INSIDE COMPLIANCE – Page 90 – Loyola University Chicago School of Law

GDPR, Data, & Blockchain: The New Wonders of the Digital World

September 20, 2018Uncategorized

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.

datacomplianceenforcementCalifornia Consumer Privacy Actcaliforniablockchainbig dataJournal of Regulatory ComplianceGDPREuropeEUTechnology and the LawtechnologyUSPrivacy & SecurityprivacyRegulation

GDPR and HIPAA: Next Steps in the U.S. Healthcare Industry

September 19, 2018HIPAA & Health Information

The EU General Data Protection Regulation (“GDPR”) is now in effect as of May 25, 2018, and has been a prominent topic of international debate across multiple sectors as companies look to adjust to new stringent regulations in data management. With a wide scope (the GDPR now applies to all organizations possessing personal data of individuals based in the EU) and steep penalties for companies that fail to comply, companies across the globe are spending millions of dollars in preparation.

GDPRHIPAA

Nearly Half of All Businesses Out of Compliance With Payment Card Security Standards

September 19, 2018Finance & Banking

While the legal community has spent much of the last year exhaustively dissecting the European Union’s new General Data Protection Regulation (GDPR), nearly half of businesses in the United States are still not compliant with standards governing the collection, storage, and disposal of payment (credit/debit) card data. Businesses of all sizes should work to ensure that they understand and are in compliance with these standards, or risk significant exposure in the event of a payment card data breach traced back to their organization.

encryptiondata securityfinanceInformation TechnologyPrivacy & SecurityPCIPayment Processing

FDA Guidance for Clinical Research Projects Using Expansion Cohorts in First-In-Human Clinical Trials to Expedite the Development of Oncology Drugs and Biologics

September 18, 2018Uncategorized

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.

clinical trialsclinical researchFDAhealthcare

How “Bring Your Own Device” Policies Increase Privacy Concerns

September 17, 2018Uncategorized

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.

Privacy & Security

Regulatory Rollbacks: Changing the Career Education System

October 8, 2018Uncategorized

In a world where students are swimming in debt, the Education Department has made an effort to regulate career education and ensure students receive a quality education. During the Obama Administration, rules were implemented that require educational institutions to prove they are preparing graduates for gainful employment. In addition, the borrower defense rule allows for federal student loan forgiveness when the student can prove their institution misled them relating to the loan or education services provided. With so many students in debt, what is the appropriate standard of review to apply when determining these regulations?

EducationderegulationDepartment of Educationborrower-defenseBetsy DeVosgainful employmentRegulation

Battle in Arizona to Adjust State Water Use Regulations as Climate Change Causes Supplies to Dwindle

October 9, 2018Uncategorized

On March 14, 2018, the United States Department of Agriculture officially designated twelve Arizona Counties as primary natural disaster areas on account of agricultural loses brought on by intensifying drought. Despite being one the hottest and driest states in the nation, the state is one of the most agriculturally productive, sustaining a multi-billion dollar industry. As drought threatens this economic boon, competing interest groups petition the state legislature to adjust water-use regulations that have failed to stem shortages.

environmental regulationArizonastate regulationWisconsin

You’ve Heard About the GDPR, but What About the CCPA?

October 23, 2018Uncategorized

On June 28, 2018 California took a page out of the European Union’s (EU) book and signed the California Consumer Privacy Act (CCPA) into law. The CCPA is a landmark privacy bill that will come into effect on January 1st, 2020 and it is being closely compared to the General Data Protection Act (GDPR).

What does this mean for California businesses and residents? In short, more privacy and more control over data. Key aspects include allowing consumers to request what data an organization has collected about them, allowing consumers the right to fully erase data, protecting children’s data, and making verification processes more stringent for businesses.

data privacydatacaliforniaCaCPACalifornia Privacy Lawbig dataGDPR CaCPAGDPREuropeEUUSPrivacy LawPrivacy & SecurityprivacyRegulation

Facial Recognition Technology: How Much Can State Law Protect Users?

October 22, 2018Uncategorized

Sei Unno Associate Editor Loyola University Chicago School of Law, JD 2019 Facial recognition has become mainstream, whether the laws are ready or not. Video games are using facial recognition to check the ages of their users and cars are being equipped with technology to identify drivers who are fatigued or distracted. In the U.S., states …
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Act on the Protection of Personal InformationCalifornia Privacy LawBiometricsGDPRFacial RecognitionFaceIDFacebookgooglePrivacy PolicyPrivacy LawPrivacy & SecurityprivacyRealNetworksSAFR

Proposed Changes to the NIH Guidelines for Human Gene Transfer Experiments

October 22, 2018Drugs & Devices

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).

Clinical Research ProtocolsClinical Research ComplianceJournal of Regulatory ComplianceNIH GuidelinesHuman Gene TransferRegulation