provenance - fhir devdays...provenance is more pronounced for interpretive concepts , but still...
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November 20-22, Amsterdam | @HL7 @FirelyTeam | #fhirdevdays | www.devdays.com
Provenance
Yegor Hanov
Yegor Hanov - Sr Director, Open Platforms Engineering
• Started as Application Developer in 1999
• Worked across desktop, backend, cloud and now interoperability solutions - all at Cerner
• Currently leading Cerner team focused on SMART on FHIR service and ecosystem implementation as well as developer engagement program
What is Provenance?
W3C PROV
• Agent-centered • Who is involved in generating or manipulating
information
• Object-centered • What are the origins of individual components of
information
• Process-centered • What actions or processes led to generating of
information
Provenance is information about entities, activities, and people involved in
producing a piece of data, which can be used to form assessments about its
quality, reliability or trustworthiness.
A Brief History of EHR Systems
A Brief History of EHR Systems
Storage Capacity Bandwidth Participants Source Systems Regulations
Why Provenance Matters in Healthcare?
• When using previously captured data, clinician needs to know where that data came from to ascertain its quality, reliability and trustworthiness
• When investigating medical errors, reviewers need to establish source, chain of custody and any modifications to the critical information that led to adverse event
• Not all data is created equal – some of it is measured (eg device generated Observations) and some is interpretive (eg clinician documented Condition or patient reported Allergy). Need for Provenance is more pronounced for interpretive concepts, but still relevant to measured as well
HL7 FHIR Provenance
Provenance provides a critical foundation for assessing authenticity, enabling trust, and allowing reproducibility. Provenance assertions are a form of contextual metadata and can themselves become important records with their own provenance. Provenance statement indicates clinical significance in terms of confidence in authenticity, reliability, and trustworthiness, integrity, and stage in lifecycle (e.g. Document Completion - has the artifact been legally authenticated), all of which may impact security, privacy, and trust policies.
Elements of Provenance
• What data (FHIR resource)
• Who created data (author & organization)
• When data was created/updated (timestamp)
• How did data come from its origin to its current owner (transmitter)
Provenance IG Use Cases
• Direct Transmission
• DIRECT call
• Web Service exchange
• FHIR ReST call
• HIE Redistribution
• Storage and forwarding of content
• Clinical content unchanged
• Original Author, Organization & Timestamp persist; Transmitter can be captured
Provenance IG Use Cases
HIE Transformation
• Information aggregated from multiple sources to new format (eg CCD)
• Clinical content typically unchanged
• Original Author, Organization & Timestamp persist per data point
• HIE may be an author of new information (eg calculations)
Provenance IG Use Cases
Clinical Information Reconciliation and Incorporation (CIRI)
• User reviews and updates, or accepts, information into their system
• Author, Organization and Timestamp information are updated based on provider running the reconciliation
• Original Author, Organization and Timestamp information may or may not be preserved
Origin vs Full History of Changes (Basic Implementation)
• Importance of the full chain of custody is acknowledged and accommodated in resource design
• Focus placed on “last hop” as that is the primary focus of the clinical use case (Transmitter)
• Chain of custody can be established by reverse engineering the chain of transmitters (mainly applicable to liability scenario)
Implementation Guidance Basic Practices
• The Author Organization SHALL be the health system or clinic the author is associated with when they create or update the data. (CONF: 1000)
• Data exchanged and stored with no user reconciliation process (e.g. V2 message) SHALL retain the Author, Author Organization, and Author Timestamp (Provenance) of the source system. (CONF: 1001)
• Data exchanged through an intermediary with no modification of the data (e.g. HIE) SHALL retain the Author, Author Organization, and Author Timestamp (Provenance) of the source system. (CONF: 1002)
Implementation Guidance Basic Practices
• Data transformed through an intermediary (e.g. V2 to CDA or FHIR), with no change of the content meaning, SHALL retain the Author, Author Organization, and Author Timestamp (Provenance) of the source system. (CONF: 1003)
• Data exchanged and stored through a user reconciliation process (e.g. Allergies, Medications) SHALL update the Author, Author Organization, and Author Timestamp (Provenance) to reflect the user who performed the reconciliation. (CONF: 1004)
Implementation Guidance Basic Practices
• When multiple authors have acted upon data within an institution, the system SHALL reflect the last author who took action in the Author, Author Organization, and Author Timestamp (Provenance), and MAY include earlier authors in additional Author, Author Organization, and Author Timestamp instances. (CONF: 1005)
FHIR-Specific Best Practices
• When only a free text provider is sent, systems SHALL provide the transmitting organization as the Author Organization and MAY include the free text provider in the Practitioner Resource. (CONF: 1012)
Provenance Will Be a Regulatory Requirement in the US
• Provenance is included in definition of USCDI resources
• https://www.healthit.gov/isa/us-core-data-interoperability-uscdi
• Provenance is defined as (according the regulation):
• Author
• Author Organization
• Author Time
• Regulation is due to be published in the next 60-90 days
• Expecting a 2-year implementation period
Key Components of Provenance (US Core)
Element FHIR Element
Target Provenance.target
Timestamp Provenance.recorded
Author Provenance.agent.who
Author
Organization
Provenance.agent.onBehalfOf
Transmitter Provenance.agent.who
Transmitter
Organization
Provenance.agent.onBehalfOf
Supports _revInclude parameter: GET [base]/[Resource]?patient=[id]&_revinclude=Provenance:target
GET [base]/[Resource]?_id=[id]&_revinclude=Provenance:target
US Core Profile
• Slices used to track Author and Transmitter (first two spots reserved)
• Additional slices can be used to track prior authors (there is only one transmitter)
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