Data with Embedded PHI Policy

Policy Regarding Data with Embedded PHI

Investigators proposing research requiring access to data which contain embedded participant personal health information (PHI) (e.g. name, address, FHS ID, etc.) must follow the policies below:

  1. To transfer the data outside of the FHS site, all PHI data must be removed from the data files. The investigators must fund the removal of the PHI.
  2. The images without PHI will simultaneously be provided to the outside investigator and to the FHS. The data without PHI may be made accessible to other researchers for approved projects.
  3. The measurements derived from the data will have the period of exclusivity specified by the NHLBI (currently 1 year of exclusive access for phenotype data/analyses). The measurement data must be provided to the FHS after one year, simultaneous with publication of results, or prior to conducting genetic analyses (whichever occurs earliest).

Examples of data with embedded PHI include, but are not limited to:

  • Image files (ECG, MRI, CT, echocardiogram, ultrasound, VCTE, etc.)
  • Voice and/or audio recordings
  • Geographic data

Last Updated: January 2021