Summary
Recent changes in U.S. national security regulations are placing new restrictions on how healthcare organisations and HIPAA-covered entities handle sensitive health data. The Department of Justice (DOJ) and the Cybersecurity and Infrastructure Security Agency (CISA) have introduced rules that limit the transfer of bulk U.S. sensitive personal data, including de-identified health information, to certain foreign countries. As a result, affected organisations must reassess their data-sharing practices and adopt enhanced security measures to comply with these new regulations. The enforcement of these rules comes with significant penalties for violations.
Key Points
- New regulations from the DOJ and CISA restrict the transfer of sensitive personal data outside the U.S., impacting HIPAA-covered entities.
- Organisations must revisit data-sharing practices, update contracts, and implement required security controls.
- Penalties for violations can be severe, with fines up to $368,136 and potential imprisonment for willful breaches.
- The definition of sensitive data now includes de-identified data, complicating previous industry practices.
- Exceptions exist for specific clinical investigations and regulatory activities, but caution is advised in all data transactions.
Why should I read this?
If you’re in the healthcare sector or handle any sort of sensitive health data, you really should get your head around these new rules. They could impact how you share and manage data like never before. Knowing the ins and outs of these regulations can save you from hefty fines and legal headaches down the line—trust us, it’s much better to be informed now than sorry later!