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.
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.
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.
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.
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.
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.
In October 2015, the tenth revision of the International Classification of Diseases (ICD-10) was implemented in the United States. Three years earlier, however, ICD had already begun beta testing for its eleventh revision (ICD-11). The ICD-10 implementation came after repeated delays and substantial requirements for healthcare organizations to reach compliance with the new codes. The United States trudged through training and compliance struggles as it transitioned to ICD-10. The threat of ICD-11’s release in 2018 promises to have drastic and far-reaching effects on the compliance actions of healthcare organizations.
Beginning January, 2018, U.S. citizens with unpaid taxes may find their U.S. passport applications denied and their existing passports revoked. The I.R.S. announced that it will begin implementation of procedures to notify the State Department of taxpayers the I.R.S. certifies as owing a “seriously delinquent tax debt.” This may come as a rude awakening to many Americans, although both the press and television news issued warnings going back more than a year ago.