Is Your Fitness Tracker Violating Your Privacy Rights?

Posted on September 11, 2018Jessica SweebCategories HIPAA & Health Information

An increasing number of companies are providing fitness trackers for their employees as a part of their benefits package. The use of fitness trackers has been steadily growing over the past few years, and is predicted to hit a shipment size of 240.1 million devices by 2021. Even though the popularity of these fitness trackers has boomed, their compliancy with HIPAA has not kept up with them as quickly. A few companies that make fitness trackers have become HIPAA compliant, such as Fitbit and Apple. However, some companies have remained silent as to whether they are or plan on becoming compliant. While fitness trackers have been shown to have an overall positive effect in corporate wellness programs, corporations should remain up to date with how to keep their employees’ health information secure as well as ensure that the fitness tracker that they are providing is HIPAA compliant.
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PFAS Contamination Crisis; States Urge EPA to Defy Trump Deregulation

Posted on September 10, 2018Michelle McGoughCategories Uncategorized

President Trump has made his opinion of federal regulations known from the very start of his presidency. He clearly believes that federal regulations, especially those established by the Environmental Protection Agency (“EPA”), inhibit economic growth and unduly burden American businesses. However, it is equally unclear how his deregulatory efforts have benefitted anyone other than corporate America. Rather than utilizing his considerable influence to protect the health of the American people, President Trump and his administration have been hard at work unraveling such protections, much to the frustration of the states.
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Compliance Failures Result in Hundreds of Accidental Foreclosures

Posted on September 6, 2018Richard ShepherdCategories Finance & Banking

Compliance failures in banking can often result in real harm to borrowers.  In the case of Wells Fargo, a compliance error resulted in 400 of the bank’s customers losing their homes.  Due to an issue in the bank’s software system, the institution denied loan modifications to borrowers who should have qualified.  This latest failure adds to the myriad of issues Wells Fargo bungled over the past several months.  For compliance professionals, the failure demonstrates the risks of automation in compliance, the importance of technical expertise, and the risks of decision-making without putting the interests of the customer first.
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Kicking Off the 2018-2019 Academic Year at the Center for Compliance Studies

Posted on September 3, 2018Ryan MeadeCategories The Art of Compliance

Ryan Meade Editor-in-Chief Director, Regulatory Compliance Studies at Loyola University Chicago School of Law The academic year for 2018-2019 has kicked off at the Center for Compliance Studies. It promises to be a big year with even more robust blog activity planned, a symposium in February 2019 that will be one of the first academic looks …
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FDA Faces Forward with Flexible Genetic Guidance

Posted on May 18, 2018Categories Drugs & Devices

In recent years, the FDA has examined a record number of revolutionary medical devices, many of which have been genetic tests. Genetics has taken the world by storm. The medical world continues to look toward genetics as a promising next step in revolutionizing treatment, while the American public has shown a growing interest in learning more about themselves through services like Ancestry and 23andMe. In an effort to gain a foothold on the rapidly developing field of technology, the FDA has recently made efforts to modernize its approach by issuing new guidance to ensure the validity of these tests.
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Closing out the 2017-2018 academic year

Posted on May 7, 2018Categories Uncategorized1 Comment on Closing out the 2017-2018 academic year

With less than a week left in the semester, the Journal of Regulatory Compliance editors are hard at work studying for exams, gearing up for summer jobs, or eagerly awaiting graduation. However, before we shutter INSIDE COMPLIANCE for the summer session, I want to take this opportunity to look back over the past year, and how much our members have accomplished.

The Journal of Regulatory Compliance is a young law journal, even for Loyola University Chicago School of Law. It’s only been a few years since our first annual symposium, and the debut of the Center for Compliance Studies here at Loyola University Chicago School of Law. In many ways, this year was an experiment—we debuted a new Board structure, a new editorial process, a new blog format and a new time of year for our Symposia. Despite that uncertainty, the 30-plus members of the Journal of Regulatory Compliance have accomplished extraordinary things.
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The Food Safety Modernization Act is Just the Beginning of the FDA Compliance We’ve Been Waiting For

Posted on April 27, 2018Manisha ReddyCategories The Marketplace

Despite the United States having one of the safest food supplies in the world, more than 48 million Americans get sick from foodborne illnesses and diseases each year, and more than 128,000 are hospitalized and 3,000 die from similar issues that are largely preventable. On January 04, 2011 President Obama signed the Food Safety Modernization Act (“FSMA”) into law. This enactment was called the “most sweeping reform” of U.S. Food Safety laws in more than seventy years. But seven years later, the act is still only partially enforced as the FDA has faced resistance from the government as well as a lack of funding. The FMSA was and is intended to enable the FDA to protect the health of the public by strengthening the food system in the United States. While change and reform in the industry are necessary, what good are new reforms if they will not be enforced for years to come?
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Digital Realty Trust: Implications for Whistleblowers and the Compliance Department

Posted on April 26, 2018Categories Uncategorized

In a 9-0 decision, the Supreme Court on February 22, 2018 decided Digital Realty Trust, Inc. v. Paul Somers, a case challenging the definition of a whistleblower under the Dodd-Frank Wall Street Reform and Consumer Protection Act, commonly referred to as Dodd-Frank. The court held that “Dodd-Frank’s anti-retaliation provision does not extend to an individual, like Somers, who has not reported a violation of the securities laws to the SEC [Securities and Exchange Commission].” This is a narrowing of the definition of whistleblower and as such has a number of implications for companies and their compliance departments.
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IRS Offshore Voluntary Disclosure Program to Shutdown: The End of Amnesty for International Tax Evaders?

Posted on April 23, 2018Jonathan BenowitzCategories Finance & Banking

The IRS has decided to shutdown its Offshore Voluntary Disclosure Program (OVDP) on September 28, 2018.  The program offers amnesty from criminal prosecution and a set penalty structure for those who have previously failed to disclose foreign bank accounts and other foreign assets, including those held through undisclosed foreign entities. Failure to disclose could include failure to file the annual FinCEN Form 114,most commonly referred to as the foreign bank account report or “FBAR”, as well as the failure to report income from such accounts and assets on tax returns and the failure to provide various other foreign information forms and returns.
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