Should Health Care Standards be Open Source?

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 Kibbe 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:


<?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”
<!–E2369-05, Standard Specification for the Continuity of Care (CCR)
– Final Version 1.0 (V1.0) November 7, 2005,  ASTM E31.28 CCR
<!–Copyright 2004-2005 ASTM, 100 Barr Harbor Drive, West
Conshohocken, PA 19428-2959. All rights reserved.–>
<xs:element name=”ContinuityOfCareRecord”>


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

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

Alan Viars is President and CEO of VIDENTITY Systems.

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