A Personal Reflection on Standards Harmonization

As HITSP prepares for the demands of ARRA by reorganizing its work around meaningful use rather than use cases, here is my view of the state of standards harmonization in the US. This is my personal opinion, not a statement from HITSP or ONC.

1. Medication management and e-prescribing

This area is very mature and widely implemented.

NCPDP Script 10.5 is the right messaging standard to support e-prescribing workflow in ambulatory and long term care settings.

The National Library of Medicine's RxNorm is the right vocabulary to specify medication names.

The Food and Drug Administration's Unique Ingredient Identifier (UNII) is the right vocabulary for chemical substances and is especially useful in allergy checking.

Structured SIG, although still evolving, is good enough to describe the way to take a medication.

The Veterans Administration's National Drug File Reference Terminology (NDF-RT) is the right vocabulary for medication class and is especially useful in drug/drug interaction checking and formulary enforcement.

There are few controversies in the medication standards area. The only outstanding issues are the fact that some of these standards such as Structured SIG and RxNorm are relatively new and continue to evolve.

2. Laboratory

HL7 2.51 is good enough for results reporting to EHRs, public health, and biosurveillance.

LOINC is the right vocabulary for lab test names.

UCUM, although very new, is a reasonable vocabulary to describe units of measure.

The only controversy around lab is the timing of implementation, given that thousands of commercial labs in the US need to update their interfaces to support HL7 2.51, LOINC and UCUM. Of these, standardizing units of measure with UCUM is probably the most controversial, given that using UCUM is new for lab stakeholders. I've recently spoken with healthcare IT leaders from other countries and all agree that standardizing units of measure for labs is a priority and should move forward.

3. Clinical Summaries

Just about all stakeholders agree that clinical summaries (problem list, medication list, allergy list, diagnostic test reports, discharge summaries, other documents) should be represented in XML.

The question is what flavor of XML - HL7's Clinical Document Architecture or ASTM's Continuity of Care Record.

HITSP harmonized these two approaches with the HL7 Continuity of Care Document (CCD).

The major controversy in the area of clinical summaries is the nature of the XML format and schema. Some have described the CDA as overly complex XML. I've also heard that some believe CCR's XML could be improved. My hope is that all stakeholders continue to work together to converge on a single, simple XML representation of a clinical summary that works for everyone and is more similar to the typical XML structures used widely on the web.

4. Quality Measures

The National Quality Forum's HITEP efforts have fostered a new way to represent quality measures in terms of a collection of data types. Additional work needs to be done to uniformly map these data types to specific standards. It's likely that the same standards mentioned above for medications, laboratory and clinical summaries will be suitable for transmitting quality measures to data marts.

The only controversy in the world of quality measures is the need to rewrite existing measures in terms of EHR data types. The National Quality Forum will be the catalyst for such a project.

5. Common Data Transport

The above discussion on medications, labs, summaries and quality has been about content and vocabularies, not the secure transmission of data from place to place. How should transport work for all healthcare data exchange?

Just about everyone agrees that the internet/TCPIP/HTTPS is the right approach. However, there are controversies about the other standards to be used - enveloping, authorization/authentication, and architecture.

Some have proposed simple RESTful web services. Some have suggested that SOAP with WS* constructs provides a more solid security framework.

In Massachusetts, we've used CAQH CORE Phase II with SOAP over HTTPS and X.509 certificates. We do nearly 100 million transactions a year with this approach and it works very well.

HITSP will work on harmonizing common data transport as part of its 2009 Extensions and Gaps efforts. It will harmonize the transport work done to date, the efforts of the NHIN pilots and the requirements of the Common Data Transport Use Case recently released to HITSP by ONC.


In general, how do we resolve remaining standards controversies by the end of 2009 when a interim final rule must be finalized per ARRA? Here's my understanding of the process:

1. The HIT Policy Committee will propose a set of priorities for "meaningful use", likely in the next 60 days. The National Coordinator will deliver these to the HIT Standards Committee.

2. The HIT Standards Committee and its 3 workgroups (Clinical Operations, Clinical Quality, Privacy and Security) will determine what existing accepted /recognized standards best support the HIT Policy Committee's priorities, likely in the next 90 days. The HIT Standards Committee will draw on the work of harmonization organizations (including HITSP), standards development organizations, and implementation guide writers. The Standards Committee will also engage NIST for standards testing.

3. The National Coordinator will review this work and if it is appropriate deliver it to the Secretary of HHS for acceptance and publication in the interim final rule.

There will be several periods of public comment and administrative review along the way.

What will HITSP's role be in this process? Initially it will provide expert testimony about harmonized standards to the HIT Standards Committee. In general, HITSP responds to the priorities established by the Office of the National Coordinator. It is independent of any particular administration/political party. If there is a need to approach priorities in a different way, HITSP will align to do that, just as it has with the ARRA focused efforts of the past 60 days.