EHR and PHR System Functional Models - Record Lifecycle Events Implementation Guide, published by HL7 International / Electronic Health Records. This guide is not an authorized publication; it is the continuous build for version 1.2.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ehrs-rle-ig/ and changes regularly. See the Directory of published versions

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EHRS Functional Model - Record Lifecycle Events - FHIR 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:

• Profile on the Provenance resource describing the information that should be retained for events involving the creation or updating of electronic health records
• 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
• 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.

Introduction

This Implementation Guide offers a methodology to support trusted electronic health record (EHR) and personal health record (PHR) management using HL7 Fast Health Interoperable Resources (FHIR). This approach is based on the Record Infrastructure Section of ISO/HL7 10781:2023 Electronic Health Record System Functional Model (EHR-S FM) Release 2.1, ISO/HL7 16527:2023 Personal Health Record System Functional Model (PHR-S FM) Release 2 and ISO 21089:2018 Trusted End-to-End Information Flows. These Standards describe how EHR/PHR/HIT system functions (software) manage health record entries (data) during the complete record entry lifespan and at each lifecycle event (RLE) occurring therein.

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, ISO 16527 and/or 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 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 may have lifecycle events (RLEs) occurring during that lifespan. Following is the current list of RLEs:

CRUDE Events

CRUDE = Create, Read, Update, Delete. 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.

^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 new instance(s).

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.

EXAMPLE - Lifecycle Events for a Record Entry

Action = Medication Request

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).