On February 02, 2023, automatic access to the APeX Care Everywhere activity will be removed from Non-Clinical Research supporting staff's APeX user accounts. Care Everywhere provides access to patient medical records from other organizations such as notes, results, history etc. This change will ensure compliance with UCSFs policy regarding the use of external PHI obtained thru the Health Information Exchange for Research.

If it is determined that your role requires access to Care Everywhere information as part of standard patient care or treatment a request for access can be initiated by clicking on the APeX Care Everywhere Exemption Request. APeX Care Everywhere Exemption Requests are processed in 3-5 business days.

As part of UCSFs Research compliance initiatives all clinical staff, who also perform research functions in APeX, will be asked to sign a Statement of Understanding regarding the use of external information obtained thru APeX Care Everywhere information.

The information available to clinicians thru Care Everywhere is to be used for patient care and treatment only. Care Everywhere information should not be used for Research or Research purposes (aside from the allowable criteria listed below). Additionally, clinical staff should not query organizations within Care Everywhere) for research purposes.

The intent of the statement of understanding is to ensure UCSF Clinical Research Staff remain aligned with UCSF and National policies around the use of information obtained thru Health Information Exchanges for research.

CRC criteria for access; all must be true:

The CRC must be:

• Working on the team of an MD or DO Principal Investigator (PI) providing direct patient treatment, in addition to the investigational research oversight, for a current UCSF patient, as defined by currenty receiving intial or follow-up care at 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.  
• Serving as a CRC on an investigational drug or device study and/or FDA-regulated post-marketing studies;
• Employed as Assistant CRC, CRC, Senior CRC, CRC Supervisor or Clinical Research Manager; and
• Involved in the monitoring of safety events for the individual patients who are consented in the research and receiving ongoing care at UCSF Health.

• Only after consent into the research study: Verifying eligibility criteria to ensure patient safety before the MD or DO PI administers an investigational study drug or product
• Monitoring current UCSF patients for adverse events, including documenting for patient safety (short term and long term), and reporting to regulatory bodies as needed (IRB, etc.) 

While it is appropriate for a qualifying CRC to access Care Everywhere for safety monitoring and adverse events, the study cannot release Care Everywhere information to the sponsor for that purpose unless:

         (1) The PI or clinician decides that the information is clinically relevant and incorporates it into the UCSF Health record; and

         (2) The sharing is either:

(a) Consistent with the participant’s UCSF HIPAA Research Authorization; or

(b)  Meets a HIPAA exception to patient authorization, such as reporting an adverse event to a sponsor who is subject to the FDA and is responsible for the quality, safety, or effectiveness of that FDA-regulated product or activity. However, to meet HIPAA’s minimum necessary standard, only the minimal amount of information needed for that purpose should be shared. Participant identifiers shouldn’t be shared if they’re not needed. Reference: https://www.hhs.gov/hipaa/for-professionals/special-topics/public-health/index.html

Any activity that is not directly providing clinical care to a current UCSF patient does not quality for Care Everywhere access, including but not limited to:

• Retrospective chart review  
• Pre-screening before consent for eligibility  
• Recruitment screening / participant identification  
• Observational research 
• Patients no longer receiving care at UCSF Health