INSIDE COMPLIANCE – Page 26 – Loyola University Chicago School of Law

FDA’s Response to Baby Formula Shortage

October 13, 2022Uncategorized

This year the Food and Drug Administration (FDA) has come under fire for its slow response to the nationwide baby formula shortage. In September 2022, FDA Commissioner Robert M. Califf authorized the release of an internal report. The report details how the baby formula shortage occurred, the FDA’s response to the shortage, and the challenges it faced in resolving the shortage. The report also revealed the changes in FDA regulatory procedure to ensure another shortage does not occur.

Abbott LaboratoriesBaby formula shortageCOVID-19FDARegulationUkraine

Merging and Acquiring Hospital Policies

October 12, 2022Healthcare Compliance

As the number of hospital mergers and acquisitions increases, legal, compliance, clinical, and administrative staff should be aware of the challenges of consolidating hospitals. One challenge often overlooked is the consolidation of hospital policies and procedures.

Health CareHealth Lawmergers and acquisitions

SEC Proposes Rules to Combat Cyber-Attacks

October 12, 2022Uncategorized

On March 9, 2022, the U.S. Securities and Exchange Commission (SEC) proposed rules on Cybersecurity Risk Management, Strategy, Governance, and Incident Disclosure by Public Companies. In an attempt to further protect against cybersecurity attacks and increase cyber transparency among issuers and investors President Biden signed into law the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA). Before CIRCIA goes into effect, it requires the Cybersecurity and Infrastructure Security Agency (CISA) to complete mandatory rulemaking activities, to develop/publish a Notice of Proposed Rulemaking (NPRM), and a final rule. The SEC proposal and CIRCIA both have different implications, but both will increase cybersecurity regulations and procedures, even making employees more conscious of potential attacks.

cyber-securitydata privacyPrivacy & Securitysocial engineering fraud

Our American Government: a Self-Serving Entity?

October 12, 2022Finance & Banking, Fraud & Abuse

As of September 2022, the current Congress has an approval rating of just 17% – an ignominious reality – and a series of recent investigations won’t serve to ease the mounting public frustration. Insider recently identified at least 72 members of Congress in noncompliance with the Stop Trading on Congressional Knowledge Act (STOCK). This revelation – among others – has prompted a push for the enactment of more stringent congressional stockholding limitations.

Possible Pitfalls in Michigan State’s Certification of Title IX

October 11, 2022Uncategorized

On Friday, September 30th, the Michigan State University Board of Trustees released an audit conducted earlier this month on the Title IX certification process. This audit was conducted after concerns arose regarding failure of compliance with the state-mandated Title IX certification process last year. Michigan State University President, Samuel Stanley, is at the forefront of the investigations.

EducationTitle IX

The Mahsa Amini Protests: The Fight for Freedom and Women’s Rights in Iran

October 9, 2022Uncategorized

On September 16, 2022, a 22-year-old Iranian woman named Mahsa Amini died on her third day in police custody after being arrested for allegedly violating Iran’s strict dress code rules by wearing her hijab too loosely. While Iranian authorities claim that Ms. Amini died of heart failure, her family and protestors across the country are alleging that she was killed by law enforcement. Thousands of Iranians have taken to the streets to protest, which has led to demonstrations in over 40 cities across Iran, resulted in thousands of arrests and dozens of deaths from clashes with security forces, and the implementation of communication restrictions by the Iranian government. Now, the United Nations and its member countries are taking action in response to Iran’s persistent violations of the International Covenant on Civil and Political Rights treaty, to which they are signatories.

FreedomInternational AffairsIranProtestsUnited NationsUnited StatesWomen's Rights

Artificial Intelligence: The Next Regulatory Frontier

October 9, 2022Uncategorized

Until recently, Artificial Intelligence (AI) was the domain of science fiction connoisseurs and Silicon Valley tech savants. Now, AI is ubiquitous in our daily lives, with a seemingly endless number of possible applications. As with any new and emerging technology, there are many novel questions and concerns that need to be addressed. Whether it be related to copyright ownership, ethics, cybersecurity obstacles, or discrimination and bias, concerns surrounding AI usage are mounting. AI system regulation has been rapidly increasing worldwide, while the U.S. regulatory landscape has remained relatively sparse. But it won’t be for long.

AIartificial intelligencedata privacydata regulationInformation TechnologyPrivacy & Security

Got (Plant) Milk? The Rise and Regulation of the Alternative Meat and Dairy Markets

October 9, 2022Food and Drug Law

The plant-based food market has been exploding in recent years, with the plant-based meat market expected to reach a value of $7.4 billion by the end of 2022 and the alternative dairy market reaching a value of $23.2 billion in 2021.

The meat and dairy alternative markets require regulation, but despite their widespread and growing popularity, the U.S. Food and Drug Administration (FDA) has been slow to issue regulations that encompass these markets. In January 2022, the FDA released a list of draft and final guidance topics that it intends to complete before the end of 2022. These topics include draft guidance for plant-based dairy alternatives, plant-based meat alternatives, and for cultured meat. The FDA is soliciting public comments on the proposed guidance, although as of now none of the draft guidance topics have been released to the public

alternative dairyalternative meatenvironmentalFDA compliancefood regulationsplant based meatplant based milk

America Has a Problem: The Ever-Worsening Water Crisis Plaguing the Country

October 7, 2022Uncategorized

As the summer came to an end, headlines about thousands of residents losing access to water swept the nation. The news came first out of Jackson, Mississippi. But although the southern city’s complete loss of access to water dominated the new cycle, it was far from the only place dealing with this issue. A few days later, reports of boil water advisories in Baltimore and NYC hit the news cycle. Unfortunately, these are only the latest instances in a long string of issues with access to safe and clean drinking water across the country.

clean water actClimate ChangeDepartment of JusticeEnvironmental Protection Agencyenvironmental regulationSafe Drinking Water Act

New Jersey Cannabis Regulatory Commission Issues Interim Guidance on Workplace Impairment

October 7, 2022Uncategorized

The New Jersey Cannabis Regulatory Commission (the Commission) recently issued interim guidance on the workplace drug testing provisions of the state’s recreational cannabis law. The guidance is meant to act as a placeholder until the standards for Workplace Impairment Recognition Expert (WIRE) certification are published, which outlines how employers should respond when employees are suspected of marijuana impairment. The interim guidance confirms that an employee’s off-duty use of cannabis cannot be the reason for any adverse employment action, but employers are allowed to terminate workers who are under the influence during work hours.

cannabisEmployment LawJournal of Regulatory ComplianceLabor and Employmentworkplace compliance