Clinical Knowledge Manager Product Description 2012 MAKING HEALTH COMPUTE
Cofounder and major sponsor Member and official submitter for HL7/OMG HSSP RLUS, EIS 'openehr' is a registered trademark of the openehr Foundation. OMG and the Member OMG logo are trademarks or registered trademarks of the Object Management Group, Inc. in the United States and other countries 'SNOMED CT' is a registered trademark of IHTSDO (International Health Terminology Standards Development Organisation) Copyright 2012 Ocean Informatics. All rights reserved. This document is provided for information purposes only, and the contents are subject to change without notice. No fitness for a particular purpose or user is claimed or implied for the products described herein. This document is not subject to or the basis of any warranty. Ocean Informatics disclaims any liability with respect to this document. This document may not be reproduced or distributed without prior written permission of Ocean Informatics. 2
Clinical Knowledge Manager (CKM) The Ocean Clinical Knowledge Manager (CKM) is a new category of solution for online collaborative development, management and publication of clinical content standards. From these, downstream technical artefacts are generated for direct use by developers. CKM implements sophisticated governance workflows and enables busy domain experts to participate asynchronously. Key Functions The Clinical Knowledge Manager (CKM) is an online collaborative e-health knowledge asset management application and repository. It is designed primarily to enable the development of knowledge assets (content models) through various intermediate forms, leading to concrete artefacts that can be disseminated to a mass audience. CKM enables web-based governance, documentation and review of standard specifications for health information in a form independent of the technical (e.g. messaging) standards in use. CKM models typically target health records and reporting, encouraging alignment of clinical data across providers and patients in a wide range of healthcare settings, as well as medical research and public health. Content standards are authored in the form of openehr (ISO 13606-2) archetypes, templates and terminology subsets, and managed online through a defined review and acceptance process to the point of publishing. Reviewers are normally a combination of clinicians, health informatics experts, technical people and vendor representatives. Documentation of Web-based governance Standards-based content models Copyright 2012 Ocean Informatics 3 Clinical Knowledge Manager (CKM)
requirements, discussions and user dashboards are provided. Reviews are open to all, but contributors can be controlled. Larger organisations can use the 'sub-domain' and 'project' functionality to manage distinct workgroups. Downstream artefacts including XML schemas and source code APIs can be generated from the models, providing direct and concrete expressions of the intended standards to industry. Because the models and generated artefacts are self-contained, publishing can occur incrementally basis. The overall effect is a standards factory that transforms the requirements of domain experts (clinicians) into a stream of artefacts directly usable by implementers (vendors). Transformations are managed in the Transform Engine facility. The CKM provides a web service (WS) interface, enabling other systems to query for and obtain artefacts matching any criteria. This facility is typically used by EHR system environments that consume the technical artefacts generated from CKM clinical models. The CKM is built on a scalable commercial digital asset management platform which allows searchable meta-data to be added to each archetype, template or other asset as required by the user. Related documentation can be stored to support the knowledge authoring. All assets are indexed via a clinical content ontology, and can have any amount of meta-data associated with them. CKM is a standards factory Web service for system integration Built on a scalable enterprise platform CKM supports diverse uses. Vendors can use it for management of the content specifications of EHR, CDR, HIE products and applications. Health jurisdictions and national programmes can use it in the development of content standards for national or regional use. For all user situations, CKM replaces time-consuming manual methods and meetings with efficient online facilities. With numerous built-in convenience functions, it greatly simplifies typically error-prone manual operations, including complex workflows. The result is measurable in terms of quality, time-to-delivery, and reduced human resources requirement. Diverse uses Reduce human resources cost Copyright 2012 Ocean Informatics 4 Clinical Knowledge Manager (CKM)
Organising the Work For large organisations / national programmes, the work of creating content standards is often done by specific jurisdictions (e.g. state health authorities) and/or major development projects (e.g. national EHR, etc). Each such organisation/project can be allocated a named sub-domain within CKM. The work of each sub-domain owner organisation is then normally split into major pieces and further organised into CKM projects. A given user can work on any number of projects. Each CKM project within a sub-domain controls a nominated set of assets, and has one or more identified editors who have commit rights to the project assets. The editors also initiate and manage reviews, which are performed on a per-asset basis. Although CKM projects typically concentrate on their own assets, users can see and reference assets from other projects, including from other sub-domains. In controlled conditions, new assets may be committed directly to a project. However, each sub-domain also can have one or more special projects known as incubators, which can be used to receive assets whose quality is unknown and/or at the first stages of development. While in an incubator, assets are not subject to normal lifecycle management controls, and can be more freely managed. A special role known as the Clinical Knowledge Adminstrator (CKA) is able to control all sub-domains and projects, and performs the tasks of adding new sub-domains and projects, and allocating editors to projects. Sub-domains Projects & Editors Incubators Admin user Identification and Versioning All asset types can retain existing identifiers, as well as having a CKM unique identifier. CEN/ISO standard archetype identification (multi-axial identifiers) is supported, as is naming and GUID identification of templates. Relationships such as archetype specialisation (inheritance), slots (compositional relationships), and template inclusion (dependency) are tracked. This enables CKM users to navigate the assets via their relationships. Asset relationships CKM includes version tracking, branch management, and release management of all primary resources. Each resource is in a known lifecycle state at any time, and is advanced through its lifecycle according to the workflow for that type of resource. Multiple alternative drafts can be tracked. Asset Re-use In any development, large or small, the starting point is almost always an existing set of assets. For example, national e-health programmes do not try to create their own set of models completely de novo, rather they obtain a copy of the existing international archetypes from the openehr.org CKM. This provides them with some hundreds of archetypes on which to base new archetypes (often specialisations), and/or for which to provide better replacements. Each working context will re-use other assets in this way, and over time contribute new and/or improved versions of existing assets back to the parent repository. Copyright 2012 Ocean Informatics 5 Clinical Knowledge Manager (CKM)
