Tag:Journal of Regulatory Compliance
Proposed Changes to the NIH Guidelines for Human Gene Transfer Experiments
The National Institute of Health (NIH) has submitted a proposal to amend the NIH Guidelinesfor research involving recombinant or synthetic nucleic acid molecules. The proposed amendmentseeks to streamline the oversight for human gene transfer clinical research protocols and reduce duplicative reporting requirements already captured within existing regulatory framework. The amendment specifically seeks to delete the NIH protocol registration submission and reporting requirements under Appendix M of the NIH Guidelines, and modify the roles and responsibilities of entities involved in human gene transfer or the Recombinant DNA Advisory Committee(RAC).
International Business Travel Comes with Potential Data Risks
The economic rebound seen in the last decade has resulted in a substantial increase in business travel, both foreign and domestic. Increasingly complex global supply chains are necessitating that business leaders travel the world in order to expand their businesses and forge valuable new partnerships. Unfortunately, this increase in travel also presents an increased risk for the theft of proprietary or confidential information.
CCPA Paving the Way For State Law’s Privacy Policy
After Equifax, one of the largest credit reporting agencies, leaked 143 million people’s personal information in 2017, many state legislators scramble to regulate how businesses collect, protect, and use customer’s personal information.
Electronic Health Record Compliance Measures Benefit Patient Centered Care
In a time when data breaches occur fairly frequently, whether it’s credit card information being stolen from department stores or a credit reporting bureau breach affecting hundreds of millions of customers, keeping personal information private seems to get harder every day. That fact may give patients pause when they are asked to sign up for an electronic health record account. A 2017 survey listed electronic health record management as one of patients top concerns. Changes in recent years have led to changes in compliance measures that make electronic health records security an added benefit to patients and ensure the continued increase of their adoption.
Election Assistance Commission Releases Funds to Help States Prepare for 2018 Elections
The U.S. Election Assistance Commission has released over $300 million in Help America Vote Act funds to 48 states and territories intended to improve election security and administration. This comes after the Consolidated Appropriations Act of 2018 appropriated $380 million into the Help America Vote Election Security Fund in March of this year.
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.
Kicking Off the 2018-2019 Academic Year at the Center for Compliance Studies
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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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.
The Food Safety Modernization Act is Just the Beginning of the FDA Compliance We’ve Been Waiting For
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?
Popularity Contest: The Importance of Reputation in Modern Compliance
Modern business thinking has come to accept that reputation is as important as financials. As investors look for companies that demonstrate this understanding, compliance professionals are in a unique position to make their companies more appealing.