INSIDE COMPLIANCE – Page 33 – Loyola University Chicago School of Law

What the Cluck is Going on? Regulatory Failures Amid a Nationwide Food Poisoning Epidemic

March 25, 2022Uncategorized

In October 2021, ProPublica published an article about a rare and virulent strain of salmonella infantis outbreak that occurred in May 2018, afflicting at least a dozen people across the country. Many who reported being sick reported that they ate chicken, and federal food safety inspectors found the infantis strain in packaged chicken breasts, sausages, and wings during routine inspections at poultry plants.

consumer protectionFDAFood ProcessingRegulation

Critical Infrastructure and Cybersecurity Legislation: America’s Cybersecurity Problem

March 25, 2022Uncategorized

Long gone are the days when cybersecurity concerns existed solely in the domain of technology teams. Various organizations, from schools to government entities (at every level), to private companies alike have fallen prey to cyberattacks. May 2021’s Colonial Pipeline attack caused chaos and a temporary gas frenzy that brought awareness of the vulnerabilities of the technology we rely on to even the least technically minded American. Cybersecurity, and more specifically, the security of critical infrastructure immediately became an issue that the U.S. Government is taking very seriously.

cyber-attacksInfrastructureinternationalInternational AffairsJournal of Regulatory CompliancePrivacy & Security

Stablecoins II: The Stablecoin Innovation and Protection Act of 2022

March 23, 2022Finance & Banking

On Tuesday, February 15, 2022, Congressman Josh Gottheimer released a draft of the Stablecoin Innovation and Protection Act of 2022 (“the bill”). This legislation attempts to both define stablecoins as well as provide a legal framework in which the issuers and users of stablecoins can safely and legally operate. The bill is surprisingly brief, only nine pages long, but Gottheimer claims that it will provide greater direction and certainty to the marketplace in order to boost innovation while also protecting consumers.

cryptoCryptocurrencycryptocurrency regulationfinanceFTCJournal of Regulatory ComplianceLegislationSEC

First Amendment Rights and Florida’s “Don’t Say Gay” Bill

March 22, 2022Uncategorized

Florida’s “Don’t Say Gay” bill, which would bar Florida educators from speaking to students about LBGTQ+ topics that are not considered “age-appropriate or developmentally appropriate for students” has passed in Florida’s House and is likely to pass in the Senate as it now moves to the Republican-controlled Senate floor for a vote. The horrific piece of legislation, formally known as HB 1557, has raised questions as to whether the bill, if passed, would violate the First Amendment rights of teachers or students in public primary schools across the sunshine state.

DeSantis free speachEducationFirst AmendmentfloridagayHB 1557Journal of Regulatory ComplianceLGBTQSchools

The First Cyber War: The Threat of Russian Cyberattacks has Thrust Cybersecurity Compliance into the Spotlight

March 22, 2022Uncategorized

The impact of Russia’s unprovoked attack on Ukraine on February 24, 2022 has not only caused a horrific human rights crisis but has also had a dramatic effect on how the world conducts business, felt well beyond the borders of Russia and Ukraine. Warnings of an imminent Russian cyberattack on critical United States infrastructure has small and large businesses alike brushing up their cybersecurity policies to ensure they are compliant with current best practices in the likely event of a Russian cyberattack and impending federal legislation.

cyber-attackscyber-securityInternational AffairsLegislationPrivacy & SecurityUkraine

Senate Brings Bipartisan Attempt to Update Health Privacy Regulations

March 19, 2022HIPAA & Health Information

On February 9, a group of senators led by Tammy Baldwin of Wisconsin and Bill Cassidy of Louisiana introduced a new bill, the Health Data Use and Privacy Commission Act (the “Act”), in attempt to revitalize current legislation regarding the protection and use of health data. The bill also has the support of a number of representatives from within the healthcare industry, including Epic, IBM, and Teladoc Health, as well as a number of professional associations like the American College of Cardiology, the Association for Behavioral Health and Wellness, and the Association of Clinical Research Organizations.

consumer protectiondata breachDepartment of Health & Human ServicesGDPRHealth InsuranceHIPAAPrivacy & Security

FDA’s Proposed Global Regulatory Harmonization for Medical Devices

March 18, 2022Drugs & Devices, The Marketplace

On February 23, 2022, the Food and Drug Administration (FDA) published a proposed regulation to amend current manufacturing practice requirements of the Quality System Regulation (QSR) (21 CFR Part 820). The FDA first announced such harmonization in 2018, however COVID-19 delayed the proposal. The FDA seeks to align Part 820 more closely with the international specific standard for medical device quality management systems set out by the International Organization for Standardizations (ISO) 13485. According to the FDA, such “harmonization should provide patients more efficient access to necessary devices, leading to improvements of life quality of the consumers.” Part 820 is part of the current mandatory regulations that ensure that all medical devices created and developed within the US market are safe. ISO 13485 is the international standard for a quality management system for medical devices required by certain countries. Therefore, any manufacturer that sells outside the US will likely need to be ISO 13485 certified. With the implementation of this new amendment, manufacturers would be able to assure their products are regulatorily compliant in both the US and international markets.

FDAFDA approvedFDA authorizedFDA regulationsJournal of Regulatory Compliance

Why a Culture Change in the Workplace Benefits your Mentoring Program

March 17, 2022Uncategorized

It’s hard and expensive to find and retain good employees. With this in mind, it’s not a surprise that companies are willing to try all sorts of things to make sure their employees stick around. For example, many companies have attempted to establish corporate mentorship programs where newer employees are paired up with veterans who can show them the way. But is this the right approach? Mentoring programs typically rely on single mentor-mentee matches and formal hierarchical pairings. Even if you can implement the best mentoring program, it is unlikely to achieve its intended result when the surrounding workplace is competitive and individualistic. For mentorship programs to have a real effect on the workplace, it seems that we all must take a step back and realize that real mentorship starts with company culture, not formal programs.

CultureEducationemployersEmploymentEthicsmentoring

The Economic War Against Russia: Sanctions, Sanctions and More Sanctions

March 16, 2022Uncategorized

As the pace of Russia’s incursion into neighboring Ukraine escalated three weeks ago, starting with a massing of troops on Ukraine’s eastern Donbas border and expanding quickly into a full-fledged military invasion, so too did the response of the United States and its Western allies. Initially, the Biden Administration proceeded cautiously, deciding against levying its harshest sanctions over concerns of how they would impact European and global economies and that a stepped approach offered the best chance for de-escalation of tensions. The government began by blacklisting two major state-owned banks that are tied to the country’s defense sector and five Russian nationals with close links to the Kremlin. The U.S. and its European allies also banned the Kremlin from raising new money in the U.S. and Europe and trading new sovereign debt in U.S or European markets. In addition, Germany unilaterally halted certification of the Nord Stream 2 natural gas pipeline which was set to go ahead sometime later this year, an action applauded by the U.S. who had long argued against the project fearing that it would increase Europe’s dependence on Russian fuel.

foreign relationsInternational AffairsRegulationSanctions

Current Status Pending: Title IX, Deliberate Indifference, & Non-Student Offenders

March 15, 2022Uncategorized

With the Biden administrations new proposed Title IX regulations set to be published in April of this year, attorneys and advocates alike have been left to speculate as to what changes the Department of Education (ED) will propose. Among this speculation, is a narrower question: will ED, in their proposed Title IX regulations, finally state directly that universities can be held liable for deliberate indifference to known sexual harassment perpetrated by a non-student guest? At this point, any answer to this threshold inquiry would be speculative, but there are a few indicators that suggest the answer may be yes.

Biden AdministrationDepartment of EducationEducationOCRTitle IX