The Asset Lifecycle For each asset that is created within a Clinical Knowledge Manager, tools exist that support its evolution through a standard lifecycle, from initial creation to publication, and potential obsolescence. Standard lifecycle Browsing and querying the existing resources are among the first tasks in developing new knowledge resources. The ontology on which the repository is based contains a classification which is used to generate the querying interface via the web. Browse and query This allows the user to build ontology-based searches that can find not only primary matches but also related archetypes. The same query semantics are supported when using the web service. Copyright 2012 Ocean Informatics 6 Clinical Knowledge Manager (CKM)
Once the need for a new asset - an archetype, template or terminology subset - has been identified, it is created and uploaded into a project, in draft state. The work of refining the asset to publication quality is done by a review, consisting of one or more review rounds. These are managed by the project editors using email, and the purpose is to gather a set of feedback on which the next set of changes can be made. Reviewers are invited by the editors, although any user may communicate a request within CKM to participate on a review. New reviews are posted in a visible way for others users to see. Reviews & review rounds In each review round, users can comment on each element of the artefact, as well as making global comments; review-specific questions can be created by the editors. When the editors close the round, they check out the asset on a branch (in a similar fashion to a source code control system), and save the changes (typically in stages), as well as posting review feedback explaining the changes. Once all the changes are complete for a review round, the asset will be re-integrated to the trunk, i.e. main line of development for that asset. Branching and merging During the review, the asset is in team review state. When a review successfully completes, the asset will be put into the published state, and published. In addition to managed reviews, any user may independently make comments on any asset, using the open discussion forum for each asset. Discussions Copyright 2012 Ocean Informatics 7 Clinical Knowledge Manager (CKM)
The asset s project group may decide to make changes to an asset based on discussion forum comments. For assets such as archetypes that support multiple languages, CKM enables new translations to be added as normal revisions to the asset. Users can select the language in which to view translated assets. Visualisation and validation of achetypes is aided with tools that show specialisation relationships between archetypes, inheritance semantics within archetypes and the full path structure of archetypes. Release management Releases are declared over specific groups of assets (e.g. a collection of templates, including their constituent sub-templates and archetypes) according to the delivery schedule. Once a release is declared, the set of resources as they were at that point in time are available for later use, e.g. by consumer organisations. Release sets can be nested, enabling the flexible definition of releases, e.g. for different projects, based on common underlying assets groups. Controlled releases of the openehr.org archetype and terminology subset library are always available for inclusion in CKM of an organisation. The openehr archetype library is growing in size and quality all the time due to ongoing submissions by user organisations, and as such offers significant work savings. Language translation Powerful visualisation tools Take advantage of the openehr archetypes Release management of templates and derived products uses specific archetype release configurations, in order to provide a stable base for enterprise-specific template development. Template releases can also be reused across organisations. Copyright 2012 Ocean Informatics 8 Clinical Knowledge Manager (CKM)
Repository Integrity Technical validation of all assets is carried out automatically each time a resource is updated. Archetypes and templates are parsed and validated both individually and with respect to the existing resources. All anomalies found generate detailed warning and error reports. Specialisations, aggregation (including archetype 'slots') and other technical relationships are continuously validated, ensuring the repository is in a valid state at all times. Event-driven or periodic asset revalidation Tracking dependencies among assets is carried out automatically by CKM. Users can determine what assets will be affected by a change in a given asset, such as an archetype, as well as references to and from other assets. Dependency tracking Managing Related Resources Existing enterprise resources such as project documentation, data sets, documents, reports and other meta-data can be incorporated into CKM, and associated with the assets under development. Add meta-data and link existing resources Managing Downstream Transformations Assets managed within CKM can be published in any number of derived formats, including various HTML, XML, PDF and any custom format supported by conversion tools. The transformers are managed in a Transform Engine, which enables uploading of new transforms, including variant versions of existing transforms. Publish in HTML, XML, PDF Publishing can be activated on changes detected in source resources or on a timed basis. Copyright 2012 Ocean Informatics 9 Clinical Knowledge Manager (CKM)
Disseminating Outputs Downstream-generated resources based on Operational Templates (OPTs) are typically the target output in CKM development. These are usually disseminated with a group of related documents, such as release notes, implementation notes and other related material. Intermediate artefacts such as the Operational Template (OPT) and terminology ref-sets are often useful to include. A releasable group of artefacts can be defined as a release set, and made available as a downloadable archive file or other convenient form. This makes releasing to industry as easy as disseminating a URL or zip-file. Disseminate controlled packages with a URL Security and Access Control CKM supports definition of roles based on sub-domains and projects, as well as installation-wide administrator roles. Secure web access (https) can be used to manage web-based user login. Installation Options CKM is available in two forms. The hosted version of CKM is a cloud installation, managed by Ocean on behalf of the customer organisation in a secure, scalable infrastructure. This version is billed according to a customer-chosen plan, based on number of users and managed assets. Hosted Various options, including branding and dedicated internet domain are typically included for national programmes and larger public and commercial organisations. For smaller organisations, flexible volume-based billing is available. The installed version is primarily aimed at government purchasers running national e-health programmes who want CKM on their infrastructure, and licensed on an enterprise basis. Installed Copyright 2012 Ocean Informatics 10 Clinical Knowledge Manager (CKM)