Why we don't need more HealthIT Standards Development

I spent a couple of hours yesterday listening to testimony given to the House Subcommittee on Technology and Innovation.  Testifying were Farzad Mostashari, Dr. Charles Romine of NIST, Mark Probst of Intermountain Healthcare, Rebecca Little of Medicity, and Professor Willa Fields, incoming chair of HIMSS.  Brian Ahier summarizes the hearing rather well.

One of the challenges in listening to this hearing for me were comments from Mr. Probst.  His concern is the lack of core, foundational standards, which he believes have yet to be produced.  I've heard this complaint before, and given than I'm deep into standards development, it always concerns me.  It even further concerns me that such a statement could be made when there's been SO much standards work over the last five years, as compared to the five years before that.

Why this is challenging should be clear when you read through what is currently going on after his list of 7 core standards below.  When he fails to point out these activities to lawmakers in his testimony, Mr. Probst fails to educate them on what the industry is doing.  Instead of hearing, "yes we are making progress" as he stated in his testimony, the message that gets communicated is that we haven't done enough.  There is a big difference between not finished, and not started.

I went back over his testimony and his answers to questions, and transcribed several portions of it which don't appear in the written record.  This first part comes from his verbal testimony starting  24'47" in.

Probst: I simply do not believe that the current voluntary approaches to standards definition work.  In my opinion what is needed is a mandate to:

1. Define the set of information system related standards which will be applied to healthcare.
2. Ensure accountability, to appropriately develop the standards and document the standards
3. Set a time frame to define and document the standards, measured in months, not years.
4. Establish a realistic time frame in which the HIT community must adopt a federally supported set of standards, say 10 to 15 years.

I've been working on standards for more than a decade, including some of the "foundational, core standards" of the Internet.  Does XML, XPath, XSLT or DOM2 ring any bells?  These were NOT defined in months, but rather years.  And yes, they were adopted over time, but not nearly so tremendous a timeframe as say a decade or more.  Yes, as Mr. Probst states, "adoption of standards" is hard, but it surely is not something that need take the HIT community so long as 10-15 years.   But we get only months for standards development?  He should come down into the trenches with the rest of us working on these standards.

This next part comes from the subcommittee chair's questions probing on Mr. Probst's remarks.  This discussion starts around 42'15" in the hearing.

Rep Ben Quayle (subcommittee chair): Mr. Probst, I want to get to your testimony, becuase in your testimony you stated that Voluntulary Consensus Built Standards Don't Work in the Healthcare Industry. In previous hearings, we've had NIST here a lot, and one of the main things with NIST, is that it is very consensus driven with the stakeholders, and it has worked very well. Why do you not think that in the healthcare industry, that is the best way to go, and instead come up with a set of standards from a top down approach rather than from a voluntary consensus approach. I just want to get your take on that.

Mark Probst: Well, I think the very fact that we are having this conversation suggests that it hasn't worked.  We've been doing it for a very long time.  That is not to slam HL7 or DICOM or any other groups that have been working on those standards.  There are varying incentives in those groups, the people that form those groups have different rationale for why they want standards, or what standards that they might like.
But again I think the fact that we haven't come to some basic standards like the guage of rail that they did in Australia.  We're dealing with all the discussions around health information exchange and what kind of contraptions we can we put together to move data from one system to another, that loses fidelity and costs time.  I just think that history is a good educator for the future.  And I don't see how we are going to get to standards without some basic direction on some basic core standards.

Quayle: And if we are going to have that direction, how in your estimation do we set those standards so that we can still have the flexibility for technological innovation going forward.  Since that seems to be from past testimony on the consensus building, where we have had some really good innovation, but in the way that you are kind of seeing this and the outlook, how do we leave that flexibility in place so that the innovation can continue to progress.

Probst: What we don't want is standards that suggest everything that we have to do.  But we do need standards, and I listed several of them in my written testimony.  Basic, core, foundational IT standards put in place.  If those are put into place, then innovation happens.Then you have Internet kinds of innovation that can occur, ubiquitously across large groups of people.  That's the gist of my testimony.

