1. Published Name of the Standard for which request is being made

ICHOM Implementation Guide: Breast Cancer

2. Standards Material/Document

STU

3. Date of Request

May 25, 2023

4. Use Period

5. Reason for extension, timeline, and actions

6. Original Publication Date

7. End date of the current STU period

8. Length of the requested extension

9. Review Process

10. HL7 Work Group making this request and date

Clinical Interoperability Council

10a. Requesting WG Date

May 25, 2023

11. URL of approval minutes

12. HL7 Product Management Group

FHIR Management Group

12a. Management Group Date of Approval

13. URL of approval minutes

14. Is the artifact ready for final publication?

Yes

15. If not ready, please describe remaining steps.

16. Tool name used to produce the machine processable artifacts in the IG

HL7 IG Publisher

17. The name of the “IG artifact” within the context of the above mentioned tool.

ICHOM Breast Cancer PCOM Set

18. Balloted Name of the standard for which request is being made

ICHOM Breast Cancer PCOM Set

19. Requested name for published standard

ICHOM Breast Cancer PCOM Set

20. If CMET, list IDs balloted

21. Project Insight Number

1744

22. Document Realm

Universal

23. Ballot cycle in which the document was successfully balloted

2023-01

25. Affirmative

38

26. Negative

2

27. Abstentions

76

28. Not Returned

19

29. Total in ballot pool

135

30. Date on which final document/standards material was supplied to HQ

31. URL of publication material/ SVN repository

https://build.fhir.org/ig/HL7/fhir-ichom-breast-cancer-ig/

32. Publishing Facilitator

Umanga de Silva

33. Special Publication Instructions

34. URL of ballot reconciliation document

http://www.hl7.org/documentcenter/public/ballots/2023JAN/reconciliation/recon_fhir_ig_ichom_breast_cancer_r1_d1_2023jan.xls

35. Has the Work Group posted its consideration of all comments received in its reconciliation document on the ballot desktop?

Yes

36. Substantive Changes Since Last Ballot?

37. Product Brief Reviewed By

Clinical Interoperability Council Workgroup

38. Date Product Brief Reviewed

May 25, 2023

39. Has the Product Brief changed?

40. Family

FHIR

41. Section

Implementation Guides

42. Topic

Clinical Quality Patient Care

43. Please Describe the Topic

This IG is meant to collect patient-centered outcome measures for Breast Cancer as defined by the International Consortium for Health Outcomes Measurement (ICHOM).

44. Product Type

Implementation Guide

45. Parent standard

FHIR

46. Parent Standard Status

Active

47. Update/replace standard

N/A

48. Common name/search keyword

ICHOM PCOM

49. Description

This Implementation Guide simplifies the efforts of healthcare provider organizations to collect data needed for the ICHOM patient centered outcome measures for breast cancer, by defining a standard representation for that data. The Guide shows how to represent the patient reported outcomes as well as the clinical data captured during the care of the patient being treated for breast cancer. The data set may then be exchanged with systems via FHIR Implementation Guides such as MedMorph or CREDS. It is intended to facilitate collection of "real world data" from clinical encounters with higher uniformity and quality, independent of the provider or HIT vendor. Data structures accurately capturing patient characteristics, disease characteristics, treatments, and outcomes that matter to patients and clinicians would rapidly accelerate progress toward optimal use of as well as the development of new clinical guidelines and processes.

This guide profiles how to represent an ICHOM PCOM for breast cancer, says when the data needs to be collected, and how a healthcare provider organization can use that profiling to automate the collection and formatting of the data.

50. Stakeholders

Clinical and Public Health Laboratories, Quality Reporting Agencies, Standards Development Organizations (SDOs)

51. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems

52. Providers

Local and State Departments of Health Healthcare Institutions (hospitals, long term care, home care, mental health)

53. Benefits

The International Consortium for Health Outcomes Measurement (ICHOM) aims to unlock the potential of value-based healthcare by defining global Patient-Centered Outcome Measure Sets that involve provider observations as well as patient reported outcomes, and that drive adoption, reporting, and benchmarking of these measures worldwide to create better health outcomes for all stakeholders.

To facilitate adoption and implementation of these ICHOM Patient-Centered Outcome Measure Sets in healthcare IT systems requires them to be published in an interoperable, open-standards-based machine-readable form. This will support the semantically-interoperable collection of the required measurements along the patient care pathway, as well as the subsequent outcomes reporting based on these measurements. The ICHOM Breast Cancer FHIR Implementation Guide will enable the representation and exchange of the ICHOM Breast Cancer measurement set, with the international scope of the set enabling global usage, adoption, and implementation in clinical practice through the implementation guide's provision of information on what and when to measure and report outcomes and measures.

54. Implementations/Case Studies

ICHOM, Philips, The Clinician, MY Synergy

55. Development Background

There is a growing need for representing the ICHOM Patient-Centered Outcome Measure Sets through HL7 FHIR APIs for the international community. The clinical elements of the ICHOM Patient-centered Outcomes Measures are already created and accepted as per international clinical research, patient represented and peer-reviewed process and are mapped to standard ontologies, such as SNOMED.

The aim of this IG is to develop and publish the HL7 FHIR representation of the already internationally validated and peer-reviewed ICHOM patient-centered outcome measure set for breast cancer. This will provide the support for interoperability in exchange of data related to the measurement of value-based healthcare as defined by our international community of experts who were gathered to create the set.