International Patient Summary Implementation Guide
2.0.0 - STU 2

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

## Design Conventions

Page standards status: Informative

### Profiling Approach

By design, the IPS dataset is a "minimal and non-exhaustive patient summary dataset, specialty-agnostic, condition-independent, but readily usable by clinicians for the cross-border unscheduled care of a patient".

Two options were therefore available for the IPS profiles:

- constraining the resources to this dataset
- flag the items that have to be supported to comply with the minimal data set, unconstraining all the others.

The second has been finally chosen for the following reasons:

- facilitate the reuse of the IPS profiles in sibling use cases.
- enable a progressive access to additional information beyond the minimal one, if available and relevant for the care provisioning.

### Open Slicing in the IPS

One of the important and useful capabilities of FHIR profiling is slicing, where multiple sets of constraints for a specific use case can be defined for a resource element or a complex element group (slicing can be used with repeating, type choice or non-repeating elements). Most of the slices specified in this guide are open (i.e. `slicing.rules` is not `closed`), which means that it is possible for resource instances with elements that do not match any of the defined slices to still be conformant with the profile as long as they satisfy the remaining profile constraints.

Having this clear is important for correctly understanding the published profiles. For example, the optional section of Social History has open slicing on the entry element allowing for the use of the IPS Tobacco Use profile, the IPS Alcohol Use profile, or any other Observation or DocumentReference. Therefore, while specific IPS profiles are described in this guide, other profiles may also be included as well.

### Narrative and Language Translation

#### Rationale for Narrative Requirements in IPS

When an IPS Composition is generated, the resulting document may be viewed in many different ways (e.g. rendered by a viewer application, converted into a printable document, etc.). The IPS Composition includes a requirement for each section to have human-readable narrative text. This includes the 16 clinical sections profiled in the IPS Composition as well as any other section included in the patient summary. This aligns with the principles of FHIR Documents and has importance in the context of cross-border IPS exchange. Specifically:

- The intent of IPS documents is to share a patient’s pertinent health information across borders where different languages may be used. Human-readable narrative renders the document with the provenance of the originating system's language (i.e. before language translation). This rendering provides a source of truth and comparison for any subsequent translation. While the IPS standard allows for language translations to be included, both in coded display and narrative, no expectation can be reliably made by downstream consumers (e.g. another system in cross-border exchange) that local language translations or local codes will be present.

- Support for this requirement is found in international standards. As stated in ISO 27269, IPS documents have the ability for attestation. While IPS documents need not be signed in all cases, the inclusion of human-readable narrative is necessary for attestation and legal authentication since that represents a presented form of the document.

- While the FHIR Narrative guidance specifies that in strictly managed trading systems narrative may be omitted, the IPS is primarily intended for cross-border use, which is not tightly coupled. Human-readable narrative provides a fallback for patient safety when two systems may not be able to process all machine readable content during exchange and when the source system might not be available to the receiver for consultation and clarification. Further, the patient and the receiving provider may be multilingual and able to read both the original language and any translation to the receiving jurisdiction language, supporting meaningful conversations at the point of care.

- While the IPS guide strongly encourages the encoding of patient information using FHIR resources and structured terminology whenever possible, some systems may not be able to encode or consume all relevant information for all patients. Having each section in an IPS document contain human-readable narrative ensures a consistent place where receiving systems will be able to display narrative information generated from the source system.

- The functional requirement of supporting coded translations has been addressed in this guide by extending the CodeableConcept datatype and Coding datatype. In addition, the use of SNOMED as a primary IPS terminology facilitates translation capabilities based on coded data. For other details about the support of narrative translations, please refer to Multi-Language support in FHIR.

The rationale above provides context for why narrative is important in the context of IPS document exchange. Since human-readable content is required in the Composition resource, this IPS guide does not require narrative text for other resources included in an IPS document. If individual resources profiled in this guide are planned for use outside of a document context, implementers can refer to the base FHIR Narrative guidance for perspective on when to include human-readable text on those resources .

#### Narrative Content Guidance

Granular requirements regarding what is considered clinically relevant for inclusion in the narrative of each section are not currently defined in ISO 27269 and are subsequently not defined or enforced in this guide.

> While a globally consistent practice has not been identified, IPS encourages implementers to review emerging best practices and guidelines regarding narrative text that are being implemented in participating nations (e.g., The Netherlands) and discussed in the FHIR Community.

> Ongoing FHIR implementations will influence future guidance, such as the FHIR Clinical Document Implementation Guide, about the content and display of narrative content, which is required in the IPS Composition. We encourage implementers to monitor this topic and provide feedback through HL7 engagement, issue logging and community discussion.

