Compliance

FDA Regulation of Medical Device Advertising and Promotion

FDA Regulation of Medical Device Advertising and Promotion

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...

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Keeping Your Whistleblower Hotline Alive

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...

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Compliance and Legal Teams: It’s Time to Get Smart About Machine Learning

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...

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The Responsible Technology Firm of the Future, Part 4

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...

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ACA Penalties Are Coming

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...

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The Responsible Technology Firm of the Future, Part 3

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...

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The Responsible Technology Firm of the Future, Part 1

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...

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How The DOJ’s New Guidelines on Monitorships is an Opportunity for Corporations

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...

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The Importance of a High-Risk Due Diligence Committee

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....

Smarsh 2018 Electronic Communications Compliance Survey Report

Smarsh 2018 Electronic Communications Compliance Survey Report

Smarsh has just released its eighth annual Electronic Communications Compliance Survey Report. The survey of compliance professionals in the financial services industry shows that organizations are not keeping pace with their retention and supervision efforts — particularly with a growing, younger workforce that relies on expanding, mobile-friendly channels, such as social media and text messaging. As a result, evolving technologies and...

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Finally, an Overhaul for AML Legislation

A New Anti-Money Laundering Regime for a New Century The landscape of AML regulations is scattered, with its primary legislative supports coming from 1970, 1996, and 2001. This article discusses the proposed bill, its bipartisan support as identified by hearings already conducted on the subject, and its implications for financial institutions if enacted. In 1970, a Big Mac cost $0.49,...

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