Bert Verhees, a colleague from the openEHR community made this post recently to the openehr-technical mailing list:
OpenEHR is not a standard, it is a formal specification. http://www.iso.org/iso/home/standards.htm ISO, What is a standard: "A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose."
I’ve grappled with this question many times over the last 20 years. My current thinking is as follows.
The ISO definition is a standards authority’s view on the concept of ‘standard’. The notion of standard meant here is de jure, i.e. ‘of the law’, or official. A de jure standard is something that some authority wants us to use. In some cases its use becomes unavoidable, due to:
- legislation – e.g. requirement for seat belts in cars;
- practicality – e.g. connecting to the power network at 220-240/110 VAC, 50/60 Hz;
- utility – it’s much easier for everyone to use ISO8601, the date/time string standard, than not to use it.
At the end of the day, a de jure standard expresses an aspiration by an authority that some population of potential users must or should use the published standard. But there’s no guarantee that it will be used. What standard actually is used, if any, is a de facto standard. TCP/IP is the prime modern example of a non-de jure standard in networking, even though the comprehensive ISO OSI standards were available. The de facto standard for the need in question may also be a de jure standard – the ISO 8601 example.
The other aspect of de jure standards, as they are in modern reality – documents published for sale, and revised only every 3 years or less frequently – speaks of their near irrelevance for IT and health IT. Much more on that in past posts. The summary of the problem: if doesn’t have a live maintenance crew, issue tracker, and responsive program of new releases and updates, it’s not going to work for IT (and that affects most industries today). One could probably argue similarly for standards in other domains, particularly modern medicine.
In e-health, openEHR is not a de jure standard but is arguably becoming a de facto standard. It’s gaining use on the ground, among vendors, national e-health programmes, academia and open source initiatives like HANDI in the UK. It is regularly compared to de jure standards in published standards reviews. Cherished colleagues won’t like me saying this, but the evidence is that the closest ISO standard – 13606 – isn’t. Related ISO standards like the HL7 RIM are also dead for practical purposes.
In the HL7 space, it is FHIR that is gaining ground, and I hear numerous times (example) that it will probably displace CDA (I think it will in places where unstructured clinical documents are unnatural things to generate, which is the majority of places outside the US hospital-like environments). FHIR will probably become a de facto standard well before it becomes a de jure standard, assuming it gets that far; at that point, its official de jure status will just be rubber stamping reality.
What matters practically is what is used. What’s used is what works. What works is what is worked on, and made to work by an active community (there are other requirements as well of course, relating to the specific nature of the standard).
In my view, top-down (de jure first) standardisation is only valid when public interest, safety and major economic costs are at stake. This is particularly true when determining the standard is an expensive and specialised activity, e.g. vehicle manufacture standards for limiting injury in traffic accidents. For most other situations, there are multiple technical solutions possible, and we should proceed with de facto standardisation, and treat de jure standardisation as a process that rubber stamps particular releases of a de facto standard.
Unfortunately official Standards Development Organisations (ISO, ICU, CCITT etc) appear to have no understanding of this. They still publish documents, not computable artefacts, standards have no maintenance team, no issue reporting capability and no update release strategy.
Even more unfortunately, many government bodies wanting to use standards don’t understand the above, and obsess that only ‘official standards’ can be candidates for use in e-health. This thinking is understandable – it just reflects how they think about standards for car safety or child carer certification. But for ICT and Health ICT standardisation, this attitude is about as close as they can get to signing the death warrant of their programme as they can get without actually cancelling it. In fact it’s probably worse: they’ll spend and lose huge amounts of money and time, and retard other more appropriate developments. Carola Hullin posted in the same thread that the Uruguay e-health programme won’t consider openEHR for this reason. But in Brazil, openEHR is the official choice for shared EHRs.
If government e-health programmes, MoHs, DoHs etc around the world want to make progress, they need to start studying what is used, what works and could be used, and nurture that. They need to facilitate, not legislate. Some of what is used will in fact be de jure standards (HL7v2 messages for example). Much of it won’t be. They need to think about issues like ‘platform’, ‘coherence’, and ‘ecosystem’, not legislating mindless obedience to out of date documents.
The health IT standards of tomorrow will be found in the grass roots, not the tree tops.