Historically there has been relatively little enforcement focus on the typical physician-ownership model used by many ambulatory surgery centers (ASCs). A qui tam lawsuit filed recently against an ambulatory surgery center company based in Nashville, however, indicates that qui tam relators are leaving no stone unturned as they look for cases. Although the federal government has declined to intervene in U.S. ex. rel Thomas Reed Simmons v. Meridian Surgical Partners, et ...
It’s well known that computer programs enjoy copyright protection - many have also been patented, but that’s another story and I’m not going to deal with that here. The South African Copyright Act has protected computer programs as a specific category of works since 1992, although prior to that they were protected as ‘literary works’ ...
On February 26, 2013, the National Institute of Standards and Technology ("NIST") issued a Request for Information ("RFI") to gather comments regarding the development of a framework to reduce cybersecurity risks to critical infrastructure. As we previously reported, the Obama Administration’s executive order, Improving Critical Infrastructure Cybersecurity (the "Executive Order"), released on February 12, 2013, directs NIST to coordinate development of this framework ...
Data Privacy Act of 2012 The Data Privacy Act (Republic Act No. 10173) seeks to protect the confidentiality of “personal information.” The latter is defined as “any information whether recorded in material form or not, from which the identity of an individual is apparent or can be reasonably and directly ascertained by the entity holding the information, or when put together with other information would directly and certainly identify an individual ...
It took thirteen years, four months, and five days of heated debates and passionate protests before the country’s first reproductive health law was passed. Four days shy of Christmas last year, President Aquino finally signed the 24-page bill into law. It is now Republic Act No. 10354 or The Responsible Parenthood and Reproductive Health Act of 2012 (RH Law). The passing of the RH Law, however, does by no means close this chapter of Philippine history ...
What it’s aboutThe Data Privacy Act (Republic Act No. 10173) seeks to protect the confidentiality of “personal information.” The latter is defined as “any information whether recorded in material form or not, from which the identity of an individual is apparent or can be reasonably and directly ascertained by the entity holding the information, or when put together with other information would directly and certainly identify an individual ...
What it’s aboutThe Cybercrime Prevention Act (Republic Act No. 10175) penalizes “cybercrimes”— acts that fall into any of these major categories:a) offenses against the confidentiality, integrity and availability of computer data and systems (e.g., illegal access, data interference);b) computer-related offenses (e.g., computer-related forgery and fraud);c) content-related offenses (e.g ...
A new program taking effect in March provides hospitals with a new option to secure funds for financing acquisitions and refinancing debt. On February 5, 2013, the Office of Hospital Facilities published a new rule that will enable qualifying hospitals to finance their acquisitions and/or refinance their existing debt with FHA insurance even if the hospitals do not have FHA-insured mortgages ...
Sixteen years since the enactment of Law No. 7 of 1996 regarding Food (“the 1996 Food Law”), the Government issued the new Food Law (ie Law No. 18 of 2012) (“Food Law”) on 18 October 2012, two days after World Food Day. The Food Law replaces The 1996 Food Law. The Food Law covers three significant areas which were not governed by the 1996 Food Law, ie imports of food; the halal requirement; and the establishment of a new non-ministerial agency in-charge of food matters ...
The Government finally issued Government Regulation No. 82 of 2012 9regarding the Implementation of Electronic Systems and Electronic Transactions (“Regulation 82”) for Law No. 11 of 2008 regarding Electronic Information and Electronic Transactions (“Law No.11”). Regulation 82 sets out significant requirements in relation to electronic registration/certification, electronic systems, electronic transactions, electronics agents, electronic signatures and domain names ...
Under the Patient Protection and Affordable Care Act (“PPACA”), an employer that employs an average of at least 50 full-time and full-time equivalent employees (a “Large Employer”) during 2013 may be subject to a penalty in 2014 if the Large Employer fails to offer “minimum essential coverage” to all but 5 percent (or, if greater, five) of its full-time employees (“No Coverage Penalty”) ...
The long awaited Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Regulation amendments (the “Changes”) to incorporate the changes made by Health Information Technologyfor Economic and Clinical Health (HITECH) in 2009 as part of the American Recovery and Reinvestment Act and by the Genetic Information Nondiscrimination Act (“GINA”) were recently released ...
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 ...
On November 16, 2012, European Data Protection Supervisor Peter Hustinx published an Opinion on the European Commission’s Communication on cloud computing (part of the Commission’s broader cloud computing strategy) ...
According to a recent article by Shoosmiths, the cloud software market generated $22 billion in revenue in 2011, and expects growth to $67.3 billion by 2016 Alongside the benefit of cloud computing, however, lies a lack of transparency for cloud customers, causing legitimate concerns about how they can comply with the Data Protection Act 1998 (DPA) ...
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 ...
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 ...
What's all this about penguins, pandas and search engine optimisation? Optimising websites to rank highly in Google search results is a lucrative industry. For years, businesses have employed search engine optimisation (SEO) providers to boost rankings ...
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 ...
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) ...
On November 10, 2012, the German working group on technical and organizational data protection matters published guidelines (in German) on the technical and organizational separation requirements for automated data processing on shared IT systems (the “Guidelines”). The working group is part of the Conference of the German Data Protection Commissioners, which recently concluded its 84th Conference in Frankfurt (Oder) ...
