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HIPAA disclosure laws: understanding the “standard of minimum necessity”

December 15, 2014 Leave a comment

hipaaEarlier this year, reports surfaced of a hospital employee facing criminal charges for violating HIPAA privacy requirements, prompting discussion about the intense scrutiny and punishment being handed down by courts in these cases. The HIPAA Privacy Rule regulates the use and disclosure of Protected Health Information (PHI) held by covered entities and gives patients an array of rights with respect to that information. But at the same time, the rule also permits the disclosure of health information (without a patient’s express written authorization) that may be needed for patient care and other important purposes, such as law enforcement purposes or to facilitate treatment, payment and health care operations. In light of the recent Ebola outbreak in West Africa and the subsequent infection of U.S. and other foreign aid workers with the disease, it’s important for hospitals, physicians and other health care providers across the country to familiarize themselves with these specific exceptions to the law. Read more…

FDA delays generic drug label warning update

December 11, 2014 Leave a comment

fdaThe U.S. Food and Drug Administration’s final rule on generic drug label warning regulations won’t be published until late next year, according to last month’s announcement from the federal agency. Since late 2013, FDA officials have collected feedback on a proposal to grant generic drug manufacturers permission to update product labels independently with new safety information without having to wait until the brand-name counterpart drug makes similar changes. Due to intense interest and a great deal of public input from various industry groups, the FDA pushed the decision back from this month until September 30th, 2015. The proposal has ignited heavy debate between plaintiff’s lawyers and the pharmaceutical industry, since the decision would overturn the U.S. Supreme Court’s 2011 ruling in Pilva v. Mensing, which limited the liability of generic manufacturers. Under the Mensing decision, generic drug labels are required to match brand name products, which shields generic makers from failure-to-warn suits since they have little control over what safety information is provided to patients. Read more…

Body cameras in healthcare

December 8, 2014 Leave a comment

dr_cameraMuch of the post-Ferguson conversation has been around cameras that might be mounted on more police officers.  Already in use in some places for the protection of the public (and sometimes, the police) from false reporting of crimes, these cameras are not limited to improving security.

Fans of author David Eggers may recall that in his recent novel The Circle (an internet age 1984 story), the fictional combo Amazon/Google monster known as The Circle mounts cameras on all of its employees. From there, it moves on to bringing truth (or at least truthiness) to the political sphere when politicians try to outdo each other for the title of “most transparent” by agreeing to wear cameras provided by The Circle.  Needless to say, this puts immense power in the hands of the three mysterious founders of The Circle, and drama and sadness follow. Read more…

B Corps pose new risk for directors and officers

November 24, 2014 Leave a comment

profit_environmentA company’s board of directors and officers hold many distinct roles and responsibilities, from setting corporate policies to investment and asset management. Their duties to both shareholders and employees mean these individuals must continually work to balance the interests of various stakeholders, thereby increasing their exposure to liability and legal claims. Defense against these risks is a challenge in and of itself, but what happens when there is an additional social benefit cause to uphold as well? The directors and officers of benefit corporations (B Corps) must simultaneously balance profit goals alongside a specific social or environmental cause that the company seeks to support. Doing so can become problematic, especially with multiple leaders at the table vying for decision-making power. Read more…

2014 has been a year of solar innovation

November 19, 2014 Leave a comment

solarThanks to creative financing programs, federal tax credits and an overall reduction in product prices, solar power usage continues to accelerate at an increasing rate. Since 2010, the number of U.S. homes with solar power rooftops has nearly tripled. From homeowners and American businesses, to the U.S. government and education system, the solar industry keeps growing. According to data from the Solar Energy Industries Association (SEIA), more than a half-million U.S homes and businesses now utilize solar power. Furthermore, over fifty percent of all new electric capacity came from solar power during the first half of 2014. Read more…

Risk management, commercial insurance and employee benefits considerations for medical marijuana start-ups

November 13, 2014 Leave a comment

medmarSay that growing and distributing cannabis for medical treatment is your business. You are a classic entrepreneur – quite possibly personally funded. You are accustomed to quickly evaluating business opportunities and you are prepared to move swiftly when the occasion warrants. You have carefully selected a corps of legal and financial advisors to compliment your high energy. They understand your business and your objectives and are able to perform proper due diligence without delay when you come upon a compelling new deal. They also allow you to move quickly, enhancing the likelihood that any new venture will be worthwhile.

Legal and financial issues immediately garner your attention; however, two oft-forgotten components in this arena are risk management and human resources. Unfortunately, inattention to these areas can potentially and without warning end an investment before it begins. Read more…

Patent trolls threaten innovation

November 12, 2014 Leave a comment

Over the past few years, the challenge of protecting Intellectual Property (IP) at developing technology companies has reached a point of crisis. The problem stems from Non-Practicing Entities lodging unwarranted litigation. They are known as NPEs or sometimes referred to as the illustrative description of patent trolls. Last year, it was reported that the patent trolls problem cost American companies close to $13 billion in litigation settlements and attorney’s fees. The business of shaking down technology companies has become a $3.2 trillion industry globally, with over 11,000 companies having been accused of patent infringement at least once in the past decade. This is an astounding amount of capital that should otherwise be spent on driving innovation and economic growth.

And there’s a reason why you don’t you hear more about it. Many companies that have been victims of a patent troll scenario rarely go public out of fear of future attacks. Read more…

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