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.
The Changing Face of Charity Care Determinations
Since the enactment of the Affordable Care Act, hospitals have faced strict and substantial regulations regarding the provision of financial assistance to patients in the form of “charity care.” An essential element in a hospital’s ability to maintain tax-exempt status and financial solvency, charity care has worked to serve uninsured and indigent patients while helping charitable hospitals serve their mission and retain the benefits that come with it. The state of Pennsylvania recently passed legislation requiring more explicit and affirmative acts to provide charity care to more eligible patients. The change is unprecedented, and other states look to be slowly responding in their own ways. Compliance with these changes is most beneficial with proactive measures and risk assessments even before change comes through the doors.
You’ve Heard About the GDPR, but What About the CCPA?
On June 28, 2018 California took a page out of the European Union’s (EU) book and signed the California Consumer Privacy Act (CCPA) into law. The CCPA is a landmark privacy bill that will come into effect on January 1st, 2020 and it is being closely compared to the General Data Protection Act (GDPR).
What does this mean for California businesses and residents? In short, more privacy and more control over data. Key aspects include allowing consumers to request what data an organization has collected about them, allowing consumers the right to fully erase data, protecting children’s data, and making verification processes more stringent for businesses.
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).
FDA Warns E-Cigarette Manufacturers: Stop Teen Epidemic or Face Consequences
The rise of electronic cigarettes was initially met with relaxed FDA regulation given optimism that they could help adult smokers curb use of more toxic combustible cigarettes. This optimism was in spite of e-cigarettes’ growing popularity among adolescents and young adults. On September 12, the FDA signaled a pivot from this approach when FDA Commissioner Scott Gottlieb described youth e-cigarette use as having reached epidemic proportions. Gottlieb announced that the FDA had issued more than 1,300 warning letters and fines to retailers caught selling e-cigarette products to minors. It also issued an order to the five major e-cigarette manufacturers (Juul, Vuse, Blu, MarkTen XL, and Logic) to each submit a plan outlining how the company will address youth access and use of their products. Failure to submit a sufficient plan could lead the FDA to revisit its earlier decision on flavored e-cigarette products, which allowed manufacturers a grace period until 2022 to receive FDA approval.
Regulatory Rollbacks: Changing the Career Education System
In a world where students are swimming in debt, the Education Department has made an effort to regulate career education and ensure students receive a quality education. During the Obama Administration, rules were implemented that require educational institutions to prove they are preparing graduates for gainful employment. In addition, the borrower defense rule allows for federal student loan forgiveness when the student can prove their institution misled them relating to the loan or education services provided. With so many students in debt, what is the appropriate standard of review to apply when determining these regulations?
Electronic Health Record Compliance Measures Benefit Patient Centered Care
In a time when data breaches occur fairly frequently, whether it’s credit card information being stolen from department stores or a credit reporting bureau breach affecting hundreds of millions of customers, keeping personal information private seems to get harder every day. That fact may give patients pause when they are asked to sign up for an electronic health record account. A 2017 survey listed electronic health record management as one of patients top concerns. Changes in recent years have led to changes in compliance measures that make electronic health records security an added benefit to patients and ensure the continued increase of their adoption.
Black Market Midwifery: Lack of Regulation Compromises the Safety of Women Who are Committed to Giving Birth Outside the Hospital Setting
Across the United States more and more women are choosing to give birth outside of hospitals. Currently, in Illinois, Certified Professional Midwives are not licensed to provide home birth services. However, over the last decade, advocates in Illinois have urged lawmakers to reconsider this restriction. The most recent attempt in 2017 was unsuccessful once again. While opponents argue that individuals with this level of training should not be providing care to women during delivery, the choice for women who are committed to home birth is not between home and the hospital. It is between home and an illegal or unassisted delivery.