Tag:Regulation
Climate Change: A Compliance Crisis
In October 2018, the Intergovernmental Panel on Climate Change of the United Nations issued a special report on the impact of global warming. The report shared extensive research about our changing atmosphere and issued a grave warning: we must act immediately. The harrowing news came just over one year after President Trump ordered the United States’ withdrawal from the Paris Climate Agreement in June 2017. This begs the question: how will changes be made when the world’s most powerful and impactful hegemon refuses to cooperate?
Fifth Circuit Faced with Post-Marks Litigation: Do We Know What an “Automated Telephone Dialing System” is Anymore?
Will new litigation affect Beto O’Rourke’s campaign? With election polls opening up for early voting last week, a one week left of campaigning and the new Telephone Consumer Protection Act (the “TCPA”) litigation to defend, it is unlikely that Beto O’Rourke will be slowing down any time soon. O’Rourke has made it his mission to reach all voters, not just those residing in the three major cities: Austin, Houston and Dallas. New litigation filed October 19, 2018, raises the question whether “Beto for Texas” reached those voters in violation of the TCPA and the recent Marks v. Crunch decision. The litigation will address whether the 5th Circuit will implement Marks expansive definition of an “automated telephone dialing system.”
SCOTUS Overturns Stay, “Dark Money” Donors Will Be Partially Disclosed
On September 18, 2018, the United States Supreme Court overturned a stay blocking a District Court ruling requiring non-profits to disclose identity of all contributors who give more than $200 a year. Prior to the ruling, IRS designated 501(c)(4) social welfare organizations and 501(c)(6) organizations such as business leagues and boards of trade, who do not register as political committees with the Federal Election Commission (FEC), were required to disclose donors only when they contributed for specific political advertisements. While the ruling requires the FEC to give guidance, newly issued FEC rules limit the scope of the court’s intention. It is likely that the new ruling will allow some donors to remain undisclosed while requiring partial disclosure of donors who contribute towards certain, but not all, expenditures.
States Fail At Mental Health
The Mental Health Parity and Addiction Equity Act (“the Parity Act”) is a federal civil rights and consumer protection law. The Parity Act prohibits most public and private insurance plans from imposing more restrictive standards on mental health (“MH”) and substance use disorder (“SUD”) benefits than they impose on similar medical/surgical benefits. However, ten years since its passage, states have failed to appropriately enforce the Parity Act.
Amazon Go versus the GDPR
New data privacy regulations entail questioning both current and future technologies. Recently, Amazon has introduced a store concept that eliminates everyone’s least favorite things about shopping, long lines and small talk. Amazon Go is the grocery store of the future and these stores allow consumers to walk in, pick up the items that they need, and then walk right back out. That’s it. No long lines, no cashiers, no shopping carts. However, as great as this concept seems, there are still concerns from a data privacy standpoint as Amazon needs to collect personal data from its consumers in order to be able to lawfully execute these checkout-less stores.
Impact of Provisions of Revised Rules of FDA-Regulated Clinical Investigations
The FDA regulationson human subject protection and Institutional Review Boards(IRBs) provide guidance to protect the rights, safety, and welfare of subjects who participate in FDA-regulated clinical investigations. The regulations conform with the requirements set forth by the Department of Health and Human Services (HHS) Federal Policy of Human Research Subjects(45 CFR 46, part A). In order to reduce confusion and burdens associated with complying with both the FDA regulations and the HHS policies regarding human subject protections, the FDA is revising the current “common rule”.
Compliance Spotlight: Joseph Adamczyk, OCC
Joseph Adamczyk, ’01 is the Senior Vice President and Chief Compliance Officer at OCC (Options Clearing Corporation). OCC is the world’s largest equity derivatives clearing organization, and works to promote stability and financial integrity in the marketplace. Mr. Adamczyk holds a J.D. from Loyola University Chicago School of Law, an MBA from the University of Chicago, and a B.S. in Business Administration from DePaul University.
SEC, DOL Advance New Fiduciary Rule After Adverse 5th Circuit Ruling
Both the Securities Exchange Commission (SEC) and Department of Labor (DOL) are pushing ahead with fiduciary standards for investment advisers despite the 5th Circuit striking down the DOL’s previous fiduciary rule earlier this year.
Managing Your Health in 2018: Mobile Medical Applications and FDA Regulations
Immediately upon introduction, mobile medical applications became favored by physicians and patients alike because the applications are user friendly and allow the patient to understand their care and participate in more meaningful discussions with their provider about their health. Due to the rapid development of technology and, as a result, a surge of mobile medical applications flooding the market, the Food and Drug Administration has issued three guidances on how they plan to regulate mobile medical applications. In order for mobile medical application manufacturers to remain compliant with the FDA guidances, they must meet the seven categories of requirements that are laid out in Appendix E of FDA’s 2015 guidance and also comply with any further guidance that is released.
How the Biggest Nitrogen Polluter of U.S. Waterways Achieves EPA Compliance
According to an Environmental Integrity Project report, an Illinois pork-processing plant discharged more nitrogen from animal waste into waterways than any other slaughterhouse in the United States. Yet, the facility has complied with the Clean Water Act since December 2015. Animal-processing operations are not only some of the top polluters, but the federal water pollution standards surrounding these operations are lacking.