AU Patient Summary Implementation Guide, published by HL7 Australia. This guide is not an authorized publication; it is the continuous build for version 0.5.0-cibuild built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7au/au-fhir-ps/ and changes regularly. See the Directory of published versions

General Requirements

Conforming to AU Patient Summary (AU PS)

Systems claiming conformance to AU PS will represent digital health information using the content models of AU PS profiles AND implement the requirements of one or both AU PS actors.

The requirements of the FHIR standard and FHIR Conformance Rules apply, and define the use of terms in this guide including the conformance verbs - SHALL, SHALL NOT, SHOULD, SHOULD NOT, MAY.

Implementers are advised to be familiar with the requirements of the FHIR standard and IPS when implementing AU PS, in particular:

• IPS Generation and Data Inclusion
• IPS Narrative and Language Translation
• FHIR Terminology requirements
• FHIR Documents and FHIR Clinical Documents
• FHIR RESTful API
• FHIR Search
• FHIR Resource formats
• FHIR Data Types

Conformance Artifacts

AU PS Profiles and Extensions

The Profiles and Extensions page lists the AU PS profiles and extensions defined for this implementation guide. An AU PS profile StructureDefinition defines the minimum elements, extensions, vocabularies and value sets that SHALL be present and constrains the way elements are used when conforming to the profile.

AU PS profile elements include mandatory and Must Support requirements. Mandatory elements are required and have a minimum cardinality of 1 (min=1). Must Support elements have defined conformance obligations in AU PS.

AU PS Actors

The Actor Definitions page lists the AU PS actors defined for this implementation guide and the requirements for implementing that actor. An AU PS profile StructureDefinition defines the obligations for an AU PS actor when implementing that profile.

Mandatory Elements

Mandatory elements are elements with minimum cardinality > 0. When an element is mandatory, the data is expected to always be present. Very rarely, it may not be, and in this circumstance the requirements defined by AU Core for Missing Data SHALL be applied.

An element can be both Must Support and mandatory, and in this circumstance the requirements defined for Missing Must Support and Mandatory Data SHALL be applied.

The convention in this guide is to mark all mandatory and conditionally mandatory elements as Must Support unless they are nested under an optional element.

Missing Data, Empty Sections, Known Absence of Data

It is important to differentiate between the following mutually exclusive circumstances:

• Affirmatively stating that a patient has “no known X” or “no history of X” (for example, that a patient has no known allergies).
• Not having data in the record for a particular section (for example, where a source system does not have information on a patient’s allergies).
• Asserting that this data is not available due to a workflow reason (for example, allergies were not reviewed and are unknown).
• Not having data for a particular element (for example, the onset date of a particular allergy is not available in the system and the system does not know the reason for the absence).

In the above circumstances the following is applied:

• Where data is missing for an element within a resource and the reason is not known, systems SHALL implement the requirements of the Missing Data section.
• Where data is missing for a section and the reason is not known, systems SHALL implement the requirements of the Empty Sections section.
• Where data is not available due to a known workflow reason, systems SHOULD implement the requirements of the Known Absence of Data Due to Workflow section.
• When stating “no known X” or “no history of X”, systems SHOULD implement the guidance of the No Known X section.

Missing Data

Missing Must Support and Optional Data

If the source system (producer) does not know the value for an optional element (minimum cardinality = 0), including elements labelled Must Support, as per the requirements defined in AU Core, the data element SHALL be omitted from the resource.

Missing Must Support and Mandatory Data

If the data element is a mandatory element (minimum cardinality is > 0), the element SHALL be present even if the source system (producer) does not know the value or the reason the value is absent. In this circumstance, the requirements defined by AU Core for Missing Must Support and Mandatory Data SHALL be applied.

Example: MedicationRequest resource where status and requester are missing

  ...
  {
    "resourceType" : "MedicationRequest",
    "status" : "unknown",
    "intent" : "order",
    "medicationCodeableConcept" : {
      "coding" : [
        {
          "system" : "http://snomed.info/sct",
          "code" : "79115011000036100",
          "display" : "Paracetamol 500 mg + codeine phosphate hemihydrate 30 mg tablet"
        }
      ]
    },
    ...
    "authoredOn" : "2018-07-15",
    "requester" : {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/data-absent-reason",
          "valueCode" : "unknown"
        }
      ]
    },
  ...

