INSIDE COMPLIANCE

EU Copyright in the Internet Age

November 21, 2018Crystal LoweryUncategorized

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.

copyrightdata privacyEuropean Union directiveGDPRInternational AffairsPrivacy & Security

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

November 21, 2018Nina HintlianFraud & Abuse, HIPAA & Health Information

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”.

FDA regulationsHuman Subjects protectioninformed consentPrivacy & SecurityRegulationresearch compliancethe common rule

Accessible UI/UX Design: Making Websites ADA Compliant

November 19, 2018Sei UnnoUncategorized

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.

ADAGilGil v. Winn-Dixie StoresGoreckiGorecki v. Hobby Lobby StoresInc.JAWSJournal of Regulatory ComplianceUIUser ExperienceUser InterfaceUXW3CWCAGWeb Design

Compliance Spotlight: Joseph Adamczyk, OCC

November 19, 2018Jan DervishCompliance Spotlight

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.

CCOChief Compliance OfficerClearingfinanceFTCInvestingJournal of Regulatory ComplianceOCCOptions Clearing CorporationRegulationSIFMU

Ethics and Compliance: Two Sides of the Same Coin

November 16, 2018Michelle McGoughThe Art of Compliance

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.

Corporate ComplianceE&CEthicsethics and compliance

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

November 15, 2018Alessandra ReedyFinance & Banking

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.

Banking Regulation

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

November 15, 2018Jonathan BenowitzFinance & Banking

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.

adviceDOLfiduciaryfiduciary rulefinancefinancial regulationRegulationSEC

Managing Your Health in 2018: Mobile Medical Applications and FDA Regulations

November 15, 2018Jessica SweebUncategorized

Immediately upon introduction, mobile medical applications became favored by physicians and patients alike because the applications are user friendly and allow the patient to understand their care and participate in more meaningful discussions with their provider about their health. Due to the rapid development of technology and, as a result, a surge of mobile medical applications flooding the market, the Food and Drug Administration has issued three guidances on how they plan to regulate mobile medical applications. In order for mobile medical application manufacturers to remain compliant with the FDA guidances, they must meet the seven categories of requirements that are laid out in Appendix E of FDA’s 2015 guidance and also comply with any further guidance that is released.

Privacy & SecurityRegulation

How the Biggest Nitrogen Polluter of U.S. Waterways Achieves EPA Compliance

November 14, 2018Isabella MasiniUncategorized

According to an Environmental Integrity Project report, an Illinois pork-processing plant discharged more nitrogen from animal waste into waterways than any other slaughterhouse in the United States. Yet, the facility has complied with the Clean Water Act since December 2015. Animal-processing operations are not only some of the top polluters, but the federal water pollution standards surrounding these operations are lacking.

agricultureenvironmental regulationEPAnitrogenRegulation

New York Federal Court Rules in Favor of CFTC in its First Ever Anti-Fraud Enforcement Action Involving Bitcoin

November 13, 2018Mary DonohueFinance & Banking, Fraud & Abuse

Judge P. Kevin Castel of the U.S. District Court for the Southern District of New York entered an Order for Final Judgment and Consent Order for Final Judgment (“the Orders”) early this month, resolving charges of a Commodity Futures Trading Commission (the “CFTC”) Complaint against a New York Corporation, Gelfman Blueprint Inc. (“GBI”) and its Chief Executive Officer, Nicholas Gelfman. The CFTC’s complaint, filed in January of 2017, marked the first anti-fraud enforcement action involving Bitcoin filed by the Commodity Futures Trading Commission. The Orders found that from approximately January of 2014-January 2016 Defendants Gelfman and GBI, through its officers and agents and employees, operated a Bitcoin Ponzi scheme in which they fraudulently solicited more than $600,000 from at least 80 customers.

Journal of Regulatory Compliance