Do clinics need to collect a consent from patients to enter their data in PFC?

Do clinics need to collect a consent from patients to enter their data in PFC?

PFC is an educational resource to assist clinicians and survivors in decision making about long-term screening follow-up and other topics.  It was developed for clinical purposes and quality improvement , not for generalized research, so no consent is required.  Consent is required for those survivors who sign up for being contacted for research purpose.

Clinicians enter data into the HIPAA compliant system and the data are stored with automated updated of the survivorship care plan as the guidelines are updated. The data are not aggregated across clinic sites, so each site has access to their own data, can search or filter their own data set, and can download their own data – but cannot see any data from outside clinic sites.

All institutions that use PFC have executed a Business Associate Agreement (BAA) with PFC, which permits us to store and process PHI on your institution's behalf under HIPAA.  In that sense, PFC operates as a clinical system rather than a research one, so consent is not required to add patient data to PFC, though some clinics have chosen to do so anyway.