IPS implementationguide 1

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This document contains: Implementation Guide International Patient Summary (0.10). The text materials belong to category cdaips.

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HL7 International Patient Summary
based on Clinical Document Architecture Release 2

International Patient Summary

Implementation Guide

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Authors and Contributors

Introduction

Responsible: Philip Scott

The international patient summary is a minimal and non-exhaustive patient summary, specialty-agnostic, condition-independent, but readily usable by clinicians for the cross-border unscheduled care of a patient.

Purpose

The goal of this Implementation Guide is to identify the required clinical data, vocabulary and value sets for an international patient summary. The primary use case is to provide support for cross-border emergency and unplanned care.

The international patient summary is specified as a templated document using HL7 CDA R2. The specification has taken account of how FHIR STU3 represents equivalent concepts and in some cases has followed a FHIR style of representation rather than a conventional CDA style. The variations from CDA R2 are explained in the relevant detail sections. The mechanism for negation, unknown data and known absent data does not follow the CDA conventions and is explained here.

This specification aims to support:

• Cross-jurisdictional patient summaries (through adaptation/extension for multi-language and realm scenarios, including translation).
• Emergency and unplanned care in any country, regardless of language.
• Where possible, value sets based on international vocabularies that are usable and understandable in any country.
• Data and metadata for document-level provenance.

The international patient summary defines SNOMED CT as the primary terminology (the meaning of "primary terminology" is discussed further in a later section) for the majority of value sets, but uses LOINC for laboratory tests, UCUM for units of measure and EDQM for dose forms and routes.

Background

This Implementation Guide has drawn upon the results of multiple previous projects on patient summaries (including but not limited to epSOS, ONC, Trillium Bridge, eHealth Exchange), rules and recommendations for vocabularies and value sets (in multilingual settings) and templates for the implementation of international patient summary documents. In particular, the white paper on Comparative Analysis Between HL7 C-CDA R1.1 CCD and epSoS PS v1.4 informed the development of this specification.

In 2010 a MoU was signed between the European Union (EU) and the United States (US) to strengthen global cooperation in eHealth/Health. As a result, the ONC S&I Interoperability of EHR work group was launched in the US in 2013 (http://wiki.siframework.org/EU-US+eHealth+Cooperation+Initiative) and the Trillium Bridge Project (www.trilliumbridge.eu) was initiated in the EU. The aim was to compare the CDA templates then specified in the EU (epSOS PS V1.4) and in the US (MU – C-CDA CCD v1.1) for patient summaries and to build a transatlantic exchange proof of concept. These initiatives identified the need for common templates and vocabularies for the patient summary. The following recommendation was endorsed by the Joint Initiative Council and by the HL7 International Council: “to advance an International Patient Summary (IPS) standard and enable people to access and share their health information for emergency or unplanned care anywhere and as needed. At minimum the IPS should include immunizations, allergies, medications, clinical problems, past operations and implants.” The Joint Initiative Council (JIC) on SDO Global Health Informatics Standardization has initiated the standard sets project with patient summary as its pilot.

The EU eHealth Digital Service Infrastructure (eHDSI) project for the operational deployment of the EU cross-borders services was launched in 2016. ART-DECOR® and the HL7 STU template exchange format are increasingly used by European countries, including for the European patient summary (epSOS) templates, so has been adopted as the specification platform for this Implementation Guide.

Scope

HL7 International and CEN/TC 251 have agreed the following vision and scope for the international patient summary:

Vision: a single, common International Patient Summary (IPS) specification that is readily usable by all clinicians for the (cross-border) unscheduled care of a patient.

Scope: a minimal and non-exhaustive patient summary, which is specialty-agnostic and condition-independent, but still clinically relevant.

The HL7/CEN agreement identified the following principles for the IPS:

A. The standards specification for the IPS will be implementable

• Promote (the evolution and convergence of) existing standards
• Rely on solutions that are already implemented or ready for implementation
• Consider new or additional solutions as they become available

B. The standards specification for the IPS will be applicable for global use

• Strive for global accessibility of standards for free
• Strive for a core set of globally accessible and usable terminologies and value sets
• Include free text in addition to the structured codes as needed
• Do not include local solutions in the core specification that are not available in other jurisdictions

C. The standards specification will be extensible and open to future use cases and solutions

• The IPS provides common content that can be extended and specialized for other use cases, or localized for specific jurisdictional needs
• The IPS is open to emerging solutions for unresolved issues or improvements

D. The standards specifications and their implementation must be sustainable through:

• A robust maintenance and update process for the IPS
• A process to ensure clinical validity of the IPS, meeting:
  • clinical requirements (including workflow)
  • clinical documentation requirements
  • information quality requirements

E. We will manage the expectations of the IPS standards specifications among stakeholders, by

• stipulating the role of the IPS as a foundation for others to extend
• justifying the inclusion of items in the IPS within the limited context of unplanned (cross-border) care.