Empty Sections

An AU PS Producer SHOULD omit non-mandatory sections when the source system does not have any information and does not know the reason the information is absent.

For a mandatory section (minimum cardinality is > 0), the section SHALL be present even if the source system does not have any information for that section or know the reason the information is absent. In this circumstance, an AU PS Producer SHALL:

• use the code unavailable from the List Empty Reasons code system

AU PS Consumers are advised that other meaningful values can be captured in Composition.section.emptyReason beyond missing or suppressed.

Example: AU PS - Allergies and Intolerances Section where the patient's allergy information is not available.
~~~
    ...
    "section" : [
      {
        "title" : "Allergies and Intolerances",
        "code" : {
        "coding" : [
          {
            "system" : "http://loinc.org",
            "code" : "48765-2",
            "display" : "Allergies and adverse reactions Document"
          }
        ]
        },
        "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en-AU\" lang=\"en-AU\">There is no information available regarding the consumer's allergy conditions.</div>"
        },
        "emptyReason" : {
          "coding" : [
            {
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable",
            "display" : "Unavailable"
            }
          ],
          "text" : "No information available"
        }
      },
    ...
~~~

Known Absence of Data Due to Workflow

Where the system does not have information for a particular section and there is a known workflow reason (for example, the patient preferred not to answer), the system SHOULD represent that reason by populating Composition.section.emptyReason:

• Prefer not to answer may be represented by sending the Data Absent Reason code “asked-declined”
• Asked but not known may be represented by sending the Data Absent Reason code “asked-unknown”

• Where the workflow does not support obtaining the information, it may be represented by sending the List Empty Reason code “notasked”

  Example: AU PS - Allergies and Intolerances Section where there is a workflow reason the patient’s allergy information is not available.

        ...
        "section" : [
          {
            "title" : "Allergies and Intolerances",
            "code" : {
            "coding" : [
              {
                "system" : "http://loinc.org",
                "code" : "48765-2",
                "display" : "Allergies and adverse reactions Document"
              }
            ]
            },
            "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en-AU\" lang=\"en-AU\">The patient was not asked about allergies.</div>"
            },
            "emptyReason" : {
              "coding" : [
                {
                "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
                "code" : "notasked",
                "display" : "Not Asked"
                }
              ],
              "text" : "Patient was not asked"
            }
          },
        ...
  

No Known X

Where the system can assert “no known X” (for example, no known conditions) or “no history of X” (for example, no history of cardiovascular system disease), the system SHOULD populate Composition.section.entry in accordance with the relevant profile specific implementation guidance.

For example, to represent that a patient does not have an allergy or category of allergies, an appropriate negation code (e.g. 716186003 |No known allergy| or 1003774007 |No known Hevea brasiliensis latex allergy|) is used in AllergyIntolerance.code as per the profile specific implementation guidance for AU PS AllergyIntolerance.

In AU PS this approach is preferred to using Composition.section.emptyReason due to the widely known and implemented patterns established within FHIR, IPS, and AU Core to assert “no known X” or “no history of X”.

Example: Condition resource representing ‘No Known Problems’

  ...
  {
    "resourceType" : "Condition",
    "clinicalStatus" : "active",
    "code" : {
      "coding" : [
        {
          "system" : "http://snomed.info/sct",
          "code" : "160245001",
          "display" : "No current problems or disability"
        }
      ]
    },
  ...

Suppressed Data

In some circumstances, specific pieces of data are hidden:

• if an optional section (minimum cardinality = 0) is not able to be shared, it MAY be omitted; but if provided use the code unavailable or withheld from the List Empty Reason in Composition.section.emptyReason.
• if a mandatory section (minimum cardinality > 0) is not able to be shared, use the code unavailable or withheld from the List Empty Reason in Composition.section.emptyReason.
• if an optional element (minimum cardinality = 0) is not able to be shared, it SHALL be omitted.