This specification does not dictate the conditions under which narrative is generated and acknowledges the wide range of implementing workflows and systems, some of which may use human manual intervention or automatic generation using resource content to generate the narrative or other means. While no constraints are implemented, early implementers have recommended that IPS documents not duplicate the content contained in `Composition.section.text` (which is required) in the `Composition.text`. This may lead to validation issues with duplicate ids and also excess document size. In addition, implementers may consider the following principles:

- Consumer friendly terms when available and appropriate
- Consistent ordering of tables (and explanation of how ordered when appropriate)
- Inclusion of multiple language narrative (with appropriate tags) when available and appropriate
- Consider information currency in narrative and encourage renderers and viewers to display `meta.lastUpdated` when available and appropriate

Additional perspective on the alignment of IPS to broader guidance around clinical documents in FHIR are included in the Alignment to FHIR Clinical Documents section.

#### Linking Narrative to Discrete FHIR Resources

Since the IPS Composition requires each section to have human-readable narrative text as XHTML, we encourage implementers to reference individual discrete entries in the XHTML using the id attribute and an accompanying "textLink" extension that links this id to the resource. This practice provides value when text from IPS documents becomes translated from the originating system language and also in debugging the presented form of a clinical document from its structured content. Linking narrative content is well established in CDA documents and provides value in other FHIR clinical documents as well.

The following illustrative example shows how this could be accomplished within an IPS `Composition.section`. Note that id attributes within the XHTML example below share the same id of the structured resources for the following example but can be unique when needed. To see a full example with all required elements and structured data, refer to examples included in this guide:

Figure 4: Example of Using textLink extension

> The extension registry that includes the textLink extension shown above has not been officially published as of the current IPS publication. Implementations can proactively adhere to the resolution of JIRA ticket FHIR-43316 , and a reference to the published textLink extension will be incorporated into the next version of this IG.

### Representation of Person Names

This specification requires that any Person Name is represented including at least one of the following components: given, family or text. Although it is recognized that there is not the concept of "family name" in all cultures, when the name of a person is provided it SHOULD be provided as a list of parts, such as given, family, prefix and suffix.

### Relationship to Gender Harmony

This specification includes some extensions from the universal realm Cross-Paradigm Implementation Guide of Gender Harmony. While not required, this guide encourages implementers to adopt patterns from Gender Harmony, which is intended to provide definitive guidance on how to exchange clinical sex and gender affirming information using HL7 models. This guide directly references a set of the Gender Harmony FHIR extensions in the IPS Patient profile. The Sex Parameter for Clinical Use extension may be used in any IPS resource. While not directly referenced in IPS profiles, implementers are encouraged to review and consider this extension for use as appropriate.

### Medication Lists in the IPS

Medication lists may vary significantly depending on the context of use (e.g. support for prescription, dispensing, medication reconciliation, etc.) and the type of information reported (e.g. patient-reported medication, prescribed, dispensed or administered medications, or active or past medications, etc.). This is also true for the medication summary in a Patient Summary. It could be, for instance, a list of "Relevant prescribed medicines whose period of time indicated for the treatment has not yet expired whether it has been dispensed or not" (European guidelines on Patient Summary); a list of actually dispensed medications; or a list of relevant medications for the patient (IHE PCC). Conversely, it could be a complete history including the full patient's prescription and dispensing history and information about intended drug monitoring (HL7 C-CDA).

For the scope of the IPS, it is important to know what medications are being taken by, or have been given to a patient, without necessarily providing all the details about the medication order, supply, administration or monitoring. This information need can be met with either the MedicationStatement or MedicationRequest profiles, both of which are included in this Implementation Guide.

The IPS medication summary is therefore a list of relevant medications, possibly built from either a prescription list or a dispensing list. In fact, in many practical cases data included in a Patient Summary are derived from the list of the medicines prescribed by a general practitioner and recorded in the electronic health record, or extracted from regional/national prescribing and/or dispensing systems.

### Medicinal Product Identification

A general introduction to the problem of cross-jurisdictional identification of medicinal product is provided in the IPS CDA implementation guide

The solution proposed for the FHIR IPS IG is slightly different from that adopted in the CDA IG and follows the current indications of the FHIR community: all the relevant product codes are represented in fact as one of the possible Codings of the product CodeableConcept, rather than being expressed as distinct attributes/resources (which is a possible approach). The same approach is followed for the vaccines.

### Provenance

While not profiled in this guide, Provenance resources may be used throughout to add contextual information to any resource included in the document bundle. In addition, this guide adopts and adapts these principles described in the IPS CDA implementation guide, as follows:

- The IPS document may be constructed by a human or an automated process, regardless of whether the IPS contains some content of both kinds. In all instances, document level authorship information is required.
- Additional provenance information below the document level is optional. The current guide does not rely on any nationally defined Provenance profile.
- Provenance can be used to emphasize patient generated health data from clinician authored data.
- Provenance can be used to distinguish subsets of data in the IPS assembled from different sources.

### Use of Persistent Identifiers in IPS

Business identifiers on resource instances are encouraged in IPS to aid with consumers being able to reconcile and deduplicate information.