Tag:Regulation
DHS’s Partnership with Private Industries Leads to a Crackdown of Fraudulent Behavior During the Pandemic
After the COVID-19 pandemic spread to the U.S. in February of 2020, there was a surge in fraudulent behavior as criminals took advantage of the fear revolving around the pandemic to profit from selling defective goods and scamming the public. This has resulted in the loss of millions of dollars by the public. Scammers will continue to benefit and take advantage of the public until the government steps in and takes preventative measures to stop this criminal behavior during the pandemic.
CMS Issues New Rigid COVID-19 Requirements for Skilled Nursing Facilities
The Centers for Medicare & Medicaid Services (“CMS”) released new guidance for skilled nursing facilities (“SNFs”) as part of a larger rulemaking agenda for healthcare institutions in the throes of the current public health emergency with COVID-19. CMS has also detailed the fines for non-compliance with the new COVID-19 requirements for SNFs and other healthcare institutions such as hospitals and laboratories.
Workplaces and Regulations During a Public Health Crisis
The U.S. Department of Labor’s Wage and Hour Division (“WHD”) recently announced alterations to its previous regulations which expanded family and medical leave provisions and paid sick leave of April’s Families First Coronavirus Response Act (“FFCRA”). These revisions serve to clarify the responsibilities of employers and the rights of workers as they relate to the paid leave of FFCRA. These revisions come after a decision from the U.S. District Court for the Southern District of New York which invalidated portions of the initial regulations. The WHD’s revisions are an example of the lack of clarity and adequate response from regulations designed to protect workers during the current pandemic.
CRISPR Technology. A Chicken-And-the-Egg Problem of Scientific Advancement and Regulatory Oversight.
It’s been nearly two years since Chinese researcher He Jiankui shocked the scientific community and the world when he claimed to have genetically modified the genome of two human babies for resistance to HIV using CRISPR technology. Jiankui operated under the guise of reducing the HIV/AIDS disease burden in Africa, a seemingly admirable pursuit. But geneticists and ethicists considered the experiment , and done in pursuit of personal gain.
DOL Proposes Rule That Could Recategorize Many Employees into Independent Contractors
The U.S. Department of Labor (“DOL”) has recently proposed a rule change that would revise its interpretation of “independent contractor” under the Fair Labor Standard Act (“FLSA”). According to DOL, which has the power to investigate worker complaints about misclassifications, this change is needed to promote certainty for stakeholders, reduce litigation, and encourage innovation in the economy. However, this proposed rule could also diminish employee rights because independent contractors have fewer protections under FLSA. This rule widens the scope of who can be considered an independent contractor. Thus, many workers classified as employees could be reclassified as independent contractors and lose protections under FLSA.
Rural Hospitals in Crisis Receive a Boost to Value-Based Care Model from New CMS CHART Model
The Centers for Medicare & Medicaid Services (“CMS”) Innovation Center (“CMMI”) recently announced a new model for health care providers in rural areas to receive payment from the federal government. The Community Health Access and Rural Transformation (“CHART”) initiative aims to improve rural health care while promoting the Trump Administration’s push to shift health care providers into a more expansive value-based payment model.
A New Housing Crisis: Navigating Changing Guidelines and Relief in a Pandemic
Patrick Gilsenan Associate Editor Loyola University Chicago School of Law, Weekend JD 2023 Americans looking for relief and regulatory protections in the face of an eviction and foreclosure crisis have been met with a patchwork system of confusing, temporary, and difficult to navigate government programs. The eviction ban established by the CARES Act has expired, …
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How COPPA and FERPA affect Education in the Age of Remote Learning
As thousands of schools across the country comply with state and local social distancing orders due to the global pandemic COVID-19 for this 2020-21 school year, many schools are now faced with having to educate students from their homes in either hybrid or fully remote models. Millions of students are now utilizing online educational services to aid in remote learning. Although these education technology companies (“EdTech”) are now providing crucial remote learning opportunities for students, school districts must also keep students’ privacy rights in mind. Many of these EdTech services will collect and use personal information of students who use their services. This is where the Federal Trade Commission’s Children’s Online Privacy Protection Act (“COPPA”) pertains.
Voting in the 2020 Election
Most United States citizens have certain expectations when they go to their polling station; voters expect to stand in a line, to be handed a ballot by an official, or to vote on a touch screen system. Yet, amid COVID-19, for many Americans, going to a polling station presents too many opportunities for the transmission of the virus. As a result of the danger of voting in-person and the desire to vote by mail, it is projected that the United States Postal Services (hereinafter “USPS”) will deliver an unprecedented number of mail-in ballots.
Pre-Approval Access and Pathways to Investigational Drugs
The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 requires pharmaceutical drugs to provide evidence of their safety before they are allowed on the market. As such, pharmaceutical companies submit applications to the Federal Drug Administration for approval. There are situations, however, in which patients seek to receive access to a particular pharmaceutical drug before the FDA approval process is complete. This blog will explore the various pathways to pre-approval access in addition to recent legislation and legal considerations for such pathways, in addition to the principles and common obstacles that pharmaceutical companies face within such pathways.