Category:Uncategorized
How the Biggest Nitrogen Polluter of U.S. Waterways Achieves EPA Compliance
According to an Environmental Integrity Project report, an Illinois pork-processing plant discharged more nitrogen from animal waste into waterways than any other slaughterhouse in the United States. Yet, the facility has complied with the Clean Water Act since December 2015. Animal-processing operations are not only some of the top polluters, but the federal water pollution standards surrounding these operations are lacking.
GDPR Enforcement Notice to AggregateIQ
On July 6, the Information Commissioner’s Office (ICO) issued their first Enforcement Notice to AggregateIQ (AIQ) under the General Data Protection Regulation (GDPR) and the United Kingdom’s Data Protection Act (DPA). The GDPR is a law regulating data protection and privacy as well as the export of personal data outside of the European Union (EU). It became enforceable on May 25, 2018. The DPA supplements the GDPR and regulates the processing of personal data. The ICO is a regulatory office in the UK which enforces regulations under the DPA and GDPR. AIQ is a Canadian digital advertising, web and software development company that was charged with violations regarding the use of data analytics in political campaigning. This article will address the AIQ enforcement notice and how companies ensure compliance with the GDPR to prevent receipt of an enforcement notice.
Black Market Midwifery: Lack of Regulation Compromises the Safety of Women Who are Committed to Giving Birth Outside the Hospital Setting
Across the United States more and more women are choosing to give birth outside of hospitals. Currently, in Illinois, Certified Professional Midwives are not licensed to provide home birth services. However, over the last decade, advocates in Illinois have urged lawmakers to reconsider this restriction. The most recent attempt in 2017 was unsuccessful once again. While opponents argue that individuals with this level of training should not be providing care to women during delivery, the choice for women who are committed to home birth is not between home and the hospital. It is between home and an illegal or unassisted delivery.
DeVos’ Deregulation Attempt Fails as Judge Upholds Borrower Defense Rules
A new set of student loan forgiveness regulations introduced earlier this year aimed to hack away at “borrower-defense” protections which shielded students from predatory loan practices by for-profit universities. Under Education Secretary Betsy DeVos, the Department of Education crafted new, more restrictive borrower-defense regulations after blocking an Obama Administration regulation from going into effect last year. U.S. District Court Judge Randolph Moss sided with consumer rights activists who argued against the Secretary of Education, alleging the Department of Education violated federal law and procedure by repealing the Borrower Defense to Repayment rule. The Trump Administration requested another opportunity to delay the regulations from taking effect, but Judge Moss has not yet ruled on their request.
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.
Massachusetts Grapples with “Adequate” Nurse Staffing Requirements
On November 6, 2018, Massachusetts voters will determine whether they want to establish patient assignment limitations for registered nurses working in hospitals. The Massachusetts Nurses Association (“MNA”) has been the driving force behind the proposed legislation. After acquiring more than 100,000 signatures for the initiative to appear on the ballot and a victorious litigation outcome regarding the legislation’s employment implications on hospitals, the Massachusetts voters will ultimately determine the legislation’s fate.
The Unintended Effects of the BEAT Provision on the Insurance Sector
A provision within the new tax overhaul is emerging as a leading concern for the property and casualty insurance sector. The industry recently experienced growing uncertainties about how a vaguely worded provision within the Base Erosion and Anti-Abuse Tax (BEAT) may affect their bottom line. However, the insurance industry is not the only group that may experience these unintentional ramifications; consumers and small businesses are also likely to see an increase in their premiums due to implications of BEAT.
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.