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.
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.
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.
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.
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.
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.
One month after the largest health care fraud enforcement action was taken, the Assistant Attorney General, Brian A. Benczkowski, of the Justice Department’s Criminal Division, announced the addition of the Newark/Philadelphia Regional Medicare Strike Force. The newly added 11th Medicare Strike Force will largely focus on healthcare fraud that is contributing to the opioid epidemic.
On March 6th, 2018 the. District Court for the Eastern District of New York upheld the classification of cryptocurrencies, such as Bitcoin and Litecoin, as commodities. The ruling subjects the cryptocurrencies to the regulation of the U.S. Commodity Futures Trading Commission (CFTC).
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 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.