One of the difficulties I have in writing regularly in this blog is that I only have so much writing time in a week, and the last few months have been extreme with regard to the consumption of that time. Another problem that I have is that I've had this blog post article rolling around in my head for the past four months but it's just not ready to come out yet. However, another topic that's been rolling around decided to squeeze it's way past.
As you probably know as a from looking at my blog, I'm a standards geek. I've been involved in a number of activities in HL7, IHE and HITSP and at the pace we are going today, I'm getting ready for the looney bin. Over the last three years the pace of standards activity in the US has picked up at such a pace that I'm reminded of a Frank Herbert short story called the "A Matter of Traces". If you don't know the story, it introduces the Beauru of Sabotage in a small part is played by a Herbert character that shows up in a number of his books, including Whipping Star (which I haven't read), and The Dosadi Experiment (which I enjoyed thoroughly).
However tempting being a Saboteur sounds, the current pace of standards development hasn't quite reached the point of needing such an institution, and I instead have another suggestion to address the pacing, equally appalling to some. If you were at the HITSP panel meeting last week, then you already heard John Halamka's brief pep talk about what is to become of ANSI/HITSP when it's contract expires. Clearly there is still a need for an organization like ANSI/HITSP in today's world, and it would be a waste to throw all that organizational knowledge away. It seems likely that there will be a request for continuation of these activities that the government will have to send out for bid at the expiration of HITSP's contact, and that the organizers of HITSP would be well placed to go for another round.
I agree that we need to retain HITSP, but my current thought is how to deal with it in a new structure that would provide several benefits missing from the current organization. Let me first outline my thoughts, and then discuss some of those benefits.
First of all, I have no complaints about the current holders of the contract, and feel that they are doing a very good job. I'd keep the same crew, but expand the scope a bit. But, how, you ask, does increasting the scope of HITSP reduce the workload that could shortly bring many to burnout. Read on:
The new organization would bring several functions current executed by several SDO, PEO and related organizations under one roof.
* Identifying healthcare standards for national use
* Making harmonization proposals to various SDOs for subequent balloting.
* Representing US interests to international organizations such as ISO, HL7, IHE, IHTSDO, OASIS (and others to detailed to list).
* Promoting the development of US National Standards for healthcare that could be passed on to international SDOs for balloting
* Maintaining US Realm Vocabularies and Extensions to international standards and profiles
* Providing educational material
* Supports Certification efforts through the creation of testing tools.
This is a fairly tall order, but it could be done. Let's look at how many of these functions are handled today.
1. ANSI/HITSP currently is in the position of identifying healthcare standards for use in the US. There are six technical committees and several others that perform non-technical functions (Education, coordination with other organizations) made up of over 400 people, many of whom are involved in multiple standards efforts. The HITSP Foundations committee is strategic, making long term harmonization proposals. This organization meets quarterly for 4 days (3 days face to face, plus one day for the panel). The committees meet weekly consuming about 2 - 4 hours a week.
2. US National interests to ISO TC215 are currently represented by the US Technical Advisory Group (USTAG) to TC 215. This is an organization that is made up of about 20 key members (I participate but not in any key roles), many of whom participate in several other SDO actitivities. Currently this organization meets about 4 times a year for 1-2 days at a time. Let's have the USTAG functions be subsumed by one committee of this organization.
3. US National interests are not directly represented to HL7 in any coordinated way. An HL7 US Affiliate has yet to be formed to perform that function. The role of an HL7 Affiliate organization is to vote on HL7 standards, and be the keeper of the national realm. Details can be found in the current affiliate agreement. The keeper of the realm establishes the realm vocabulary bindings for the HL7 standards and develops realm specific standards localization. Localization is a process which allows the realm to extend or limit the scope of a current HL7 standard to meet realm specific needs. The current de facto keeper of US realm vocabulary bindings is the ANSI/HITSP Care Management and Health Records TC, which has established bindings for use in HL7 standards used in the US. The current de facto promoter of US realm standards development is HL7 itself, a problem that has been especially noted among HL7 international members. There is no organization that can presently localize HL7 standards for US use.
4. US National interests are not directly represented to IHE. IHE is in the process of forming IHE USA. The role of a National Deployment Committee is described in the IHE Principles of Governance document. You will note that a key function of the national deployment organization is to support testing and deployment activities within that country. For the US, these activities are currently executed by IHE International, and testing is very kindly and ably supported by NIST and members of the IHE Testing and Tools committee. IHE testing tools are currently used and enhanced by NIST to support HITSP interoperability testing. Another function of the National Deployment Committee would be to take responsibility for National Extensions to IHE profiles. The current de facto keeper of national extensions is distributed among various committees in ANSI/HITSP.
5. US National interests are represented to the IHTSDO by the National Library of Medicine. This is all very well and good except that these interests are one step removed from standards developers who need to interact more directly with the IHTSDO.
