Welcome to this week's update on the Department of Justice. The most significant headline this week comes from the DOJ's publication of its Final Rule to implement President Biden's Executive Order 14117, aimed at restricting the flow of bulk sensitive personal data to countries of concern, including China, Russia, Iran, North Korea, Cuba, and Venezuela[1].
This Final Rule, published on January 8, 2025, marks a critical step in safeguarding Americans' personal data. It prohibits certain data brokerage transactions and transactions involving human 'omic data, which includes not just genomic data but also epigenomic, proteomic, and transcriptomic data. The rule also sets cybersecurity requirements for vendor agreements, employment agreements, and investment agreements involving U.S. persons.
The implications are far-reaching. For American citizens, this means enhanced protection of their personal data from unauthorized access by foreign entities. For businesses and organizations, it means a need to review and possibly revise their data handling practices to comply with the new regulations. The rule also includes sweeping enforcement authority for the DOJ, with civil penalties that can reach up to $368,136 or twice the amount of the transaction, and willful violations can be fined up to $1 million or 20 years' imprisonment.
The rule is set to go into effect on April 8, 2025, with certain due diligence requirements taking effect on October 5, 2025. This timeline gives organizations a window to adjust their compliance programs and ensure they meet the new standards.
In other news, the healthcare industry should be aware that the DOJ will continue to prioritize investigating alleged fraud, waste, and abuse in the industry, focusing on private equity investment, the Anti-Kickback Statute, pandemic relief fraud, and cyber fraud[5].
Looking ahead, it's crucial for organizations to develop comprehensive compliance programs that include governance, objectives, work steps, and recordkeeping. The DOJ emphasizes the importance of proactive compliance efforts, and organizations should be prepared to demonstrate their commitment to these efforts[3].
For more information on the DOJ's latest developments and how they might impact you, visit the Department of Justice's official website. And remember, public input is always valued, so stay engaged and informed about these critical issues.
Next steps to watch include the implementation of the Final Rule and the ongoing enforcement activities in the healthcare industry. Stay tuned for further updates and insights into the DOJ's efforts to protect Americans and uphold justice.
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