INSIDE COMPLIANCE – Page 71 – Loyola University Chicago School of Law

Sunscreen Regulations: Providing Protection for Consumers and Difficulties for Manufacturers

March 12, 2019HIPAA & Health Information

In 2014, Congress passed the Sunscreen Innovation Act in the hopes of encouraging innovation for new sunscreen ingredients. Recently, the United States Food and Drug Administration (FDA) proposed new regulations regarding over-the-counter sunscreens to keep up with recent scientific and safety information. This proposal will be available for ninety days from its announcement on February 21, 2019, and addresses safety concerns of common sunscreen ingredients. Further, the proposal addresses the labeling of sunscreen, trying to make it easier for consumers to identify the product information. While this proposal seeks to alleviate safety concerns, the regulation could potentially make it more difficult for new ingredients to be approved.

FDAFDA regulationsFederal Drug AdministrationRegulationSunscreen

The Tumultuous Regulation and Deregulation of Payday Loans

March 12, 2019Uncategorized

Each year, approximately twelve million Americans resort to payday loans for quick money to pay off bills and cover emergency expenses. The small, short-term unsecured loans give borrowers a quick way to get money with little consideration of their creditworthiness. Borrowers are plagued with extremely high annual percentage rates to offset the seemingly substantial risk to the lender. However, many studies have shown that payday loans carry no more long-term risk to the lender than other forms of credit. Lenders are able to gain from the high interest rates that burden borrowers while simultaneously benefitting from the relatively low-stakes gamble of the nature of the loan. This illuminates a harrowing truth: the real victims of exploitative and predatory “cash advances” are the borrowers themselves who continue taking on more and more of these high-interest loans in a vicious cycle to repay small debts.

CFPBConsumer Financial Protection BureauFederal Trade CommissionFTCJournal of Regulatory Compliancepayday loansUniform Small Loan LawUSLL

Rush University Medical Center’s 2019 Privacy Breach Incident

March 8, 2019HIPAA & Health Information

In March 2019, Rush University Medical Center (“Rush University”) sent out breach notification letters to approximately 45,000 patients. The letter advises patients that a privacy incident occurred that may have involved the patients’ personal information. The privacy incident was caused by an employee of a third-party financial services vendor. The employee released a file that contained patient information to an unauthorized person. According to the breach notification letter, law enforcement and regulatory officials were involved in the investigation of the privacy incident. Rush University sent the breach notification letter in compliance with the Health Insurance Portability and Accountability Act’s privacy and security rules.

compliancecompliance programhealthcareHHSHIPAAprivacyPrivacy & Security

Public Health in the Court of Public Opinion: The Pacific Northwest’s Vaccine Crisis

March 7, 2019Uncategorized

A measles outbreak that has affected 71 people in Washington and4 people in Oregon has ignited public health discourse over vaccinations. Vaccination rates in the Pacific Northwest are among the lowest in the nation. Both Washington and Oregon allow personal belief exemptions from immunizations for school-age children. The outbreak, which continues to spread, may lead Oregon and Washington to follow California’s example of eliminating personal belief exemptions. Eliminating personal belief exemptions, however, may not be the panacea that lawmakers seek. The rise in medical exemptions for vaccines in California indicates the need for a comprehensive vaccination framework.

californiaHerd immunityJournal of Regulatory ComplianceMeaslesOregonpublic healthVaccinationsVaccinesWashingtonWHOWorld Health Organization

Tragic Dam Collapse Leads to Calls for Real Change

March 4, 2019Uncategorized

At 12:28pm on January 25, 2019, a thirty-story high tailings dam operated by Brazilian mining giant Vale suffered a catastrophic failure, unleashing an estimated 12 million cubic meters of mining waste on the town of Brumadinho, Brazil. The collapse killed 177 people, and 133 others are missing and presumed dead. Perhaps the most devastating part of this tragedy is the simple fact that it should have never happened.

