Health Informatics — A Classic Standards Tale

What makes a classic standards story?  Money, politics, dueling committees  — listen, health informatics has it all!

Standards for Electronic Medical Records (EMR, also known as Electronic Health Records, EHR) are just a new development in a process that has been going on in the medical industry for some time.  Frankly, many of the document formats and records management protocols in recent years have been in response to the medical sector’s heavy investment in technology to improve patient care.

But with the entry of the U.S. Federal government into the fray with the e-Health initiative that is part of the stimulus package, we’ve definitely entered a new era for standards development and EMR products.  The recent release of the Department of Health and Human Services’ RIN 0991 – AB58  (Interim Final Rule on Health Information Technology:  Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology) makes it clear that the Federal Government is going to be a big player in this process.

Let’s see, money…  Health Informatics has already been identified as a hot growth sector, with estimates of market being in the range of $1 billion in 2005, with a growth potential of $4 billion in 2013.  But, with regulators looking to mandate the use of EMR to submit Medicaid and Medicare transactions, the estimates could be significantly understated.

Politics?  The government’s stated intention to become a major user of EMR has generated responses from Doctors, Health Care Privacy organizations, and from the Standards Organizations that are already involved in this work.  Believe me, the idea of electronic health records in the hands of government bureaucrats gets some people going.  Add to this the draft stimulus package’s requirement to use EMR-generated databases to provide “biosurveillance,” and life gets exciting!

And of course, no standards classic would be complete without competing standards.  Like VHS and BetaMax, there are 2 sides to this story.  ASTM is on one side, with the CCR Standard (Continuity of Care Record) and Health Level 7 (HL7) is on the other with CDA (Clinical Document Architecture) and CCD (Continuity of Care Document).

It appears the the ASTM-led effort has produced a Standard that is less complicated and is used successfully in software products geared for private physician practices.  The HL7 set has been implemented for larger scale products aimed for hospital applications.   And wouldn’t you know it?  Google and Microsoft are getting into this business, with the Google application being based on CCR and Microsoft’s using both the CCR and CDA/CCD approaches!

But wait!  RIN 0991-AB58 suggests that the Dept. of Health and Human Services (DHHS) is going to sponsor a whole new round of standards development in order to satisfy newly issued government requirements.  Thank goodness the American National Standards Institute (ANSI) has created a Standards Panel (HITSP) in the hopes of providing assistance to keep everything straight.  Looks like it’s just another day in the wonderful world of Standards….