• if a mandatory element (minimum cardinality > 0) is not able to be shared, use the code unknown or masked from the DataAbsentReason Code System following the section on Missing Data.

  Example: AU PS - Allergies and Intolerances Section where the patient’s allergy information is not allowed to be shared.

        ...
        "section" : [
            {
              "title" : "Allergies and Intolerances",
              "code" : {
                "coding" : [
                    {
                    "system" : "http://loinc.org",
                    "code" : "48765-2",
                    "display" : "Allergies and adverse reactions Document"
                  }
                ]
              },
              "text" : {
                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en-AU\" lang=\"en-AU\">This information is withheld.</div>"
              },
              "emptyReason" : {
                "coding" : [
                    {
                    "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
                    "code" : "withheld",
                    "display" : "Withheld"
                    }
                ],
                "text" : "Withheld"
              }
            },
        ...
  

Must Support and Obligation

Labelling an element Must Support means that systems that produce or consume resources SHALL provide support for the element in some meaningful way. The FHIR standard does not define exactly what ‘meaningful’ support for an element means, but indicates that a profile SHALL make clear exactly what kind of support is required when an element is labelled as Must Support.

In AU PS, the meaning of Must Support is specified in terms of Obligation Codes in obligation extensions on the element definition. The obligation codes used to define the minimum obligations of Must Support elements in this implementation guide are reiterated below.

Must Support elements are treated differently between AU PS Consumer and AU PS Producer actors. Must Support on a profile element SHALL be interpreted as follows.

Presentation of Must Support and Obligation in Profiles

All elements with Must Support in AU PS are accompanied by an explicit obligation that identifies the expectations for one or more actors. When rendered in an implementation guide, each profile is presented in different formal views under tabs labelled “Differential Table”, “Key Elements Table”, and “Snapshot Table”. Elements labelled with Must Support and stated obligations in these views are represented by SO as shown below.

Figure 1: Key Elements Table View

Implementers need to refer to the “Key Elements Table” to see the full set of elements that are mandatory or Must Support with obligations, and the full set of terminology requirements. Implementers need to be aware that the full set of constraints (i.e. invariants) are only presented in the “Detailed Descriptions” tab or the raw representation (e.g. XML or JSON) of the profile.

Interpreting Profile Elements Labelled Must Support

The section is provided as additional support in understanding the application of Must Support and Obligations on elements in AU PS. This section does not override the Obligations defined for an actor - implementers are recommended to also read the profile specific implementation guidance for any qualifying requirements placed on the Obligations for a Must Support element.

Profiles defined in this implementation guide flag Must Support on elements (e.g. Patient.name) and sub-elements of a data type (e.g. Patient.name.use). The explanation on how to interpret Must Support for an element does not address rules defined in each profile - which may limit or extend what is allowed for each element.

The sub-elements for each supported element in a profile are defined by a combination of the data type from the core specification and any additional rules included in the profile. A profile may include rules that:

• limit what is considered ‘valid’
• extend the potential sub-elements by including an extension

For example, the profile AU PS Patient limits what is considered valid for the element Patient.name with the invariant “au-core-pat-02: At least one patient name shall have a family name”.

Typically AU PS profiles will inherit extended sub-elements from the base HL7 AU Core profile (which itself is based on an HL7 AU Base profile), e.g. the element Medication.code in profile AU PS Medication is of type CodeableConcept and is extended by inheriting a medicine specific sub-element Medication.code.coding.extension Medication Type extension from the source profile AU Base Medication.

The full set of sub-elements is visible in the “Key Elements Table” or “Snapshot Table” which shows the sub-elements defined in this profile (shown in the “Differential Table”) and the sub-elements inherited from a base profile.

