Recently there has been some chatter on Twitter about health standards and open source, so I thought I would write a little commentary on the topic.

Anyone who knows me well, knows that I am huge fan of Linux and open source.  This is perhaps why I get so frustrated with the US health care industry and its general lack of interoperability.  I could use many standards as an example, however, for this discussion I’m using the ASTM Continuity of Care Record (CCR) as an example.  Now I’m not picking on the CCR. The format is XML (good), and while there is always room for improvement, I think the general structure is reasonable and workable.  I’d also point out that David Kibbie and Steven Waldren, two keep champions for the CCR, have always been nice and helpful any time I’ve asked a question on the list serve. I’m using the CCR as example just because the barrier to access is so low ($100).  Much of the following is summarized from an inquiry I made to the CCR list serve about a year ago.

Why isn’t the CCR Open-Source? Why is there a $100 Fee to Access the Format?

Well those questions can be answered in with a single answer.  CCR is a product of the standards development organization (SDO) ASTM.  It is ASTM’s model to charge for access fees to the standards they create.  I always get the same response every time I ask this question.  I always hear something similar to, “If we don’t charge for membership/access, the how else can we pay for the standard to be developed? …This is the model of the SDO.  Besides, a $100 is such low barrier”.  Agreed.  $100 is a low barrier, but if you look at some of the other SDO generated formats, namely HL7, you will find that the cost is much greater.

My argument is that the $100 really isn’t the point, but it is the lack of access, the lack of “eyeballs” that this situation causes acts as an impediment to health care transformation.  The fact that Jack, the computer science undergraduate, can’t just go download a copy and start building the next big Health 2.0 company should be a real source of concern.  I’d argue that the total openness of protocols such as HTTP, and TCP/IP is one of the key reasons why the Internet itself works and is generally interoperable.  In the words of Linus Trorvalds, “Given enough eyeballs, all bugs are shallow”. More formally “Given a large enough beta-test and co-developer base, almost every problem will be characterized quickly and the fix will be obvious to someone.”  Health care standards need to take the same approach.  It is my belief that a truly open, easy to access format would act as fertilizer in the garden of health transformation.  I’ve been following a thread  by @SusannahFox on e-patients.com talking about Open Access to Publicly funded works. Someone posted a TED talk there of, HTML inventor, Tim Berners Lee talking about the importance of openness in computer systems.  I thought I’d share because he shares my sentiments.

A Schema without a Home (URL)?

Not to get too geeky on my readers, but let us consider the relationship between an XML document at its schema definition (XSD).  A schema definition is used to validate the adherence to the format of an XML document.  As many of you already know it is normal XML/Web Service practice to give the schema itself, the XSD, a URL (web address).  This way all applications and services that rely on the format can have a central place to point to for correctness.

So the CCR standard schema (XSD) would have a URL (e.g. http://www.ccrstandard.com/ccr.xsd)?

If the XSD is published on the web, then CCR validation is open to all applications, developers, doctors and patients on the Internet.  This would allow http://www.ccrstandard.com/ccr.xsd to be the true, formal, point or reference for the standard…warding off one-offs and increasing its overall use and acceptance.  Wouldn’t this make it drop dead simple for anyone to determine if the output of HealthVault, Google Health, or other personal health record (PHR) is indeed compliant with the standard?  My friends this is the way XML and XSD was meant to be used.  Because of the lack of access, fees. we cripple the full power of the technology.  Even if we charged only $1, we still have the same access issues.

For illustration purposes, I’ve created a sample of what the CCR URL header (first few lines of XML in the XSD) would look like:

BEFORE:

<?xml version=”1.0″ encoding=”UTF-8″?>
<xs:schema xmlns=”urn:astm-org:CCR
xmlns:xs=”http://www.w3.org/2001/XMLSchema” xmlns:ccr=”urn:astm-org:CCR
targetNamespace=”urn:astm-org:CCR” elementFormDefault=”qualified”
attributeFormDefault=”unqualified”>
<!–E2369-05, Standard Specification for the Continuity of Care (CCR)
– Final Version 1.0 (V1.0) November 7, 2005,  ASTM E31.28 CCR
Subcommittee–>
<!–Copyright 2004-2005 ASTM, 100 Barr Harbor Drive, West
Conshohocken, PA 19428-2959. All rights reserved.–>
<xs:element name=”ContinuityOfCareRecord”>
<xs:complexType>
<xs:sequence>
.
.
.

AFTER:

<?xml version="1.0" encoding="utf-8" ?>
<xs:schema xmlns:xs="http://www.w3.org/2001/XMLSchema"
targetNamespace="http://www.ccrstandard.com"
xmlns="http://www.ccrstandard.com"
elementFormDefault="qualified">
<!--E2369-05, Standard Specification for the Continuity of Care (CCR)
- Final Version 1.0 (V1.0) November 7, 2005,  ASTM E31.28 CCR
Subcommittee-->
<!--Copyright 2004-2005 ASTM, 100 Barr Harbor Drive, West
Conshohocken, PA 19428-2959. All rights reserved.-->
<xs:element name="ContinuityOfCareRecord">
<xs:complexType>
<xs:sequence>
.
.
.

Should we Consider Fundamental Changes to the Role of the Standards Development Organizations?

Now there is nothing wrong with Standards Development Organizations.  Certainly they need a revenue source just like any other business. Membership fees and fees to access formats are one way to achieve this goal. The real question is, should the health care industry and the US government consider revising the role or at least the accessibility resulting standards?  There are a lot of taxpayer dollars going into the development of many of health care standards.  If it is information about me and my tax payer dollars are paying for the development, if only in part, then shouldn’t I have access to the format?  Sure most people don’t care.  But shouldn’t  someone who does care have the right to access the formats? Even if I wasn’t a computer scientist, I would still like the idea of the formats being open even if I never used it.  Just the fact of knowing it is open gives me, the consumer, a warm and fuzzy feeling.

Could the US government, namely HHS, the newly formed HIT Standards Committee, HITSP, and NIST find another way to support the SDO while ensuring all the resulting work product be open access for everyone?  I truly believe that standards development will accelerate with total openness.  We will only get to a state of interoperability when the standards themselves are in the public domain subject to the scrutiny of the collective open source community.  In the long run, this may bring down the cost of health IT systems and open up the market by bringing in even more vendors.  Depending on who you are, or who you work for, this could be a good or bad thing.  As American citizens however, we need to demand access to the formats and standards that your tax dollars help create.  Its your health.  Its your data.  Its your right.  Write your senators and congressmen!

So world, what do you think?  – Alan