CIMI progress…

Just spreading the news…

The Clinical Information Modelling Initiative met again recently and the minutes are now available from the early but rapidly evolving CIMI wiki site - http://www.cimiwiki.org

Intro from the latest CIMI minutes:

CIMI held its 5th group meeting in San Antonio from January 12 – 14, 2012. Over 35 people attended in person with an additional 5 participants attending via WebEx.

At this meeting, the group:

• Established the criteria for membership and the process for adding members to the CIMI group
• Authorised an interim executive committee
• Determined a tentative schedule of meetings for 2012
• Moved forward with the definition of the modeling framework
• Formalized two task forces to begin the modeling work so that example models can be presented at the next meeting
• Recognized the formation of a Glossary Group (lead to be announced)
• Agreed to plans for utilizing existing tools to rapidly develop and test a candidate reference model and to create a small group of example CIMI models that build on the reference model work

Full Minutes are here

Are we there yet?

No, but we are definitely moving in the right direction… Conversations are happening that were uncommon generally, and downright rare in the US only 18 months ago.

I’ve been rabbiting on for some time about the need for a ‘universal health record – an application-independent core of shared and standardised health information into which a variety of ‘enlightened’ applications can ‘plug & play’; thus breaking down the hold of the proprietary and ‘not invented here’ approach of proprietary clinical applications with which we battle most everywhere today.

So it was pleasing to see Margalit Gur-Arie’s recent blog post on Arguments for a Universal Health Record. While I’m not convinced about the reality a single database (see my comments at the end of Margalit’s post), I wholeheartedly endorse the principle of having a single approach to defining the data – this is a very powerful concept, and one that may well become a pivotal enabler to health IT innovation.

In addition, Kevin Coonan has started blogging in recent days – see his Summary of DCMs regarding principles of Detailed Clinical Models (aka DCMs). Now I know that Kevin’s vision for an implementable HL7 DCM is totally different to the openEHR DCMs (=archetypes) that I work with. But we do agree on the basic principles about the basic attributes of these models that he has outlined in his blog post – it is quite a good summary, please read it.

Now these two bloggers are US-based – and this is significant because in the US there has been a huge emphasis on connecting between systems and exchange of document-based health information up until recent times. I view their postings as indicative of a growing trend toward the realisation that standardisation of clinical content is a necessary component for a successful health IT ecosystem in the (medium-longterm, sooner the better) future.

Note that “Detailed Clinical Models”, is the current buzz phrase for any kind of model that might be standardised and shared but is also used very specifically for the HL7 DCMs currently in the midst of an interminable ballot process and the Australian national program’s DCMs, which are actually openEHR archetypes being used as part of their initial specification process. ”Detailed Clinical Models” is being used in many conversations rather blithely and with many not fully understanding the issues. On one hand it is positively raising awareness of our need to standardise content and on the other hand, it is confusing the issue as there are so many approaches. See my previous post about DCMs – clarifying the confusion.

It is worth flagging that there has been considerable (and I would also venture to say, rather premature) effort put in by a few to formalise principles for DCMs in the draft ISO13972 standard (Quality Requirements and Methodology for Detailed Clinical Models), currently out for ballot. My problem with this ISO work is that the DCM environment is relatively immature – there are many possible candidates with as many different approaches. It is also important to make clear that having multiple DCMs compliant with generic principles outlined in an ISO standard may mean that the quality of our published silos of “DCM made by formalism X” and ”DCM made by formalism Y” models might be of higher quality, but it definitely will not solve our interoperability issues. For that you need a common reference model underpinning the models or, alternatively, a primary reference model with known and validated transformations between clinical model formalisms.

The more recent evolution of the CIMI group is really important in this current environment. It largely shares the principles that Kevin, openEHR and ISO13972 espouse – creation of standardised and shareable clinical content models, bound sensibly to terminology, as the basis for interoperability. These CIMI models will be computable and human readable; they will be based on a single Reference Model (yet to be finalised) and common data types (also yet to be finalised), and utilising the openEHR Archetype Definition Language (ADL) 1.5 as its initial formalism. Transformations of the resulting clinical models to other formalisms will be a priority to make sure that all systems can consume these models in the future. All will be managed in a governed repository and likely under the auspice of some kind of an executive group with expert teams providing practical oversight and management of models and model content.

