 15 October 2012, the Federal Government announced the appointment of an expert panel to review pharmaceutical patents in Australia (Review). The Review will focus particularly on the extension of term provisions in Chapter 6, Part 3 of the Patents Act 1990 (Cth). Those provisions currently allow the extension of pharmaceutical patents up to five years beyond their standard 20-year term ...
On Aug. 31, 2012, the United States Court of Appeals for the Second Circuit issued its decision in In re Charter Communications Inc., (2d Cir. Aug. 31, 2012), expressly adopting an abuse of discretion standard for reviewing equitable mootness determinations ...
Following the important judgment rendered by the Court of Appeal on August 2, 20121, the Court has ruled once again, on September 27, 20122, on the exclusions for gross fault with respect to professional liability insurance. In addition, the decision confirmed, as provided in the Civil Code, that an intentional fault is never covered ...
Following the important judgment rendered by the Court of Appeal on August 2, 20121, the Court has ruled once again, on September 27, 20122, on the exclusions for gross fault with respect to professional liability insurance. In addition, the decision confirmed, as provided in the Civil Code, that an intentional fault is never covered. THE FACTS After their mother’s death, Pierre Audet and Marie Audet ("the Audet") hired Jacques-André Thibault ("Thibault") to manage their assets ...
Over the course of 2012, on at least three occasions the Federal Circuit has found anticipation in a situation in which previously the invention would have merely been viewed as obvious:(1) where the prior art merely proposes the steps of the method, without knowledge of whether those method steps will achieve any result, much less the result claimed in the therapeutic method; (2) where the prior art discloses a broader range without providing a “pattern of preference” for a later-claimed narrow
