Making the IPS real - ehealth-standards.eu · HL7 IPS project overview •October 2016: Project formally approved by the HL7 TSC •CDA R2 Implementation Guide for the IPS, with an

Making the IPS real

An IPS Workshop

in conjunction with IHE Connectathon, Venice, April 5th 2017

Making the IPS real

Opening and Welcome

Robert Stegwee

Chair of CEN/TC 251

Objectives of the IPS workshop

1. To raise awareness of the IPS project – 2-way: informing the audience and asking for their expertise – To ensure quality implications for IPS implementations are considered

throughout the development process.

2. To identify the constituents of the conformity assessment , – including the requirements and test methods – resulting in the validation of the compliance to the specifications.

3. To connect the various ‘Patient Summary’ focused projects to IHE existing profiles and current projects – What is needed to organize a productive Connectathon for this topic?

International Patient Summary (IPS) Workshop, 5 April 2017,

Agenda

13.30 – 13.45 Opening and Welcome Robert Stegwee 13.45 – 14.00 Envisioning the IPS Stephen Kay 14.00 – 14.10 eStandards and the IPS projects Giorgio Cangioli 14:10 – 14.20 What the IPS development needs from IHE experts Stephen Kay 14.20 – 15.30 Input from IHE vendors for IPS development Karima Bourquard & Vincent van Pelt Relevant developments from IHE projects (14.20 - 14.35 ) Questionnaire a live with the attendees (14.35 - 15.30 ) 15.30 – 15.45 Coffee Break 15.45 - 16.30 Adding value to IPS Stakeholders Panel discussion with specific stakeholder perspectives: (e.g. Hospitals, centres of competence, procurers…) Stephen Kay 16.30 - 16.45 Input for IPS project going forward

Envisioning The IPS

Stephen Kay

CEN IPS Project Team Leader

Envisioning the IPS Project

• What does ‘envisioning’ mean?

• What is the purpose of the IPS Project?

3/16/2017 TC 251 The International Patient Summary 6

conceive anticipate envisage realize visualize conceptualize externalize

grasp imagine materialize objectify view look upon vision

to imagine (something not yet in existence); picture in the mind

to conceive of as a possibility, especially in the future

To realize/objectify a usable and useful international patient summary standard; the product of a project that epitomizes SDO collaboration and cooperation.

The Vision

7

“In order to further the care for citizens across the globe, collaborate on a single, common International Patient Summary (IPS) specification that is readily usable by all clinicians for the (cross-border) unscheduled care of a patient.”

draft, 17th November, 2016. OSLO

CEN IPS project overview

• Started on May 2016

• February 2017 : Launched new Work Items proposals for EN and TS ballot.

prEN: The Patient Summary for Unscheduled, Cross-border Care

prTS: The International Patient Summary: Guidance for European Implementation Technical Specification (TS)

HL7 IPS project overview

• October 2016: Project formally approved by the HL7 TSC

• CDA R2 Implementation Guide for the IPS, with an eye to possible FHIR implementation.

• Plan: Standard for Trial Use ballot September 2017.

• Open template: extensible core specifications

• Challenge: globally usable value sets for the IPS

Envisioning the IPS

• The ‘IPS’ acronym is used to refer to the project team and to the product itself.

• So, why is there a need to envision the International Patient Summary itself? – The concept ‘Patient Summary’ covers a

multiplicity of terms, meanings and implementations that renders the term itself virtually meaningless

– IPS is used to differentiate the PS standardisation activity …


Standardization frames the question…

Patient summaries are pervasive, in use and useful, BUT they can be made much more useful and safer… The focus here is away from the ‘pervasive Patient Summary’ which is currently:

– ill defined with unclear meanings and wide-ranging scope – Ambiguous with many misunderstandings – Confused with the EHR and PHR applications – Unhelpful with combinations of mixed containers and mixed up content – Inconvenient for the clinical process and workflow – Is a pain for interoperable solutions within and between organisations

The ‘pervasive Patient Summary’ is grossly unfocused.