Watch for news of the CIMI group. It has a influential initial core membership that embraces multiple national eHealth programs and standards bodies, plus all the key players with clinical modelling expertise – bringing all the heavy lifters in the clinical modelling environment into the same room and thrashing out a common approach to semantic interoperability. They met for 3 days recently prior to the HL7 meeting in San Antonio. The intent (and challenge) is to get all of this diverse group singing from the same hymn book! I believe they are about to launch a public website to allow for transparency which has not been easy in these earliest days. I will post it here as soon as it is available.

Maybe the planets are finally aligning…!

I have observed a significant change in the mind sets, conversations and expectations in this clinical modelling environment, over the past 5 years, and especially in the past 18 months. I am encouraged.

And my final 2c worth: in my view, the CIMI experience should inform the ISO DCM draft standard, rather than progressing the draft document based on largely academic assumptions about clinician engagement, repository requirements and model governance – there is so much we still need to learn before we lock it into a standard. I fear that we have put the cart before the horse.

To HIMSS12… or bust!

This blog, and hopefully some others following, will be about my thinking and considerations as I man an exhibition booth at the huge HIMSS12 conference for the first time next month…

Well, we’ve committed. We’re bringing some of the key Ocean offerings all across the ocean to HIMSS12 in Las Vegas next month. If it was just another conference, I wouldn’t be writing about it. But this is a seriously daunting prospect for me. I’ve presented papers, organised workshops, and run conference booths in many places over the years – in Sarajevo, Göteborg, Stockholm, Capetown, Singapore, London, Brisbane, Sydney, Melbourne – but this is sooooooo different!

The equivalent conference here in Australia would gather 600-800 delegates, maybe 40-50 exhibition booths. Most European conferences seem to be a similar size, admittedly these are probably with a more academic emphasis, rather than such a strong commercial bent, which might explain some of the size difference. By comparison, last year’s HIMSS conference had 31,500 attendees and over 1000 exhibition booths – no incorrect zeros here – just mega huge!

I can’t even begin to imagine how one can accommodate so many people in one location. I have never even visited HIMSS before – we are relying heavily on second hand reports. You may start to understand my ‘deer in headlights’ sensation as we plan our first approach to the US market in this way.

Ocean’s profile is much higher elsewhere internationally. Our activity in the London-based openEHR Foundation and our products/consulting skills have a reasonable profile in Australia and throughout much of Europe; and awareness is growing in Brazil as the first major region in South America. In many ways the US is the one of the last places for openEHR to make a significant impression – there are some pockets of understanding, but the limited uptake is clearly an orthogonal approach to the major commercial drivers in the US at present, however we are observing that this is slowly changing… hence our decision to run the gauntlet!

openEHR’s key objective is creation of a shareable, lifelong health record – the concept of an application-independent, multilingual, universal health record. The specification is founded upon the the notion of a health record as a collection of actual health information, in contrast to the common idea that a health record is an application-focused EHR or EMR. In the openEHR environment the emphasis is on the capture, storage, exchange and re-use of application-independent data based on shared definitions of clinical content – the archetypes and templates, bound to terminology. In openEHR we call them archetypes; in ISO, similar constructs are referred to as DCMs; and, most recently, there are the new models proposed by the CIMI initiative. It’s still all about the data!

So, we’re planning to showcase two products that have been designed and built to contribute to an openEHR-based health record – the Clinical Knowledge Manager (CKM), as the collective resource for the standardised clinical content, and OceanEHR, which provides the technical and medico-legal foundation for any openEHR-based health record – the EHR repository, health application platform and terminology services. In addition, we’ll be demonstrating Multiprac – an infection control system that uses the openEHR models and is built upon the OceanEHR foundation. So Multiprac is one of the first of a new generation of health record applications which share common clinical content.

This will be interesting experience as neither are probably the sort of product typical attendees will be looking for when visiting the HIMSS exhibition. So therein lies one of our major challenges – how to get in touch with the right market segment… on a budget!

We are seeking to engage with like-minded individuals or organisations who prioritise the health data itself and, in particular, those seeking to use shared and clinically verified definitions of data as a common means to:

• record and exchange health information;
• simplify aggregation of data and comparative analysis; and
• support knowledge-based activities.

These will likely be national health IT programs; jurisdictions; research institutions; secondary users of data; EHR application developers; and of course the clinicians who would like to participate in the archetype development process.

