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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

Implementation Guide

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Authors and Contributors

Introduction

Purpose

The goal of this Implementation Guide is to identify the required clinical data with associated vocabulary bindings and value sets for patient summary, in the context of specific use cases, and to build an international document and associated templates based on HL7 CDA R2 (or a future CDA release) and potentially the FHIR standards, with value sets to support data elements within those templates. The initial use cases will be the patient summary, providing support for emergency care and unplanned care.

These templates/profiles aim to:

Serve for both cross-jurisdictional (through adaptation/extension for multi-language and realm scenarios, including translation) and national (through localization) patient summaries.
Support emergency care and unplanned care in any country (home and foreign), regardless of language
Define value sets based on international vocabularies that are usable and understandable in any country

The deliverable(s) will address the requirements of an international patient summary:

For the exchange of structured and coded information (section headings, entries)
For administrative data in order to support content commitment, audit/logging/provenance

The Implementation Guide will receive input from the EHR WG regarding the specification of functional requirements on patient summaries.

This includes a compilation of the required clinical data, based on results of multiple previous projects on patient summaries (including but not limited to epSOS, ONC, Trillium Bridge, eHealth Exchange), rules and recommendations for the use and maintenance of associated vocabulary bindings and value sets (in multilingual settings), and templates for the implementation of international patient summary documents.

Therefore this Implementation Guide has its primary focus on provisions for semantic interoperability.

Templates/profiles should take in consideration, where applicable, legal, organizational, security and infrastructure requirements based on experiences of pilot implementations (Trillium Bridge).

The white paper on Comparative Analysis Between HL7 C-CDA R1.1 CCD and epSoS PS v1.4 will inform the development of the harmonized template and associated value sets.

Background

In 2010 a MoU was signed between EU and US to strengthen global cooperation in eHealth/Health. As a result, the ONC S&I “Interoperability of EHR” work group was launched in US in 2013 (http://wiki.siframework.org/EU-US+eHealth+Cooperation+Initiative) and the Trillium Bridge Project (www.trilliumbridge.eu) in Europe to compare the CDA templates specified at that time in Europe (epSOS PS V1.4) and in US (MU – C-CDA CCD v1.1) for Patient Summaries (PSs) and to build a Trans-Atlantic exchange proof of concept. Both initiatives resulted identifying the need for a common template and vocabularies for the Patient Summary, in particular the following recommendation was offered and endorsed by all members of 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.”

Meanwhile

A new version of the EU/US MOU Transatlantic eHealth/health IT Cooperation Roadmap entered consultation in November 2015 , ;
(US) a Shared Nationwide interoperability roadmap was published in November 2015 ;
The Joint Initiative Council (JIC) on SDO Global Health Informatics Standardization, initiated the standard sets project with patient summary as its pilot ;
A maintenance process for the European Patient Summary Guidelines is in progress (expected release on Nov 2016);
The European eHealth Digital Service Infrastructure (project for the operational deployment of the EU cross-borders services) has been launched (2016-2018)
ART-DECOR® and the HL7 DSTU (now STU) template exchange format are being more and more used by European countries, including for the European Patient Summary templates (aka epSOS PS template). ART DECOR is also connected to the IHE

Scope

Ballot Status of the Document

This Implementation Guide is a draft.

Audience

Relationships with other projects and guides

Connection with CEN IPS ?
epSOS/eHDSI; C-CDA; IHE-PCC

Prerequisite Knowledge

How to read this document

Conventions

Contributions

Principles and background

What is a CDA

Templated CDA

Open and Closed Templates

Template versioning

Identifiers

(OID,...)

Terminologies

Focus on Value Sets

How to extend Value Sets

Datatypes used in this guide

Design conventions and principles

How to use terminology (preferred binding)

Notion of "Primary Code"

Usage of translations

Principle on negations and data known absent

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

General implementation guidance

How to populates IDs, where I can get IDs

Standards used

SNOMED-CT, ...

Legend

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

Conformance clause

Different conformance levels (to be explored)

Functional requirements and high-level use cases

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.