In recent years, the FDA has examined a record number of revolutionary medical devices, many of which have been genetic tests. Genetics has taken the world by storm. The medical world continues to look toward genetics as a promising next step in revolutionizing treatment, while the American public has shown a growing interest in learning more about themselves through services like Ancestry and 23andMe. In an effort to gain a foothold on the rapidly developing field of technology, the FDA has recently made efforts to modernize its approach by issuing new guidance to ensure the validity of these tests.
With less than a week left in the semester, the Journal of Regulatory Compliance editors are hard at work studying for exams, gearing up for summer jobs, or eagerly awaiting graduation. However, before we shutter INSIDE COMPLIANCE for the summer session, I want to take this opportunity to look back over the past year, and how much our members have accomplished.
The Journal of Regulatory Compliance is a young law journal, even for Loyola University Chicago School of Law. It’s only been a few years since our first annual symposium, and the debut of the Center for Compliance Studies here at Loyola University Chicago School of Law. In many ways, this year was an experiment—we debuted a new Board structure, a new editorial process, a new blog format and a new time of year for our Symposia. Despite that uncertainty, the 30-plus members of the Journal of Regulatory Compliance have accomplished extraordinary things.
Despite the United States having one of the safest food supplies in the world, more than 48 million Americans get sick from foodborne illnesses and diseases each year, and more than 128,000 are hospitalized and 3,000 die from similar issues that are largely preventable. On January 04, 2011 President Obama signed the Food Safety Modernization Act (“FSMA”) into law. This enactment was called the “most sweeping reform” of U.S. Food Safety laws in more than seventy years. But seven years later, the act is still only partially enforced as the FDA has faced resistance from the government as well as a lack of funding. The FMSA was and is intended to enable the FDA to protect the health of the public by strengthening the food system in the United States. While change and reform in the industry are necessary, what good are new reforms if they will not be enforced for years to come?
In a 9-0 decision, the Supreme Court on February 22, 2018 decided Digital Realty Trust, Inc. v. Paul Somers, a case challenging the definition of a whistleblower under the Dodd-Frank Wall Street Reform and Consumer Protection Act, commonly referred to as Dodd-Frank. The court held that “Dodd-Frank’s anti-retaliation provision does not extend to an individual, like Somers, who has not reported a violation of the securities laws to the SEC [Securities and Exchange Commission].” This is a narrowing of the definition of whistleblower and as such has a number of implications for companies and their compliance departments.
The IRS has decided to shutdown its Offshore Voluntary Disclosure Program (OVDP) on September 28, 2018. The program offers amnesty from criminal prosecution and a set penalty structure for those who have previously failed to disclose foreign bank accounts and other foreign assets, including those held through undisclosed foreign entities. Failure to disclose could include failure to file the annual FinCEN Form 114,most commonly referred to as the foreign bank account report or “FBAR”, as well as the failure to report income from such accounts and assets on tax returns and the failure to provide various other foreign information forms and returns.
The Dr. Larry Nassar abuse scandal recently rocked the world of sports. Dr. Nassar, in his role as athletic trainer for the USA Gymnastics team, is alleged to have abused over 250 girls and young women, though he has only admitted to ten of the accusations. The resulting fallout has brought to light many issues in the world of amateur sports, unfortunately an issue that affects young adults and children. In particular, the US Olympic Committee is now facing multiple lawsuits from athletes who were abused by Dr. Nassar. Aly Raisman, the two time-Olympian who has become the face of Nassar’s victims, alleges that the Committee knew or should have known that Dr. Nasser was abusing her and other young girls.
Every day, thousands of gigabytes of data flow around the world. Transfers between consumers and producers make up a large portion of that data. There has been talk recently of the commercialization of said data, such as Facebook and Google selling their users’ data to third parties. These third parties are more than willing to pay large sums for this information, as it provides actionable data on consumer trends, such as their likes and dislikes. This data can be used by companies to shift their marketing strategies to capture a greater market share. For the e-commerce retailer, whether large or small, this data can be valuable as a resource and a commodity. As such, knowing what you can and can not do with the data is important. Here, we will be discussing Data Management risks when it comes to the collection of consumer data.
Compliance standards in the United States come from the laws and policies enacted by the government and its related agencies. Administering U.S. standards on foreign institutions, public or private, poses a unique challenge. Our public and private companies are held accountable by federal, state, local, or agency rules, as well as the guidelines providedby the United States Sentencing Commission. But foreign organizations, in theory, have no real obligation to follow our lead. There have been several notable attempts in recent years to enact legislation on foreign organizations and impose sanctions for noncompliance, and it is likely a continuing trend as the compliance industry grows.
Congress has granted the President the authority to withdraw the Secretary of the Interior’s grants of mineral rights on public lands. However, President Trump has used that same grant of power to remove withdraws of some of the protections President Obama placed. On May 3, 2017, a group of environmental non-profits filed a lawsuit against the Trump Administration in the Federal District Court of Alaska, alleging that his actions were an unauthorized use his Presidential power. On March 20, 2018, the Court denied the Defendant’s motion to dismiss.
Modern business thinking has come to accept that reputation is as important as financials. As investors look for companies that demonstrate this understanding, compliance professionals are in a unique position to make their companies more appealing.