IPS Introduction 1

Introduction

The International Patient Summary (IPS) 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 international patient summary is specified as a templated document using HL7 CDA R2. The primary use case is to provide support for cross-border emergency and unplanned care.

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.

Project 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, Sequoia eHealth Exchange), rules and recommendations for vocabularies and value sets (in multilingual settings) and templates for the implementation of international patient summary documents.

The idea of the International Patient Summary has been one of the main results of the 2010 EU/US Memorandum of Understanding through its two operational arms: the European project Trillium Bridge and the Interoperability of EHR work group formed under the ONC Standards and Interoperability Framework (ONC S&I) EU/US eHealth Cooperation Initiative. These initiatives identified the need for common templates and vocabularies for the patient summary.

The Joint Initiative Council (JIC) on SDO Global Health Informatics Standardization has initiated the standard sets project with patient summary as its pilot; and the IPS became one of the main subjects of the new EU / US roadmap , having as declared goal “to enable a standardized international patient summary (IPS) to be in use by 2020”.

The first standardization activity concerning the IPS was initially promoted in April 2014 by ONC within HL7 International. The project was called “INTernational PAtient Summary (INTERPAS)”. In May 2016, the European Commission Granted an Agreement with CEN/ TC 251, recognizing the need to effectively support the leadership and active participation in IPS standardization activities. Thanks to the new boost from the European Commission (EC) and ONC a revision of the HL7 project was started in May 2016, as well as the standardization activities in CEN/TC 251 for the European standards on Patient Summaries. Since the beginning of this new phase, the initiatives were envisaged as a single common IPS project supported by different organizations; where the CEN/TC 251 and the HL7 teams worked together, taking in account the inputs of the JIC Standard Sets initiative on Patient Summary, with the common intent of developing coherent set of standards to support the International Patient Summary concept.

To expedite progress it was also agreed to set up an informal collaboration, promoting a continuous alignment process between the two SDO-specific projects, thanks also to a cross-participation in the project teams. Overlaps have thus been minimized: the CEN/TC 251 activities have been focused on the IPS dataset, formalized by the CEN/TC 251 European standard (EN) "The Patient Summary for Unscheduled, Cross-border Care" (the CEN/TC 251 EN PS in ); the HL7 ones on its implementation based on HL7 CDA R2 - this guide - and hopefully on FHIR (the HL7 IPS IGs in ). The figure shows how the products of these standardization activities are placed in the HL7 SAIF Interoperability Matrix.

Standards in the HL7 SAIF Interoperability Matrix

A formal agreement between HL7 International and CEN/TC 251 has been finally signed in April 2017 in which these organizations established “in order to further the care for citizens across the globe <…> to collaborate on a single, common International Patient Summary (IPS) specification”); and that “the IPS specification shall focus on a minimal and non-exhaustive Patient Summary, which is specialty-agnostic and condition-independent, but still clinically relevant.”.

Scope

As expressed in the introduction, 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.

In this context, minimal and non-exhaustive means that an IPS is not intended to reproduce (the entire) content of an Electronic Health Record (EHR). It covers the so-called SAMPLE history and beyond. SAMPLE “Forefront Emergency Data” is a list of items (see ), the information a physician wants to know when he comes to an emergency situation. This list mentions

• S – Signs/Symptoms
• A – Allergies (emergency medical care relevant allergies like caused by medication, radiocontrast agents),
• M – Medications (current, as recent as possible) and
• P – Past Illnesses such as chronical (still active) like coronary heart disease, renal failure or past (not active) diseases like a former myocardial infarction. Other desired information in case of an emergency focuses on
• L – last meal/oral intake and the
• E – event preceding the accident or emergency situation or leading up to present illness (although both last two items of course cannot be part of a Patient Summary).

Specialty-agnostic means that an IPS is not filtered for a speciality. As an example, allergies are not filtered to the speciality of internal medicine, thus may also include food allergies, if considered to be relevant for, e.g. unplanned care.

Condition-independent means that an IPS is focused on the actual situation (e.g. unplanned care) and not intended to represent the entire patient's medical history.

Furthermore the scope of the IPS is global. Although this is a major challenge, this implementation guide takes various experiences and newer developments into account to address global feasibility.

General Principles for this Specification

With the formal agreement signed on April 2017 HL7 International and CEN/TC 251 expressed their intent to collaborate under the following principles for the IPS.

The IPS Principles

1. 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
2. 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
3. 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
4. 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

Moreover HL7 International and CEN/TC 251 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.

The more relevant consequences of these principles in the template design are:

• The adoption of a meet in the middle approach in the templates’ design to balance the need of maximizing the reuse of existing implemented templates (epSOS, C-CDA CCD; IHE PCC…) and facilitate implementers; with that of optimizing the fitness for purpose within the IPS scope. All this trying to avoid a pure technical exercise of templates harmonization; or, on the other hand, an academic exercise that does not take in account what is already implemented.

