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GDPR, Data, & Blockchain: The New Wonders of the Digital World
In a world where our reliance on technology and the cloud is increasing exponentially, data security’s growth has stagnated. The European Union (EU) passed the General Data Protection Regulation (GDPR) in hopes of ensuring that consumer data is protected and not harbored by businesses. The effects of the GDPR, however, have passed the borders of the European Union. In a world where our actions extend internationally with just the click of a button, the GDPR’s impact circles the globe as well. The GDPR has pushed for a shift in data privacy and regulation for companies within and outside of the EU as it holds to protect European citizens, no matter where they are in the world. This international reach has not only created forces to drive U.S. companies to comply, but states within the U.S. are now creating GDPR-inspired laws to protect their own citizens. The GDPR has started a trend that will soon become the norm and finally push compliance to keep up with the exponential growth of technology.
FDA Guidance for Clinical Research Projects Using Expansion Cohorts in First-In-Human Clinical Trials to Expedite the Development of Oncology Drugs and Biologics
In early August 2018, the Food and Drug Administration (“FDA”) announced the availability for guidance in Clinical Research projects relating to expansion cohorts used in first-in-human (“FIH”) clinical trials that are used to expedite the development of Oncology Drugs and Biologics. The guidance is directed towards clinical sponsors in their design and conduct of FIH clinical trials intended to expedite the development of cancer drugs, including biological products that use multiple expansion cohort study designs. These studies typically employ multiple, concurrently accruing, patient cohorts, which use individual cohorts that assess the different aspects of the safety, pharmacokinetics, and antitumor activity of the drug. The FDA provides guidance for (1) the characteristics of drug product best suited for consideration for development under a multiple cohort study; (2) information to include in investigational new drug application submissions to justify the design of multiple expansion cohorts; (3) when to interact with FDA on planning and conduct of multiple expansion cohort studies; and (4) safeguards to protect patients enrolled in FIH expansion cohort studies.
How “Bring Your Own Device” Policies Increase Privacy Concerns
With the increased integration of laptops, cellphones, and tablets in both work and personal life, many companies have started adopting a “bring your own device” (BYOD) policy into employment protocols. BYOD policies allow employees to use their personal device for work, removing the need for employers to provide work devices. Although BYOD policies allow for easy transition from home to work, they increase security risks for employers. BYOD policies create differing advantages and disadvantages for employees and employers; thus, it is important that they are carefully assessed before implementation. If a BYOD policy is adopted, strict regulation and oversight of company policies and procedures is required.
The Woes of Hanford Workers: Convoluted Contracts and Burdensome Bureaucracy
Since the Hanford Site stopped producing plutonium in 1987, contractors continue to clean up leftover radioactive contamination and hazardous solid and liquid waste. Although precautions are being taken to prevent workers from being contaminated by or exposed to the waste, the risk remains and worker’s compensation claims follow. The Department of Energy (DOE) OIG recently published an audit report concluding that the DOE does not have effective policies and procedures concerning the Workers’ Compensation Program at the Hanford Site.
Can Congress Regulate Big Pharma?
Drug companies need to fund the research and development necessary to create better products. This means that pharmaceutical companies have fought for years to maintain control over the prices of said drugs. But this standard is being challenged with a new bill that was introduced to the House of Representatives on June 25, 2018.
Trump Tower Sued for Non-Compliance with Clean Water Act
Trump Tower is one of many buildings along the Chicago River that uses river water for its cooling systems. Trump Tower is the second largest intake system from the river. Illinois Attorney General, Madigan, filed a lawsuit against the property to ensure that such a large quantity user is not allowed to continue to violate the law. As the value of riverfront property rise, and development continues, enforcement of these types of permits is likely to increase.
PFAS Contamination Crisis; States Urge EPA to Defy Trump Deregulation
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.
Call for Papers: February 15, 2019 Compliance Symposium
“What is the Future of Compliance in Enterprise Risk Management?” February 15, 2019 Loyola University Chicago School of Law Philip H. Corboy Law Center Power Rogers & Smith Ceremonial Courtroom 25 E. Pearson Street Call for Papers The Center for Compliance Studies at Loyola University Chicago School of Law and The Loyola Journal of Regulatory …
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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.
Digital Realty Trust: Implications for Whistleblowers and the Compliance Department
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.