6. Other vocabulary services are provided and managed in the US by the National Cancer Institute (a division of NIH which also manages NLM).
7. Management of the HL7 US Realm Vocabulary bindings is presently under the management of HL7 International because their is no US realm.
8. Some portions of US national interests in standards are managed by ANSI, which according to their web site: "...oversees the creation, promulgation and use of thousands of norms and guidelines that directly impact businesses in nearly every sector..." and "...is also actively engaged in accrediting programs that assess conformance to standards ..."
9. Testing tool developement is currently handled rather ably by NIST for IHE, HITSP and HL7, but could certainly benefit from participation by others.
10. Education is provided by the various SDO and PEO organizations on their work.
As you can see, the workload is rather spread out, in a somewhat disorganized fashion, across a variety of governmental and non-profit organizations. People like me who develop healthcare standards for a living wind up traveling quite a bit (I'm out for more than half this month on three separate trips), and having to coordinate amonst many different organizations.
So, what's the plan? I'm not a business plan sort of person, but I can give a rough napkin sketch of how I'd like to see this problem solved:
1. Some group of non-profits bands together to form a body to accomplish all of these tasks. Current suspects in my mind include organizations like ANSI, HIMSS, HL7, IHE International, RSNA and AHIMA, which all have a stake in this game.
2. They form an organization which has the following arms:
* National Standards Selection and Harmonization
* National Standards Development
* Standards Education and Certification Testing
* Localization of International Standards and Profiles
* Representation of US National interests in healthcare to standards bodies (not just Healthcare standards, because healthcare also needs other standards -- workflow, business process management, IT infrastructure, et cetera)
* Conformance Testing and Tools Development
3. They propose a contract that would involve collaboration with US Federal Healthcare interests (e.g., ONC, NIST, FDA, CDC, VA, DOD, NIH, NCI, NLM, CMS, and HHS) to perform the various functions I described above.
How would we all benefit from this:
1. Administrative functions across numerous organizations would be collapsed, reducing overhead. I would expect an organization like ANSI would play a key role in this area, as they have so ably done for ANSI/HITSP.
2. Coordination and communication among these functions would be vastly improved due their being combined under one organization.
3. Organzations with strong education programs like HL7 and IHE that participate in this effort could extend their expertise in this area. Regional extension centers could take advantage of the reach of these organizations to educate providers on interoperability and standards.
4. Strategic planning could be done in a way that promotes faster development of nationally useful standards and profiles, and would take guidance from the Standards and Policy committees. When strategies are set for these activities independently, it takes a great deal of work of key people to ensure that these strategies are aligned. There have been many tactical failures because of strategic misalignment over the past three years, and more yet to come if we up the pace.
5. The effort and expenses of so many volunteers across so many organizations could be greatly reduced by the increase in coordination and a reduction in necessary travel to work across many of these functions in so many different places.
6. The saved time needed to coordinate across these bodies would be better spent creatively resolving real problems in healthcare, rather than trying to coordinate among disconnected bodies.
How much would this cost? I don't know. I suspect that it would be somewhat in excess of a million dollars a year, but would be less than 2 million a year.
How could this be funded? I believe a substantial portion of this would need to be Federally funded initially. Some of that could be made up through grants by various interested organizations. Some revenues could be retained from fees retained for training and testing activities, but those would likely be break-even or slightly lower than that.
There may be a way to obtain funding by having an annual conference that brings in revenue from outside the membership, but I'm very frankly opposed to having members of this organization pay to travel, spend time to contribute, and then have to pay to participate in the real work. We wouldn't have gotten the participation in HITSP that we did in the last 90 days if there had been a fee to join. If there needs to be a membership fee, it should be very low (e.g., <$100 per person) to make it possible for participation by as broad a stakeholder group as possible. I also believe that the organization should make it possible for students enrolled in accredited programs (medicine or related fields) to participate for free.
There are a lot of details I've missed, and key organizations that I've likely annoyed because I haven't included them in the above list. For these mistakes I apologize in advance. I cannot keep up with it all, and I've only talked about what I know, not what I don't. If I didn't include you, it's not because I don't think you could contribute, I either don't know who you are or how you can, please don't take offense.
I also realize that there's more idealism than realism in this idea. I'd like to see the ideal become real, rather than let reality intrude on my temporary a vision of perfect world. Some day I want to go to my doctor and have him use what we've all worked so hard on. We're so very close.
Any way, if you think this is an interesting idea, don't talk to your local congressman. Instead, speak to the leadership of your SDO, PEO or related organization. We've been pushing a giant boulder uphill from all sides for the last five or so years. I'd like to see us all get behind it from the same direction and crest the top of the hill. If you think the idea stinks, let me know why and let us see if there's a way to make it better.
Time to go back to work, I have two documents to complete before Tuesday...
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