Answer: A data usage agreement is required when a researcher wishes to share PHI in the form of a restricted data set (defined as a data set that does not contain identifiers other than certain „indirect identifiers“) with a person who is not otherwise involved in the research protocol (i.e. a person who is not mentioned as the recipient of PHI in authorizing or waiving the authorization authorized by the IRB). If the person or entity on the other site is part of the trial version and is included in the permission or waiver authorization for the trial version, you do not need a data usage agreement. On the contrary, a data usage agreement is used if you want, for example. B, share a limited set of research data with a colleague from another institution who is not participating in the study or a private registry that is not participating in the study. The JHM IRB should be notified if you intend to disclose a limited record for a person who was not mentioned in the original IRB application. If you provide another JHM researcher with a limited set of data, that person must sign the unilateral data usage agreement on the JHM IRB site. If you disclose a restricted data set to a non-JHM researcher, the recipient must sign the JHM data usage agreement before the research data containing PHIs are disclosed. If the JHBSPH faculty and/or students are listed in the research authorization form as parties with which SOM-PI PHI will share, SOM-PI is not obligated to follow this information.

There is an exception to this general rule for disclosures to JHBSPH faculties or students who are formal members of a research team led by AN SOM PI and who have completed all necessary SOM HIPAA training. For the performance of their duties as members of the research team, these faculties/students are considered to be SOM HIPAA staff when they act under the direct control of the IP. SOM employees must comply with all JHM HIPAA guidelines, but the IP does not have to follow PHI`s disclosures for them. Answer: Not necessarily. PHI is information about a person`s health, a person`s state of health or the compensation of health care provided to a person. If we had only one DOB and DOB was not related to other health information and could not be obtained from a provider (z.B JHM), the DOB would not be the only PHI.