Actions and Record Entries

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. (This is also intended applicable to upcoming ISO/HL7 16527 Personal Health Record System Functional Model (PHR-S FM) Release 2, which will incorporate the Record Infrastructure Section.)

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 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 AuditEvent resource instance and, in the case where content is new or updated, a Provenance resource instance in the Record Entry.

Record Lifecycle Events (RLEs)

As described above, Record Entries have a lifespan and lifecycle events (RLEs) occurring during that lifespan. The list of RLEs is offered below, along with FHIR resources pertinent to each RLE. RLE metadata is captured in the AuditEvent resource (for all RLEs) and also a Provenance resource (for each RLEs where Record Entry content is new or updated). CRUDE = Create, Read, Update, Delete, Execute

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)… / CRUDE / FHIR Resources
in Record Entry
Audit
Event / Prove-nance / Action Related
1 / Originate/Retain / Content is originated and retained – often during the course of an Action itself – to document the Action and its context / C / 1 / 1 / 1..*
2 / Amend/
Update / Content is modified (from its original or previously retained state) – typically upon conclusion of an Action – to correct, update or complete content / U / 1 / 1 / 1..*
3 / Translate/ Transform / Content is amended to include translation of content – typically to transform coded data from one coding/classification scheme to another, also from one human language to another / U / 1 / 1 / 1..*
4 / Attest / Content is attested for accuracy and completeness – typically during/after conclusion of an Action / U / 1 / 1 / 1..*
5 / Access/View / Content is viewed or accessed / R / 1 / 0 / 1..*
6 / Output/Report / Content is output or reported / E / 1 / 1 / 1..*
7 / Disclose / Content is disclosed according to organizational policy and/or jurisdictional law / E / 1 / 1 / 1..*
8 / Transmit / Content is transmitted – typically to an external entity or system / E / 1 / 1 / 1..*
9 / Receive/Retain / Content is received and retained – typically from an external entity or system / C / 1 / 1 / 1..*
10 / De-Identify / Content is transformed into de-identified version / U / 1 / 1 / 1..*
11 / Pseudonymize / Content is transformed into an pseudomynized version / U / 1 / 1 / 1..*
12 / Re-Identify / Content is re-identified from a previously pseudonmynized version / U / 1 / 1 / 1..*
13 / Extract / Content is extracted to render subsets, derivations, summaries or aggregations / U / 1 / 1 / 1..*
14 / Archive / Are archived – typically to off-line (less readily available) storage media / U / 1 / 0 / 1..*
15 / Restore / Are restored from archive / U / 1 / 1 / 1..*
16 / Destroy/Delete / Are destroyed or identified as missing / D / 1 / 1 / 1..*
17 / Deprecate / Are deprecated (e.g., improperly identified or otherwise invalid) / U / 1 / 1 / 1..*
18 / Re-Activate / Are made active again after being previously Destroyed/Deleted or Deprecated / U / 1 / 0 / 1..*
19 / Merge / Are merged together / U / 1 / 1 / 1..*
20 / Unmerge / Are unmerged from previous merge / U / 1 / 1 / 1..*
21 / Link / Are linked together / U / 1 / 1 / 1..*
22 / Unlink / Are unlinked from previous linkage / U / 1 / 1 / 1..*
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) / U / 1 / 1 / 1..*
24 / Remove Legal Hold / Are released from legal hold (previously marked and held in unaltered state) / U / 1 / 1 / 1..*
25 / Verify / Content is verified for accuracy, completeness / U / 1 / 1 / 1..*
26 / Encrypt / Content is encoded in a cipher / U / 1 / 0 / 1..*
27 / Decrypt / Content is decoded from a cipher / U / 1 / 0 / 1..*

Record Lifecycle Event Metadata Captured in FHIR Resources

The following table shows the FHIR Resources and applicableAttributes captured–event, provenance and evidentiary metadata – at each occurrence of a Record Lifecycle Event.

