STU 3 Ballot

This page is part of the FHIR Specification (v1.6.0: STU 3 Ballot 4). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R4 R3 R2

FHIR Infrastructure Work Group Maturity Level: 1 Ballot Status:Draft

E.0 FHIR Record Lifecycle Events Implementation Guide

This implementation guide describes the expected capabilities for an Electronic Health Record System (EHR-S) that intends to adhere to the ISO/HL7 10781 Electronic Health Record System Functional Model Release 2 which covers the logging of record lifecycle events. This implementation guide consists of three parts:

  • A Profile on the Provenance resource describing the information that should be retained for events involving the creation or updating of electronic health records
  • A Profile on the AuditEvent resource describing the information that should be retained for events involving the access or any other manipulation of electronic health records
  • A Conformance Statement which describes the operations an EHR system claiming conformance to this implementation guide must support.

For the purposes of this implementation guide, "must support" means that the system must be capable of capturing and recording those data elements which are so-marked.

E.0 Introduction

This Implementation Guide offers a methodology to support trusted electronic health record (EHR) management using HL7 Fast Health Interoperable Resources (FHIR). This approach is based on the Record Infrastructure Section of ISO/HL7 10781 Electronic Health Record System Functional Model (EHR-S FM) Release 2 and ISO DTS 21089 Trusted End-to-End Information Flows. (This IG is also intended to be applicable to upcoming ISO/HL7 16527 Personal Health Record System Functional Model (PHR-S FM) Release 2, which will incorporate the Record Infrastructure Section.)

E.0 Actions and Record Entries

From EHR-S FM, Record Infrastructure, Section RI.1, Record Lifecycle and Lifespan:

"Actions are taken to support patient health. Actions are taken in provision of healthcare to individuals. Actions are taken as the result of rules-based EHR System algorithms. Actors (i.e., patients, providers, users, systems) take Actions. (Actions broadly encompass tasks, acts, procedures or services performed or provided.)

"The EHR System captures Actions taken and creates corresponding Record Entries. Record Entries provide persistent evidence of Action occurrence, context, disposition, facts, findings and observations. From the point of Record Entry origination to the end of its lifespan, the EHR System manages each Entry consistent with and according to scope of practice, organizational policy, and jurisdictional law. In support of individual health and in provision of healthcare to individuals, Actors perform Actions and Actions have corresponding Entries in the EHR Record, (i.e., Action instances are documented by Record Entry instances). Record Entries may be captured during the course of the Action or sometime thereafter. The Actor (author/source) of the Record Entry may be the same as an Actor performing the Action or not...

"Actions have associated metadata (e.g., who, what, when, where, why, how, under what conditions, in what context). The corresponding Record Entry captures this metadata along with other Action and Record Entry related information.

"Each Record Entry also includes its own provenance metadata such as who (authoring Actor) and when (documented). Record Entries may be encapsulated to bind Actor (individual, organization, and/or system) signatures to data and metadata content and data/time of occurrence. Actions and related Record Entries capture a chronology of patient health and healthcare and also a chronology of operations and services provided in/by a healthcare enterprise. Record Entries reflect changes in health information from the time it was created, to the time it was amended, sent, received, etc. In this manner, each Record Entry serves as persistent evidence of an Action taken, enabling providers to maintain comprehensive information that may be needed for legal, [clinical,] business, and disclosure purposes. To satisfy these purposes, Record Entries must also be retained and persisted without alteration. Record Entries have both a lifecycle and a lifespan. Lifecycle Events include originate, retain, amend, verify, attest, access/view, de-identify, transmit/receive, and more. Lifecycle Events occur at various points in a Record Entry lifespan, always starting with a point of origination and retention (i.e., when the Entry is first created and stored).

"A Record Entry may have a pre and post Event state if content is modified. In this case, the original Record Entry is preserved (with signature binding) and a new Entry is created (with new signature binding). A Record Entry contains data and metadata, in multiple formats, following various conventions and standards. Included data may be tagged, and/or delimited, structured (concise, encoded, computable), or unstructured (free form, non-computable). Data may be encoded as text, document, images, audio, waveforms, in ASCII, binary or other encoding."

