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Archive for August, 2013

FDA’s new cyber security lab tests for “fuzzing” to promote medical device safety

August 26, 2013 Leave a comment

pacemakerThe FDA will reportedly launch a new cyber security laboratory to address security concerns for medical devices. The administration says that it is in the midst of developing new product regulations for medical device manufacturers to guard against hacking attempts. The labs will be used to test medical devices for vulnerabilities to data “bugs” that cause software to crash and disable system functions. The process, called “fuzzing” subjects a piece of software in the device to an influx of unintended input data requests in order to test how the device responds. The results help determine any vulnerabilities and allow manufacturers to fix them before the product is released, thus making products safer for patients and less likely to break down.

The announcement comes in response to several warnings from the National Institute of Standards and Technology (NIST), security researchers and other government agencies about the need Read more…

Massachusetts Wellness Tax Credit for small employers

kates blogThe financial savings of a wellness program have long been debated between Human Resource and Finance professionals. Large employers, those with 100 or more employees enrolled on their medical plan, have the ability to monitor claims and thus view any improvement in claims.  Therefore, large employers have been more likely to institute a wellness plan since they are able to track the potential impact of a wellness program on their population’s health. Even still, this argument is often not concrete enough to convince large employers to spend the money required to see meaningful improvements in employee health.

Convincing smaller employers to institute wellness programs has been even more difficult. Since small employers are often partially community-rated and do not generally have access to claim data, Read more…

NIH cancels 40 clinical trials in India

August 12, 2013 Leave a comment

pills 2Six months after an apex court slammed Indian pharma MNC’s and researchers for failing to regulate the country’s drug trials environment, the National Institute of Health (NIH) has canceled 40 ongoing clinical trials in India. Despite the Health Ministry’s attempts to improve laws and procedures surrounding the trials, NIH (a branch of the US Department of Health and Human Services) called the regulatory environment still too unstable to continue.

Last January, India’s Supreme Court ordered that all clinical drug trials be performed under the Centre Health Secretary, after the apex court blamed the Health Ministry for neglecting to regulate illegal trials that caused the deaths of thousands of trial subjects. In turn, a growing number of trial sponsors have been driven out of the country to other Read more…

Protecting the health and safety of your employees that volunteer

habitatWhat exactly is your duty of care for your employees that volunteer for company sponsored activities?

Volunteer activities have a very wide range, from direct service activities such as serving food, performing home repair services to providing transportation, fundraising, tutoring, or coaching a sport.

The U.S. Bureau of Labor Statistics reported that about 64.5 million people volunteered through or for an organization at least once between September 2011 and September 2012. Given the millions of volunteers and the thousands of different roles they play, it is inevitable that on occasion, a volunteer will be injured Read more…