Ballot Status of the Document

This Implementation Guide is STU with the intention to go normative.

Audience

The audience for this Implementation Guide includes:

Public

• Citizens who want to carry or access their healthcare data for emergency care purposes.

Regulatory

• Policy makers such as healthcare payers or government agencies.
• Healthcare information governance authorities and regulatory bodies.

Clinical

• Healthcare providers that offer unscheduled and emergency care.
• Healthcare providers that populate regional and national patient summaries.

Technical

• Vendors of EHRs unplanned care system, personal health records and mobile health data applications.
• System integrators.
• Organizations that manage regional and national patient summaries.

Relationships with other projects and guides

• CEN/TC 251 IPS
• epSOS/EXPAND/eHDSI
• C-CDA
• IHE-PCC
• Input from the EHR work group about how to define the source(s) of the IPS content, described in the provenance section .

How to read this document

Kai to write a paragraph

Principles and background

Responsible: Kai Heitmann, Giorgio Cangioli

IPS Principles

(here or in the introduction?)

Identifiers

• (OID,...)

Terminologies

• Focus on Value Sets

Design conventions and principles

How to use terminology (preferred binding)

Responsible: Rob Hausam

Notion of "Primary Code"

Responsible: Rob Hausam

Usage of translations

Responsible: Rob Hausam

Principle on negations, data known absent and data unknown

Responsible: Philip Scott, Giorgio Cangioli, Kai Heitmann, Francois Macary

• See Paris slides
• Usage of negations
• The choice for negation it is not that of using negation indicator @negationInd but rely on the terminologies to do this
• @negationInd in CDA has been superseded in V3 later by two other negation indicators: actNegationInd valueNegationInd
• Alignment with FHIR

The representation of “condition/activity unknown” and of “condition/activity known absent”is normalized for the IPS by leveraging the expressiveness of SNOMED CT as opposed to relying on specific mechanisms of the underlying syntactical standard (such as nullFlavor and negationInd for CDA). The main rationale for this choice is to provide one single method to express either the presence or absence of a particular condition (e.g., an allergy) or activity (e.g., an immunization), or the lack of knowledge regarding this kind of condition or activity, resulting in a more robust and easily implementable specification. The other rationale is to have a representation of the clinical content of the patient summary which is less dependent on a particular format or syntax, enabling a more practical path to transforming and exchanging data from one standard format (e.g., CDA R2) to another (e.g., FHIR).

Provenance

Responsible: Philip Scott; Gary Dickinson

Document-level not section level

Cite types: human-curated, assembled, hybrid; responsibility on source system to identify.

Possible future work: IPS functional profile by EHR WG

General implementation guidance

Responsible: Kai Heitmann

How to populates IDs, where I can get IDs

Relevant times for a patient summary

Description of the different status definitions

Authorship

Go here or somewhere else?

Standards used

SNOMED-CT, ...

Legend

Description of formalisms used, symbols, icons, how to read ART-DECOR tables

Conformance clause

Responsible: Steven Chu

Different conformance levels (to be explored)

Functional requirements and high-level use cases

Responsible: NN

• Add a reference to the CEN prEN. (to be analyzed)
• PSS
• Add a reference to the data set included in the html package
• Include in the functional area that no assumption on transport has been made…
• PS comes from one source, and covers different cases.
• Specify, how the provenance could be managed without going into details) to be included in next versions.
• To be further discussed, in any case add a paragraph in which explain the problem and how it might be faced.

Appendix

Responsible: NN

Integrated examples, links to instances

Responsible: Kai Heitmann

Validation artifacts (xsd, schematrons)

Responsible: Kai Heitmann

List of all artifacts used in this guide

Responsible: Autogenerated, assisted by Kai Heitmann

Examples (in progress)

Responsible: NN