The International Patient Summary (IPS) has to be focused.

The eHealth Network Guidelines


Release 1

Adopted November 2013

‘BASIC’ (essential)

& ‘EXTENDED’

(recommended)

data items

Revised eHN Guidelines


Release 2 had a different structure with a common ‘exchange’

umbrella for the PS and eP applications:

Approved November

2016

The ‘BASIC’ & ‘EXTENDED’

categorization of the dataset was removed.

eHN Guidelines as input to the IPS

• The eHN guidelines provides a valuable starting point – They provide the focus, i.e., the ‘unplanned care, cross-border’

use case is articulated clearly – They provide examples of what a ‘Minimal but non-exhaustive’

dataset would look like, the flexibility permitting usable summaries and extensions.

• However, the definitions and the data elements require further formalisation for a standard specification to be useful. For example; – if we take the eHN guidelines V2 as-is then all the sections/data

elements would be ‘undefined’ or made ‘OPTIONAL’ in the proposed standard. Raises the possibility of empty documents!

– Multiplicities and ‘absent data’ require meaningful specification to avoid error and misunderstandings.


Sections

• Medications [epSOS/eHDSI required] [EU/US roadmap] [AMPLE]

• Allergy [epSOS/eHDSI required] [EU/US roadmap] [AMPLE]

• Problems [epSOS/eHDSI required] [EU/US roadmap]

Required

How do we in the IPS project make decisions about Section optionality? Consider evidence of current use, e.g. from e-safe anaesthesia… Take a rapid focussed history:

Allergies Medication Past medical history Last ate (time of last food or drink) Events (what happened, mechanism of injury)

Sections

• Medications [epSOS/eHDSI required] [EU/US roadmap]

• Allergy [epSOS/eHDSI required] [EU/US roadmap]

• Problems [epSOS/eHDSI required] [EU/US roadmap]

Required

• Immunizations [epSOS/eHDSI optional] [EU/US roadmap]

• Procedures [epSOS/eHDSI required] [EU/US roadmap]

• Devices [epSOS/eHDSI required] [EU/US roadmap]

Suggested

Sections

• Diagnostic Results [epSOS/eHDSI optional]

• Past history of illnesses [epSOS/eHDSI optional]

Optional

• Functional Status (Autonomy/Invalidity) [epSOS/eHDSI optional]

• Plan of care [epSOS/eHDSI optional]

• Social History [epSOS/eHDSI optional]

• Pregnancy (expected day of delivery) [epSOS/eHDSI optional]

• Advance Directive [not in epSOS/eHDSI]

Others

17


...formalises 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….

The dataset is minimal and non-exhaustive <…> specialty-agnostic, condition-independent and usable by all clinicians for the unscheduled care of a person…

…usable as a valuable subset of data items for scheduled care…

This international standard does not cover workflow processes of data entry, data collection, the summarisation act nor subsequent data presentation. ..

prEN: The Patient Summary for Unscheduled, Cross-border Care


prTS: The International Patient Summary: Guidance for European Implementation Technical Specification (TS)

….provides implementation guidance to support the use of the International Patient Summary dataset in a European context….

….It addresses both functional and non-functional requirements for the dataset’s interchange…

...gives selection criteria and provides examples of various transport formats and terminologies shown to be suitable for interchanging the International Patient Summary dataset…

…Compliance, deployment & migration Guidance are also included.

