INSIDE COMPLIANCE – Page 93 – Loyola University Chicago School of Law

Proposed Changes to the Clinical Laboratory Improvement Amendments of 1988

March 14, 2019The Marketplace, Drugs & Devices

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 researchJournal of Regulatory ComplianceHealth LawRegulation

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.

cosmeticsbeautyJournal of Regulatory ComplianceFood Drug and Cosmetic ActFood and Drug AdministrationFDAskincareRegulation

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 AdministrationSunscreenRegulation

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.

Consumer Financial Protection BureauCFPBJournal of Regulatory ComplianceFTCFederal Trade CommissionUniform Small Loan LawUSLLpayday loans

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.

compliance programcomplianceHIPAAHHShealthcarePrivacy & Securityprivacy

Regulating the Un-Explainable: The Difficulties in Regulating Artificial Intelligence

April 9, 2019Uncategorized

From Siri to Alexa, to deep learning algorithms, artificial intelligence (AI) has now become commonplace in most peoples’ lives. In a business context, AI has become an indispensable tool for businesses to utilize in accomplishing their goals. Due to the complexity of the algorithms required to make quick and complex decisions, a “black box problem” has emerged for those who utilize these increasingly more elaborate forms of AI. The “black box” simply refers to the level of opacity that shrouds the AI decision-making process. While no current regulation explicitly bans or restricts the use of AI in decision making processes, many tech experts argue that the black box of AI needs to be opened in order to deconstruct not only the technically intricate decision-making capabilities of AI, but the possible compliance-related problems this type of technology may cause.

AIartificial intelligenceblackboxJournal of Regulatory ComplianceTechnology and the LawtechnologyRegulation

How Will Recreational Marijuana Impact Illinois?

April 10, 2019The Art of Compliance

During Governor-elect J.B. Pritzker’s election campaign, he heavily advocated for Illinois to be more accommodating to recreational marijuana usage. In Illinois, medical marijuana has already been legalized, and new bills are being introduced to make it more accessible. If recreational marijuana is legalized, Illinois will join ten states, and the District of Colombia, in its authorization.

Controlled Substances ActDrug-Free Workplace ActEmploymentDEAmarijuanamedical marijuanaJ.B. PritzkerJournal of Regulatory ComplianceFood and Drug AdministrationFDAfederal preemptionrecreational marijuanaRegulation

A US Data Privacy Law That Bites, Hopefully

September 17, 2019Uncategorized

Despite industry groups’ and tech companies’ numerous efforts over the past few months to water down and ultimately halt the first-ever U.S. data privacy law, the California Consumer Privacy Act of 2018 (“CCPA” or “the Act”), the CCPA now has its final language set on September 13, 2019, the end of California’s legislative calendar, and will go into effect on January 1, 2020. The goal is to give California residents control of their personal information collected and processed by companies.

Consumer Rightdata privacycomplianceCalifornia Consumer Privacy ActCCPAPrivacy LawPrivacy & Security

When the American Dream Causes an American Nightmare

May 13, 2019Drugs & Devices

At first, the story of John Kapoor’s rise to the top of the pharmaceutical industry sounds like the American dream played out in real life. The first to attend college in his family, Kapoor graduated from Bombay University in India with a degree in pharmacy. He came to the United States after securing a fellowship at the University of Buffalo, and earned his Ph.D. in 1972. His scientific and business savvy was evident from the start – in a matter of a decade, Kapoor took over a struggling pharmaceuticals business, turned it around, and netted a personal gain of $100mm. From there Kapoor became a serial entrepreneur, with INSYS Therapeutics marking the pinnacle of his success. The company made him a billionaire, but later made him the target of a criminal racketeering investigation and the face of one of America’s darkest problems.

Regulation