PACIO Advance Healthcare Directive Interoperability Implementation Guide, published by HL7 International / Patient Empowerment. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-pacio-adi/ and changes regularly. See the Directory of published versions

Content Type Overview

Page standards status: Informative

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This section provides additional guidance on the relationship between the associated profiles and the structure of the interoperable advance healthcare directive documents defined in this IG.

Advance Healthcare Directive Document Types

There is a very important distinction for the three types of ADI content that will be covered in this IG. Below is a description of each type of content that will be covered by the ADI FHIR IG with versions.

 

	Person-Authored Advance Healthcare Directive Documents
		Used as a tool for establishing a healthcare agent (delegation of rights consenting to appoint an authorized personal representative in the role of healthcare agent) and sharing an individual’s medical treatment intervention and care experience preferences, and care goals and priorities (GPP). Provides guidance that a person would want others to know to inform treatment and care planning during a potential future medical emergency, in the case where the patient is unable to communicate with caregivers and medical personnel and the appointed healthcare agent needs to make decisions on the patient's behalf. There is NO “contract” between the author (patient) and any other party involved in the future medical emergency that the GPP is required to be followed (i.e., no offer or acceptance, no consideration, no consequences for failure to follow the patient’s directives) A Mental Health Advance Directive is a special type of Person-Authored document focused on treatment and care experience preferences relevant to behavioral health conditions. This type of document may appoint a behavioral healthcare agent whose powers are constrained to addresses mental health related care decisions during times when the patient is not able to make decisions. In some cases, a practitioner may assist a person with creating their advance directive or mental health advance directive document. The practitioner functions as a facilitator, assisting the patient to document their preferences accurately and completely. The facilitator is not an author of the document. The document reflects the thoughts and words of the patient. The facilitator is recorded in the document as someone who has performed advance care planning services to support the patient’s creation of their own document.
	Encounter-Centric Instructions
		Clinician or Practitioner-authored Directives are related to the current, immediate episode of care The patient, or their healthcare agent, provides direct input in the creation of the instructions which specify decisions that have been made about treatments that may, or may not be, utilized during a medical emergency occurring within the current episode of care.
	Provider-Authored Portable Medical Orders for Life-Sustaining Treatments
		Practitioner-authored documents A set of medical orders intended to follow a patient and be available across the continuum of care The patient, or their healthcare agent, provides direct input in the creation of the orders but the documents are authored by a licensed practitioner. These orders are used to document a provider’s orders for, or preferences against, treatments that are to be utilized during a future medical emergency that would necessitate life-sustaining treatment and interventions, and are based on the patient’s expressed goals, preferences, and priorities for such care. In some cases, a provider who authors (and signs) the portable medical order document may be supported by a different practitioner functioning as a facilitator, discussing options and decisions the patient may want to make. The facilitator is not an author of this type of document. The document reflects the orders issued by the authoring provider. A facilitator is recorded in the document as someone who has performed advance care planning services to support the authoring provider.

The current version, STU2, of this ADI with FHIR IG covers the use of RESTful API interactions for creation, sharing, query/access, and verification of advance directive information between systems. This IG is not intended to cover medical intervention goals, preferences, priorities for individuals who are not able to create and document their own advance healthcare decisions.

STU2 supports only Person-Authored Advance Directives and PMO documents. Future versions of this FHIR IG will address Encounter-centric Instructions.

Structure and Resource Relationships

Advance healthcare decision documents may take several forms, including scanned PDF documents, CDA documents, other binary documents, as well as native FHIR documents (using the Composition and other ADI-specific profiled FHIR resources). This guide defines the interoperable guidance necessary to support creation, update, query, and access to all of these types and other potential ADI document types (through encoding in a Binary resource). Today, most of these documents are shared through scanned images housed in EMRs, EHRs and other systems.

