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Title | Response |
Description | Creation of PRO Data Registry. Activity includes (1) obtaining approval for PRO data collection and (2) data collection and (3) transmission of data by health systems from multiple sites. |
Primary actor/participant | Registry Creation Contractor, Health System Compliance bodies, Research Participant. |
Support actor/participant | Health system staff collecting data, third party data collection contractors operating on behalf of the health system |
Preconditions |
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Post conditions |
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Alternatives |
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Considerations |
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Data Elements Considered | Electronic health data from multiple sites and patient reported outcomes |
Purpose of the Data Collection | Clinical care, tracking patient outcomes, creating a registry for quality improvement and research use |
Purpose of Data Use | Quality Improvement, analysis under a specific research protocol
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Terms of Transfer to the Data Holders | Heterogeneous: agreements, waivers of authorization, and/or consent |
Terms of Transfer to Researchers | (Researcher access to data not contemplated in this scenario – See Use a Registry that Includes Patient Reported Outcomes) |
[i] The National Quality Forum defined PROs as "any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else."
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