The SUPPORT Act of 2018: New Anti-Kickback Provisions

On October 24, President Trump signed a new bill aimed at combatting issues arising from the opioid epidemic. This bill, entitled the Substance-Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT” Act) is a combination of seventy bills that effect the healthcare industry. This act includes new and revised Medicaid and Medicare laws that relate to the opioid crisis through the expansion of substance use disorder services. However, this bill, primarily aimed to combat the opioid epidemic, contains key provisions that will affect healthcare providers. Healthcare providers should be especially mindful of this new Act, as there are new anti-kickback provisions that require compliance officers and departments to ensure that their healthcare entities are in compliance with this new law.

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.

City of Chicago Paid Sick Leave Ordinance Gaining Momentum

The City of Chicago enacted the Paid Sick Leave Ordinance to protect employees who work within the city limits. Effective July 1, 2017, the Ordinance requires employers who operate or conduct business in the City of Chicago to provide Paid Sick Leave to eligible employees. While there are some limitations about who is a “Covered Employee,” the Ordinance sets a precedent for worker’s rights. Only eight states have enacted Paid Sick Leaves Laws. Illinois is not one of those states; however the City of Chicago may be moving Illinois workers one step closer to mandatory paid sick leave.

EU Copyright in the Internet Age

On September 12, 2018, the European Parliament approved amendments to the Directive on Copyright in the Digital Single Market, commonly known as the EU Copyright Directive (the “Directive”). The amendments primarily cover copyright protection over internet resources. There are two parts of the Directive that have caused concern: Articles 11 and 13. Article 11, also referred to as the “link tax,” provides publishers with a method to collect revenue from news content shared online. Article 13, also referred to as the “upload filter,” holds Internet platforms, such as Facebook and Twitter, liable for copyright infringement committed by users. Together, large and small platform providers that would have to comply with these new regulations have declared that the enactment of these articles places a heavier burden on service providers. Critics of these amendments also say the requirements are likely to lead to increased taxation and more lawsuits. The final vote on the directive is scheduled for January 2019.

Impact of Provisions of Revised Rules of FDA-Regulated Clinical Investigations

The FDA regulationson human subject protection and Institutional Review Boards(IRBs) provide guidance to protect the rights, safety, and welfare of subjects who participate in FDA-regulated clinical investigations. The regulations conform with the requirements set forth by the Department of Health and Human Services (HHS) Federal Policy of Human Research Subjects(45 CFR 46, part A).  In order to reduce confusion and burdens associated with complying with both the FDA regulations and the HHS policies regarding human subject protections, the FDA is revising the current “common rule”.

Accessible UI/UX Design: Making Websites ADA Compliant

The World Wide Web Consortium (“W3C”) is a collaborative community that develops standards for the Internet. One of W3C’s goals is to make the web accessible to everyone, regardless of an individual’s accessibility needs. Section 508 of the Rehabilitation Act requires that the electronic and information technology of federal agencies are accessible to people with disabilities, whether they are employees or members of the public. W3C publishes the Web Content Accessibility Guide (WCAG), which addresses how to create accessible websites. The WCAG was used by the U.S. Access Board to create standards for Section 508. Recent cases like Gorecki v. Hobby Lobby Stores, Inc. and Gil v. Winn-Dixie Stores, Inc. reveal the need to not only comply with these laws and regulations, but to adopt a culture that goes above and beyond the minimum.

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.

Ethics and Compliance: Two Sides of the Same Coin

Most major American corporations develop and implement an ethics and compliance (E&C) program.  However, too often, the ethics division of these programs falls to the wayside, with companies putting more focus on legal compliance rather than creating an ethical corporate culture.  While it is true that compliance can technically function without an ethics component, a robust ethics program can be an extremely efficient way for a company to promote legal compliance, as well as consumer trust and loyalty.

Banks to Receive Looser Capital and Liquidity Requirements in a New Fed Proposal

On October 31, 2018 the Federal Reserve (the “Fed”) announced a proposal for looser capital and liquidity requirements for some U.S. banks. This announcement is in line with the latest moves to reduce regulatory burdens on community and regional financial institutions, but marks one of the most significant rollbacks of bank regulations since the Trump administration took office. The proposed changes will divide big banks into four categories based on their size and other risk factors. The proposal will generally affect large U.S. lenders, yet leave some of the largest banks untouched.