Comments on the Interim Final Rule

The comment period for the Interim Final Rule on Standards runs from January 15 to March 15. I've spoken to many stakeholders in industry, hospital IT departments, and government. Here are the five general themes I'm hearing from the comments they'll be submitting:

1. Need for additional guidance on content standards

As I've noted in earlier posts, the IFR is a regulation and ONC did not want to provide too much specificity that would require changing regulation to support evolving implementation guidance. Although this was the right thing to do, the lack of constraints on HL7 2.51 and CCD creates ambiguity that could result in a tower of Babel - thousands of incompatible implementations of these standards. ONC needs to rapidly provide HL7 2.51 and CCD implementation guides (such as the HITSP Lab and HITSP C32 specifications)

2. Need for additional guidance on vocabulary standards

Do the vocabularies required - RxNorm, SNOMED-CT and LOINC apply to EHRs themselves or just the transactions sent between EHRs? What if a proprietary, self built medication vocabulary is integrated to the EHR but is mapped to RxNorm for all health information exchange? What about a proprietary problem list vocabulary that is mapped to SNOMED-CT? If mapping is allowed, what subset of these vocabularies should be used i.e. NLM's SNOMED-CT Core problem list subset, LOINC Lab ordering compendium etc.

3. Need for additional guidance on transmission standards

Transmission approaches need implementation guidance, per my previous blog posts. Stating that REST and SOAP are acceptable does not foster interoperability among various implementations.

4. Need for additional guidance on security standards

Encryption needs clarification. Is encryption of EHR data at rest required in certified EHRs? Although the intent is that data in transit and data on mobile devices needs to be encrypted, should vendors provide encryption in their products because they cannot know how they will be installed and used.

5. Need for additional guidance on quality measurement

The NQF Healthcare Information Technology Expert Panel work on quality measures is based entirely on CDA/CCD, yet patient summaries are summary may be sent in CCR or CCD. Thus, the NPRM's quality measures cannot be extracted from CCR using the current retooling. How do we reconcile incompatible definitions of patient summaries and quality measures?

I look forward to reviewing all the public comments, which will be made available by ONC via the web.