Tag:

compliance

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?

The Balancing Act: Exclusive Ownership Rights and Digital Content Sharing

The Internet has given millions of people the capability to share information with each other with just the click of a button. People have grown accustomed to learning about current events, researching, and gathering information all through digital news sources. Unfortunately, the ease of the Internet has also created complications with regulating how users share that information. As technology rapidly advances, the legal limitations concerning intellectual property rights have become blurred, resulting in different interpretations of the Copyright Act of 1976. This has complicated user compliance and created difficult questions for the courts to answer based largely on law that was created before many of the capabilities of the Internet existed. There is a need for consistency and balance in this area of the law so that copyright owners are afforded adequate protection and the Internet can continue to serve as an information gathering, content sharing platform without fostering infringement.

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.  

Building a Compliance Framework from the Ground Up

Large companies generally have well established programs and systems in place to remain compliant with ever-changing regulations within their industry. But at a time when the percentage of job seekers starting their own businesses is at a recent high, young firms and start-ups are at a disadvantage when it comes to compliance, having to build a system from the ground up. In order to have an effective compliance program, an organization must “exercise due diligence to prevent and detect criminal conduct” and must establish and maintain an organizational culture that “encourages ethical conduct and a commitment to compliance with the law.” Thus, management not only has to focus on structure, but also culture in building their compliance systems.

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.

Bracket Busted: NCAA Compliance the Clear Loser of March Madness

For the National Collegiate Athletic Association (NCAA), March is supposed to be a showcase of the best about college sports, and the ideals the NCAA claims up uphold.  March is about student-athletes representing their schools, in a tournament full of upsets, uplifting stories, and some of the more dramatic moments in sports.  However, this March, the spectacle of March Madness is overshadowed by headlines of criminal conduct, corruption, rules violations, and plenty of criticism for the NCAA.  While many of these stories are just beginning to unfold, there are several ethical and compliance issues raised, which have application to all areas of compliance.

FanFiction: Crossing the Line from Infringement to Fair Use

Over the years, the Internet has become a vast space for people to create and view content shared by millions of Internet users. The abundance of content makes it nearly impossible to regulate everything that is posted. This has created a problem for authors, songwriters, and artists whose work is protected by copyright laws, because it has become increasingly easy for anyone to use, copy, and share copyrighted works that they do not have the right to use. Copyright law exists to “promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.” While the Copyright Act clearly grants artists certain exclusive rights to their work, claims of infringement often cause courts to engage in subjective analyses that leave some areas of copyright protection unclear. This has been especially problematic with fanfiction. In Fanfiction, fans of existing books, movies and television shows used different elements of those works to write their own stories, which are often then posted on websites such as, fanfiction.net. Fanfiction raises questions of copyright infringement and whether online forums should be more strictly regulated to monitor compliance with copyright laws.

Threat of the Border Wall: Impact on the Enforcement of Environmental Regulation

In early January of this year, the House Committee on Armed Services granted an extension to a bill that would increase border security. An unlikely opponent of this bill is the environmental lobby, since the bill would allow the Department of Homeland Security (DHS) to waive the requirements of some of the most important environmental protection statutes. These statutes have been the basis for almost all the citizen enforcement in the environmental arena; they work to maintain protections for 73 different areas along the border, along with numerous endangered species.

How will the Supreme Court’s new rule barring the government from refusing offensive trademarks affect the marketplace?

On June 19, 2017, the Supreme Court, in an 8-0 ruling, found that the government can no longer sensor trademarks on the grounds that they may be offensive. In Matal v. Tam, the Supreme Court Justices found the seventy-one year old rule allowing the government to refuse offensive trademarks to be unconstitutional and to violate free speech and first amendment rights. The justices were unable to agree on exactly what legal standard was to apply to the present case or future cases. The revocation of this seventy-one year old rule that has affected the registration of many marks over the years is bound to have an effect on the future of trademark law and trademark litigation. Immediately following the Supreme Court’s decision, the United States Patent and Trademark Office (USPTO) was inundated with requests to register offensive trademarks.

ICD-11 on the Horizon: How Soon Will Healthcare Providers Actually Need to Comply?

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.