HL7 IPS project overview

• CDA R2 Implementation Guide for the IPS

https://art-decor.org/art-decor/decor-project--hl7ips-

HL7 Progress Status

• 25 conference calls;

• 2 F2F meeting (HL7 WGM San Antonio; Paris 21-13 March 2017)

• Sections selected

• First analysis of the sections accomplished

• First draft specification for allergies, medications, immunization, diagnostic results and problems in ART DECOR others in progress. (revision in progress)

• IG Editing environment (mediaWiki) available

Open process… Ensuring Relevance? <<focus>>

Adding value, getting buy-in by stakeholders throughout the process Synchronising outputs with other initiatives/roadmaps, different time-lines What ‘extensions’ can be considered… are worthwhile? Concise? Which principles and products to include as outputs this time round Jurisdiction considerations, e.g. consent Governance of the IPS e.g. dataset (refinements and additions), maintenance

Maximizing usability? <<filter>> The use and value of interoperability assets Terminologies and bindings Clinical validation of future content Guidance, consistency and education Licensing and costs Conformance criteria, testing Quality… the PS vs the source(s) of data Interactive, updateable, not just immutable ‘viewer’? Proper summarisation rather than ‘simple selection’…

Managing process? <<frame>> Answering the right questions, formalisation and sustainability Agility and responsiveness to change Implementation experiences; incremental enhancement Managing expectations and feedback on quality and outcomes (not just outputs)

… Both CEN/HL7 IPS teams would appreciate your input!

eStandards and the IPS projects

Giorgio Cangioli

CEN IPS & HL7 IPS Project Team member

eStandards eHealth Standards and Profiles in Action for

Europe and Beyond


Deliver a Roadmap for alignment, iterative consolidation, and broad acceptance of eStandards

Participate in EU/US MoU roadmap actions as the International Patient

Summary standard.

eStandards

Enable the use of standards for eHealth deployment

1. Achieving easy interoperability across eHealth applications

2. Accessibility and usability of eHealth standards and specifications

3. Reusing knowledge through tooling for eHealth deployment

4. Achieve consistency across the different phases of eHealth (standards) development and deployment

5. Enlarging the pool of contributors to HIT within an interoperable eHealth ecosystem


The standard and the deployment lifecycles

Requirements / Vision

Design

Development / Procurement

Testing Deployment

Maintenance


The standard and the deployment lifecycles


SDOs

SMEs

…..

CxOs

Architects

Vendors

HCOs

….

Fulfill different expectations Assure consistency across phases

Facilitate Communication

The combination of tools and standard formats


Less Costs

Better Management

Less Ambiguities

Improved Access &

Reuse

Easier Validation

Tools Standards

Computable Formats

What about IPS ?


Compliance / Traceability

International Patient Summary


Requirements Design Implementation

EU Guidelines

CEN prEN

Co

nfo

rman

ce

Pro

du

cts

Templates exchange format; FHIR profiles; IHE Object Checker

ART DECOR®; Forge; IHE Gazelle®;…

HL7 CDA IG

HL7 FHIR IG

How IPS might be used ?

• Compliance with CEN prEN IPS

– The document implements the information elements defined by the CEN IPS prEN

• Different levels of compliance are possible…


The document is conformant with a specification that is compliant with the CEN prEN IPS

It may be non technically interoperable.

How IPS might be used ?

• The HL7 IPS Template is an open template: – It means that it could be extended

• Conformity to the CDA IPS – The document fulfills the rules of this the document-level IPS

template (or of its specialization) [IPS as document]

• Conformity to CDA IPS templates – The document fulfills the rules of one or more IPS templates

(section or entry levels) [IPS as library]

• Adaptation from the CDA IPS template – The document is based on the IPS templates but some rules are

broken.. [IPS as reference] – Conformity cannot be claimed or assessed… but differences

could be limited…


..to conclude…


What the IPS development needs from IHE experts

Stephen Kay

CEN IPS Project Team Leader

Reaching out to IHE

• IHE is part of the Joint Initiative Council (JIC)

• The 3 member steering committee for CEN IPS includes IHE

• The CEN IPS project team has deliberately selected IHE experts

• We could do with some more!

• We are here to ask for your active participation going forward!

• BUT…


Changing Practice?

