Compliance

Pharma Giant Graduates to Compliance 2.0 In this post from 2018, Donna Boehme dubbed Novartis a new "rock star" on the corporate compliance landscape, claiming the company had elevated its approach to compliance, culture and trust to best practice “Compliance 2.0” status. My readers are familiar with my analysis of the many Compliance 1.0 train wrecks over the past decade,...

Updated 2018 There are tens of thousands of medical devices being advertised and promoted in the U.S. The Food and Drug Administration (FDA) has statutory authority to regulate the advertising and promotion of “restricted” medical devices as well as any medical devices that are not authorized by FDA for sale or distribution for their intended use. A “restricted device” is...

Ideas to Maximize Hotline Effectiveness It could be a good sign if the phones aren’t ringing at your organization’s hotline – or it could be indicative of a failing ethics and compliance program. Ron Kral discusses how to maintain a successful hotline program. Is your whistleblower hotline alive or dying a slow death? Whether it’s an effort to jumpstart your...

5 Ways Organizations Can Benefit from ML Heidi Maher, Executive Director of the Compliance, Governance and Oversight Council (CGOG), discusses the machine learning (ML) use cases for compliance and legal teams, plus key first steps for taking advantage of ML technology. Compliance and legal teams are struggling to keep pace with an ever-evolving regulatory and legal landscape – from constantly...

Corporate Social Responsibility Suggestions to increase diversity and measure the improvement; monitor evolving stakeholder expectations, particularly around social responsibility; help those displaced by technology through training to improve people’s lives; and manage brand image and reputation. In addition, we offer key questions for each of the 10 suggestions to provide tech executives and directors a useful diagnostic for assessing their...

What You Need to Know Within the last few months, employers have begun to be assessed fines by the IRS in Letters 226J for not complying with employer shared responsibility payments (ESRPs) dating back to 2015. Employers have 30 days to challenge or accept an ESRP penalty. While there is nothing they can do to prevent penalties from 2015, employers...

Market Forces Suggestions to maximize the company’s innovative potential within the confines of social responsibility, pay attention to emerging risks and better position risk management and compliance within the organization and adopt a compliance framework. Read part 3 of this four-part series from Protiviti here. Read part 2 here. Read part 1 here. This series was originally shared on Protiviti's...

Uptick in Companies Taking Steps to Combat This Scourge More and more companies are combating modern slavery. The scourge is a particular problem in the Asia-Pacific region, but the fight is also going strong there. Wendy Wysong and team discuss steps being taken in Asia-Pacific to curb the infringement of human rights. with co-authors Peter Coney, Nick Turner and Amanda...

Corporate Governance and Regulatory Compliance Suggestions to build and manage a strong corporate governance operation, manage conduct at the top and culture across the organization and prepare for increased government scrutiny. Read part 2 of this four-part series from Protiviti here. Read part 1 here. This series was originally shared on Protiviti's corporate blog and is republished here with permission.

A Rapidly Changing and Unpredictable Landscape The changing landscape is altering the conversation at the highest levels of technology companies, necessitating action to make the transition to a more balanced focus in the C-suite and boardroom agendas on governance and regulatory concerns, social responsibility to the greater community issues, and other matters germane to preserving enterprise value along with all...

Navigating New Criminal Division Guidance and Accelerating Remediation The Department of Justice’s Criminal Division has recently issued new guidelines for corporate compliance and monitorships, and Bart Schwartz, Chairman of Guidepost Solutions, discusses the opening they provide to businesses to reassess and bolster their compliance programs. In his remarks at the Corporate Compliance and Enforcement Conference earlier this month, Assistant Attorney...

A Call for Greater Multidisciplinary Oversight As your company’s reliance on third parties grows, so too does the risk associated with doing business with these relatively unknown partners. Michael Volkov entreats companies to put in place more robust due diligence processes to minimize their third-party risks. Believe it or not, but companies are still struggling with third-party risk management systems....