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ABPI sets new clinical trials standards; compensation regulations amended

January 15, 2015 Leave a comment

lab06The Association of the British Pharmaceutical Industry (ABPI) recently released updated guidelines for all UK clinical trials beginning January 1st, 2015. The standards consist of two main sections:

  • Phase 1 Clinical Trials Compensation Guidelines
  • Phase II, III and IV Clinical Trials Compensation Guidelines

Read more…

Disrupters: Flying in the face of regulations and risks

January 13, 2015 Leave a comment

fishThe shared economy continues to expand – from home rentals and personal drivers, to babysitting and cleaning jobs – this new breed of businesses are popping up all over, allowing customers to make simple online arrangements with service providers for a myriad of tasks. The premise behind the shared economy takes established business models and turns them on their head, and thanks to their unconventionality, these companies are “disrupting” major markets by luring consumers away from the more traditional forms of the same service. Entrepreneurs are launching their online companies via an app that can promise faster, cheaper and more accessible services, all while quietly avoiding many of the cumbersome insurance and regulatory laws that govern their traditional counterparts. Read more…

TRIPRA passes Senate – six-year extension relief for terrorism insurance buyers

January 9, 2015 1 comment

court2The U.S. Senate voted 93-4 yesterday in favor to pass the Terrorism Risk Insurance Program Reauthorization Act of 2015 (TRIPRA) following passage of the same version of the bill (H.R. 26) in the House on Wednesday. Thursday’s vote ended weeks of anxiety for buyers of terrorism insurance caused by the Senate’s failure to reauthorize the bill on December 31st, 2014. Once signed by President Barack Obama, the law extends the federal terrorism reinsurance program for six years.

The bill includes several changes with respect to the reinsurance mechanics of the Act, none of which are expected to impact insurance buyers:

  • Program Trigger phased in increase starting on January 1, 2016 by $20 million per year:
    • 2015 – $100 million
    • 2016 – $120 million
    • 2017 – $140 million
    • 2018 – $160 million
    • 2019 – $180 million
    • 2020 – $200 million
    • Read more…

The Top Ten Risks of 2015

10risks2015WGA announces the Top Ten Risks of 2015, a forecast of some of the major business risks facing companies over the coming year.

1.   Clean Tech Risks in Response to Lima Protocol

The recent U.N. Climate Change Conference in Lima, Peru just ended, calling for nearly 200 countries to set out specific climate change targets during Q1 of 2015. Massive new concentrations of wind and solar energy farms bring about new risk aggregations for the coming decades. Read more…

2015 OSHA regulations shorten notification period to 24 hours

December 23, 2014 Leave a comment

hardhatConstruction companies will face stricter federal injury and accident reporting requirements next year, as the U.S. Occupational Safety and Health Administration (OSHA) aims to improve jobsite safety and enhance tracking and analysis of worksite injuries. Beginning January 1st, 2015, construction employees and contractors must report all jobsite fatalities, hospitalizations, amputations and eye injuries to OSHA within 24 hours. Worksite fatalities must be reported within eight hours. The new law revises current regulations, under which employers are only required to notify OSHA in the event of a worksite fatality or an accident that sends three or more employees to the hospital. Under the new laws, OSHA officials expect to see an increase in the number of reported injuries and gather more detail into the specific causes of these accidents. Doing so will help improve risk analysis and mitigation strategies on construction sites. Read more…

TRIA expiration two weeks away as Senate fails to reauthorize bill

December 18, 2014 1 comment

terrorismTRIA Set to Expire on December 31, 2014  Senate Fails to Reauthorize
The insurance industry and policyholders of TRIA coverage were shocked by the news that the U.S. Senate failed to reauthorize the Terrorism Risk Insurance Act (“TRIA”) before the 113th Session of Congress adjourned for the year at midnight on December 16th.

What does this mean for buyers of insurance?
Since the Senate failed to either extend or reauthorize TRIA, the backstop it automatically provided to insurance Carriers will cease as of December 31, 2014. However, some Carriers have provided buyers with policies that contained special provisions would continue to provide the coverage in the event that TRIA expired and that continues through the end of the policy period. While it’s unclear how the industry will respond during the coming year, certain Carriers have stated that they will continue to provide coverage, even without a formal provision in effect. Read more…

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…

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