INSIDE COMPLIANCE – Page 80 – Loyola University Chicago School of Law

The Shift from Sectoral to Comprehensive Data Protection in Thailand

March 21, 2019Uncategorized

Ever since the enactment of the General Data Protection Regulation in the European Union, data privacy and data protection have become a hot topic for businesses and countries around the world. In the digital age where personal data is constantly collected, processed, and used, the need for strong data collection regulations has never been more important. Many countries have begun to enact data protection laws, and the most recent addition to a comprehensive data protection act is seen in Thailand. On February 28th, 2019 Thailand’s National Legislative Assembly approved the very first comprehensive data protection law in the country, the Thailand Personal Data Protection Act, which will be effective after a one-year transition period to help ensure compliance.

The Many Ethical Questions Arising from the Conduct of Michael Avenatti

March 19, 2019Uncategorized

By now, Michael Avenatti is a household name. He shot to fame in 2018 while relentlessly representing adult film actress Stormy Daniels in her pursuit of the invalidation of a 2016 non-disclosure agreement regarding an alleged affair with President Donald Trump. Avenatti is famously brash and confrontational, and since his rapid rise to fame, numerous allegations of professional misconduct have come to the public’s attention. While he has avoided formal discipline thus far, it seems like only a matter of time until Avenatti faces some consequences for his actions.

ABA Model RulesAvenattiEthicsMichael Avenattirules of professional conductStormy Daniels

The Future of Online Prescribing

March 15, 2019The Art of Compliance

Telehealth allows for the delivery and facilitation of medical services through technology. It is rapidly evolving as the tech industry grows. Ten years after the passage of the Ryan Haight Act, the Drug Enforcement Agency (DEA) has still not taken any action to assist physicians in their usage of telehealth. Recently, Congress finally stepped in and passed a bill that requires the DEA to take action within the next year. But, the question still remains whether the DEA will finally act, or continue their history of avoidance?

CongressDEAJournal of Regulatory Complianceonline prescribingRegulationSpecial Registration for Telemedicine Clarification Acttelehealthtelemedicinethe Ryan Haight Act

Proposed Changes to the Clinical Laboratory Improvement Amendments of 1988

March 14, 2019Drugs & Devices, The Marketplace

The Department of Health and Human Services Center for Medicare and Medicaid Services have proposed a ruleto update the proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The new rule seeks to address current analytes, substances or constituents for which the laboratory conducts testing, and newer technologies. The rule would further make technical changes to the PT referral regulations to be more closely aligned with the CLIA statute.

clinical researchHealth LawJournal of Regulatory ComplianceRegulation

HIPAA May Not Be Enough to Protect Our Health Information

March 14, 2019HIPAA & Health Information

On March 1, 2019, the College of Healthcare Information Management Executives (“CHIME”) sent a six-page letter to Congress which discussed how technology has impacted health care costs. CHIME believes that too much money is being allocated towards making sure that health care organizations are complying with the Office of Civil Rights (“OCR”) and the Department of Health and Human Services (“HHS”) requirements, while not enough resources are being given towards actually protecting against cybersecurity attacks. The letter contains multiple suggestions in which patient data could be better protected, such as incentivizing health care organizations to implement more cybersecurity safety measures. However, many of CHIME’s proposals would require Congress to amend multiple provisions in acts, such as the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH Act”).

Regulation

The Ugly Side of Beauty: How Under-Regulation of Cosmetics Harmed Consumers for Decades

March 13, 2019Uncategorized

It is no secret that the beauty industry in America is frighteningly under-regulated. Cosmetics companies and beauty brands have managed to escape meaningful regulatory oversight for roughly a century and are largely left to self-regulate. In 2017, the global cosmetic products market was valued at $532 billion and is expected to reach a market value of $806 billion by 2023, registering a compound annual growth rate of 7.14%. Despite the colossal financial growth, regulatory shortcomings leave much to be desired by consumers. On the back of numerous harmful side-effects scandals and multi-million dollar class-action settlements, the FDA must grapple with renewed demand for cosmetics regulation as new beauty trends emerge.

beautycosmeticsFDAFood and Drug AdministrationFood Drug and Cosmetic ActJournal of Regulatory ComplianceRegulationskincare

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