INSIDE COMPLIANCE – Page 41 – Loyola University Chicago School of Law

SEC Brings First Charges Involving Regulation Crowdfunding

October 19, 2021Finance & Banking, Fraud & Abuse

On September 20, the United States Securities and Exchange Commission charged three individuals with conducting fraudulent crowdfunding schemes while also bringing charges against the crowdfunding portal where the offerings were conducted in SEC v. Shumake. As the first case being pursued under Regulation Crowdfunding, a number of questions wait on the horizon regarding the responsibility of crowdfunding platforms to protect investors when orchestrating such offerings.

crowdfundingfraudissuerssecuritiesSecurities and Exchange Commission

A Case for Regulating Facebook

October 18, 2021Drugs & Devices

Recently, whistleblower Frances Haugen testified before a Senate subcommittee that Facebook has been deliberately putting its own profits before users’ safety. As Facebook’s former product manager for civic misinformation, Haugen calls for federal regulation of social media platforms and asserts that Facebook will not solve what she calls a “crisis” of deliberately ignoring users’ wellbeing for the sake of its own profits without Congress’s help. She points to tobacco, automobiles, and opioids, stating that when it became clear that those products were harming people, the government took action.

Journal of Regulatory Compliancemental healthPrivacy & SecurityRegulationsocial mediatechnologytobaccowhistleblower

Regulating Government Agencies & Contractors: Banning the Use of ‘Hostile Architecture’ Through A City-Wide Ordinance

October 17, 2021Uncategorized

The way we construct our buildings, parks, and communities are reflective of our collective interests and values. Often when constructing public spaces, contractors and city officials employ deliberate methods of design that discourage their use by homeless people, this is known as hostile architecture. From bifurcated city benches to boulders being placed under city overpasses, hostile architecture is an affirmative policy action that is used by cities to discourage and eliminate use of public spaces by those who are unhoused. Collectively, these actions amount to another weapon in the arsenal of government actors in their war against homeless people, instead of homelessness. In order to stop these harmful building and design policies, cities around the United States, including Chicago, should implement regulatory policies banning their use with public funds or through governmental contractors.

homelessnessHostile ArchitectureJournal of Regulatory Compliance

SEC Whistleblower Program Surpasses $1 Billion in Award Payouts

October 14, 2021Finance & Banking, Fraud & Abuse

The U.S. Securities and Exchange Commission (SEC) reached a rather auspicious milestone in September when it announced that, with the addition of two recent awards totaling $114 million, the aggregate amount of monies paid out under the SEC’s whistleblower program since its implementation in 2011 has exceeded $1 billion. In fiscal year 2021 alone, the SEC has awarded a record $500 million. The SEC also reported that award payments have been made to a total of 207 whistleblowers. In a statement, SEC Chairman Gary Gensler said, “[This] announcement underscores the important role that whistleblowers play in helping the SEC detect, investigate and prosecute potential violations of the securities laws.” The two most recent awards included a payment of $110 million to an individual who, according to the SEC, provided the SEC and another regulatory agency with “independent analysis that substantially advanced the SEC’s and the other agency’s investigation” and culminated in successful enforcement actions. Another whistleblower also provided original information to the SEC and received an award of approximately $4 million, although the smaller amount reflects the fact that the information passed on was significantly more limited in scope. As is its standard policy, the SEC declined to specifically name either of the whistleblowers involved or the cases and companies to which they were connected.

financefraudwhistleblower

Demonetize the Children

October 14, 2021Uncategorized

The Fair Labor Standards Act (“the Act”), enacted in 1938, protects public and private employees with a federal minimum wage, requirements for overtime pay, and youth employment standards. Despite protections established for children under the Act, children in the entertainment industry are expressly excluded from its protections. Instead, minors in the entertainment industry must rely on state regulation of their employment, which is often stricter and more protective than the Act. However, there is a massive loophole in that the entertainment industry in most states does not include child influencers and social media stars. With the increase in social media in the last decade, children in the social media sector are left in limbo about their rights and employment protections. State entertainment laws for minors must be extended to include the fast-growing number of children growing up in social media fame.