So far I have in my arsenal:

• The usual on-site marketing approach:
  • a booth – 13342
  • company and product-related material on the HIMSS Online Buyers Guide; and
  • marketing material – we have some plans for a simple flyer, with a mildly Australian flavour;
• Leverage our website, of course;
• Developing a Twitter plan for @oceaninfo specifically with activity in my @omowizard account to support it, and anticipating for some support from @openEHR – this will be a new strategy for me;
• And I’m working on development of a vaguely ‘secret weapon’ – well, hopefully my idea will add a little ‘viral’ something to the mix.

So all in all, this will definitely be learning exercise of exponential proportions.

To those of you who have done this before, I’m very keen to receive any insight or advice at this point. What suggestions do you have to assist a small non-US based company with non-mainstream products make an impact at HIMSS?

Clinical Knowledge Repository requirements

I’ve been hearing quite a lot of discussion recently about Clinical Knowledge Repositories and governance. Everyone has different ideas – ranging from sharing models via a simple subversion folder through to a purpose-built application managing governance of combinations of versioned knowledge assets (information models, terminology reference sets, derived artefacts, supporting documentation etc) in various states of publication.

It depends what you want to achieve, I guess. In openEHR it became clear very quickly that we need the latter in order to provide a central resource with governance of cohesive release sets of assets and packages suitable for organisations and vendors to implement.

In our experience it is relatively simple to develop a repository with asset provenance and user management. What is somewhat harder is when you add in processes of collaboration and validation for these knowledge assets – this requires development of review and editorial processes and, ideally, display transparency and accountability on behalf of those managing the knowledge artefacts.

The most difficult scenario reflects meeting the requirements for practical implementation, where governance of configurable groups of various assets is required. In openEHR we have identified the need for cohesive release sets of archetypes, templates and terminology reference sets. This can be very complicated when each of the artefacts are in various states of publication and multiple versions are in use in ‘on the ground’ implementations. Add to this the need for parallel iso-semantic and/or derived models, supporting documents, and derived outputs in various stages of publication and you can see how quickly chaos can take over.

So, what does the Clinical Knowledge Manager do?

1. CKM is an online application based on a digital asset management system to ensure that the models are easily accessed and managed within a strong governance framework.
2. Focus:
   1. Accessible resource – creation of a searchable library or repository of clinical knowledge assets – in practice, a ‘one stop shop’ for EHR clinical content
   2. Collaboration Portal – for community involvement, and to ensure clinical models that are ‘fit for clinical use’
   3. Maintenance and governance of all clinical knowledge and related resources
3. Processes to ensure:
   1. Asset management
      1. uploading, display, and distribution/downloading of all assets
      2. collaborative review of primary* assets  to validate appropriateness for clinical use
         1. content
         2. translation
         3. terminology binding
      3. publication life cycle and versioning of primary assets
      4. primary asset provenance, differential and change log
      5. automatic generation of secondary**/derived assets or, alternatively, upload and versioning when auto generation is not possible
      6. upload of associated***/related assets
      7. development of versioned release sets of primary assets for distribution
      8. identify related assets
      9. quality assessment of primary assets
      10. primary asset comparison/differentials including compatibility with existing data
      11. threaded discussion forum
      12. flexible search functionality
      13. coordinate Editorial activity
      14. share notification of assets to others eg via email, twitter etc
   2. User management
   3. Technical management
   4. Reporting
      1. Assets
      2. Users
      3. Editorial activity support

In current openEHR CKM the assets, as classified above, are:

1. *Primary assets:
   1. Archetypes
   2. Templates
   3. Terminology Reference Set
2. **Secondary assets:
   1. Mindmaps
   2. XML transforms
   3. plus ability to add transforms to many other formalisms, including CDA
3. ***Associated assets:
   1. Design documents
   2. References
   3. Implementation guides
   4. Sample data
   5. Operational templates
   6. plus ability to add others as identified

While CKM is currently openEHR-focused – management of the openEHR artefacts was the original reason for it’s development – with some work the same repository management, collaboration/validation and governance principles and processes, identified above, could be applied for any knowledge asset, including all flavors of detailed clinical models and other clinical knowledge assets being developed by CIMI, or HL7 etc. Yes, CKM is a currently a proprietary product, but only because it was the only way to progress the work at the time – business models can always potentially be changed

It will be interesting to see how thinking progresses in the CIMI group, and others who are going down this path – such as the HL7 templates registry and the OHT proposed Heart project.

