The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has begun the pilot phase of HIPAA privacy and security audits of health care providers, health insurers and health care clearinghouses (“covered entities”) to assess HIPAA compliance efforts. Up to 150 covered entities will be subject to the initial audits, to be conducted by KPMG, LLP, the OCR audit contractor ...
The Centers for Medicare and Medicaid Services (CMS) on February 16, 2012 proposed rules1 implementing Section 6402(a) of the Affordable Care Act,2 requiring persons to report and return Medicare overpayments by the later of 60 days after an overpayment is identified or the date any corresponding cost report is due. Twice in the past, CMS had proposed rules requiring the return of Medicare overpayments, but did not finalize the regulations ...
Today, Google have made the very interesting (but arguably provocative) move of completely rejecting the French data protection regulator's request to put a hold on the implementation of proposed changes to its privacy policies. In doing so it has become the subject of a Europe-wide investigation. What has changed? Up until today, the information collected by Google on each of its platforms, such as Gmail and YouTube, was kept separate ...
Law no.11/2012 of 8 March establishes new rules for prescription and dispensing of medicines. Prescriptions for medicines must now include the International Nonproprietary Name (INN) of the active substance,its pharmaceutical form, the dosage, the presentation and the posology. The prescription may also include a trade name by brand or indication of the name of the holder of the marketing authorisation ...
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 ...
The U.S. Fourth Circuit Court of Appeals has reversed a $44 million judgment against Tuomey Hospital in Sumter, South Carolina that arose from Tuomey’s employment arrangements with physicians that allegedly violated the federal Stark Law.1 The Stark Law prohibits hospitals from submitting claims to Medicare for designated health services that were referred by physicians with whom the hospital has a financial relationship, unless the relationship fits within an exception ...
In Greek mythology, Prometheus stole fire from Zeus to give to mankind. It seems that Zeus is now reclaiming some of that fire in the guise of Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150 (U.S. Mar. 20, 2012), the Supreme Court’s latest decision addressing patent-eligible subject matter. But a practical analysis of Prometheus reveals strategies one can use in drafting patent claims to keep those claims burning ...
The Fourth Circuit has just released its highly anticipated keyword advertising decision in Rosetta Stone Ltd. v. Google Inc., No. 10-2007 (4th Cir. Apr. 9, 2012), vacating much of a district court order favorable to Google ...
A trubunal has ruled that an employee was fairly dismissed for makng vulgar comment to female colleague on his facebook page while at home. A recent decision from a tribunal in Northern Ireland held that an employee was fairly dismissed because comments which he posted on his Facebook page amounted to harassment of a female colleague and was in breach of the employer’s Dignity at Work Policy ...
With the Information Commissioner's Office (ICO) grace period for enforcing the new cookies rules almost at an end, companies should work with their website developers at an early stage to ensure compliance. The ICO will soon be confirming that its 12 month ‘lead in’ implementation period has come to an end. Website operators then run the risk of enforcement action and fines if they fail to comply with the new cookies regime ...
On 1 March 2012, Google launched a new privacy policy by consolidating over 60 of its global privacy policies into one document. The new privacy policy does not indicate that Google will collect any new or additional data about users. What it does do, however, is inform people that Google will merge data which it already collects from services such as YouTube and Web History (which records all searches performed on Google ...
New law regarding the use of cookies on websites was introduced in the UK in May last year. Broadly speaking, the new law requires a website owner/operator to: - tell users that cookies are used on its website; - explain to users what the cookies are doing; and - obtain users’ explicit consent to store cookies on their device. The Information Commissioner is responsible for enforcing this new law ...
Three recent decisions bolster a generic manufacturer’s ability to challenge Orange Book listings and obtain ANDA approval through section viii “carve-outs.” In Caraco v. Novo Nordisk1 the U.S. Supreme Court unanimously held Caraco could use the Hatch-Waxman’s counterclaim provision to correct Novo’s overbroad use code. In AstraZeneca v. Apotex, the U.S ...
In the great George Orwell novel “Nineteen Eighty-Four,” the Ministry of Truth is a vast bureaucracy that ironically exists to falsify historical events in the service of political ideology. Its headquarters is an 80-story building of 3,000 rooms, and its outside walls bear the words “War is Peace,” “Freedom is Slavery,” and “Ignorance is Strength ...
New amendments to the Regulation on Health Conformity of Dietetic Products have entered into force on 28 May 2012. Here are some of the most significant changes that are prescribed by these amendments to the Regulation. As a reminder, this is a regulation that introduced the obligation of the registration of dietetic products (including supplements) in July 2010, and is a regulation that regulates the issues of labelling and the composition of these products in details ...
The provision of gifts and hospitality to public officials has recently been the subject of a number of news stories in the Serbian media, covering not only the official reports on the variety of protocol gifts received by the high ranking officials from the leaders of other countries, but also the alleged corruption affairs involving the potential bribing of various lower-level officials by companies and individuals seeking an unfair advantage in the market ...
After several delays, ICANN has published the list of generic top level domain (“gTLD” or “string”) applicants and the gTLDs they have applied for. This new initiative from ICANN will allow a wide variety of entities to act as registrars for gTLDs of their choosing. Once these systems are up and running, consumers will be able to access websites not only ending with .com or .net, but also ending with .NETFLIX, .AOL, and .PIZZA. The list can be found at:http://newgtlds.icann ...
On January 24, 2011 the Attorney General of the Federal Republic of Brazil signed a document restricting the powers of ANVISA (Brazil’s regulatorybody) in the examination of pharmaceutical applications, giving the rights to the Brazilian PTO to do so without any interference of ANVISA. The dispute between ANVISA and the Brazilian PTO in the examination of pharmaceutical applications had apparently been solved ...
Creators of software programs may not be able to prevent the resale of 'used' copies of software programs legitimately paid for and downloaded by their own customers from the internet.It follows a recent Opinion from Advocate General Yves Bot, a legal adviser to the European Court of Justice (ECJ), in Axel W. Bierbach (liquidator of UsedSoft GmbH) v Oracle International Corp ...
CLS Bank and Bancorp: Back to Back Federal Circuit Decisions Offer Different Conclusions on Patentability 08/03/2012 Richard D. Rochford, Casey H. Kempner The issue of whether particular inventions include “patent eligible” subject matter under § 101 of the patent statute has become highly controversial in recent years, raising questions with high economic stakes and profound legal and philosophical implications. Twice the Supreme Court has entered the fray, first in Bilski v ...
Introduction Title and date of national law The Act on the protection of privacy in relation to the processing of personal data of December 8,1992 (the 'Data Protection Act' or 'DPA') and its Royal Decree of February 13, 2001. Relation with international instruments The DPA implements EU Directive 95/46/EC on the protection of individuals regarding the processing of personal data and the free movement of such data ...
Few may rebate that internet, is majorly responsible for most of the mayor changes in the past fifteen years in fields such as science, communications, technology, commerce amongst other being necessary to adapt the legal system regulating it. Honduras has not been the exception in this modernization process regardless of the civil code nature of its legal system which is not as adaptable as common law systems are ...
On September 17, 2012, the Department of Health and Human Services (“HHS”) announced a $1.5 million settlement with the Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates Inc. (“MEEI”) for potential violations of the HIPAA Security Rule ...
Currently a large part of politicians, economists and lawyers are working hard to ensure that a recent Lithuania’s bank bankruptcy story would not repeat itself. Sometimes people still associate the term “bank” with instability, possibility to lose something or lack of transparent governing. Maybe this is the reason why there are no biobanks in Lithuanian which are widespread in the EU and other countries of the world ...
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 ...