This implementation guide is designed to guide a range of digitization levels, ranging from scanned documents to fully discrete FHIR documents. Some types of advance healthcare directive documents can be more digitized than others. For example, PMOs need to have more structured data than person-authored advance healthcare directives which contain more free-text care preferences.This is described in more detail in the ADI FHIR Document Structure section.

The diagram below further illustrates how these documents are organized. The FHIR DocumentReference resource is used for "indexing" of documents, similar to the way a library uses a card catalog to index books based on different search criteria, for example, by title, author, date, or classification code. The DocumentReference can be used in the same way for searching and finding documents with specific attributes such as type of document, subject (e.g., patient), author, dates. These attributes are provided in the metadata of the DocumentReference so that the actual documents do not have to be accessed for most common searches. A complete list of search capabilities on DocumentReference can be found in the Search Parameters section.

Digital signatures are defined as optional in this guide, for a myriad of factors including maturity of systems that can create and exchange digital ADI. If supported by a Content Creator or Document Registry Server system, the digital signature “authenticity information” will be captured in a Binary resource that is referenced by an additional DocumentReference resource where the relatesTo relationship of the “signature page” to the source document is “signs”.

There is movement within the FHIR community to begin using the Provenance resource as a standard way to capture the digital signature of a document. The signature within the Provenance resource would be used hold the digital signature authenticity information associated with a document, not an additional DocumentReference. As the DocumentReference resource begins to be used for many different types of documents, it may be more effective to keep signature pages in the Provenance Resource. A future version of the implementation guide will be updated to follow the standard FHIR guidance on signatures when it is finalized.

There is movement within the FHIR community to move towards using the Provenance resource as a standard way to apply a digital signature to a document in FHIR. The signature within the Provenance resource would be used to encrypt the binary (the actual document itself), not the DocumentReference. A future version of the implementation guide will be updated to follow the standard FHIR guidance on signatures when it is finalized.

ADI FHIR Document Structure

ADI native documents using FHIR are instances of the Bundle resource with the type = document. The document should have all content contained within the Bundle with no external references except for the references to external documents in the DocumentationObservation through the focus data element.

FHIR Bundle documents consist of multiple entry resources within it. The first entry SHALL be a Composition resource. The Composition resource acts as the header and organizational construct. It contains information about the document such as the category and type of document, dates, and references to the various participants of the document, as well as document sections used to categorize or organize the contained entries.

Utilizing Minimally Structured Documents

The ADI document types follow an approach which initially supports the minimal amount of required structured data. Under this approach, the native Source Form of the document is always included in the initial section of the Composition. The Source Form section is the section in the Composition resource where section.code equals Composition.type. The Source Form Section includes the Binary representation (The Source Form entry) of the source document information as it was operated on by individuals involved in the completion of the document. The Source Form Entry also may include additional machine processable data about the jurisdiction associated with the Source Form, its copyright holder, or other identifying information use as a Source Form designation established by the local jurisdiction, such as "Louisiana LaPOST".

This approach ensures that all of the information in the document is available to support human readability. Subsequent sections include information from the source document which are required in machine readable format to enable additional processes of that information. Only information required by document receivers to be available as structured data needs to be included in machine processable format.

This structure is common to all ADI document types. The original Source Form of the document must alway be referenced in a section of the FHIR Composition. Requirements for inclusion of additional machine processable data depend on:

• the form of advance healthcare directive document
• the ADI content type
• the readiness of document recipients to perform data processing on included content

Reference the IG section, Advance Directive Structure Requirements, for further guidance.

Minimally Structured Documents: A Better Implementation Approach

Minimally Structured Documents enable an optimizable Progressive Structuring design which supports Progressive Interoperability. Healthcare interoperability has long presented implementers with an uncomfortable choice. Unstructured documents faithfully preserve the complete human-readable clinical story but expose little information for machine processing. Fully structured documents maximize computable content but require substantial implementation effort and the resulting rendered information feels unfamiliar for human users. Minimally Structured Documents provide a practical middle ground by preserving the native source form within a structured document framework and requiring the minimal structured data needed to support downstream workflows and clinical decisions by meeting implementers where they are today. Rather than treating interoperability as an all or nothing proposition to be achieved in a single leap, the Minimally Structured Documents approach offers optimal evolution through Progressive Interoperability. This incremental approach reduces implementation risk while steadily increasing interoperability, computable value, and practical utility over time. It is an intermediate goal as implementers increase the amount of structured data as it adds value.