We can keep re-inventing the wheel, take the ‘not invented here’ point of view or we can explore models to collaborate and enhance work already done.

Why the buzz about CIMI?

With the recent public statement from the Clinical Information Modelling Initiative (CIMI) my cynical heart feels a little flutter of excitement. Maybe, just maybe, we are on the brink of a significant disruption in eHealth.

Personally I have found that the concept of standardising clinical content to be compelling and hence my choice to become involved in development of archetypes. During my openEHR journey over the past 5 or so years it has been very interesting to watch the changing attitudes internationally – from curiosity and ‘odd one out’  through to “well, maybe there’s something in this after all”.

And now we have the CIMI announcement…

So what has been achieved? What should we celebrate and why?

At worst, we have had a line drawn in the sand: a prominent group of thought leaders in the international health informatics domain have gathered and, through a somewhat feisty process, recognised that a collaborative approach to the development of a single logical clinical content representation (the CIMI core reference model) is a desirable basis for interoperability across formalisms. Despite most of the participants having significant investment and loyalty to their own current methodology and flavor of clinical models, they have cast aside the usual ‘not invented here’ shackle and identified a common approach to an initial modelling formalism from which other models will be derived or developed. Whether any common clinical content models are eventually built or not, naming of ADL 1.5 and the openEHR constraint model as the initial formalism is a significant recognition of the longstanding work of the openEHR Foundation team – the early specifications emerged nearly 20 years ago.

At its idealistic best, it potentially opens up a new chapter for health informatics, one that deviates from the relatively safe path of incremental innovation that we have followed for so many years – the reliance on messages/documents/hubs to enable us to exchange health information. There is an opportunity to take a divergent path, a potentially transformational innovation, where the focus is on the data itself, and the message/document/EHR becomes more simply just the receptacle or vehicle for the data. It could give us a very real opportunity to store lifelong health information; simplify data exchange (whether by messages or documents), aggregation, querying and analysis; and support knowledge-based activities such as decision support – all because we will (hopefully) have non-proprietary, common, agreed and fully defined models of clinical content and known transformations between each formalism.

Progress during the next few months will be telling. In January 2012, immediately before the next HL7 meeting in San Antonio, the group will gather again to discuss next steps.

There is a very real risk that despite best intentions all of this will fade away to nothing. The list of participating organisations, including high profile standards organisations and national eHealth programs, is a veritable Who’s Who of international health IT royalty, so they will all come with their own (organisational and individual) work experience, existing modelling resources, hope, enthusiasm, cynicism, political agendas, bias and alliances. It could be enough to sink the work of this fledgling group.

But many are battle-weary, having been trudging down this eHealth path for a long time – some now gradually realising that the glacial incremental innovation is not delivering the long-term sustainable answers required for creating 21st Century EHRs as they had once hoped. So maybe this could be the trigger to make CIMI fly!

I think that CIMI is a very bright spark on the health IT horizon. Let’s hope that with the right management and governance it can be agilely nurtured into a major positive force for change. And in the future, when its governance is mature and processes robust, we can integrate CIMI into the formal standards processes.

Best of luck, CIMI. We’re watching!

CIMI – initial public statement

The following public statement has been released by the Clinical Information Modelling Initiative today:

Public release

The Clinical Information Modeling Initiative is an international collaboration that is dedicated to providing a common format for detailed specifications for the representation of health information content so that semantically interoperable information may be created and shared in health records, messages and documents. CIMI has been holding meetings in various locations around the world since July, 2011. All funding and resources for these meetings have been provided by the participants. At its most recent meeting in London, 29 November – 1 December 2011, the group agreed on the following principles and approach.

Principles

1. CIMI specifications will be freely available to all. The initial use cases will focus on the requirements of organisations involved in providing, funding, monitoring or governing healthcare and to providers of healthcare IT and healthcare IT standards as well as to national eHealth programs, professional organisations, health providers and clinical system developers.
2. CIMI is committed to making these specifications available in a number of formats, beginning with the Archetype Definition Language (ADL) from the openEHR Foundation (ISO 13606.2) and the Unified Modeling Language (UML) from the Object Management Group (OMG) with the intent that the users of these specifications can convert them into their local formats.
3. CIMI is committed to transparency in its work product and process.