• It is often [erroneously] believed that SDO’s and PDO’s don’t mix well…

• the former creating the base standards which are then refined, shaped extended and turned into derivative profiles by the latter… (‘johnny come lately’s to a well-oiled process)

• IHE does their profiling well and actually produces stuff that actually works…

• much to the SDO’s annoyance as it implies, perhaps, that their original efforts were too grandiose, too complicated, unworkable or any combination thereof.)

• The feedback-loop from the extensions to the base-standards can be troublesome and sometimes missing.


The Plan going forward

• Involve IHE in the process from the start • Build mechanisms into the IPS that permits ‘clean

profiling’ from the start (i.e. the dataset is minimal but not exhaustive…, condition specific and specialism specific components will be required.)

• Consider conformance criteria, conformance statements, and conformity assessment from the outset to make testing meaningful… what would an IPS Connectathon look like? How do we plan for one?

• Understand how confidence of quality can be engineered from the outset and communicated to our stakeholders.


What opportunity does this

workshop (& the IPS project

more generally) offer?

An opportunity to reach another part of the community as it contributes,

reviews and validates the IPS in a formative, more agile way

An opportunity to present a ‘joined-up’ mutual understanding and

sharing of standards specification and implementation to those who see only a dis-jointed enterprise…

Still complex… but a beautiful harmonious work!

Input from IHE vendors for IPS development

CEN IPS Team members:

Karima Bourquard, IN-SYSTEM

Vincent Van Pelt, NICTIZ

Input from IHE vendors for IPS development

• Relevant developments from IHE projects:

1. IHE profiles

2. Tooling

3. National or regional projects

4. Vendors implementation

5. Questions

1. IHE Profiles • IHE has been developing for several years in the Patient

Care Coordination domain several profiles related to Medical Summaries called Content profiles

• These profiles should be used in a coordinated infrastructure that serves the information sharing needs of the community. The most popular environment is based on IHE XD* /PIX/PDQ profiles

http://ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_TF_Vol1.pdf

http://ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_TF_Vol1.pdf

2. Tooling: Art Decor • Art-Decor:

– Support creation and maintenance of HL7 templates, Value Sets and Data Sets

– MS profiles in progress (all profiles in 2017)

– Used also for deployment projects (see next slides)

– Art Decor is interfacing with Gazelle Object Checker

2. Tooling: Gazelle Object Checker

Validation of XML clinical documents • The tool provides:

– Model based validation using UML class diagram description (CDA guides)

– OCL formal description requirements

• +40 validators are available: – IHE profiles – epSOS – National and regional projects

• Coupled with Art Decor

3. National and regional projects Country/Region Documents Art Decor/ Object Checker/EVS

Client

epSOS Patient Summary ePrescription eDispensation

+/+/+

France Oncology Vaccination Lab report Patient with cardiology deseases

-/-/- (but schematron)

Luxemburg Patient Summary Lab report

+/-/+

Abrumet (Belgium) Referral Summary +/+/+

Arsenal IT (Italy) Lab report -/-/+

EFA (Germany) EPPC ? -?/-/+

Austria Medication Lab report Care report Discharge letter Other

+/-/- but validator

Kela Lab report -/-/+

Sequoia (USA) CCDA +/+/+

4. Vendor Implementation

• Worldwide/ Connectathons – 115 companies implement Content Creator (all profiles) – 126 companies implement Content Consumer

• Last Connectathon in Europe (2016) – 11 companies implement Content Creator (all profiles) – 11 systems implement Content Consumer – 22 profiles

Adding value to IPS Stakeholders Panel discussion

Chair: Stephen Kay

The information the clinician sees in cases of unscheduled care…

Continuity of care

Point of care

unplanned

urgent

unexpected

A window is an opening in an otherwise solid, opaque surface, through which light can pass (and, if not closed or sealed, air and sound).

Different Perspectives…


Panel discussion

Making the IPS real

Input for IPS project going forward

Stephen Kay