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Factors to Consider Regarding FDA Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

Posted by Bruce Ball on Aug 9, 2016 9:44:00 AM

On June 16, 2016 the Food and Drug Administration (FDA) released long awaited guidance on benefit and risk factors entitled Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions. This draft guidance will be important to Life Science diagnostic and therapeutic medical device companies when evaluating appropriate responses to nonconforming product or regulatory noncompliance issues, such as determining whether to limit the availability of a medical device.

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Topics: FDA compliance, medical device insurance, medical device risk, fda benefit-risk medical device product, medical device liability

Why the Increase In Securities Suits Means a Challenging Insurance Market for Life Sciences Companies

Posted by Bruce Ball on Jun 21, 2016 4:06:24 PM

As has been the trend in prior years, life sciences companies have seen a greater number of securities class action lawsuits than those in other industries. In 2015, of the 191 total class action lawsuits, 39 of them involved companies in the life sciences sector. No other sector experienced anywhere near this number of securities class action lawsuit flings.

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Topics: life sciences, securities suits, life sciences insurance, insurance for life sciences, directors and officers insurance

Why Ohio BWC Coverage May Not Be Enough

Posted by Bruce Ball on Mar 11, 2016 11:48:00 AM

If you have locations or workers in multiple states, then your workers’ compensation coverage may be more complicated than you realize.

Workers’ compensation coverage written in one state may not protect you if workers are injured in another.

BWC Other State Coverage Program Begins March 1

Effective March 1, BWC launches its Other States Coverage program, a law enacted in 2014 granted BWC the authority to contract with an insurer licensed in other states to provide coverage to eligible Ohio employers for out-of-state exposures. By contracting with an insurer licensed in other states, BWC now offers an option that ensures proper coverage, regardless of jurisdiction.

Watch the video below for a better understanding of the Ohio BWC Other States Coverage program.

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Topics: workers' compensation, ohio bwc, other state coverage, bwc other states coverage program

Why You Should Evaluate Employee Benefits Plan Throughout the Year

Posted by Colleen Weston on Jun 1, 2015 12:13:36 PM

Employee benefits become a lot easier for business leaders to manage when a process is developed that takes the element of surprise out of the equation.

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Topics: Employee Benefits, group benefits, employee benefits broker

3 Simple Ways to Prevent a Go Kart Accident

Posted by Eric Treend on May 12, 2015 9:18:00 PM

Today I was made aware of a tragic, yet preventable accident on an Ohio concession go kart track. A teenage girl was partially scalped while operating an indoor go kart. 

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Topics: FECs, Family Entertainment Centers, go kart, scalping accident, go kart accident, FEC

Does Loss of Value Really Eliminate Risk for College Athletes?

Posted by Colleen Weston on May 11, 2015 12:11:47 PM

A recent article in the New York Times examined just how effective loss of value coverage is for college athletes.

Many critics believe that the insurance, intended to protect athletes who may become injured and miss the opportunity for payouts on professional contracts, is not as helpful as it seems.

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Topics: professional athlete insurance, loss of value, nfl draft, loss of value insurance

EEOC Issues Proposed Rule on the ADA & Wellness Programs

Posted by Caitlin Myor on Apr 24, 2015 9:52:17 AM

On April 16, 2015, the U.S. Equal Employment Opportunity Commission (EEOC) released a proposed rule that describes how the Americans with Disabilities Act (ADA) applies to employee wellness programs that include questions about employees’ health or medical examinations. Although the ADA limits when employers may inquire about employees’ health or require them to undergo medical examinations, these inquiries and exams are permitted if they are part of a voluntary wellness program.

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Topics: benefit plan, Equal Employment Opportunity Commission, Americans with Disabilities Act, Voluntary Wellness Programs, Wellness Programs

How Telemedicine Get's You to a Doctor and Keeps Up with Your Day

Posted by Colleen Weston on Apr 21, 2015 1:39:28 PM

As technology’s evolved, so has people’s ability to overcome the traditional communication barriers of time and distance. The practice of telemedicine is a step forward in the health care industry to use telecommunications to bridge the gap of time, distance and affordability to reach patients in need of medical attention.

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Topics: Employee Benefits, telemedicine, on demand health care, health care costs

Why Corporate Wellness Programs Need to Provide Opportunities for Everyone

Posted by Colleen Weston on Mar 2, 2015 11:48:10 AM

The ideal corporate wellness program brings together employees from different backgrounds and helps them focus on making choices that lead to longer, healthier lives. The challenge is working through those differences to arrive at a plan that allows everyone the best chance to participate and achieve their own individual goals.

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Topics: Employee Benefits, group benefits, Affordable Care Act, wellness program, wellness incentives, corporate wellness

Why Benchmarking Benefits Helps You Provide Value for Your Employees

Posted by Colleen Weston on Feb 17, 2015 7:30:00 AM

This article first appeared in Smart Business Cleveland, February, 2015.

Employers have the ultimate responsibility on how to effectively communicate benefits information to employees. It has a tremendous impact on how well the programs are understood, utilized and perceived by employees. If that understanding does not exist, it’s a critical failure of the company’s leadership team.

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Topics: Employee Benefits, Benefits advisor, group benefits, benefit plan, benchmarking benefits