EHR, PHR and other Systems, designed to follow ISO/HL7 10781 and ISO 21089 record management methodology and incorporate FHIR resources natively, will create Record Entries with one or more FHIR resource instances. These FHIR resources will be bound to an AuditEventresource instance and, in the case where content is new or updated, a Provenanceresource instance in the Record Entry.

E.0 Record Lifecycle Events (RLEs)

As described above, Record Entries have a lifespan and may have lifecycle events (RLEs) occurring during that lifespan. Following is the current list of RLEs:

Sec RI.1.1.x Record Entry Lifecycle Event

From ISO/HL7 10781 EHR-S Functional Model R2
• RI - Record Infrastructure
• RI.1 - Record Lifecycle and Lifespan

Occurs when Record Entry(ies)...

1 Originate/Retain Content is originated and retained - often during the course of an Action itself - to document the Action and its context
2 Update/Amend Content is modified (from its original or previously retained state) - typically upon conclusion of an Action - to correct, update or complete content
3 Transform/Translate Content is transformed/translated - typically coded data from one coding/classification scheme to another, also from one human language to another - into a new version
4 Attest Content is attested for accuracy and completeness - typically during/after conclusion of an Action
5 Access/View Content is viewed or accessed
6 Output/Report Content is output or reported
7 Disclose Content is disclosed according to organizational policy and/or jurisdictional law
8 Transmit Content is transmitted - typically to an external entity or system
9 Receive/Retain Content is received and retained - typically from an external entity or system
10 De-Identify Content is transformed into de-identified version
11 Pseudonymize Content is transformed into an pseudomynized version
12 Re-Identify Content is re-identified from a previously pseudomynized version
13 Extract Content is extracted to render subsets, derivations, summaries or aggregations
14 Archive Are archived - typically to off-line (less readily available) storage media
15 Restore Are restored from previous archive
16 Destroy/Delete Are destroyed or identified as missing
17 Deprecate Are deprecated (e.g., improperly identified or otherwise invalid)
18 Re-Activate Are made active again after previous Destroy/Delete or Deprecate
19 Merge Are merged together
20 Unmerge Are unmerged from previous merge
21 Link Are linked together
22 Unlink Are unlinked from previous linkage
23 Add Legal Hold Are marked (and held in an unaltered state) for purposes of a legal hold (typically as the result of court or legal action)
24 Remove Legal Hold Are released from legal hold (previously marked and held in unaltered state)
25 Verify Content is reviewed and affirmed for accuracy, completeness
26 Encrypt Content is encoded in a cipher
27 Decrypt Content is decoded from a cipher

E.0 CRUDE Events

CRUDE = Create, Read, Update, Delete, Execute. Record Lifecycle Events (RLEs) are specializations of basic CRUDE events for purposes of health data/record management end-to-end. End-to-end means: 1) for the duration of data/record lifespan within the source EHR, PHR or other system, and 2) following the path of data/record exchange system by system downstream to the ultimate point of access/use.

FHIR resources – when captured natively in the source EHR, PHR or other system Record Entries – include resources resulting from the Action taken (e.g., register patient, order medication, take progress note). Plus, all RLEs depend on the AuditEvent resource to capture basic metadata. Plus, all RLEs which Create or Update resource content depend on the Provenance resource to capture content-related metadata. The following table shows how RLEs relate to CRUDE events. Some RLEs create separate new artifacts as shown.

RLEs in blue are included in FHIR Connectathon Tracks and are currently limited to basic C, R, and U events.

