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Description

To protect privacy and conform to regulatory concerns, unique identifiers for research must be applied with researcher-administered systems to link data over time and across data sources.

Primary actor/participant

Research Teams, Covered Entities, Patients/Participants

Support actor/participant

Information systems  

Preconditions

Identifying information that can be used to reliably link records across independently regulated data sources is available.

Postconditions

Unique, potentially reusable identifiers are created in according to well-accepted known regulatory standards.

Alternative

• Deterministic identifiers provided as part of multi-institutional operations
• Participant-managed linkage systems
• In cases where data systems already exchange information (e.g. payers and providers or networked providers), researchers may be able to link on non-PII data.

Data Elements Considered

Personally Identifiable Information (PII) and encrypted versions of PII

Purpose of the Data Collection

Treatment, Payment, Operations

Purpose of Data Use

Creation of potentially reusable unique identifiers

Terms of Transfer to the Data Holders

Treatment, Payment, Operations
(Alternative – Consent)

Terms of Transfer to Researchers

IRB approval, potentially waiver of authorization