What health care and life sciences organizations need to know:
- “Bulk” Has a New Definition: The volume thresholds under the U.S. Department of Justice’s (DOJ’s) Bulk Sensitive Data (BSD) Transfer Rule are surprisingly low—sharing genomic data on just 100 people can trigger compliance requirements, catching many organizations off guard.
- HIPAA Compliance Is Not Enough: The BSD Transfer Rule creates an entirely new compliance layer that goes beyond existing privacy frameworks, such as the Health Insurance Portability and Accountability Act (HIPAA), applying even when data has been de-identified or anonymized.
- It’s About Access, Not Just Transfers: Simply giving a foreign vendor, board member, or investor the ability to view sensitive data can trigger the BSD Transfer Rule—no formal data-sharing agreement is required.
In this episode of Diagnosing Health Care®, Epstein Becker Green attorneys Laura DePonio, Elizabeth McEvoy, and Elena Quattrone walk health care and life sciences organizations through the DOJ’s BSD Transfer Rule—from scoping and compliance to enforcement risks and exemptions.
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