Sec RI.1.1.x Record Lifecycle Event FHIR Resources
in Record Entry
CRUDE - At each RLE,
per Record Entry instance
C - Create
R - Read
U - Update
D - Delete
E - Execute
New Artifacts
Created at RLE
Audit
Event
Prove-
nance
Action Related
1 Originate/Retain 1..1 1..1 1..* C New Instance(s) ---
2 Update/Amend 1..1 1..1 1..* C or U Instance(s) ---
3 Transform/Translate 1..1 1..1a 1..* --- C New transformed/ translated artifact
4 Attest 1..1 1..1 1..* C or U Instance(s)
(Provenance incl. Signature)
---
5 Access/View 1..1 1..1a 1..* R Instance(s) C New extract artifact
6 Output/Report 1..1 1..1a 1..* --- C New output/report artifact
7 Disclose 1..1 1..1a 1..* --- C New disclosure artifact
8 Transmit 1..1 1..1a 1..* --- C New transmittal artifact
9 Receive/Retain 1..1 1..1 1..* C New Instance(s) ---
10 De-Identify 1..1 1..1a 1..* --- C New de-identified artifact
11 Pseudonymize 1..1 1..1a 1..* --- C New pseudomynized artifact
12 Re-Identify 1..1 1..1b 1..* C or U Instance(s) Note b ---
13 Extract 1..1 1..1a 1..* --- C New extract artifact
14 Archive 1..1 1..1a 1..* --- C New archive artifact
15 Restore 1..1 1..1b 1..* C or U Instance(s) - Note b ---
16 Destroy/Delete 1..1 0..0 1..* D Instance(s) ---
17 Deprecate 1..1 1..1b 1..* C or U Instance(s) - Note b ---
18 Re-Activate 1..1 1..1b 1..* C or U Instance(s) - Note b ---
19 Merge 1..1 1..1b 1..* C or U Instance(s) - Note b ---
20 Unmerge 1..1 1..1b 1..* C or U Instance(s) - Note b ---
21 Link 1..1 1..1b 1..* C or U Instance(s) - Note b ---
22 Unlink 1..1 1..1b 1..* C or U Instance(s) - Note b ---
23 Add Legal Hold 1..1 1..1b 1..* C or U Instance(s) - Note b ---
24 Remove Legal Hold 1..1 1..1b 1..* C or U Instance(s) - Note b ---
25 Verify 1..1 1..1b 1..* C or U Instance(s) - Note b ---
26 Encrypt 1..1 1..1a 1..* --- C New encrypted artifact
27 Decrypt 1..1 1..1b 1..* C or U Instance(s) - Note b ---

a: RLE typically Creates a new artifact (see last column) and the (one) Provenance Resource is bound to this artifact (not Record Entry instance(s)).
b: Depending on system design, RLE may Create or Update Record Entry instance(s) and thus the (one) Provenance Resource is bound to these instance(s).

E.0 Record Lifecycle Event Metadata Captured in FHIR Resources

The following table shows the FHIR Resources and applicable Attributes captured - event, provenance and evidentiary metadata - at each occurrence of a Record Lifecycle Event. W5 metadata includes who, what, when, where, why attributes as shown below. W5 metadata elements are required.

Record Lifecycle Event Metadata FHIR Resource Resource Element(s)
WHO
Organization Provenance signature : Signature 0..*
Provenance.agent : 0..* role : Coding 1..1 « ProvenanceAgentRole+ »
actor : Reference(Organization) 0..1
userId : Identifier 0..1
AuditEvent.agent : 1..* role : CodeableConcept 0..* « ActiveParticipantRoleCode »
reference : Reference(Organization) 0..1
userId : Identifier 0..1
Patient Provenance signature : Signature 0..*
Provenance.agent : 0..* role : Coding 1..1 « ProvenanceAgentRole+ »
actor : Reference(Patient) 0..1
userId : Identifier 0..1
AuditEvent.agent : 1..* role : CodeableConcept 0..* « ActiveParticipantRoleCode »
reference : Reference(Patient) 0..1
userId : Identifier 0..1