Approach

• ADL 1.5 will be the initial formalism for representing clinical models in the repository.
• CIMI will use the openEHR constraint model (Archetype Object Model:AOM).
• Modifications will be required and will be delivered by CIMI members on a frequent basis.
• A set of UML stereotypes, XMI specifications and transformations will be concurrently developed using UML 2.0 and OCL as the constraint language.
• A Work Plan for how the AOM and target reference models will be maintained and updated will be developed and approved by the end of January 2012.
•  Lessons learned from the development and implementation of the HL7 Clinical Statement Pattern and HL7 RIM as well as from the Entry models of 13606, openEHR and the SMART (Substitutable Medical Apps, Reusable Technologies) initiative will inform baseline inputs into this process.
• A plan for establishing a repository to maintain these models will continue to be developed by the group at its meeting in January.

Representatives from the following organizations participated in the construction of this statement of principles and plan:

• B2i Healthcare www.B2international.com
• Cambio Healthcare Systems www.cambio.se
• Canada Health Infoway/Inforoute Santé Canada www.infoway-inforoute.ca
• CDISC www.cdisc.org
• Electronic Record Services www.e-recordservices.eu
• EN 13606 Association www.en13606.org  
• GE Healthcare www.gehealthcare.com
• HL7 www.hl7.org
• IHTSDO www.ihtsdo.org
• Intermountain Healthcare www.ihc.com
• JP Systems www.jpsys.com
• Kaiser Permanente www.kp.org
• Mayo Clinic www.mayoclinic.com
• MOH Holdings Singapore www.mohh.com.sg
• National Institutes of Health (USA) www.nih.gov
• NHS Connecting for Health www.connectingforhealth.nhs.uk
• Ocean Informatics www.oceaninformatics.com
• OpenEHR www.openehr.rog
• Results4Care www.results4care.nl
• SMART www.smartplatforms.org
• South Korea Yonsei University www.yonsei.ac.kr/eng
• Tolven www.tolven.org
• Veterans Health Administration (USA) www.va.gov/health

Further Information:

In the future CIMI will provide information publicly on the Internet. For immediate further information, contact Stan Huff (stan.huff@imail.org)

CIMI & beyond…

The Clinical Information Modelling Initiative (#CIMI) is currently meeting in London. It comprises a significant group of healthcare IT stakeholders and was formed some months ago as an initiative by Dr Stan Huff. After a number of face to face meetings and email list exchanges, the intent is that at the end of this 3 day meeting there will be an agreed decision on a common clinical content modelling formalism/methodology for our Electronic Health Records.

For background, from Sam Heard’s email to the openEHR email list on November 2, 2011:

The main topic I want to address is the international initiative to develop a standardised clinical modelling methodology. This has some IHTSDO secretarial support and is led by Dr Stan Huff of Intermountain Healthcare, a former HL7 Chairperson and co-founder of LOINC, who has been advocating a model-based approach for many years. The current approach at Intermountain has been influenced by openEHR and uses a two-level modelling approach. Stan has established a leadership group through trust and reputation, which includes a variety of agencies who have been working in the area and national eHealth programs or major initiatives who are interested in consuming the models. It has grown out of an HL7 Fresh Look initiative and is currently known as the Clinical Information Modelling Initiative (CIMI).

The group has committed to determining a single formalism for clinical modelling and ADL and openEHR are on the list of alternatives which is as follows:

• Archetype Object Model/ADL 1.5 openEHR
• CEN/ISO 13606 AOM ADL 1.4
• UML 2.x + OCL + healthcare extensions
• OWL 2.0 + healthcare profiles and extensions
• MIF 2 + tools HL7 RIM – static model designer

Proponents of the five different approaches have been presenting to members of the group, who have a variety of experience in these matters. Fourteen organisations will cast a vote on the formalism to use including openEHR, Singapore, UK NHS, Results 4 Care, HL7, Canada Infoway, 13606 Association, Tolven, CDISC, GE/Intermountain, US Departments, CDISC, SMArt and Mitre.

At the preliminary vote, held recently on November 20, the two most popular options were openEHR ADL 1.5 and UML.

Today CIMI will vote on a proposal for either ADL 1.5 or UML to be adopted as the initial common formalism for use, and determine a road map for coordinated development of semantically interoperable clinical models into the future. The potential impact of this is huge and exciting. It could be a disruptive change in health IT.

We hold our collective breath!