Access to quality, comprehensive health care services seems to always be at the forefront of our health care industry. One’s ability to gain access measured in terms of utilization, is dependent upon financial affordability, and physical accessibility. While a seemingly small issue under the overarching ‘access to health care’ topic, talks about access to medication and its affordability in particular for the vulnerable and underinsured patients must also be addressed. A number of health organizations have sued HHS for delaying the implementation of rules that would force drug companies to be transparent about their pricing and punish them for overcharging participating hospitals in the federal program that discounts outpatient medication. Due to HHS’ delays, hospitals cannot challenge drug manufacturers for overpricing outpatient medication thus they cannot access refunds of discounts that are due to them under statute.
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.
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.
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.
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.