Must Support - Composition Sections

Obligations vary significantly for elements in the AU PS Composition profile, in particular obligations on Composition.section reflect the expectations of The “IPS” and ISO 27269. A summary is provided below:

• AU PS Consumers SHALL consume Compositions if a section is present and containing any valid value, and SHOULD display the content of the section when presenting the data to a human user.
• For all mandatory sections (Composition.section minimum cardinality > 0) AU PS Producers SHALL correctly populate the section if a value is known, SHALL be capable of populating Composition.section.entry with the referenced profiles, and SHOULD correctly populate Composition.section.entry if a value is known.
• For all recommended sections AU PS Producers SHOULD correctly populate the section if a value is known and SHOULD correctly populate Composition.section.entry if a value is known.
• For all optional or undefined sections AU PS Producers MAY correctly populate the section if a value is known and MAY correctly populate Composition.section.entry if a value is known.

See Structure of the Australian Patient Summary (AU PS) for information on the mandatory, recommended, and optional sections.

Must Support - Primitive Elements

Primitive elements are single elements with a primitive value. If a primitive element is labelled as Must Support:

• AU PS Producers SHALL correctly populate the element if a value is known.
• AU PS Consumers SHALL consume resources if the element is present and containing any valid value, and SHOULD display the value of this element (if the SHOULD:display Obligation is defined) when presenting the data to a human user.

For example, the AU PS Organization Profile name element is a primitive string datatype. Therefore, when claiming conformance to this profile:

• AU PS Producers SHALL correctly populate a value in Organization.name if a value is known.
• AU PS Consumers SHALL consume the Organization resource if Organization.name is present and containing any valid value, and SHOULD display the value of Organization.name when presenting the data to a human user.

Must Support - Complex Elements

Complex elements are composed of primitive and/or other complex elements. Elements may have additional rules defined in the profile that also apply, e.g. terminology binding, or invariants.

If a complex element is labelled as Must Support:

• AU PS Producers SHALL correctly populate the element with at least one of the sub-element values if the value is known.
• AU PS Consumers SHALL consume resources if the element is present and containing any valid sub-element, and SHOULD display the value of this element (if the SHOULD:display Obligation is defined) when presenting the data to a human user.

For example, the AU PS AllergyIntolerance Profile note element is labelled Must Support and has no Must Support sub-elements. When claiming conformance to this profile:

• AU PS Producers SHALL correctly populate a value in any valid AllergyIntolerance.note sub-element if a value is known e.g. AllergyIntolerance.note.text.
• AU PS Consumers SHALL consume the AllergyIntolerance resource if AllergyIntolerance.note is present and containing any valid sub-elements, and SHOULD display the value of AllergyIntolerance.note when presenting the data to a human user.

If a sub-element is labelled as Must Support:

• AU PS Producers SHALL correctly populate the element with all Must Support sub-elements for which a value is known.
• AU PS Consumers SHALL consume resources if Must Support sub-elements are present and containing any valid value, and SHOULD display the value of this element (if the SHOULD:display Obligation is defined) when presenting the data to a human user.

For example, in the AU PS Practitioner Profile, the name element is labelled Must Support and has Must Support sub-elements family and given. When claiming conformance to this profile:

• AU PS Producers SHALL correctly populate a value in Practitioner.name.family and Practitioner.name.given if the value for those sub-elements is known.
• AU PS Consumers SHALL consume a Practitioner resource if Practitioner.name is present and contains valid values in Practitioner.name.family and Practitioner.name.given sub-elements, and SHOULD display the value of at least the sub elementsPractitioner.name.family and Practitioner.name.given when presenting the data to a human user.

Must Support - Resource References

Some elements labelled as Must Support reference multiple resource types or profiles such as Observation.performer. In such cases:

• AU PS Producers SHALL correctly populate the element with at least one referenced resource or allowed profile if the value is known.
• AU PS Consumers SHALL consume resources if the element is present and containing any valid referenced resource or profiles, and SHOULD display the value of this element (if the SHOULD:display Obligation is defined) when presenting the data to a human user.

The table below provides a list of AU PS profile elements that allow multiple referenced resource types or profiles.

