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Journal of Regulatory Compliance

Election Assistance Commission Releases Funds to Help States Prepare for 2018 Elections

The U.S. Election Assistance Commission has released over $300 million in Help America Vote Act funds to 48 states and territories intended to improve election security and administration. This comes after the Consolidated Appropriations Act of 2018 appropriated $380 million into the Help America Vote Election Security Fund in March of this year. 

GDPR, Data, & Blockchain: The New Wonders of the Digital World

In a world where our reliance on technology and the cloud is increasing exponentially, data security’s growth has stagnated. The European Union (EU) passed the General Data Protection Regulation (GDPR) in hopes of ensuring that consumer data is protected and not harbored by businesses. The effects of the GDPR, however, have passed the borders of the European Union. In a world where our actions extend internationally with just the click of a button, the GDPR’s impact circles the globe as well. The GDPR has pushed for a shift in data privacy and regulation for companies within and outside of the EU as it holds to protect European citizens, no matter where they are in the world. This international reach has not only created forces to drive U.S. companies to comply, but states within the U.S. are now creating GDPR-inspired laws to protect their own citizens. The GDPR has started a trend that will soon become the norm and finally push compliance to keep up with the exponential growth of technology.

Proposed Changes to the NIH Guidelines for Human Gene Transfer Experiments

The National Institute of Health (NIH) has submitted a proposal to amend the NIH Guidelinesfor research involving recombinant or synthetic nucleic acid molecules.  The proposed amendmentseeks to streamline the oversight for human gene transfer clinical research protocols and reduce duplicative reporting requirements already captured within existing regulatory framework.  The amendment specifically seeks to delete the NIH protocol registration submission and reporting requirements under Appendix M of the NIH Guidelines, and modify the roles and responsibilities of entities involved in human gene transfer or the Recombinant DNA Advisory Committee(RAC).

International Business Travel Comes with Potential Data Risks

The economic rebound seen in the last decade has resulted in a substantial increase in business travel, both foreign and domestic. Increasingly complex global supply chains are necessitating that business leaders travel the world in order to expand their businesses and forge valuable new partnerships. Unfortunately, this increase in travel also presents an increased risk for the theft of proprietary or confidential information.

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.

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.

The Tumultuous Regulation and Deregulation of Payday Loans  

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.

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.