INSIDE COMPLIANCE – Page 40 – 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.

COVID-19Abbott LaboratoriesBaby formula shortageFDAUkraineRegulation

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.

mergers and acquisitionsHealth CareHealth Law

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.

data privacycyber-securitysocial engineering fraudPrivacy & Security

Our American Government: a Self-Serving Entity?

October 12, 2022Fraud & Abuse, Finance & Banking

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.

IranInternational AffairsFreedomWomen's RightsUnited StatesUnited NationsProtests

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.

data privacydata regulationAIartificial intelligenceInformation 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

environmentalalternative meatalternative dairyfood regulationsFDA complianceplant based milkplant based meat

DOJ’s Unveils New Tool to Fight Corporate Crime: Care About Compliance

September 23, 2022Uncategorized

In an effort to deter corporate crime, the Justice Department (DOJ) has implemented a new policy aimed at giving chief compliance officers more authority. Chief Compliance Officers (CCOs) may now need to certify the integrity of their compliance programs and be personally liable if their programs do not “reasonably prevent and deter compliance issues.” According to Brian Michael, a former chief compliance officer (CCO), some industry professionals fear that such a policy would place compliance officers in a position to be personally liable for decisions that they have little say over. There is also worry that implementing such a policy would place CCOs in direct conflict with senior executives. However, Kenneth Polite, assistant attorney general in charge of the DOJ’s criminal division, insists that the new policy will place CCOs in a better position to ensure the integrity of their compliance programs. Polite hopes to force corporations to invest in compliance now rather than pay later.

compliance officercomplianceDepartment of JusticeDOJBiden AdministrationRegulation

Imperative Progress in Your Data Privacy and Protection

September 22, 2022HIPAA & Health Information

Amanda Scott Associate Editor Loyola University Chicago School of Law, JD 2024 In June 2022, a draft of a bipartisan bicameral bill known as the American Data Privacy and Protection Act was introduced. This bill was proposed as a replacement to current laws to further protect and strengthen federal data privacy and protection regulations. This …
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data privacyJournal of Regulatory CompliancePrivacy & Security