Diversified Insurance Group has been a member of TechAssure almost since its inception.  TechAssure is a non-profit organization founded in 2001 for insurance and risk management professionals dedicated to serving clients in the Technology, Life Sciences, Digital Media, and Venture Capital industries.

Check out this video featuring John Love, the President of TechAssure

At the inception of TechAssure it was agreed that the insurance policies then in existence did not adequately address the major risks of the average technology or life science company. These companies were typically venture-backed and were growing rapidly. TechAssure members came up with a wish-list of coverage enhancements and pricing targets and partnered with the leading insurance carriers in these areas to create best-in-class coverage forms that are offered at preferred rates. TechAssure later did the same thing for Venture Capital and Private Equity Funds creating an Asset Protection Program endorsed by the NVCA that addresses the unique exposures that VC/PE managers and members have in running their funds. It is much like a D&O policy but tailored to cover big liability holes that exist for fund managers and members in the execution of their duties in their respective roles.

I have recently had a very real, very personal experience regarding the value of Electronic Medical Records (EMRs). My mother suffered a stroke over a year ago but is largely recovered and living independently in the Southeast. While visiting a daughter in Texas she had an unexplained “episode” for which she would have visited her primary care physician. Because she was away from home and thus with no medical history that followed her, she chose not to visit the emergency room as the immediate symptoms had passed. Unfortunately, she had a repeat episode that was a bit more severe and was whisked away to the local emergency room outside of Dallas. She was subjected to a whole battery of tests, from simple bloodwork to a full MRI in an attempt to diagnose her symptoms. We are still awaiting the results. Had the doctors at the medical facility in Texas been in possession of her full medical history, they may have much more quickly (and possibly much more inexpensively) diagnosed her condition.

At the most basic level, EMRs are digital documentation of a doctor visit, including patient histories, exam notes, tests ordered, drugs prescribed, and any test results. Some systems check for drug interactions, access X-rays, or deliver a prompt when a patient has not had a flu shot. The preventive aspects alone can save millions of dollars and thousands of hospitalizations. The problem with our current situation is the incentive system at play. Doctors get paid for service, not wellness. EMRs require time and money to implement for which doctors are not compensated.

Privacy Concerns have dogged the adoption of Electronic Medical Records but EMRs allow for a number of very real advantages. People with significant or lengthy health / medical records often find it hard to shop for doctors. EMRs allow an easier transfer of information for people seeking specialists and can greatly reduce the number of expensive tests required for a person.

Doctors can debate, but it looks as if Electronic Medical Recprds are here for the longterm. The American Recovery and Reinvestment Act states that every American should have an electronic medical record by 2014. The Obama administration is looking to speed the transition by providing financial incentives, up to $65,000 apiece to eligible physicians, starting in 2011.

Wired magazine has a good article about EMRs that further discusses additional ramifications and concerns.

For a somewhat opposing view on the problems with implementing EMRs, BusinessWeek has an interesting story.

The good folks over at Philadelphia Insurance Loss Control provided a great update on the Swine Flu (Influenza A Virus subtype H1N1) and I am sharing it below:

The Obama administration declared recently a public health emergency in response to the increase in Swine Flu cases in the United States and in the world. Like seasonal flu, swine flu is a respiratory disease caused by viruses that usually effect pigs. Swine Flu has spread from person-to -person, like influenza, in the past, but was limited and not so widespread.
About the Swine Flu:
The Swine Flu that has caused these actions is a respiratory disease of pigs caused by type A influenza viruses that causes regular outbreaks in pigs and in the past was not generally transmittable to people. Occasionally these viruses change and it appears that this strain has and is now transmittable to people.

Where it Originated:
The outbreak that has been in the news appears to have originated in Mexico and at this point in time has affected people who were in Mexico (in some cases students on spring break and on school trips) or who might have been in contact with affected individuals. The symptoms of Swine Flu in people are similar to the symptoms of regular flu we are accustomed to dealing with and include fever, cough, sore throat, body aches, headache, chills and fatigue. Centers for Disease Control and Prevention (CDC) recommends that U.S. travelers avoid all non-essential travel to Mexico.

What We Can Do:
Swine Flu can be transmitted in ways similar to the ‘regular’ flu, through coughing, sneezing or by touching something with flu viruses on it and then touching the mouth or nose. Because there is no vaccine available now to prevent this flu, it is important that we all practice the everyday actions that can help prevent the spread of germs that cause respiratory illnesses like influenza.

These steps include:

• Covering your nose and mouth with a tissue when you cough or sneeze.
  Then make sure to throw the tissue in the trash after you use it.
• Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hand cleaners are also effective.
• Avoid touching your eyes, nose or mouth. Germs spread this way.
• Try to avoid close contact with sick people.
• If you get sick with influenza, it is recommended that you stay home from work or school and limit contact with others to keep from infecting them.