Must Support - Choice of Data Types

Some elements labelled as Must Support allow different data types such as Observation.effective[x]. In such cases:

• AU PS Producers SHALL correctly populate the element with at least one data type allowed by the element definition if the value is known.
• AU PS Consumers SHALL consume resources if the element is present and containing any valid data type allowed by the element definition, and SHOULD display the value of this element (if the SHOULD:display Obligation is defined) when presenting the data to a human user.

The table below provides a list of AU PS profile elements that allow multiple data types.

Some data type choices are labelled as Must Support and apply an additional obligation of SHOULD:able-to-populate. In such cases:

• AU PS Producers SHOULD be capable of correctly populating the element with this data type. Typically, this means that an application needs to demonstrate during some conformance testing process that there are some conditions under which it populates the element with a correct value. (i.e. not a data-absent-reason or equivalent.)

The table below provides a list of AU PS profile elements where a data type choice is labelled SHOULD:able-to-populate.

Must Support - Choice of Identifiers

A profile may support one or more than one identifier type and will include the supported identifiers in a profile by slicing the element and placing Must Support on each identifier slice. In such cases:

• AU PS Producers SHALL correctly populate the element with identifiers from at least one supported identifier type where the identifier is known.
• AU PS Consumers SHALL consume resources if the element is present and containing any identifier type allowed by the element definition, and SHOULD display the value of each populated identifier when presenting the data to a human user.

The table below provides a list of AU PS profile elements that allow multiple identifier types.

For example, the profile AU PS Patient requires support for the following choices Patient.identifier defined in AU Base Patient to support Individual Healthcare Identifier (IHI), Medicare Card Number, Department of Veterans’ Affairs (DVA) Number. When claiming conformance to the AU PS Patient Profile:

• AU PS Producers SHALL correctly populate Patient.identifier with an IHI, or Medicare Care Number, or DVA Number, or any combination of them where the identifier is known.
• AU PS Consumers SHALL consume Patient resource if Patient.identifier is present containing any valid value. A valid value may be an IHI, Medicare Care Number, or DVA Number identifier, or may be some other allowed identifier. The AU PS Consumer SHOULD display the value of each populated identifier type (IHI, Medicare Number, DVA Number, or some other identifier) when presenting the data to a human user.

Systems MAY support populating other identifiers, but this is not a requirement of AU PS.

Must Support - Choice of Profile Elements

A resource may support two elements that are used to indicate a reason, e.g. Encounter.reasonCode and Encounter.reasonReference in the profile AU PS Encounter. In such cases:

• AU PS Producers SHALL correctly populate at least one element choice if the value is known.
• AU PS Consumers SHALL consume resources if any element allowed by the profile is present and containing any valid value.

The table below lists the applicable profiles and elements in AU PS.

Must Support - Choice of Terminology

In AU PS, elements that define support for more than one value set only apply to the Coding part of the element and are not intended to prevent systems from supplying only a text value. In such cases:

• AU PS Producers SHALL correctly populate the element with concepts from each supported value set where the applicable concept is known.
• AU PS Consumers SHALL consume the resource if the element is present and containing any valid value, and SHOULD display the value of this element (if the SHOULD:display Obligation is defined) when presenting the data to a human user.

The table below lists the applicable profiles and elements in AU PS that support multiple value sets.

For example, the profile AU PS Medication requires support for the following terminology choices Medication.code.coding defined in AU Base Medication to support Australian Medication and PBS Item Codes as indicated by flagging Must Support on those two terminology slices.

When claiming conformance to the AU PS Medication profile:

• AU PS Producers SHALL correctly populate Medication.code.coding with either a code from Australian Medication or PBS Item Codes, or both, if a coded value is known. AU PS Producers MAY populate with only text if no coded value is known.
• AU PS Consumers SHALL consume a Medication resource if Medication.code.coding is present and containing any valid value. A valid value may be text, or may be a code from Australian Medication or PBS Item Codes, or both, or some other code. AU PS Consumers SHOULD display the value of this element (if the SHOULD:display Obligation is defined) when presenting the data to a human user.

Systems MAY populate other code systems but this is not a requirement of AU PS.