Action - Performer

Record - Author/User

Provenance signature : Signature 0..*
Provenance.agent : 0..* role : Coding 1..1 « ProvenanceAgentRole+ »
actor : Reference (Device) 0..1
userId : Identifier 0..1
AuditEvent.agent : 1..* role : CodeableConcept 0..* « ActiveParticipantRoleCode »
reference : Reference(Device) 0..1
userId : Identifier 0..1
Record - System/Device Provenance signature : Signature 0..*
Provenance.agent : 0..* role : Coding 1..1 « ProvenanceAgentRole+ »
actor :Reference(Organization|Practitioner|Patient|Device|RelatedPerson) 0..1
userId : Identifier 0..1
AuditEvent.agent : 1..* role : CodeableConcept 0..* « ActiveParticipantRoleCode »
reference : Reference(Organization|Practitioner|Patient|Device|RelatedPerson) 0..1
userId : Identifier 0..1
WHAT
Action - Taken Provenance Activity : Coding 0..1 « ProvenanceActivity »
AuditEvent Event : BackboneElement 1..1
Record - Lifecyle Event AuditEvent type : Coding 1..1 « AuditEventType+ »
subtype : Coding 0..1 « AuditEventSubType+ »
action : code 0..1 « AuditEventAction»
AuditEvent.entity : 0..* identifier : Identifier 0..1
reference : Reference(Any) 0..1
type : Coding 0..1 « AuditEventEventType »
role : Coding 0..1 « AuditEventEventRole »
lifecycle : Coding 0..1
WHEN
Action - Date/Time Provenance period : Period 0..1
AuditEvent recorded : instant 1..1
Record - Date/Time Provenance recorded : instant 1..1
AuditEvent : 1..1 recorded : instant 1..1
WHERE
Action - Physical Location Provenance location : Reference(Location) 0..1
AuditEvent site : BackboneElement 0..1
identifier : string 1..1
type : Coding 0..* « AuditEventSourceType »
Record - Network Address Provenance location : Reference(Location) 0..1
AuditEvent.agent.Network address : BackboneElement 0..1
type : code 0..1 « AuditEventAgentNetworkType »
WHY
Action - Reason, Rationale, Purpose Provenance reason : Coding 0..*
AuditEvent purposeOfUse : Coding 0..* « AuditEventPurposeOfUse »
Record - Reason, Rationale, Purpose Provenance reason : Coding 0..*
policy : uri 0..*
AuditEvent : 1..1 purposeOfEvent : Coding 0..*
Additional Evidentiary Metadata, as applicable
Digital Signature(s) Provenance
one per signature
signature : Signature 0..*
Record Entry ID Provenance Target : Reference(Any) 0..*
AuditEvent.entity : 0..* identifier : Identifier 0..1
reference : Reference(Any) 0..1
Record Entry Content ID(s):
data, docs, artifacts
Provenance Target : Reference(Any) 0..*
Provenance.entity : 0..*
one per Record Entry
role : Coding 0..1 « ProvenanceEntityRole »
type : Coding 0..1 « ProvenanceResourceType »
reference : Reference(Any) 0..1
agent : [see Provenance.agent]
AuditEvent.entity : 0..*
one per Content item
identifier : Identifier 0..1
reference : Reference(Any) 0..1
Corresponding/linked Record Entry(ies) Provenance.entity : 0..*
one per linked Record Entry
role : Coding 0..1 « ProvenanceEntityRole »
type : Coding 0..1 « ProvenanceResourceType »
reference : Reference(Any) 0..1
agent : [see Provenance.agent]
AuditEvent.entity : 0..*
one per linked Record Entry
identifier : Identifier 0..1
reference : Reference(Any) 0..1
Amendment/Translation Sequence Provenance.entity : 0..*
one for each Record Entry in sequence
role : Coding 0..1 « ProvenanceEntityRole »
type : Coding 0..1 « ProvenanceResourceType »
reference : Reference(Any) 0..1
agent : [see Provenance.agent]
AuditEvent.entity : 0..* lifecycle : Coding 0..1
Pointer to Pre Event Entry, if chained Provenance.entity : 0..*
one per previous instance
role : Coding 0..1 « ProvenanceEntityRole »
type : Coding 0..1 « ProvenanceResourceType »
reference : Reference(Any) 0..1
agent : [see Provenance.agent]
AuditEvent.entity : 0..*
one per previous instance
identifier : Identifier 0..1
reference : Reference(Any) 0..1
Source of Copied Content
(e.g. copy/paste template)
Provenance.entity : 0..*
one per source
role : Coding 0..1 « ProvenanceEntityRole »
type : Coding 0..1 « ProvenanceResourceType »
reference : Reference(Any) 0..1
agent : [see Provenance.agent]
AuditEvent.source : 1..1
one per source
site ; BackboneElement 0..1
identifier : string 1..1
type : Coding 0..* « AuditEventSourceType »
AuditEvent.entity : 0..*
one per source
identifier : Identifier 0..1
reference : Reference(Any) 0..1
type : Coding 0..1 « AuditEventEventType »
role : Coding 0..1 « AuditEventEventRole »
Event is known Disclosure AuditEvent.entity : 0..* lifecycle : Coding 0..1
where lifecycle = "disclosure"
Record Entry Permissions AuditEvent.agent : 1..*
one per agent
[for role-based permissions]
role : CodeableConcept 0..* « [as specified] »
[for user-based permissions]
reference : Reference(Practitioner|Organization|Device|Patient|RelatedPerson) 0..1
userId : Identifier 0..1
AuditEvent.entity : 0..*
One per agent label
securityLabel : Coding 0..1 « [as specified] »
Event Transaction Entries Provenance.entity : 0..*
one per Record Entry
role : Coding 0..1 « ProvenanceEntityRole »
type : Coding 0..1 « ProvenanceResourceType »
reference : Reference(Any) 0..1
agent : [see Provenance.agent]
AuditEvent.entity : 0..*
one per Record Entry
identifier : Identifier 0..1
reference : Reference(Any) 0..1
type : Coding 0..1 « AuditEventEntityType »
Identifier/Version of Translation Tools Provenance.entity : 1..*
one per translation event
role : Coding 0..1 « ProvenanceEntityRole »
type : Coding 0..1 « ProvenanceResourceType »
reference : Reference(Any) 0..1
agent : [see Provenance.agent]
AuditEvent.agent : 1..*
one per translation event
role : CodeableConcept 0..* « ActiveParticipantRoleCode »
reference : Reference(Device) 0..1
userId : Identifier 0..1

