Tag:Regulation
Joint Agency Decision Serves Up A New Regulatory Framework For Cell-Based Meat
Following a public meeting in October, the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) agreed to share joint regulation of cell-culture “meat” technology. This decision came on the tail end of public squabble between the two regulatory bodies regarding the oversight of cell-culture, or lab-produced meat. The regulatory framework for this type of quasi-agriculture has been unclear, especially after the White House Office of Science and Technology Policy issued the Coordinated Framework for the Regulation of Biotechnology initiative that attempted to coordinate the roles of various agencies involved in emerging biotechnology. The new, definitive regulatory structure has been thoroughly praised and welcomed by top cell-culture meat companies, who have expressed open frustration with the older, confusing framework, claiming that it hindered both consumer protection and technological innovation.
OIG Work Plan on Nursing Facility Staffing Levels
In August, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) made an additional focus in its Work Plan for the oversight of nursing facility staffing levels. These changes were made in the light of backlash from a July 2018 news article which reported that nearly 1,400 nursing homes had fewer qualified staff on duty than they were required or failed altogether to provide reliable staffing information to the Centers for Medicare and Medicaid Services (“CMS”).
Illinois Law Makers Seeking to Curb E-Cigarette Use Among Teens and Children
In the wake of rising e-cigarette use among teens and children, Illinois lawmakers seek a legal solution to protect Illinois youths from smoking-related illnesses and pre-mature death. Illinois’s Congress introduced Tobacco 21, a bill designed to raise the legal age to purchase tobacco products like e-cigarettes to 21 years of age. Despite a lack of support from Governor Bruce Rauner, Illinois politicians continue to fight to save the bill, and with good reason. The United States Food and Drug Administration (FDA) recently announced its Youth Tobacco Prevention Plan, which addresses the rising e-cigarette use among adolescents. The FDA’s plan is two-fold: (1) crack down on the sale and marketing of e-cigarettes and (2) educate teens and children about the dangers of using e-cigarettes. Tobacco 21 provides support for the FDA’s Plan.
Facebook’s Watching… For Now
Ever since the Facebook and Cambridge Analytica scandal, concerns surrounding data privacy and protection have been growing. Both government agencies and individual users have particularly been concerned on how their data is being collected and used on social media websites such as Facebook. Germany has taken action in response to such concerns and recently took a step against Facebook’s collection of data in a decision that outlawed Facebook’s entire advertisement regime.
The “Regulatory Sprint” to Value-Based Care: Adjusting Stark Law and the Anti-Kickback Statute
The current Deputy Secretary of the Department of Health and Human Services and former Loyola University Chicago School of Law professor Eric D. Hargan was sworn into his position as the Deputy Secretary on October 6, 2017. Since then, he has been working on assisting providers to help them better understand the intricacies of the Stark law by gathering provider concerns about present governing efforts. All of this work is being done in an effort to shift the healthcare system away from fee-for-service care and towards value-based care in what Hargan is calling the “Regulatory Sprint to Coordinated Care.” Hargan stated that “removing unnecessary government obstacles to care coordination is a key priority for this Administration.”
The Years Long Process to a Revised Common Rule and Implementation
The Common Rule, the Federal policy protecting human subjects of biomedical and behavioral research, was published in 1991. The process to update the policy has taken place over the last several years, leading to the final rule revisions which were effective as of July 19, 2018. After January 20, 2019, institutions are now permitted to implement the entirety of the revised Common Rule. Any institution receiving funds, supervision, or review from any of the twenty Federal Departments and Agencies that have codified the Common Rule must implement this revised rule in their compliance programs.
“On Demand” Abortions: Protection for Women’s Rights or Expansion of Late-Term Abortions?
With the recent change of New York’s abortion law, legislators granted women the affirmative right to abortions under the state’s public-health law. Under the Reproductive Health Act, restrictions on abortion past twenty-four weeks are removed legalizing abortion up until the day of birth. This bill was passed on the 46th anniversary of the Roe v. Wade decision. The new bill comes as a reaction to the confirmation of conservative Supreme Court Justice Brett Kavanaugh, giving protection to women’s access to abortion if Roe v. Wade is overturned. Proving to be very controversial, the change has advocates and critics at odds with its potential future effects.
Changing Washington Water Quality Standards for Salmon Survival
The state of Washington is proposing new water quality regulations in an effort to encourage growth to the salmon population. The campaign against the dams in the Columbia and Snake river basins has been fought for decades and continually struggles to balance the environmental impacts with industry and energy. This regulation is the newest strategy to attempt to strike a balance between the environmental concerns and the industry concerns. Further, as more attention is given to the dwindling population of killer whales, many are calling this an emergency requiring immediate action. This action is a timely response to the recent calls to action.
Protections for Accused Students or Problems for Victims?
The Trump administration has proposed new rules for schools dealing with sexual assault and harassment allegations that narrow the definition of sexual harassment and offering greater protections for the accused. Under the new rules, the Education Department is altering the procedures colleges that receive federal funding use to adjudicate complaints of assault and harassment. The new proposed rules come during the #MeToo movement, which will likely prove to be very controversial to both those who support the changes and those who oppose the changes. The federal guidelines stem from Title IX, which bars sex discrimination at schools that receive federal funding.