It was with great interest that I read about the the recommendation for a universal exchange language in the recent release of the US report to the President: REALIZING THE FULL POTENTIAL OF HEALTH INFORMATION TECHNOLOGY TO IMPROVE HEALTHCARE FOR AMERICANS: THE PATH FORWARD. I had asked the Direct project about the existence of a national plan for standardising clinical content only recently... It appeared that here was a plan after all.
So, to the report. The approach and benefits proposed started well...
The best way to achieve a national health IT ecosystem is to ensure that all electronic health systems can exchange data in a universal exchange language. The systems themselves could be designed in any manner desired — they could accommodate legacy systems that prevail or new recordkeeping systems and formats. The only requirement would be that the systems be able to send and receive data in the universal exchange language. (p41)
I have previously blogged about a universal health record underpinned by an application independent library of clinical content definitions, so the intent and benefits are well aligned with my preferred approach.
But then alarm bells started to ring....
Because of its multiple advantages, we advocate a universal exchange mechanism for health IT that is based on tagged data elements in an extensible markup language. If there were another equally good solution, it should also be considered; we have collectively been unable to think of one. (p43)
Issue #1: Isn't it more appropriate for step one to identify the need for standardised clinical content as a policy, rather than specify the format up front? Isn't that really the domain of health informatics experts as part of a subsequent work plan? I feel like we've skipped a couple of steps in the decision-making process. And are they really advocating the creation of this metadata-tagged XML from a zero starting point?
Issue #2: The last 9 words of that paragraph, "...we have collectively been unable to think of one." I'm glad that they are still open to equally good solutions being considered as indeed there are many ways that individuals, groups and organisations are exploring how to standardise clinical content definitions as the basis for a universal exchange mechanism.
In ISO TC 215, the International Standards Organisations Technical Committee for Health Informatics, there is a new work item which has been evolving for at least 2 years, although yet to attain committee draft status, known as ISO 13972 - Quality criteria for detailed clinical models. This work item is targeting a new international standard for determining quality criteria about the development of detailed clinical models - all clinical models, pick your flavour! In the world of international standards it has been recognised for years that with the plethora of different approaches to developing clinical models for EHRs, there is a need for some criteria to support quality aspect in their development. This work is being led by modellers from the Netherlands, with experts participating from the Australian, Danish, German, Swedish, US and Canadian standards organisations. Creating clinical content is definitely not a new field of endeavour by the time it enters the international standards arena.
So, I am extremely surprised that this expert PCAST group have not been able to 'collectively think' of an existing alternative.
In my last blog - Clinical Knowledge Governance in a Web 2.0 world – I pointed to a number of approaches to standardised clinical content to support health information exchange.
1. In the US – including, but by no means limited to:
- the HL7 standards organisation - where my UK colleague, Charlie McKay, informs me that there are more than 20 different approaches to clinical content development. Keith Boone (@motorcycle_guy) has posted his response to the PCAST report from a HL7 point of view - The Language of HealthIT;
- Stan Huff's group at Intermountain Health in Utah have had extensive experience in defining standardised clinical content across all of Intermountain's systems – they are leading experts in this domain; and
- I understand Don Mon and his team from AHIMA have also been working in this area.
2. In Europe, and Australia:
- The Australian National eHealth Transition Authority (NEHTA) has just launched a national clinician-led CKM approach to grassroots clinical content standardisation creating NEHTA's Detailed Clinical Models (DCMs).
- The Swedish national eHealth program has been actively working to integrate openEHR archetypes with its' VTIM architecture.
In addition, a few more points...
Firstly, the focus of the PCAST report is still only on data exchange, not on ensuring a sound foundation of a person-centric electronic health record. I'll say it again... get the data right and then the data will be able to be re-used, to multitask, be liquid, flowing to where it needs to be. It will become the solid foundation on which to build lifelong health records, simpler health information exchange, data integration & aggregation, research, reporting and knowledge-based activities. By focusing on exchange alone, then... you'll hopefully be able to exchange well and the rest will be considerably more uncertain.
Secondly, the proposed variant of XML is described as a 'straightforward' and 'superior' solution (p44), and the assumption that it will be scalable, protected by encryption, and that data element access services will be enough to support the health information exchange required. By contrast HL7, ISO/CEN 13606 and openEHR have taken decades to develop and refine underlying reference models to ensure that they have an unambiguous, consistent, secure way to represent personal health information – so you know who created the data, who is the subject of care, what the data means, what are the access rules applicable etc. In the openEHR environment, the specification authors developed Archetype Definition Language (ADL) for the purpose - and now part of the ISO 13606 standard - because the alternatives such as standard XML were not robust enough to represent health information. A 'straightforward' XML approach has a strong possibility of failure without a RM underpinning it.
And finally, there is the area of clinical knowledge governance itself. Health is dynamic, complex and diverse. The work required to represent healthcare as computable clinical content definitions or specifications is huge – don't underestimate the sheer volume of work that will be required. It is not realistic to expect a 'rapid mapping' of existing proprietary data structures into tagged data elements. Who will decide the clinical content in the models? If there are over 7000 clinical vendors in the US, which will be 'the source' or sources? Which are 'correct' or 'authoritative'? What methodology will be used to create the models? What level of granularity for each clinical element? How will they be aggregated together to represent clinical documents or events, and constrained to be useful for the clinical purpose? I have a million more questions...
Once the information models are defined, there will be a need for them to be validated before they can become the basis for a standardised or national clinical content library – suitable for consumers, clinicians, organisations, vendors, researchers and jurisdictions. A requirement will be recognised for life-cycle management and publication of these models, roadmaps for legacy data to migrate towards, and harmonise with, the new national health information 'source of truth', plus ongoing maintenance and governance.
Eric Browne stated in his recent blog, Recasting e-Health in the USA:
The work in Sweden, the UK, Singapore and even Australia, based on openEHR or ISO 13606 archetypes (i.e. implementable renditions of Detailed Clinical Models) is far more advanced and promising than that offered by the PCAST approach.
openEHR, which is my interest, has an approach to defining, agreeing and governing clinical content models for electronic health records, known as archetypes. It has taken more than 18 years to develop the openEHR technical specifications, and the last 10 years to achieve its' current approach and position in terms of clinical modelling. It is gaining traction, albeit with a modest volunteer community, especially now that it has a collaborative portal, known as the Clinical Knowledge Manager, to support sharing or models, reviews of clinical content, translation and terminology binding, and model governance.
Standardising health information definitions for health records or exchange is not a trivial task. Learn from what has already been achieved – all shapes, flavours and doctrines. Whatever you do, don't reinvent the wheel and create yet another universal language!