The IPS meet-in-the-middle approach

• Cooperate with the HL7 Terminology Authority and the organizations that own the used code systems (e.g. SNOMED International) to make available a set of free value sets that could be globally usable when the IPS would be implemented.
• When global identifiers are not (or not yet) available, as in the case of the medicinal products, enhance the model proposed for that element with relevant identifying and descriptive attributes that could help the global identification of that element.
• Select a set of reference global terminologies, leaving however space for the inclusion of the locally used terminologies.
• Do not choose solutions (e.g. identifiers, terminologies, standards), even promising in the resolution of some of the well-known issues (as the medicinal product identification), that are not yet available for concrete global use. When possible, the IPS has been however already designed in order to be ready when these solutions will be made available for real use (e.g. the IDMP identifiers) or to support since now the parts of those solutions that could be used today.
• Within the scope of the IPS and of the “implementable” principle, attempt to be enough generic in the design of the templates in order that the IPS templates might be hopefully extensible to support new scenarios; or specific specialties or conditions; through templates specialization or adaptation mechanisms.

Structuring Choices

The International Patient Summary is specified as a templated document using HL7 CDA R2. The specification has taken account of how FHIR 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.

To be universally exchangeable, a patient summary must rely on multilingual international reference terminologies. The International Patient Summary defines SNOMED CT as a primary terminology (the meaning of "primary terminology" is explained in a later section) and it is used for the majority of value sets. Other primary terminologies used by this specification are LOINC for observations (e.g., laboratory tests) and document sections, UCUM for units of measure and EDQM for dose forms and routes.

This specification adopts ART-DECOR® as the specification platform for this Implementation Guide and uses the HL7 template exchange format. This tool and format are increasingly used by several regions, including European countries, and have been adopted by the EU eHealth Digital Service Infrastructure (eHDSI) project for the operational deployment of the EU cross-borders patient summary and ePrescription services.

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 guidelines

This guide is one of the products of the International Patient Summary project (see the Project Background section for details). This project relates to other projects and products as:

• The European Commission CEN/TC 251 Grant Agreement “The International Patient Summary Standards Project” (SA/CEN/GROW/EFTA/000/2015-16).
  This project has as one of its goal “to participate in the creation of an International Patient Summary specification, at a global level, and turn this into a European standard, in line with the Guidelines on Minimum/Nonexhaustive Patient Summary Dataset for Electronic Exchange as adopted by the European eHealth Network"
  Under this project two other standard work items have been promoted under CEN/TC 251:
  • The CEN/TC 251 “prEN: The Patient Summary for Unscheduled, Cross-border Care”.
    Its goal is to “formalise the dataset required to share information about the medical background and history of a patient …. It uses the European guidelines (version 2, November 2016) as an official source for the requirements….”
    Even if it is a European standard it is designed to be applicable in a wider global context.
  • The CEN/TC 251 “prTS: The International Patient Summary: Guidance for European Implementation Technical Specification.
    Its goal is to “provide implementation guidance to support the use of the International Patient Summary dataset in a European context”
    This document is focused on the European cross-country services.

The European Commission CEN/TC 251 Grant Agreement

• The European eHealth Network Guideline on the electronic exchange of health data under Cross-Border Directive 2011/24/EU. Release 2.
  This Guideline, together with the general guidelines for the electronic exchange of health data under Cross-Border Directive 2011/24/EU, document the clauses agreed among the European Countries to support the exchange of Patient Summary data for unscheduled care.

The relationships among these standards are shown in the figure included in the section Conformance clause below.

• The HL7 Consolidated CDA (C-CDA) implementation guide was developed and produced through the joint efforts of HL7, two Sub-Work Groups of the Office of the National Coordinator (ONC) Standards and Interoperability (S&I) Framework — Longitudinal Care Plan (LCP) and Long-Term Post-Acute Care (LTPAC) Transition) — and through the SMART C-CDA Collaborative hosted by ONC and Harvard Medical School. It provides a library of CDA templates for implementing a set of CDA documents.
  This is one of the primary sources for this Implementation Guide.
• The IHE Patient Care Coordination (PCC) Cross-Enterprise Sharing of Medical Summaries (XDS-MS) – “defines a mechanisms to automate the sharing process between care providers of Medical Summaries, a class of clinical documents that contain the most relevant portions of information about the patient intended for a specific provider or a broad range of potential providers in different settings.” .
  This is one of the primary sources for this Implementation Guide.
• eHealth Digital Service Infrastructure (eHDSI) Patient Summary Service. This European initiative operationalizes the work done by the epSOS and EXPAND projects for the implementation of European Cross-border services for the exchange of patient summaries and ePrescriptions. eHDSI specifications are available at https://ec.europa.eu/cefdigital/wiki/display/EHOPERATIONS/Specifications.
  This is one of the primary sources for this Implementation Guide.
• The Data Provenance is an ONC S&I Initiative addressing the “source data” challenge so that trust in the authenticity of the data can help inform decision making. The HL7 CDA® Release 2 Implementation Guide: Data Provenance, Release 1 is one of the products as result of joint efforts of Health Level Seven (HL7), and the Office of the National Coordinator (ONC) Standards and Interoperability Standards and Interoperability Framework-Data Provenance Initiative.

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