Tag:

Regulation

FCPA Establishes Corporate Regulation of Text Messaging Apps

On March 12, 2019, the Department of Justice (“DOJ”) announced revisions of the Corporate Enforcement Policy in the Foreign Corrupt Practices Act. The changes now require company oversight of ephemeral messaging apps used by any employee, stock holder, or agent who discusses business records via the messaging platform. Publicly traded companies must now establish internal compliance policies to review use of ephemeral messaging services, provide ongoing oversight of the messaging services, and may want to completely prohibit the use of such messaging apps for business purposes.

How Will Recreational Marijuana Impact Illinois? 

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.

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

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.

“Grounding”: Federal Regulation in the Context of Aircraft Suspensions

On March 10, 2019, Ethiopian Airlines Flight 302 en route to Nairobi, Kenya crashed shortly after take-off leaving no survivors. It became the carrier’s most deadly crash and its first fatal crash since January 2010. Most notably, however, it was the second fatal crash involving Boeing’s new 737 MAX jet in less than five months after the Lion Air Flight 610 accident in October 2018. The day following the tragedy, Ethiopian Airlines grounded all of its Boeing 737 MAX 8 fleet until further notice. Many other airlines suspended operations of the aircraft as well and countless countries banned the 737 MAX from airspace.

Data Privacy Rules Step Up to the Next Level

The Federal Trade Commission (“FTC”) recently proposed two amendments to the Privacy Rule and Safeguards Rule under the Gramm-Leach-Bliley Act (“GLBA”). The Safeguards Rule requires financial institutions to develop, implement, and maintain a comprehensive information security system. This rule went into effect in 2003. The Privacy Rule requires financial institutions to inform customers about its information-sharing practices and allows customers to opt out of having their information shared with certain third parties. This rule went into effect in 2000. The recent amendments to these two rules are intended to further protect consumers’ data from third parties. However, the changes could also adversely affect businesses. 

The Future of Online Prescribing

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?

Proposed Changes to the Clinical Laboratory Improvement Amendments of 1988

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.

HIPAA May Not Be Enough to Protect Our 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”).

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

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.

Sunscreen Regulations: Providing Protection for Consumers and Difficulties for Manufacturers

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.