E.0 EXAMPLE - Lifecycle Events for a Record Entry

Action = Medication Order

Record Lifecycle Event (RLEs), in sequence: 1) originate/retain, 2) update/amend, 3) attest, 4) access/view...

Note that Record Entries have a pre-lifecycle event state (except for the genesis originate/retain event). Record Entries also have a post-lifecycle event state (except for the terminus destroy/delete event).

Event Sequence Record Lifecycle Event Record Entry Content - including
FHIR Resource Instances
Retaining
without Alteration
1 - Pre Originate/Retain Order --- ---
1 - Post Medication v1
MedicationOrder v1
AuditEvent v1
Provenance v1
---
2 - Pre Update/Amend Order Medication v1
MedicationOrder v1
AuditEvent v1
Provenance v1
All v1 Instances
2 - Post Medication v2
MedicationOrder v2
AuditEvent v2
Provenance v2
All v1 Instances
3 - Pre Attest Order Medication v2
MedicationOrder v2
AuditEvent v2
Provenance v2
All v1/2 Instances
3 - Post Medication v3
MedicationOrder v3
AuditEvent v3
Provenance v3 (with signature )
All v1/2 Instances
4 - Pre Access/View Order Medication v3
MedicationOrder v3
AuditEvent v3
Provenance v3
All v1/2/3 Instances
4 - Post AuditEvent v4 All v1/2/3 Instances
And on...