Care Everywhere

Background

Care Everywhere is a Health Information Exchange that allows institutions to share electronic PHI for treatment purposes. The patient information displayed in APeX Care Everywhere belongs to the outside organization that provides it; this data is not part of the UCSF Health medical record and does not belong to UCSF. Care Everywhere data displayed in the patient chart is marked with a Care Everywhere symbol.

Under Federal privacy law (HIPAA) and Epic’s rules, Care Everywhere data can only be used for the patient’s treatment. It is not legal to use data in Care Everywhere for research outside of patient treatment, and UCSF IRB protocol approvals do not cover this outside data.

Below is a set of criteria for Clinical Research Coordinator (CRC) access to Care Everywhere (CE). Access is dependent on the CRC working under the supervision (direct or indirect) of an MD/DO caring for a UCSF patient.  

In all cases, access to outside organizations’ information via Care Everywhere by CRCs in the course of a clinical trial is the responsibility of the Principal Investigator (PI) that is the patient’s treating MD/DO.

  • The CRC’s role and activities listed below do not replace the responsibilities mandated of the PI by the FDA 1572.
  • CRCs should not rely on Care Everywhere records as an exclusive source of safety information. Care Everywhere records are a supplemental source of safety information in addition to conversations with the patients, UCSF medical records, and medical releases from outside facilities.
  • CRC access to Care Everywhere will need to be renewed every two years and be approved by PI in confirming the criteria below.

The CRC must acknowledge, understand, and agree to the following:

  • Electronic Health Information available through Care Everywhere is not to be used for Research purposes, aside from the activities listed below.
  • I will not query outside organizations through Care Everywhere for patient information for Research purposes, aside from the activities listed below.
  • My use of Care Everywhere information will be for direct patient care and treatment only.
  • I will not incorporate external data obtained through Care Everywhere in Research Data Reporting, aside from the activities listed below.

I understand that:

  • The National Health Information Exchange Governance Body has not approved any Research Use Cases.
  • The single existing permitted use case for Health Information Exchange and Research is for COVID-19, between Epic Organizations only, for a limited time window.
Criteria for a CRC to have access to Care Everywhere - ALL must be TRUE:

a) Employed as Assistant CRC, CRC, Senior CRC, CRC Supervisor or Clinical Research Manager

b) Working on the team of and under supervision (direct or indirect) of an MD or DO Principal Investigator (PI) providing direct patient care, in addition to the investigational research oversight, for a current UCSF patient, as defined by a patient who receives initial or follow-up care through UCSF Health. This includes patients who are referred to UCSF Health for investigational research if they are currently under the care of a UCSF Health MD/DO Principal Investigator. 

c) Working on an investigational drug or device, and/or FDA-regulated post-marketing studies, and/or a study where a procedure, test, or intervention is performed through UCSF Health. 

d) Involved in the monitoring of safety events or study outcomes for the individual patients who are enrolled in the research. 

Care Everywhere uses that are PROHIBITED
  • Retrospective chart review 
  • Pre-screening before consent for eligibility for non-treatment trials
  • Recruitment screening / participant identification for non -treatment trials
  • Observational research not related to a procedure, test, or intervention received through UCSF
  • Patients who did not receive initial or follow-up care through UCSF Health  
When it is acceptable to use Care Everywhere for screening:

CRCs may use Care Everywhere to access clinically relevant information when determining the treatment course for a patient, including when a treatment trial is a viable option. Accessing Care Everywhere is allowed when it is necessary for making treatment decisions. Care Everywhere cannot be utilized for observational research not related to a procedure, test, or intervention received through UCSF.  

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