DSTU2

This page is part of the FHIR Specification (v1.0.2: DSTU 2). 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 EHRS Functional Model - Record Lifecycle Events Implementation Guide

This implementation guide describes the expected capabilities for an Electronic Health Record System (EHRS) 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. (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.)

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 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 anAuditEventresource instance and, in the case where content is new or updated, aProvenanceresource instance in the Record Entry.

E.0 Record Lifecycle Events (RLEs)

As described above, Record Entries have a lifespan and 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 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). Plus, all RLEs depend on the AuditEvent resource to capture basic metadata. Plus, all RLEs whichCreate orUpdate 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 blueare included in FHIR Connectathon and are currently limited to basicC,R, andUevents.

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

C reated at RLE

Audit

Event

Provenance

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..1 a

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..1 a

1..*

R Instance(s)

C New extract artifact

6

Output/Report

1..1

1..1 a

1..*

---

C New output/report artifact

7

Disclose

1..1

1..1 a

1..*

---

C New disclosure artifact

8

Transmit

1..1

1..1 a

1..*

---

C New transmittal artifact

9

Receive/Retain

1..1

1..1

1..*

C New Instance(s)

---

10

De-Identify

1..1

1..1 a

1..*

---

C New de-identified artifact

11

Pseudonymize

1..1

1..1 a

1..*

---

C New pseudomynized artifact

12

Re-Identify

1..1

1..1 b

1..*

C or U Instance(s) Note b

---

13

Extract

1..1

1..1 a

1..*

---

C New extract artifact

14

Archive

1..1

1..1 a

1..*

---

C New archive artifact

15

Restore

1..1

1..1 b

1..*

C or U Instance(s) – Note b

---

16

Destroy/Delete

1..1

0..0

1..*

D Instance(s)

---

17

Deprecate

1..1

1..1 b

1..*

C or U Instance(s) – Note b

---

18

Re-Activate

1..1

1..1 b

1..*

C or U Instance(s) – Note b

---

19

Merge

1..1

1..1 b

1..*

C or U Instance(s) – Note b

---

20

Unmerge

1..1

1..1 b

1..*

C or U Instance(s) – Note b

---

21

Link

1..1

1..1 b

1..*

C or U Instance(s) – Note b

---

22

Unlink

1..1

1..1 b

1..*

C or U Instance(s) – Note b

---

23

Add Legal Hold

1..1

1..1 b

1..*

C or U Instance(s) – Note b

---

24

Remove Legal Hold

1..1

1..1 b

1..*

C or U Instance(s) – Note b

---

25

Verify

1..1

1..1 b

1..*

C or U Instance(s) – Note b

---

26

Encrypt

1..1

1..1 a

1..*

---

C New encrypted artifact

27

Decrypt

1..1

1..1 b

1..*

C or U Instance(s) – Note b

---

Note a: RLE typicallyCreates a new artifact (see last column) and the (one) Provenance Resource is bound to this artifact (not Record Entry instance(s)).
Note b: Depending on system design, RLE mayCreate orUpdate 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 Attribute(s)

WHO

Organization

Provenance

signature : Signature 0..*

Provenance.Agent : 0..*

role : Coding 1..1 « ProvenanceAgentRole+ »

actor : Reference (Organization|Practitioner| Patient|Device|RelatedPerson) 0..1

userId : 0..1 Identifier

AuditEvent.Participant : 1..*

role : CodeableConcept 0..* « DICOMRoleId+ »
reference : Resource( Organization|Practitioner| Patient|Device|RelatedPerson) 0..1

userId : Identifier 0..1

requester : Boolean 1..1

Patient

Provenance

signature : Signature 0..*

Provenance.Agent : 0..*

role : Coding 1..1 « ProvenanceAgentRole+ »

actor : Reference (Organization|Practitioner| Patient|Device|RelatedPerson) 0..1

userId : 0..1 Identifier

AuditEvent.Participant : 1..*

role : CodeableConcept 0..* « DICOMRoleId+ »
 reference : Resource(Organization|Practitioner| Patient|Device|RelatedPerson) 0..1

userId : Identifier 0..1

requester : Boolean 1..1

Action - Performer

[See W5 Report for specific resource attribute]

Record - Author/User

Provenance

signature : Signature 0..*

Provenance.Agent : 0..*

role : Coding 1..1 « ProvenanceAgentRole+ »

actor : Reference ( Organization|Practitioner| Patient|Device|RelatedPerson) 0..1

userId : 0..1 Identifier

AuditEvent.Participant : 1..*

role : CodeableConcept 0..* « DICOMRoleId+ »
reference : Resource(Organization|Practitioner| Patient|Device|RelatedPerson) 0..1

userId : Identifier 0..1

requester : Boolean 1..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 : 0..1 Identifier

AuditEvent.Participant : 1..*

role : CodeableConcept 0..* « DICOMRoleId+ »

reference : Resource(Organization|Practitioner| Patient|Device|RelatedPerson) 0..1

userId : Identifier 0..1

requester : Boolean 1..1

WHAT

Action - Taken

AuditEvent

Event ; BackboneElement 1..1

Record - Lifecyle Event

AuditEvent.Event : 1..1

type : Coding 1..1 « AuditEventType+ »
subtype : Coding 0..1 « AuditEventSubType+ »
action : code 0..1 « AuditEventAction »

AuditEvent.Object : 0..*

identifier : Identifier 0..1
reference : Resource(Any) 0..1
type : Coding 0..1 « AuditEventObjectType »
role : Coding 0..1 « AuditEventObjectRole »
lifecycle : Coding 0..1 [Placeholder – TBD]

WHEN

Action - Date/Time

Provenance

Period : Period 0..1

Record - Date/Time

Provenance

recorded : instant 1..1

AuditEvent.Event : 1..1

dateTime : instant 1..1

WHERE

Action - Physical Location

Provenance

location : Resource(Location) 0..1

Record - Network Address

Provenance

location : Resource(Location) 0..1

AuditEvent.Participant.Network

address : string 0..1
type : code 0..1 « AuditEventParticipantNetworkType »

WHY

Action - Reason, Rationale, Purpose

Provenance

reason : CodeableConcept 0..1

Record - Reason, Rationale, Purpose

Provenance

reason : CodeableConcept 0..1

policy : uri 0..*

AuditEvent.Event : 1..1

purposeOfEvent : Coding 0..*

Additional Evidentiary Metadata

Digital Signature(s)

Provenance

signature : Signature 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 : Coding 0..1 [Placeholder – TBD]

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 : Coding 0..1 « AuditEventObjectType »
role : Coding 0..1 « AuditEventObjectRole »

Event is known Disclosure

AuditEvent.Object : 0..*

lifecycle : Coding 0..1 [Placeholder – TBD]

where lifecycle = “disclosure”

Record Entry Permissions

AuditEvent.Participant : 1..*

one for each participant

[for role-based permissions]

role : CodeableConcept 0..* « [as specified] »

[for user-based permissions]

reference : Resource(Practitioner|Organization| Device|Patient|RelatedPerson) 0..1
userId : Identifier 0..1

AuditEvent.Object : 0..*

securityLabel : Coding 0..1 « [as specified] »

Event Transaction Entries

AuditEvent.Object : 0..*

one for each Record Entry

identifier : Identifier 0..1
reference : Resource(Any) 0..1
type : Coding 0..1 « AuditEventObjectType »

Identifier/Version of Translation Tools

AuditEvent.Participant : 1..*

one for each tool

role : CodeableConcept 0..* « DICOMRoleId+ »

reference : Resource(Practitioner|Organization| Device|Patient|RelatedPerson) 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

Provenanc e 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