Tag:Regulation
Kicking Off the 2018-2019 Academic Year at the Center for Compliance Studies
Ryan Meade Editor-in-Chief Director, Regulatory Compliance Studies at Loyola University Chicago School of Law The academic year for 2018-2019 has kicked off at the Center for Compliance Studies. It promises to be a big year with even more robust blog activity planned, a symposium in February 2019 that will be one of the first academic looks …
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FDA Faces Forward with Flexible Genetic Guidance
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.
The Food Safety Modernization Act is Just the Beginning of the FDA Compliance We’ve Been Waiting For
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?
Digital Realty Trust: Implications for Whistleblowers and the Compliance Department
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.
Dodging Pitfalls on the Path to Success: Data Management Risks and How to Mitigate them
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.
Popularity Contest: The Importance of Reputation in Modern Compliance
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.
Trump Administration Deregulates Housing
As President Donald Trump continues to deliver on his promise to deregulate, the Department of Housing and Urban Development (HUD) has been instrumental in reversing Obama-era regulations. President Trump, who made his fortune in real estate development, has a checkered past when it comes to fair housing and discrimination. Now his administration is working to cut funding to HUD and unwind many fair housing and discrimination rules. Administration proponents say this is a necessary step to fix a broken and corrupt bureaucracy, while many advocates have expressed concern over the government scaling back enforcement of fair housing laws. Any reform effort should seek to balance concerns about bureaucracy with the vital missions of fair discrimination-free housing, inclusive communities, and civil rights.
How Would a New Bipartisan Bill that Encourages the DEA to Increase Opioid Quotas Affect Drug Manufacturer Efforts to Remain Compliant?
After years in an opioid crisis, the United States now faces an opioid epidemic that has left the government and public desperate for relief and a workable solution. A group of senators hopes to be part of the solution with the introduction of a bipartisan bill that aims to better enable the DEA to establish opioid quotas. Despite already-present struggles to effectively manage its quota system and policies, the DEA would be given significantly more responsibility under this bill. Drug manufacturers, directly responsible for following DEA, FDA, and OIG regulations to hopefully resolve the epidemic, will need to grow their compliance efforts and create responsive solutions to remain both profitable and compliant.
TAX TALK SERIES: IRS Clarifies Post-TCJA Confusion on Home Equity Interest
On December 20, 2017, Congress passed the Tax Cuts and Jobs Act (“TCJA”) designed to decrease the taxable rate for corporations and individuals, and significantly limited allowable deductions. Since this change to the Tax Code was one of the largest since the Reagan era, the Internal Revenue Service will need to publish many regulations and advisories in the coming months to better clarify provisions of the TCJA. This multi-part series will explore prominent IRS regulations and advisories as they relate to the TCJA, and what these regulations and advisories mean for both individual and corporate taxpayers.
Deregulation of Uranium Mining or: How I Learned to Stop Regulating and Love the Bomb
Compliance professionals all over the country are paying close attention to the Trump administration’s deregulatory campaign. While deregulation in finance has received the most media attention, the uranium mining industry has been a quiet beneficiary of the President’s new regulatory scheme.