Handling Expiration Dates

ADI documents should have a time period whereby the patient preferences or the PMOs are legally valid. These are indicated by expiration dates within the Person-Authored Composition and PMO Composition profiles as such:

• the start date for the AD: Composition.date
• the expiration date for the AD: Composition:extension:ExpirationDateExtension

Clause Extension

Advance healthcare directive source form documents often contain contextual information in the various sections of the document. Contextual information may be relevant to preserve the meaning of information represented in structured data entries associated with a section. To enable representation of contextual information and make it more processable, this guide has defined a clause extension. The clause extension can be used to represent various types of contextually relevant information in any Composition section and within the context of a Consent Resource. Information that is not contextually relevant does not get represented using the clause extension. That information remains accessible as part of the source form.

Examples of clauses include: statements made by a document author or their witness as well as administrative information associated with an advance healthcare directive.

Advance Healthcare Directive Document Content Principles

In order to accurate represent the semantic content contained in Advance Healthcare Directive Documents, the following principles have been applied when creating machine processable entries to represent information expressed in the source form of the document.

Observation Resource Is Used for Patient Preferences

Use of FHIR Observation Resource to express Care Experience Preferences: Care experience preferences captured for an individual are semantically represented as Observations. This information exists to inform the care team who is providing care for the individual what is meaningful or important to the person, from a personal or spiritual or cultural perspective. This type of person-authored information is documented using Observations with semantic coding and are typically not conditional in nature.

Consent Resource Is Used to express Delegation of Rights

The FHIR Consent Resource is used to model the designation of an individual the person, or patient, has named who is to make care and treatment decisions on their behalf if the person, or patient, is unable to do so themselves at some point, due to health status. The delegation of medical and treatment decision-making involves use of "consent" as the person, or patient, agrees or consents to someone other than themselves to be able to interact with the care team on their behalf, decide on medical and treatment decisions, decide on sites of care where treatment is to be received, and otherwise act on their behalf in alignment with what is known about them based on their beliefs, values, personality, and other informing factors that the named designee believes are in the person's best interests.

ServiceRequest Is Used to Express "Portable" Directives Ordered by a Physician Intended to Travel With the Patient

The FHIR ServiceRequest Resource is used to communicate "portable medical orders" regarding treatment interventions. On paper, and within the ADI guidance, these orders are written by a practitioner and signed, and are typically also signed by the Patient or their health care designee. As these orders are not constrained to a single episode of care or encounter, but are instead intended to move across care settings in a persistent manner, the signing practitioner may not have authority to place an actual order in the receiving/treating EHR where the actual care is being provided. As these portable medical orders are indeed practitioner-authored medical orders related to treatment interventions, which have been captured by the care team and properly signed by a practitioner as appropriate to the originating jurisdiction, the contents found in ServiceRequests are actionable as intended when transitions in care occur. These orders are commonly known in the vernacular as a POLST, MOLST, DNR, DNAR and derivatives of those common labels. A POLST-type document may address many types of treatment intervention preferences, thereby containing many individual orders, whereas a DNR or DNAR represents a single order against use of CPR should the person be appropriate for that type of emergency intervention in the future. Each individual portable medical order within the document is represented as ServiceRequest with an intent of "directive".

When nested in the context of a CarePlan, which can express the circumstances or conditions under which this order would be pertinent, the ServiceRequest is conditional upon the stated conditions being true.

