The International Patient Summary Standards Project *

1. TheInternationalPatientSummary StandardsProject* *Funded by the European Commission

2. Trillium-II – MOCHA meeting for “Digital health policies for Children’s Health” Brussels, 17th September 2018 (updated) Stephen Kay Vice Chair of CEN/TC 251 CEN IPS Project Team Leader

3. Stakeholder Influences TC 251 The International Patient Summary

4. What is the IPS ? It emphasizes the need to provide generic solutions for global application beyond a particular region or country. • International Health record extractcomprising a standardized collection of clinical and contextual information (retrospective, concurrent, prospective) that provides a snapshot in time of a subject of care’s health information and healthcare SOURCE: ISO/TR 12773-1:2009 (en) Business requirements for health summary records — Part 1: Requirements] Patient Summary

5. The IPS Project: the HL7 Int. & CEN/TC 251 agreement (April, 2017) IPS Principles

6. The International Patient Summary(Scope and Principles) Data Set Principles ..but still clinically relevant

7. The International Patient Summary(scope) • Reflects the ideas of ‘summary’ and the need to be concise • It alludes to the existence of a core set of data items that all health care professionals can use;

8. The International Patient Summary(scope) • It recognises that the ideal dataset is not closed, and is likely to be extended, not just in terms of requirement evolution, but also pragmatically in instances of use. • Such data is outside the scope of the IPS standards until review.

9. The International Patient Summary(scope) • It does not imply that all the items in the dataset will be used in every patient summary. • It is a starter set of data to help inform a person’s treatment at the point of care, irrespective of the condition of the patient or of the specialist trying to manage the care.

10. International Patient Summary(Principles) 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 Implementation-independent in that the IPS dataset can be used by eclectic exchange mechanisms

11. International Patient Summary(Principles) • Strive for global accessibility of standards for free • Strive for a core set of globally accessible and broadly usable terminologies   • Do not include local solutions in that are not available in other jurisdictions • Include free text in addition to the structured codes as needed

12. International Patient Summary(Principles) Provide common content that can be extended  for other use cases Be open to emerging solutions for unresolved issues or improvements (e.g. IDMP) Consensus-driven and OPEN

13. International Patient Summary(Principles) • Ensure robust maintenance and update process forthe IPS • Ensure clinical validity of the IPS, meeting requirements regarding • Clinical Workflow • Clinical Documentation • Information Quality

14. The Four IPS Project Deliverables eHN EU PS Guidelines refine CEN/EN 17269 IPS implement Provide guidance for EU CEN/TS 17288 IPS refer refer HL7 IPS FHIR IG HL7 IPS CDA IG

15. What is the first iteration of IPS ? The focus of use for the 1st IPS is unscheduled (cross-border) care ..the data model for the IPS has been constructed to serve this case… …but it also provides a base-line that is usable with scheduled and planned care cases. It was asked whether the first iteration of IPS was able to consider how it might satisfy other scenarios…

16. The IPS Use Case, 4 Scenarios, and the Subject of Care (SoC) • Original Use Case was scoped to address a single, primary scenario, i.e., to exchange a Patient Summary cross-border for unscheduled care (of a visitor). But this was one of four, i.e., • IPS Scenario 1: Cross-Border, Unscheduled care • IPS Scenario 2: Local, Unscheduled care • IPS Scenario 3: Cross-border, Scheduled care • IPS Scenario 4: Local, Scheduled care • SoC (or visitor) was assumed to be an ‘adult’, on business or on holiday TC 251 The International Patient Summary

17. The CEN/TC251 IPS Sections

18. IPS Progressive Approach Today.. FUTURE HIGH ..tight focus: Cross-border, Unscheduled care… Time Resolution …SoC assumed to be adult, on Business/for pleasure… IPS …refining constraints, consider local and scheduled care LARGE Scale TC 251 The International Patient Summary

19. IPS Progressive Approach The IPS Dataset matures… FUTURE HIGH ..increasing detail as required by stakeholder community… IPS Time Resolution … and recognising different capacities and potential gain/pain! IPS LARGE Scale TC 251 The International Patient Summary

20. IPS Progressive Approach • Acceptance & adoption FUTURE HIGH Education and skills Subjects of Care concerns are amplified impacting data description and use of IPS IPS Time Resolution IPS LARGE Scale TC 251 The International Patient Summary

21. IPS Progressive Approach • Allergies: • No known Allergies • Asserter: patient • Problems: • Essential hypertension • Allergies: • No known Allergies • Medications • hydrochlorothiazide 25 mg + triamterene 37.5 mg • Diagnostic Results: • 11/11/2017 Procedure XYZ • Specimen <..> • Performer <…> • Exam1 xxx/xx • InterpretationCode • Exam 2… • Report ID = 123456 • Diagnostic Results: • 11/11/2017 XYZ 999 • Vital Signs: • Average Blood pressure 150/100 • Medical Devices • No known devices • History of Procedures • <…..>

22. IPS Progressive Approach extensions Trillium II IPS Webinar

23. In the context of Child Health… Specifically: Trillium-II – MOCHA meeting for “Digital health policies for Children’s Health” How does the IPS support a Child at the point of care? Particularly, because the epSOS specification and then the eHN PS Guidelines envisage the SoC as being an adult! As does the first iteration of the IPS which builds on the first and formalises the latter!! TC 251 The International Patient Summary

24. IPS and Child Health (1) • MOCHA claims the “child is not a mini-adult” • There is wisdom in this, in the sense that the governance, including legalities, policies and protection) afforded to a child are likely to be more stringent and sensitive. IPS implementations will require to consider this and be aware of any jurisdiction differences. This will impact the IPS guidelines of use. • But • does it require different clinical content within the ‘adult’ IPS? • and if so to what extent does the IPS need to be extended in future iterations? TC 251 The International Patient Summary

25. If the Child is not a ‘mini-adult’ it is also true that the IPS is not a ‘mini-EHR’!

26. IPS and Child Health (2) • Much, if not all of the IPS content in the IPS Sections is broadly appropriate and relevant for all ages in the first iteration, e.g. : • Problems, Allergies, Medication, Results, Addresses and roles (e.g. parent, guardian)… Procedures, Immunizations, medical devices, Care Plan, Past history, Functional status, Pregnancy history and Advance Directives • However, optional, additional area should be considered for the next iteration, including: • Development • Feeding • Schooling/education • Prenatal Birth • Family • Risk • … others? TC 251 The International Patient Summary

27. Extending the IPS Use Case All ages ! Local Needs TC 251 The International Patient Summary

28. EN ISO 13940: 2016 System of Concepts for Continuity of Care TC 251 The International Patient Summary

29. CEN IPS prEN 17269 The Patient Summary for Unscheduled, Cross-border Care ...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. ..

30. CEN IPS DTS 17288 The International Patient Summary: Guidance for European Implementation Technical Specification (TS) • …. provides European implementation guidance for the International Patient Summary (prEN 17269). • … it is also intended to be usable for more localised deployment, <…> as an additional benefit, its components may be reused to improve the interoperability of EHRs through common exchange formats. • ..it addresses: Jurisdictional requirements; • Governance, Privacy and data protection and Conformance. • ..it includes examples of transport formats… • Out of Scope: recommend a particular delivery platform/service/template.

31. IPS as Collaboration Framework CGA methodology (from eStandards) IPS provide a collaboration framework for harmonising and for conformance IPS value operates at the strategic and operational levels of the life cycle IPS Life Cycle (from eStandards) TC 251 The International Patient Summary

33. International Patient Summary