It is important to note that as of now there is no epidemic or a reason to panic. The U.S. and other governments are taking actions in order to prevent this from developing into a Pandemic and to raise awareness to everybody about the importance of following these preventive tips.

To learn more about Swine Flu, please view the following Links:

Safe Wise Swine Flu Release
Safe Wise is a preferred vendor of Philadelphia Insurance and they provide Risk Management consulting, training and support services to national organizations.

The CDC Swine Flu Main Page – The Centers for Disease Control and Prevention (CDC) runs up to date information on the escalating problem with the Swine Flu. Interim Guidance Updates are made daily on the CDC website.
The Pandemic Flu Website
The Pandemic Flu website provides comprehensive government wide information on Pandemic flu viruses for the general public. This includes Swine Flu, Avian Flu, General Influenza, etc.

I was doing some internet research on clinical trials for one of our clients yesterday and ran across a piece that was quite interesting and relevant to any company contemplating clinical trials. It is actually over a year old, but the information is just as current and appropriate today. I found it on ClinPage which is a daily online publication about the operational aspects of clinical trials.

If you’re a small sponsor getting ready for a clinical trial, plan on shelling out at least $10,000 to $25,000 more per year than the actual cost of that study.

This is not for investigators who suddenly want more money, or for extra recruiting efforts. It’s for clinical trial insurance. And it’s a must.

“Most trials won’t move forward unless the sponsor has insurance,” said Julie Davis, a managing director with Chicago-based insurance brokerage Aon Corp. While such insurance isn’t required by law in the U.S., she says, venture capital backers and hospitals who work with a sponsor won’t even get involved in a trial if the insurance isn’t in place.

Litigious Environs

“We’re in such a litigious environment here in the U.S. now, it’s just a prudent business practice,” added Tom Konopka, senior vice president of business development and marketing for Medmarc Insurance Group, an underwriter of clinical trials insurance.

The clinical trials insurance business—product liability coverage designed to respond to claims brought by study subjects or their families for bodily injury—has been around as long as there have been clinical trials. But only in the last decade has the field seen the emergence of underwriters who specialize in it, said Davis. Today, in the U.S., those are Medmarc, Chubb, CNA Insurance and ACE Group of Companies. There are, of course, more brokers who market and sell this insurance to sponsors, yet even that field is relatively small. But it’s picking up steam.

More Drugs; More Insurance

Why? Several factors are coming together, said Davis. Increasing government involvement in clinical trial regulation is causing all in the industry to be more careful, and fearful of lawsuits. In addition, the introduction of drug distribution by mail in trials has added a layer of risk.  Then there is the fear brought about by the drug disasters of recent years, and the fact that more lawyers are specializing in bringing claims on behalf of clinical trial subjects. The push in the industry for drugs to be developed faster is also a factor.

“The push to make trials shorter can add risk,” said Davis. “If you have a product you’re trying to go out with in one year versus three years, underwriters will want to know what the shortcuts are that you’re going to be taking, and what the risks are that are associated with that.”

The Matrix

Cost varies widely. Konopka said that calculating the price of clinical trial insurance is not unlike working with a Rubik’s cube. Among the multiple factors to be considered in the matrix: Is it a Phase I, II or III study? How many subjects? Is the protocol in order? Is the informed consent document airtight? How quickly and successfully was the sponsor able to recruit subjects for its last trial? How good is the reputation of the contract research organization (CRO) that’s doing the recruiting?

Konopka said most sponsors buy a yearly policy instead of insuring each trial separately. And many of the firms that have ongoing trials just roll the cost of trial insurance into their overall policy.

Big Dogs Opt Out

Interestingly, most big pharmaceutical companies don’t buy clinical trial insurance. Some may instead have a dedicated risk management division on the premises. Or they know that their cash reserves are enough to handle any settlements that need to be made. “Their balance sheet allows them to take on more risk,” said Davis. Others may buy such insurance, but will opt for a huge deductible because of their financial position, she added.

Medical device developers should purchase between $1 million and $5 million in coverage annually; drug makers probably need between $5 million to $10 million.

Complications for CROs

Buying insurance is fairly straightforward for sponsors, but it’s not so for CROs. “For CROs, it gets interesting,” said Ty Howe, national practice leader for CROs at insurance brokerage firm Marsh, Inc.

CROs, he explained, must purchase vicarious bodily injury risk, as they will likely get sued along with the sponsor, hospital and investigator, if a test subject is injured. And then secondly, they need liability insurance for claims that could be brought by the sponsor if the sponsor feels the CRO failed in any of its duties.

And these days, along with the rest of the research industry, clinical trials insurance brokers and underwriters have had to go international, opening offices around the globe and coming up to speed on trials-insurance requirements in different countries (for instance, in France and Germany, it’s against the law to go without clinical trials insurance).

—by Suz Redfearn