This page describes the proposed terms of reference for openEHR International clinical modelling operations and governance.

For further context, a visual indication of how the COP and it’s entities fit within a larger openEHR modelling community infrastructure can be viewed in the following image.

Double click to view the broader context of how the proposed COP fits within the larger openEHR ecosystem.

1 Glossary

In this document, the following specific terms are used:

Term	Definition

Term	Definition
openEHR International Board	Refers to the top board of openEHR International, formally known as the openEHR CIC Board
openEHR Member	A member of openEHR is any individual who is either: a currently subscribed individual or professional member of openEHR OR an employee of a currently subscribed Industry or Organisation Partner of openEHR.
‘The Authority’	International Clinical Modelling Authority (ICMA). The overarching governing body of the openEHR International Clinical Operations Program, including coordination and prioritization for all operational activities across all collaborating entities, other openEHR Program Boards and other stakeholders.
‘The Editorial Committee’	International Modelling Editorial Committee (IMEC) The coordinating body responsible for all day-to-day modelling operations, activities and priorities within openEHR International's library of archetypes, templates, and terminology value sets.
Collaborating entity	An organisational member that operates a clinical modelling program at the national, regional, or domain level and intentionally chooses to align with the modelling program of openEHR International as the international source of truth, where feasible. In addition, it actively contributes models and resources to the expand and enhance the openEHR International model ecosystem.

2 Roles

In this document, specific roles are referenced:

Role	Definition

Role	Definition
Chief Clinical Information Officer (CCIO)	An individual, appointed by the openEHR CIC Board, to oversee the all clinical aspects of openEHR International and lead and coordinate activities of the Authority.
Clinical Knowledge Administrator Lead (CKAL)	An individual, appointed by the openEHR CIC Board, as a CKA to lead and coordinate activities of the Editorial Committee.
International Clinical Knowledge Administrator (iCKA)	An individual appointed by the openEHR CIC Board to oversee the operational aspects of the openEHR International library of clinical artifacts. This individual must possess significant editorial experience, having served as a Senior Editor within the Editorial Committee for over five years, or be recommended as among the most experienced modelling individuals available within a collaborating entity.
Clinical Knowledge Administrator (CKA)	An individual appointed by the governing Board of a Clinical Knowledge Manager (CKM) to oversee the operational aspects of the CKM library of clinical artifacts. CKAs will be appointed for each instance of a CKM. A CKA of a local CKM may also be appointed as an iCKA by the openEHR CIC Board.
Senior Editor	An individual who is appointed by the International Clinical Modelling Authority to operate within the International Modelling Editorial Committee and under the supervision of openEHR International Clinical Knowledge Administrators to: design archetypes, templates and terminology value sets that align with openEHR International Editorial guidelines independently run and manage openEHR clinical artefact reviews to publication participate in the maintenance and governance of the library of openEHR clinical models and related artefacts mentor other clinical modelers to further grow openEHR modelling capacity. This individual must possess significant editorial experience, having served as a Editor within the Editorial Committee for over five years or having been a responsible Editor for at least 5 published clinical artefacts, or be recommended as among the most experienced modelling individuals available within a collaborating entity. Senior Editors with appropriate experience may be promoted to the position of iCKA, subject to the consensus agreement of the iCKAs.
Editor	An individual who appointed by the International Modelling Editorial Committee to have the clinical modelling skills and capability to actively participate in the design, publication, maintenance, and governance of openEHR clinical models and related artefacts. Editors with appropriate experience may be promoted to the position of Senior Editor, subject to the agreement of the iCKAs.

3 Introduction

This document constitutes the formal Terms of Reference for the openEHR Clinical Operations Program (COP), as approved by the openEHR International Board and agreed by the openEHR Clinical Program Board (CPB).

The intention of these Terms of Reference is to provide a clear basis for:

Clinical Operations Program (COP)
- Purpose
- Scope of responsibility
- Structure
- Operations
- Deliverables
Relationship with the openEHR International Board
Relationship with the Clinical Program Board
Relationship with other openEHR Program Boards
Professional conduct
Conflict of interest

This document does not seek to define all the working structures, plans or communications specific to the work of the Program.

4 Clinical Operations Program (COP)

4.1 Purpose

The openEHR Clinical Operations Program is responsible for:

establishing openEHR International’s library of clinical models and related artefacts as an internationally available and authoritative source of healthcare data semantics for users of any EHR architecture or interoperability standard, not least the global openEHR community.
managing openEHR International’s library of clinical models and related artefacts, serving as a resource for the global public good within the digital health domain.

4.2 Scope of responsibility

The COP manages the development, maintenance and governance of openEHR International’s archetypes, templates and terminology subsets, including supporting documentation and guidance, relevant to the international setting.

4.3 Structure

Governance and coordination of the Clinical Operations Program (COP) is conducted by two distinct entities:

International Clinical Modelling Authority (the ‘Authority’)
International Modelling Editorial Committee (the ‘Editorial Committee’)

The Authority will be responsible for achieving the deliverables of the COP as a whole and will oversee the Editorial Committee's management of daily operations. It is designed to be scaleable and to be able to grow and adapt as collaborating entities are request to participate in the openEHR International COP.