Employmententertainment lawFLSAJournal of Regulatory Compliancesocial mediaYouTube

The Quiet Corporate Health Cybersecurity Struggle Playing Out in Plain Sight

October 13, 2021HIPAA & Health Information

Cyberattacks on the healthcare industry have reached a fever pitch. In 2020 alone, there was a drastic increase in healthcare organization cybersecurity breaches. In 2021, the average cost of a healthcare data breach increased by over $2 million to $9.23 million. Healthcare providers continue to be the most targeted industry for cybersecurity breaches, with over ninety-three percent of healthcare organizations experiencing a data breach over the past three years. 306 breaches of unsecured protected health information (“PHI”) impacting 500 or more individuals were reported to the U.S. Department of Health and Human Services (“HHS”) in 2020. Yet healthcare organizations continue to be ill-equipped to handle this growing problem.

breachcyber-securityhealthcareHIPAAphiPrivacy & Security

Talk Kickback to Me: Healthcare Provider Remuneration by Big Pharma

October 12, 2021Drugs & Devices, Fraud & Abuse

Recently, pharmaceutical companies are gaining increased notoriety for violations of the False Claims Act, the Anti-Kickback Statute, and general fraudulent practices directed toward physicians and medical care providers with the intent to increase profits. In 2019, Avanir Pharmaceuticals settled with the Department of Justice to pay more than $108 million of criminal penalties and civil damages for engaging in kickbacks with physicians, and misleading marketing of their drug Nudexta for unapproved purposes. Then, in May of 2021, Incyte Corp., a Delaware-based pharmaceutical manufacturer agreed to pay $12.6 million for unspecified damages arising under a violation of the Federal False Claims Act for improperly using an independent foundation to cover copays of individuals consuming Incyte’s cancer drug, Jakafi. Despite widespread prosecutions against pharmaceutical drug manufacturers, and the fraud deterrent provisions of the False Claims Act, the risk of fraud and remuneration still runs high in relationships between healthcare professionals and pharmaceutical companies.

Anti-Kickback StatuteBig Pharmafalse claims actfraud schemeshealth care fraud and abusehealthcarekickbacksOIGqui tamremunerationspeaker events

The Ableist and Racist Public Charge Rule

October 12, 2021Uncategorized

The Public Charge Rule perpetuates anti-immigrant sentiment and keeps poor, disabled migrants who were often Black, Brown, and ethnically oppressed out of the United States. It makes pathways to citizenship contingent upon wealth and the absence of disability. As the Autistic Self Advocacy Network puts it, the Public Charge Rule is a “clear echo of the racist and ableist policies of the eugenics era.”

AbleistbenefitsChinese Exclusion ActhealthcareImmigrationImmigration Act of 1882International AffairsJournal of Regulatory CompliancePublic BenefitsPublic Charge RuleRacismRegulation

The Explosion of Remote Patient Monitoring in the Wake of COVID-19

October 8, 2021Fraud & Abuse, HIPAA & Health Information

The COVID-19 pandemic has fundamentally changed many aspects of healthcare delivery. Most notably, the pandemic increased the demand for digital health services. Telemedicine saw ten years’ worth of expansion in one year, but it was not the only digital health service that exploded as a result of the pandemic. Telehealth has evolved from merely meeting with a provider via a video conference to include more sophisticated technologies. Remote Patient Monitoring (“RPM”) allows for providers to collect patient data without the patient having to go to a healthcare facility for monitoring. RPM can improve the quality of healthcare delivery by more closely monitoring a patient while also reducing patient volumes within a healthcare setting. In addition, because RPM allows patients to get more care at home, it can largely reduce costs to the patient and the payor while increasing access. Despite the many benefits associated with RPM, there are considerable risks and compliance issues.

COVID-19digital healthRPMtelehealthtelemedicine

Administration Matters: The Evolution of Cross-Examination Requirements under Title IX

October 8, 2021Uncategorized

On August 24, 2021, the U.S. Department of Education’s Office for Civil Rights (OCR), released guidance clarifying that, effective immediately, it will stop the enforcement of 34 C.F.R. § 106.45(b)(6)(i). With this new guidance, a decision-maker at a post-secondary school may now consider outside information submitted by a survivor-complainant during the Title IX grievance process, even if the survivor-complainant does not partake in cross-examination.

Department of EducationEducationsexual misconductTitle IX