Provenance set includes the who, what, when, where and why as metadata for USCDI data classes and data elements. Data State is part of “what”.
Data State must be associated with each USCDI dataset or data element that has a unique provenance set. Occurs when data is originated (captured, collected or sourced), updated, verified, attested, transformed (e.g., to/from exchange artifact such as HL7 v2 message, document or FHIR resource instance).
Note that Data State is intrinsic to what the source EHR/HIT system already knows, thus it does not require extra data collection (burden) by the clinician or other end user.
|Submitted By: Gary Dickinson / EHR Standards Consulting|
|Data Element Information|
|Rationale for Separate Consideration||Data State offers essential assurance for transparency, accountability, trust, traceability and data integrity. Is the dataset or data element as originally collected (captured, sourced), has it been updated, verified, attested or transformed?|
|Use Case Description(s)|
|Use Case Description||All use cases (including health data/record exchange) where essential assurance of transparency, accountability, trust, traceability and data integrity is required.|
|Estimated number of stakeholders capturing, accessing using or exchanging||Any/all stakeholders for any/all use cases.|
|Maturity of Use and Technical Specifications for Data Element|
|Current Use||Extensively used in production environments|
FHIR Core Release 4.0.1 – Record Lifecycle Event Implementation Guide
ISO 21089:2018 – Trusted End-to-End Information Flows
ISO/HL7 10781 – Electronic Health Record System Functional Model, Release 2.1
|Number of organizations/individuals with which this data element has been electronically exchanged||5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.|
|Restrictions on Standardization (e.g. proprietary code)||None|
|Restrictions on Use (e.g. licensing, user fees)||None|
|Privacy and Security Concerns||None. In fact enables health data/record audit events and audit logs (audit trails).
• Who did what when where and why (actions taken)
• Who documented what when where and why (health record entries)
|Estimate of Overall Burden||As stated previously, most all of the submitted Provenance elements are intrinsic to what the source EHR/HIT system already knows, thus will not require extra data collection (burden) by the clinician or other end user.|
|Other Implementation Challenges||The usual resistance from certain stakeholders – those who believe Provenance is unnecessary – after all, who would believe that transparency, accountability, assurance, traceability and data integrity are essential/integral to trusted health data/record management and use?|