Clinical Operations Program structure

These entities will support and guide all openEHR international-focused clinical modelling activity that will occur at grass roots level, including those in Projects and Incubators within tools such as the openEHR International Clinical Knowledge Manager, or equivalent.

4.4 Deliverables

The COP as a whole is responsible for:

Delivering a high-quality and coherent set of openEHR clinical artefacts, which will be freely available for the openEHR community, reuse within the modelling programs of collaborating entities, and global public good.
1. Development and execution of a clinical modelling roadmap, as concept-level guidance for the development of new clinical artefacts within the existing clinical ecosystem;
2. Development, documentation and maintenance of methods and methodology related to model development, publication, maintenance and governance;
3. Development, publication, maintenance, and governance of openEHR International’s library of clinical artefacts
4. Quality control and evaluation of the openEHR International library of clinical artefacts
Coordinating clinical modelling requirements, activities, and priorities from:
1. openEHR International activities and projects
2. collaborating entities
3. other Program Boards
4. openEHR stakeholders, including Industry and Organisation partners, and
5. other standards bodies.
A commitment to organically growing global openEHR clinical modelling capability by supporting broad community participation in COP day-to-day activities, through opportunistic mentoring and experiential-based training.

4.4 Operations

4.4.1 International Clinical Modelling Authority (the ‘Authority’)

The Authority is the overarching governing body of the openEHR International Clinical Operations Program, including coordination and prioritization for all operational activities across all collaborating entities, other openEHR Program Boards and other stakeholders.


Participants	Chief Clinical Information Officer for openEHR International (as Chair/Coordinator) All International Clinical Knowledge Administrators (iCKAs) PLUS Nominated Clinical Knowledge Administrators (CKAs) from Collaborating entities.
Initial establishment:	The initial Authority will comprise up to nine participants, including up to three CKAs from each of the following: openEHR International openEHR Norway CKM and Catalonia CKM
Participation	The composition of the Authority will be dynamic and mutually agreed by the participants, ensuring equitable representation from the International CKM and all collaborating entities. This will be facilitated by the CCIO and any disputes escalated to the openEHR CIC Board for resolution. Each individual CKA must consistently demonstrate the capability, capacity, availability, and commitment to collectively take responsibility for the COP. This includes active involvement in planning, prioritizing, and reporting activities, even when these efforts do not directly benefit the collaborating entity they represent. The duration of service by each CKA will be determined by the organisation which they represent. New CKAs may be proposed by the Authority, openEHR International Board or a collaborating entity. Acceptance will require a consensus of the Authority. This role must be undertaken with the full knowledge and support of the CKA's employer, where applicable. An expected minimum engagement of 2-4 hours per month, which may include a mix of real-time meetings or chats and other asynchronous contributions.
Removal	A CKA may be asked to resign by the CCIO, in consultation with their organisation, in the following situations: persistently not meeting expected levels of engagement conflict of interest or ethical issue disruptive or other unprofessional behavior, according to the openEHR Code of Conduct.
Responsibilities:	Overarching responsibility for all aspects of the library of the openEHR International clinical models and related artefacts, including the Editorial Committee operations Design, develop, maintain and govern the principles and patterns that underpin the openEHR International clinical modelling library ecosystem, including consideration of downstream impact in collaborating entity CKMs, or equivalent. Grant final approval for the publication of an artifact following the completion of reviews and recommendation for publication by the Editorial Board. Develop, monitor and evaluate progress on a coherent clinical modelling roadmap that provides proactive insight and perspective for new model development. Determine direction, priorities and resourcing needs, including human resources and funding for the COP operations Communication to the openEHR community about Authority activities on a regular basis. Risk management at ‘all of program’ operations level
Size	Maximum of 12, to keep the size of the group formally responsible for oversight of the day-to-day work to a manageable leadership team. If the total representation from collaborating entities plus International CKAs exceeds this number, this approach will need to be be reviewed by the Authority and escalated to the openEHR CIC Board for resolution, if deemed necessary.
Reporting	Monthly progress report to the CIC Board by CCIO. Regular communication with the openEHR CEO by CCIO re: progress risks and remediation; resourcing requirements; fiscal position; and all other matters of relevance to the delivery of the COP.
Work program	The approach will be dynamic, developed, and adapted by the Authority to respond effectively to the identified requirements, priorities, and available resources within the Editorial Committee.
Community development	Mentor and grow capability of CKAs and Senior Editors by supporting their participation in CKA activities.
Decision-making	Decision-making processes will be developed and documented as they evolve, aligning with the emerging work program.

4.4.2 International Modelling Editorial Committee (the ‘Editorial Committee’)

The Editorial Committee is the coordinating body responsible for all day-to-day modelling operations, activities and priorities within openEHR International's library of archetypes, templates, and terminology value sets. This group will design and manage the archetypes that will comprise the openEHR International CKM and potentially be reused across other collaborating entities.


