Tag:

Regulation

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.

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.  

We Need to Change the Way We Deal with Food Recalls

In September 2018, the Food and Drug Administration (“FDA”) announced a new policy that provides for the release of a list of retailers that have received a food subject to recall. In the past, the FDA did not release such information because the agency deemed it confidential commercial information. The lack of information on the part of the FDA has been a huge detriment to the public. Prior to the new guidance, the public would only find out information about the particular food that was being recalled, not where this recalled food was available for purchase. The public was told just to stop purchasing that recalled food, whether it be romaine lettuce or beef, even if there were retailers who were selling non-contaminated products. This procedure not only hurts the public but also has a huge financial effect on those retailers who are not selling contaminated or recalled products. The FDA has effectuated a new guidance because they have found that such information is necessary to enforce a recall and to ensure public safety.

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”).

Amazon Go versus the GDPR

New data privacy regulations entail questioning both current and future technologies. Recently, Amazon has introduced a store concept that eliminates everyone’s least favorite things about shopping, long lines and small talk. Amazon Go is the grocery store of the future and these stores allow consumers to walk in, pick up the items that they need, and then walk right back out. That’s it. No long lines, no cashiers, no shopping carts. However, as great as this concept seems, there are still concerns from a data privacy standpoint as Amazon needs to collect personal data from its consumers in order to be able to lawfully execute these checkout-less stores.

Compliance Spotlight: Joseph Adamczyk, OCC

Joseph Adamczyk, ’01 is the Senior Vice President and Chief Compliance Officer at OCC (Options Clearing Corporation). OCC is the world’s largest equity derivatives clearing organization, and works to promote stability and financial integrity in the marketplace. Mr. Adamczyk holds a J.D. from Loyola University Chicago School of Law, an MBA from the University of Chicago, and a B.S. in Business Administration from DePaul University.

SEC, DOL Advance New Fiduciary Rule After Adverse 5th Circuit Ruling

Both the Securities Exchange Commission (SEC) and Department of Labor (DOL) are pushing ahead with fiduciary standards for investment advisers despite the 5th Circuit striking down the DOL’s previous fiduciary rule earlier this year.

California to Corporations: No More Male-Only Boards

California Governor Jerry Brown signed a historic bill on September 30 that mandates every publicly held corporation whose principal offices are located in California to have a representative number of women on its board of directors. In a letter announcing Senate Bill 826, Governor Brown admits that there are serious legal concerns to the bill and that its potential flaws could “prove fatal to its ultimate implementation” but that it is time to force action regarding the lack of gender diversity on company boards.

Stemming the Tide of Medical Information Data Breaches

Protected Health Information is seeing a surge of breaches on the cyber security front due to contractor error. It’s also impacting the most consumers in comparison to other data breaches and, in some cases, has the power to cause chaos in national infrastructure. Advances in technology and compliance measures can stem the tide and protect the most valuable information in consumers lives.