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Archive for August, 2010

Pending changes to insurance standards for Russian clinical trials

August 31, 2010 3 comments

Effective 9/1/10, there are changes to the Federal Drug Law pending in Russia that will have a material effect on the approval and management of clinical trials that are being conducted there. The changes are related to the regulatory approval process being transferred from the Federal Service on Surveillance in Healthcare and Social Development to the Ministry of Health and Social Development. The majority of this criteria is related to investigator sites, mainly to contracts with investigators, investigator experience, patient consents and insurance amounts. Unfortunately, the current version of the law is full of inconsistencies and requires further clarification. Many CROs are still evaluating how these changes will affect studies (specifically on start-up operations) and continue to report any new developments. The relationship between the Insurer, Insured (sponsor) and the Patient (test subject) will be defined in these new proposed regulations which are still pending approval by the Government of the Russian Federation. At this time no such “regulations” have been approved and this continues to be closely monitored.

SoCal earthquakes happen more frequently and overdue for a big one

Reports from researchers at Arizona State and UC Irvine who have investigated earthquakes along the San Andreas fault over the past 700 years suggest that Southern California is overdue for a major shock.

These researchers, as reported by the Insurance Journal, outlined that major quakes take place along the Carrizo Plain which stretches 100 miles northwest of Los Angeles every 45 to 144 years. But, it has been since 1857 that the last major quake ranging from 6.5 to 7.9 on the Richter scale took place at Fort Tejon. The research is contrary to previous studies that suggested the frequency of such large earthquakes to be much lower.

If these academics are correct, they are being mostly ignored by the insurance industry. Availability and cost of Earthquake Insurance continues to improve for most buyers. Capacity is up by about 25% Read more…

Patient records discovered at dump – perfect example of hospital privacy dilemma

On August 13, 2010, the front page of The Boston Globe reported that four Massachusetts hospitals are investigating how the unshredded health records of thousands of patients ended up at a public dump. At least some of the records contain sensitive medical information and Social Security numbers. The situation highlights the difficulties that organizations – and healthcare organizations in particular – face in protecting confidential patient or other personal information when many different people have access to such information in the normal performance of their duties. Read more…

Considerations for those with college-bound children

There is so much to consider when you send you child to college, enrolling in classes, meal plans, books, dorm rooms, spending money, tuition, clothes, safety, the list seems endless.  An article from our colleagues at Hemenway & Barnes touches areas of preparedness we may not think of, but are nonetheless very important. One area being insurance – most college students are covered under parent’s health care policies. Recent federal reform allows them to stay on as dependents until the age of 26. Additionally, many colleges also offer plans for students not already covered. Parents should also review their homeowners policies to determine in their child’s belongings would be covered in the dorm. If renting an apartment, leases may require a separate policy to cover the contents. If you have a college-bound child, I urge you to take a moment to review this article, it could save you time and worry (speaking as the father of three recent graduates).

MA town mistakenly emails personally identifiable information

On August 4, 2010, it was reported that officials in the town of Hingham, Massachusetts would be notifying approximately 1,300 individuals whose names and Social Security Numbers were mistakenly sent to about 30 town officials. Hingham officials indicated that they were notifying the state attorney general’s office and the Office of Consumer Affairs and Business Regulation of the breach in accordance with Massachusetts law.

A town official had emailed a document containing the personally identifiable information to about 30 department heads. When the official was notified that the document contained confidential personal information, he recalled the email, which had been sent to accounts maintained on the town’s protected server. The official said that about half of the emails had been successfully retrieved and destroyed before the recipients had opened them and seen the personal information. Read more…

UAE disrupting data security exposes tech companies to expanded risks

Another front in the battle over Data Security and Privacy broke out this week when the United Arab Emirates (UAE) announced its intention to shut down mobile services over Blackberry smart phones made by Research in Motion (RIM). The UAE, concerned about security and looking for ways to intercept illegal and terrorist activity, threatened to shut down the popular email and text messaging services due to RIM’s practice of encrypting such communications. Other governments are seeking similar control and access over data.

Should RIM and other service providers agree to government access to data, however, they expose themselves to increased litigation from customers and third parties. Foreign government access to data may be misused for profit by rogue elements in governments. Data Security and Privacy insurers, in a nascent field, still have little way of quantifying such data risks. Nonetheless, insurance coverage for these types of risks to telecom and data providers is available with some limitations.

The cost of Health Net’s privacy and security breach

August 2, 2010 1 comment

Health Net’s recent settlement with the Connecticut Attorney General shines a light on some of the noteworthy costs and risks of data breaches. It’s a sobering view.

In early July 2010, Health Net settled allegations by the Connecticut Attorney General that Health Net had violated its obligations under the HIPAA privacy and security rules. The settlement capped the first enforcement by a state Attorney General of HIPAA violations since such state enforcements were authorized by the Health Information Technology for Economic and Clinical Health (HITECH) Act. Read more…