Thursday, August 3, 2017

Working with Standards Organizations

One of the challenges for any organization when working with standards is that there are so many to choose from.  For many years I had the luxury of being in a position that was nearly entirely devoted to the creation, tracking, management and leadership in standards development.

Participating in standards development is challenging.  Many organizations haven't considered it to be important.  Some simply don't have the resources, or cannot justify them.  However, over the last decade though, we've seen significant advances in Health IT in the use of standards, and in organizational participation and attention. Government mandates have certainly played a part in this, but that's not necessarily a bad think.  In fact, for the most part, this has been a good thing, but there have been a number of problems.

It's hard to get the time, the money and the essential organizational resources and commitments to do all the necessary things. Even was I was focused on developing standards I had a challenge paying attention to everything that MIGHT be important, and to every organization that wanted to play in healthcare.  I mostly restricted my activities to those organizations which had already demonstrated that they had an effective process: HL7 and Integrating the Healthcare Enterprise, and government (ONC) initiated activities like HITSP, the Direct Project, and the Standards and Interoperability Framework.  The latter were (mostly) an adjunct to my already existing IHE and HL7 work, although separately organized and driven by ONC, and to some degree, had a secondary governance process (often different for each project).

When things come in from elsewhere, it becomes more challenging.  Working within an established standards development framework with a well-understood governance is really helpful, because it establishes a baseline and a methodology which you can learn once, and reuse over and over.  But when you have to learn this over and over again, this becomes a problem, because you are basically going through the storming and forming process every time. This is what it was like participating in many S&I Framework processes was like, because each one set its own structure.  Eventually, they came closer together, but it was never quite as "organized" as IHE or HL7.  And even HL7 and IHE insiders know that stuff that happens inside IHE or HL7 still varies depending on where you sit. EHR is different from imaging, is different from Public Health, and so on.

What's the time commitment like?  To participate actively in one of these organizations, you pretty much have to give up 5-10% of your time, or 15-20% to take on a stronger leadership role.  To do that over multiple organizations, it's pretty much impossible for the typical developer to do more than one.

Other activities, such as Argonaut have been quite helpful, at the same time, the fact that they started "outside" of the established bodies and then brought their work into the SDOs was also challenging. It was just one more "place to go" to pay attention.  I'm also not fond of various initiatives that are pony up or be part of an invitation only group to play, as it's just one more place to spend limited influential or financial capital. Some like to complain that HL7 or IHE allow the insiders to have too much influence.  The reality is, that either organization will accept anyone who a) wants to work with them, and b) steps up to a leadership role.  The fastest way to a leadership position is not based on who you know, but on what you can demonstrate you can do.  Some past Ad Hoc winners are just the type of people I'm talking about. You cannot just buy your way in (though some have tried).

In the last decade, I've seen a number of different efforts try to speed up the standards development process.  I've been deeply involved in many of those.  In fact, I participated in one HL7 Standards setting process that went from 0 to done in about 2 months (3 months to award of an Ad Hoc Harley). It went fast because we were refining an existing standard (something IHE does a lot) with some very clear requirements (something we are often missing in the standards development process).  The reality is, there isn't a magic bullet.  When you start with something good, and it is easy (or already well understood) for implementers, you can go fast.  When it's novel, it's still going to take time, and you are going to have to come back and polish the rough edges.  It's that willingness to take on ownership for something that endures past the creation stage where SDOs have even more value. What should happen today if we find we want to advance (heaven forbid) the Direct Standard? Who owns it (ONC effectively, as it was never handed off to an SDO), and who has the people with the right skill set and desire to maintain it (a really good question)?

Over the past 18 months, I've now been in charge of implementing standards, rather than creating them, and I've come to appreciate even more the challenges of implementers.  I don't need for there to be "only one organization", but I've always liked it to be a small set, based on organizations that already have the right people paying attention, and I like it even more now given that I have much less time to spend outside of implementation activities.

FHIR has been a solid, driving force towards integration of standards in Health IT.  IHE, HL7 and others have acknowledged it as a path forward for all.  Even payers are joining in the fray (FHIR could be sounding the death-knell for EDIFACT based standards, now some 30 years old).  The recent SMART on FHIR ballot consolidates yet another issue under the HL7 FHIR banner. Continued collaboration between IHE and HL7 has been pursued by both organizations, as well as members of both organizations.

Could we get to a place where it could be simpler for all?  It is my enduring hope.


P.S.  I'm back (I hope) to posting on a more regular basis, although I was out most of this week due to some bad seafood I ate over the weekend.  I'm still not completely back to full health, but close enough to write a blog post.


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