Participants	CKA Lead (CKAL) for openEHR International, as Chair/Coordinator PLUS CKAs from openEHR International and collaborating entities. Senior Editors from openEHR International and collaborating entities
Initial establishment	CKAL plus all iCKAs.
Participation	The composition of the Editorial Committee will be dynamic and agreed by the Authority, to meet operational skills and requirements as required, including equitable representation from all collaborating entities. This will be facilitated by the CCIO and any disputes escalated to the openEHR CIC Board for resolution. Each individual Senior Editor or CKA must must consistently demonstrate the capability, capacity, availability, and commitment to collectively take responsibility for the operations of the COP. This includes active involvement in planning, prioritizing, and reporting activities, even when these efforts do not directly benefit the collaborating entity they represent. The duration of service by each Senior Editor or CKA will be determined by the organisation which they represent. New Senior Editors may be proposed by the Authority or a collaborating entity. Acceptance will require consensus of the Editorial Committee and agreement by the Authority. This role must be undertaken with the full knowledge and support of the CKA's employer, where applicable. An expected minimum engagement of 2-4 hours per month, which may include a mix of real-time meetings or chats and other asynchronous contributions.
Removal	A Senior Editor or CKA may be asked to resign by the CCIO, in consultation with their organisation, in the following situations: persistently not meeting expected levels of engagement conflict of interest or ethical issue conflicts of interest disruptive or other unprofessional behaviour, according to the openEHR Code of Conduct.
Responsibilities:	Overarching responsibility for all operational aspects of the library of the openEHR International clinical models and related artefacts Apply agreed openEHR design and governance principles and practices to the design, development, publication, maintenance of all governable clinical models and related artefacts. Execute instructions from the Authority regarding modelling principles and priorities. Management of the participating CKM community and the community workspace, including assignment of roles, projects/incubators Communication with the openEHR community about the day-to-day clinical modelling operations. Provide recommendations to the Authority on the principles and modelling patterns to develop and maintain a coherent clinical artifact library Provide regular feedback to the Authority on topics such as progress, resourcing needs, issues and risk management as part of the Editorial Committee’s daily operations.
Size	Maximum of 12, to keep the size of the group formally responsible for oversight of the day-to-day work to a manageable leadership team. If the total representation from collaborating entities plus International Senior Editors exceeds this number, this approach will need to be reviewed by the CCIO and Authority, and escalated to the openEHR CIC Board for resolution, if deemed necessary.
Reporting	Monthly progress report to the CIC Board and the Authority by CKAL. Regular communication with the CCIO by CKAL re: progress; risks and remediation; resource requirements; fiscal position, if relevant; all other matters of relevance to the day-to-day operations of the Editorial Committee.
Work program	The approach will be dynamic, developed, and adapted by the Editorial Committee to respond effectively to the identified requirements, priorities, and available Editorial resources. This may involve development of working groups or special interest groups where there is an identified community of interest and available resources.
Community development	Mentor and grow capability of new clinical modelers and Editors by supporting broad community participation in modelling activities.
Decision-making	Decision-making processes will be developed and documented as they evolve, aligning with the emerging work program.

5 Relationship with the openEHR International Board

The COP operates under the oversight of the openEHR International Board, which delegates responsibility for managing the Clinical Operations Program to the Authority.

The Authority is required to report to the openEHR International Board on a regular basis and must obtain approval for any proposed changes to these Terms of Reference. In matters of unresolved disagreement or misconduct, the openEHR CIC Board is responsible for final decision-making and resolution.

6 Relationship with the openEHR Clinical Program Board (CPB)

The COP will operate independently of the CPB and its Expert Panel.

The relationship between the COP and the Clinical Program Board will need to be further clarified to ensure a discrete separation of operational activities, responsibilities and scope, but will function cooperatively, including supporting each other’s initiatives and engaging in regular reciprocal reporting.

7 Relationship with other openEHR Program Boards

The COP will coordinate and collaborate with the other openEHR International Program Boards, as required, to ensure a unified and collaborative approach to the delivery of the openEHR international’s policies, specifications and products.

8 Professional conduct

All COP members are required to respect the openEHR Code of Conduct.

In order for the COP development and decision-making processes to run efficiently, and to provide an enjoyable experience for participants, contributions should follow the following guidelines:

contributions to discussions and debates should be based on considerations (e.g. technical, clinical) relevant to the matter at hand;
debates (online and face to face) should be conducted in a professional and scientific manner, with a willingness to follow the governance principles stated here, and in cases of dispute, to accept consensus, votes, and the outcome of any arbitration.

In the event of a member's participation causing problems, the matter should be referred to in the first instance to the chair of the relevant COP entity, and if necessary, an extraordinary meeting or meetings called for the purpose of arbitration. Arbitration will proceed at the level of reporting or escalated to the next level higher within the COP hierarchy – to either the Authority and/or the openEHR CEO. If an agreement cannot be reached this way, the matter will be referred to the openEHR International Board.

9 Conflict of Interest

Any potential conflicts of interest must be declared by the individual, and the individual must agree to indicate any such conflict of interest in the discussions and decision-making processes of the COP in which they are involved.

openEHR Clinical

openEHR Clinical Operations Program - Terms of Reference