Now, let's have a look at those "Basic, Core, Foundational Standards" that he referred to, that we need to work on.  My definition of "foundational" is that which you build upon.

1. Standard terminologies.
2. Detailed clinical models.
3. Standard clinical data query language based on the models and terminology.
4. Standards for security (standard roles and standards for naming of types of protected data).
5. Standard Application Program Interfaces.
6. Standards for expressing clinical decision support algorithms.
7. Patient identifiers.

Are they foundational?  Standards terminologies and patient identifiers certainly meet my definition.  What I find interesting is that he doesn't reference transport at all.  Surely, if you were to continue the analogy to the Internet, there needs to be an "HTTP" over which the "HTML" was carried.  Yes, we have Direct and Exchange.  Perhaps Mr. Probst believes these are good enough. 

We do have standard terminologies for problems (SNOMED CT), labs (LOINC), medications (RxNORM) and medication allergies (RxNORM again), and they have been adopted in Meaningful Use.  Yes, we are missing comprehensive standard terminologies for non-medication allergies, and that clearly needs work.

We don't have standards for patient identifiers in the US.  But standards for patient identifiers do exist.  It's not an issue for standards developers, but rather one for Congress (search for "unique health identifier").  That law is still on the books.

The rest don't fit my definition of foundational.  Even so, much of this is work either already done, or in flight.  And [all too] often, driven by the government agency (ONC) that has a mandate to select the standards.

HL7, ISO and CIMI have been working on Detailed Clinical Models for several years.  The ISO work goes back to 2009 and earlier.  Will a mandate increase the speed in which this work will be completed?  I think not.  Any DCM I have ever seen builds on top of a framework of existing standards including a reference information model (either HL7's RIM, or OpenEHR's Reference Model), and terminology.  Yes, this important work.  But foundational?  This is like saying that RDF, OWL and the Dublin Core are foundational to the Internet.

Standard clinical data query language based on the models and terminology?  We have quite a few of these standards already.  Some use OWL, others GELLO, others AQL (OpenEHR), and HL7 is developing HQMF based on V3 and the RIM.  I've written about HQMF quite a bit as it applies to the ONC Query Health activity.  I agree that this is necessary work.  Will a mandate increase the speed in which it is done?  We are now piloting Query Health after several months of consensus building.  I expect these specifications to be ready for consideration in Stage 3.

On standards for security, e.g., roles and naming types of protected data, I would refer Mr. Probst to the HL7 Role Based Access Control Permission Catalog (circa 2010).  Yes, more work is needed here, but probably more so in the case of PKI deployment.

With regard to standard programming interfaces, perhaps VMR or CTS2 might excite him.  The ONC ABBI project is building a RESTful API to provide patients with access to their health information.  HL7 has also developed FHIR which might meet some of what he is looking for.  I expect the ABBI specifications to be ready for consideration in Stage 3.

Clinical Decision Support languages is something that I've written about before.  Frankly, I'm much happier using the programming language tool that fits the algorithm that needs to be implemented.  Even so, the ONC Health eDecisions project and HL7 are working on this.  I expect the standards to be ready for consideration in Stage 3.

I'm a little tired of hearing that standards aren't moving fast enough, or that we haven't done enough.  Few people in the Health IT industry have the luxury of spending their full time on standards development.  Even I have responsibilities outside of my standards work.  And I know from experience IN OTHER INDUSTRIES, that no other industry moves any faster with respect to the development of standards.  I'll probably get hammered by some of my Health IT colleagues for saying this, but it isn't standards development where the pace needs to increase, but rather in adoption and more importantly, in DEPLOYMENT.  I disagree that HIT Community needs 10 years or more to deploy the standards that we have today.

But to be fair, we also need balance.  HHS needs to realize that in order for there to be innovation, as Rep. Quayle so strongly emphasized, there also needs to be time to innovate with the standards we are adopting.  Without that time, the innovation that HHS and our lawmakers are looking for won't happen until after the Meaningful Use program is over, and that would be a shame.