CarePlan Is Used to Express Conditional Preferences or Complex Statements Including Relevant Scenarios or Intended Goals Pertinent to the Intention of the Situation

TThe FHIR CarePlan Resource is used to express complex conditional statements that involve a medical situation or health scenario, which can also include a potential prognosis, all of which results in a specific treatment intervention or care experience preference. To express this in mathematical terms, this type of complexity can be found on forms currently in use such as: IF this happens, AND the prognosis is X, THEN I want to express my goals or treatment preference to be Y. These complex statements of possible health scenarios that result in goal or treatment preferences are complex and yet if expressed should be done using the CarePlan Resource. Additionally the Procedure Resource is used to express the actual intervention procedure in the details of that expression. The semantic nuances of the person's care experience, goal of care, and/or treatment intervention preference needs to be conditionally reflected in the person's, or patient's, overarching plan of care.

Patient Is Used to Represent the Subject or Subject and Author for Person-Authored Document Types

The FHIR Patient Resource is used to represent the person, or patient, who is the subject of the Portable Medical Order or Person-Authored advance directive.

RelatedPerson Is Used for Healthcare Agent, Witness, and Notary

The FHIR RelatedPerson Resource is used to represent an individual who is being designated as the person's, or patient's, Healthcare Agent. This resource is also used to represent an individual who acts as a Witness or Notary when an advance healthcare directive is completed.

PractitionerRole Is Used for Professional "Care Providers" Playing a Role in Document Creation and Completion

The FHIR PractitionerRole Resource is used to represent a practitioner employed by a specific care organization who in involved in facilitating the creation, update or completion (including signing) of the completed portable medical order. Professionals other than practitioners may also be involved in the creation or update of portable medical orders or advance directives as facilitators, who support the person, or patient, who is the subject of the document. The care team member facilitating or completing the document is represented using a FHIR Practitioner Resource, while the provider organization that employs that care team and practitioner is represented using a FHIR Organization Resource.

Practitioner Is Used to Represent Individuals Acting in a Professional Capacity as a Care Provider

The FHIR Practitioner Resource is used to represent the individual care provider. Professions also may be involved as facilitators supporting a person to fill out a personal advance directive.

Organization Is Used to Represent Organizations

The FHIR Organization Resource is used to represent the provider organization that is providing care to the person, or patient. The employer of the practitioner or facilitating care team member may also be expressed using the Organization Resource, if a portable medical order is the document being created, updated, or completed.

Provenance Is Used to Record Relevant Activities Performed on the Document

The FHIR Provenance Resource is used to record relevant actions taken on or for an advance healthcare directive document throughout the life-cycle of of the document. This resource documents important elements such as authorship and verification of the directive, providing easily accessible transparent auditability for trust and integrity when measurement and clinical reliance are needed.

Composition Is Used to Organize the Attested Source Form and Human Readable Content along with Associated Machine Processable Entries

The FHIR Composition Resource is is used to hold and expose the attested content of the source form, and enable inclusion of computable data essential to usability and exchange between systems.

Bundle Is Used to Instantiate a Completed Version of the Document

The FHIR Bundle Resource is used to establish a persistent snapshot of the document at a point in time to preserve it in an immutable record of the completed document. When appropriate it can also include relevant Provenance Resources associated with the document to support accessible transparency of the Provenance of the information. To avoid potential loss of context in the contents when the information is parsed, it is required that advance healthcare directive documents be expressed using Bundle to protect intent of the information and enable contextual concepts intended to be represented as a single document.

DocumentReference Is Used to Register and Index a Document to Enable Searching and Retrieval Through a FHIR Document Management Server

The FHIR DocumentReference Resource is used to record important information such as the most current version of the document, important at the point of care, and provides proof that the directive exists in the system. This resource expresses elements such as status, composition document status, author, custodian, and content attachment to name a few data elements.

Alignment with CDA Representations

This FHIR IG is the primary source for defining Advance Healthcare Directive Documents and their digital representation formats. However, it operates in harmony with the CDA IG produced for the same purpose. The structured document representation principles are aligned between these two IGs and CDA templates are not updated to remain in synch with information representation designs developed in FHIR.