Record Lifecycle Event Metadata / FHIR Resource / Resource Attribute(s)
WHO
Organization / Provenance / signature : string 0..*
Provenance.Agent : 0..* / role : Coding 1..1 « ProvenanceAgentRole+ »
type : Coding 1..1 « ProvenanceAgentType+ »
reference :uri 1..1
Patient / Provenance / signature : string 0..*
Provenance.Agent : 0..* / role : code 1..1 « ProvenanceEntityRole »
type : Coding 1..1 « ProvenanceEntityType+ »
reference :uri 1..1
AuditEvent.Participant : 1..* / role : CodeableConcept 0..* « DICOMRoleId+ »
reference : Resource(Organization|Practitioner|Patient|Device) 0..1
requester : Boolean 1..1
Action - Performer / TBD
Record - Author/User / Provenance / signature : string 0..*
Provenance.Agent : 0..* / role : Coding 1..1 « ProvenanceAgentRole+ »
type : Coding 1..1 « ProvenanceAgentType+ »
reference :uri 1..1
AuditEvent.Participant : 1..* / role : CodeableConcept 0..* « DICOMRoleId+ »
reference : Resource(Practitioner|Patient|Device) 0..1
userId : string 0..1
requester : Boolean 1..1
Record - System/Device / Provenance / signature : string 0..*
Provenance.Agent : 0..* / role : Coding 1..1 « ProvenanceAgentRole+ »
type : Coding 1..1 « ProvenanceAgentType+ »
reference :uri 1..1
AuditEvent.Participant : 1..* / role : CodeableConcept 0..* « DICOMRoleId+ »
reference : Resource(Practitioner|Patient|Device) 0..1
userId : string 0..1
requester : Boolean 1..1
WHAT
Action - Taken / TBD
Record - Lifecyle Event / AuditEvent.Event : 1..1 / type : CodeableConcept 1..1 « AuditEventType+ »
subtype :CodeableConcept 0..* « AuditEventSubType+ »
action : code 0..1 « AuditEventAction »
policy : uri 0..*
AuditEvent.Object : 0..* / identifier : Identifier 0..1
reference : Resource(Any) 0..1
type : code 0..1 « AuditEventObjectType »
role : code 0..1 « AuditEventObjectRole »
lifecycle : code 0..1 « AuditEventObjectLifecycle »
WHEN
Action - Date/Time / TBD
Record - Date/Time / Provenance / recorded : instant 1..1
AuditEvent.Event : 1..1 / dateTime : instant 1..1
Action - Duration/Elapsed Time / TBD
WHERE
Action - Physical Location / TBD
Record - Network Address / Provenance / location : Resource(Location) 0..1
AuditEvent.Participant.Network / identifier : string 0..1
type : code 0..1 « AuditEventParticipantNetworkType »
WHY
Action - Reason, Rationale, Purpose / TBD
Record - Reason, Rationale, Purpose / Provenance / reason : CodeableConcept 0..1
policy : uri 0..*
AuditEvent.Event : 1..1 / reason : CodeableConcept 0..1
Additional Evidentiary Metadata
Digital Signature(s) / Provenance
< Signature Resource – TBD> / signature : string 0..*
Record Entry ID / AuditEvent.Object : 0..* / identifier : Identifier 0..1
reference : Resource(Any) 0..1
Record Entry Content ID(s): data, docs, artifacts / AuditEvent.Object : 0..*
one for each Content item / identifier : Identifier 0..1
reference : Resource(Any) 0..1
Corresponding/linked Record Entry(ies) / AuditEvent.Object : 0..*
one for each linked Record Entry / identifier : Identifier 0..1
reference : Resource(Any) 0..1
Amendment/Translation Sequence / AuditEvent.Object : 0..* / lifecycle : code 0..1 « AuditEventObjectLifecycle »
Pointer to Pre Event Entry, if chained / AuditEvent.Object : 0..*
one to previous instance / identifier : Identifier 0..1
reference : Resource(Any) 0..1
Source of Copied Content (e.g., copy/paste template) / AuditEvent.Object : 0..*
one for each source / identifier : Identifier 0..1
reference : Resource(Any) 0..1
type : code 0..1 « AuditEventObjectType »
role : code 0..1 « AuditEventObjectRole »
Event is known Disclosure / AuditEvent.Object : 0..* / lifecycle : code 0..1 « AuditEventObjectLifecycle », where lifecycle = “disclosure”
Record Entry Permissions / AuditEvent.Participant : 1..*
one for each participant / [for role-based permissions]
role : CodeableConcept 0..* « DICOMRoleId+ »
[for user-based permissions]
reference : Resource(Practitioner|Patient|Device) 0..1
userId : string 0..1
AuditEvent.Object : 0..* / sensitivity : code 0..1 «AuditEvent.object.sensitivity »
Event Transaction Entries / AuditEvent.Object : 0..*
one for each Record Entry / identifier : Identifier 0..1
reference : Resource(Any) 0..1
type : code 0..1 « AuditEventObjectType »
Identifier/Version of Translation Tools / AuditEvent.Participant : 1..*
one for each tool / role : CodeableConcept 0..* « DICOMRoleId+ »
reference : Resource(Practitioner|Patient|Device) 0..1
userId : string 0..1

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 bound FHIR Resource Instances / Retaining
without Alteration
1 - Pre / Originate/Retain Order / N/A / N/A
1 - Post / Medication v1
MedicationPrescription v1
AuditEvent v1
Provenance v1 / N/A
2 - Pre / Update/Amend Order / Medication v1
MedicationPrescription v1
AuditEvent v1
Provenance v1 / N/A
2 - Post / Medication v2
MedicationPrescription v2
AuditEvent v2
Provenance v2 / All v1
Instances
3 - Pre / Attest Order / Medication v2
MedicationPrescription v2
AuditEvent v2
Provenance v2 / N/A
3 - Post / Medication v3
MedicationPrescription v3
AuditEvent v3
Provenance v3 (with signature) / All v1-2
Instances
4 - Pre / Access/View Order / Medication v3
MedicationPrescription v3
AuditEvent v3
Provenance v3 / N/A
4 - Post / AuditEvent v4 / All v1-3 Instances
And on…