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DOJ Further Revises Corporate Criminal Enforcement Policies: Focusing on Individual Accountability, Corporate Responsibility, and Additional Demands on Chief Compliance Officers

Health Law Advisor

To that end, the new policies build upon the 2015 Yates Memo , requiring corporations to disclose “all relevant, non-privileged facts and evidence about individual misconduct” in a timely fashion, particularly if corporations want to receive cooperation credit. that the compliance program is “reasonably designed and implemented.”.

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New Safe Harbor and General Compliance Program Guidance Provides Opportunity for Buyers to Mitigate Litigation and Fraud Risk

Health Law RX

Although the DOJ was silent about application of the M&A Safe Harbor to civil enforcement under the FCA, other DOJ guidance emphasizes the DOJ’s willingness to provide benefits to entities and individuals who voluntarily self-disclose in the FCA context. But robust pre-closing due diligence is not always practicable.

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What Happens if You Break HIPAA Rules?

HIPAA Journal

Whether there was knowledge that HIPAA Rules were being violated, or by exercising due diligence, it should have been clear that HIPAA Rules were being violated. These penalties are applied when the individual was aware that HIPAA Rules were being violated or should have been aware had due diligence been exercised.

HIPAA 112
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Seven Elements of a Compliance Program

HIPAA Journal

The first of the seven elements of a compliance program is a suitable example of why it is important to view a compliance program holistically because it calls for the development of standards (etc.) under the direction of a compliance officer.

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The ABC’s of Integrating AI Into Your Compliance Strategy 

YouCompli

This will ensure awareness about protecting data and safeguards required when using AI in a healthcare setting, as well as capture key state and federal regulatory considerations. If not already at the table, be ready to deploy the same due diligence and compliance program oversight as part of your vendor oversight initiatives.

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Mitigating Risks from Online Tracking Technologies 

YouCompli

Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) and the Federal Trade Commission (FTC) recently issued a warning regarding online tracking technologies. You will notice their site asks about sharing your cookies before you can access it! Once acknowledged, you can access their videos.

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Anti-Kickback Statute Enforcement in Healthcare 

YouCompli

Tips for Compliance Officers to Manage Risk A patient undergoes surgery requiring a medical device. Routine occurrences – and a potential compliance issue if it looks like financial kickbacks are involved. This site publishes data about payments to physicians from medical device and pharmaceutical companies.