INSIDE COMPLIANCE – Page 82 – Loyola University Chicago School of Law

FDA Declares War on Flavored E-Cigarette

October 2, 2018Drugs & Devices, The Marketplace

In July 2017, the Food and Drug Administration revealed a new policy that sought to reduce the deaths and diseases caused by smoking which takes nearly 500,000 lives annually in the United States. In early September 2018, the FDA followed up on its mission by unveiling a plan to address the e-cigarette epidemic. E-cigarettes, and in particularly, a brand of flavored e-cigarettes called “JUULs,” have taken the teenage and adolescent market by storm. While the FDA is primarily concerned with reducing the overall number of smoking-related casualties, it notes a particular concern for a vulnerable young demographic and the effects of nicotine intake on a developing brain.

adolescentsFDAFood and Drug AdministrationhealthjuulRegulationtobacco

DeVos’ Deregulation Attempt Fails as Judge Upholds Borrower Defense Rules

October 1, 2018Uncategorized

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.

Betsy DeVosborrower-defenseEducationRegulation

A Way Around HHS 340B Program Delays

September 28, 2018Drugs & Devices

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.

340BAccessAmerican Patients FirstcompliancediscountsDrug Manufacturersdrug pricinghealthcareHHSHospital ComplianceInflationLegislationMedicaidMedication affordabilitypharmacyRegulationreimbursementTrump Administrationunderinsured

Election Assistance Commission Releases Funds to Help States Prepare for 2018 Elections

September 25, 2018Uncategorized

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.

electionIllinoisJournal of Regulatory CompliancemidtermsRegulationrussiavoters

Massachusetts Grapples with “Adequate” Nurse Staffing Requirements

September 24, 2018Uncategorized

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.

EmploymentNurse Staffingpatient safety

The Unintended Effects of the BEAT Provision on the Insurance Sector

September 21, 2018Uncategorized

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.

BEATInsurancetax

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.

big datablockchaincaliforniaCalifornia Consumer Privacy ActcompliancedataenforcementEUEuropeGDPRJournal of Regulatory ComplianceprivacyPrivacy & SecurityRegulationtechnologyTechnology and the LawUS

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.

data securityencryptionfinanceInformation TechnologyPayment ProcessingPCIPrivacy & Security

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 researchclinical trialsFDAhealthcare