BrazilDamMiningRegulationVale

Health and Human Services Promulgates New Abortion “Gag” Rule; Opponents Prepare for Legal Challenges

February 28, 2019Drugs & Devices

On February 22, 2019, the Department of Health and Human Services submitted a final rule to the Federal Register, substantially altering existing guidelines for family planning programs’ reception of federal funds under Title X of the Public Health Service Act (PHS Act). Among other things, the new regulations prohibit qualifying programs from referring patients to abortion providers. Public statements from organizations such as Planned Parenthood suggest lawsuits for injunctive relief are imminent.

abortionHealth and Human ServicesRegulationTitle X

The Value of Privacy: How Facebook Paid for Access to the Personal Data of Teens and Adults

February 28, 2019Uncategorized

On January 29, 2019, TechCrunch released an investigation finding that Facebook had been paying users as young as 13 for unlimited access to their data. Facebook marketed the application, not available through the iOS app store, to users aged 13-to-35 by offering to pay $20 per month plus referral fees for downloading and using a “Facebook Research” app. The app, once downloaded, provided Facebook with unrestricted access to all private data on the users iPhone including messages, photos and videos, and website usage. This was not the first app launched by Facebook to track user’s data, Apple removed a similar app called Onavo from the app store in 2018. This app is a clear violation of the 2011 consent decree Facebook signed with the Federal Trade Commission.

data collectionFacebookFederal Trade CommissionFTCPrivacy & Security

Facebook’s Watching… For Now

February 27, 2019The Art of Compliance

Ever since the Facebook and Cambridge Analytica scandal, concerns surrounding data privacy and protection have been growing. Both government agencies and individual users have particularly been concerned on how their data is being collected and used on social media websites such as Facebook. Germany has taken action in response to such concerns and recently took a step against Facebook’s collection of data in a decision that outlawed Facebook’s entire advertisement regime.

complianceconsentenforcementFacebookGermanyInternational AffairsJournal of Regulatory ComplianceprivacyPrivacy & SecurityRegulationrulemaking

Charitable Solicitation: Do Threatened Penalties and Sanctions Ever Actually Reach the Non-Profit Organizations Misappropriating Funds?

February 25, 2019The Art of Compliance, Uncategorized

In order to operate, non-profit organizations rely heavily on the ability to fundraise. The government leaves the regulation of that “charitable solicitation” to individual states, with most requiring formal registration to engage in such activities. With firms vying for organizations’ business to hire consultants to obtain funds, and ethics and oversight firms highlighting the careful approaches that must be utilized to appropriately raise funds for non-profit operations, charitable organizations may find themselves confused and threatened in the space between needing charitable solicitation to survive and maintaining regulatory compliance to engage in the activity itself. While the threats of penalties and sanctions are large and imposing, it appears that few organizations ever face their true weight. Charitable organizations must, of course, comply with each state of registration, but is the fear instilled equal to the reality of the consequences of non-compliance?

501(c)(3)corporatefinancialfinancial auditfundraisingJournal of Regulatory Complianceliabilitymonetary penaltiesnon-profitpersonal liabilitysolicitsolicitation compliancestate regulationTax-Exemption

The “Regulatory Sprint” to Value-Based Care: Adjusting Stark Law and the Anti-Kickback Statute

February 25, 2019Fraud & Abuse

The current Deputy Secretary of the Department of Health and Human Services and former Loyola University Chicago School of Law professor Eric D. Hargan was sworn into his position as the Deputy Secretary on October 6, 2017. Since then, he has been working on assisting providers to help them better understand the intricacies of the Stark law by gathering provider concerns about present governing efforts. All of this work is being done in an effort to shift the healthcare system away from fee-for-service care and towards value-based care in what Hargan is calling the “Regulatory Sprint to Coordinated Care.” Hargan stated that “removing unnecessary government obstacles to care coordination is a key priority for this Administration.”

Regulation