By now, we have had an opportunity to review and comment on the Notices of Proposed Rule Making (NRPM) from ONC and CMS covering the 2014 Edition of Certified EHR Technology (CEHRT) and Meaningful Use Stage 2 (MU2).
I observed different reactions to the NPRM, ranging from “just needing a few tweaks” to “this really is difficult to understand” from some vendors and provider organizations. This month, I would like to provide a different take on the NPRM.
As one contemplates the complexities of these proposed regulations in trying to maintain backward compatibility, versioning and orchestrating implementation guides, vocabularies and transports, one suddenly realizes that ONC is using federal regulations to write functional and interoperability specifications.
ONC, in implementing HITECH, chose to either select base standards recommended by the HITSC or develop, through the S&I Framework working with Standards Development Organizations, implementation guides for its base standards. The two most illustrative of the latter are the HL7 C-CDA Guide and the HL7 Laboratory Results Interface Guide.
Neither of these guides, nor others that ONC names, provide a complete specification on how to implement a real-world solution to address the business requirements. These guides represent modules in the interoperability stack. Reference implementations and pilots are not based on an overall design document, and in any case, are lagging.
ONC was left with the challenge of using federal regulations to create de facto “interoperability specifications” to define the business rules, constraints and orchestration of different implementation guides and standards. This is, in some way, analogous to Healthcare Information Technology Standards Panel’s (HITSP) interoperability specifications that defined the design, use, constraints and orchestration of underlying components, guides and standards to fulfill the requirements of a use case.
The ONC NPRM is the only document that:
- Establishes the vocabulary, content structure, transport and security functions for the key interoperability exchanges for transitions of care clinical summaries.
Also, the NPRM:
- Specifies the conditions and constraints for the use of guides to standards and vocabularies for implementing lab results reporting, discharge medications, reporting to public health, immunization and cancer registries.
Starting with the rule itself, an implementer will still have to open multiple implementation guides, base standards and vocabularies to understand what to do. For the most part, these artifacts remain the intellectual property of SDOs and are not in a standard or computable format.
This does not solve the indirection problem.
If the Office of the National Coordinator is trying to ensure backward compatibility, coordination and reuse of standards and vocabularies across initiatives through regulation, its challenges will grow exponentially.
Since the NPRM is really the second in a series of implementation specifications, it created the need for a cross-walk, versioning and backward compatibility. These tasks will only become more complex with more initiatives, particularly without some base technical framework and cross-initiative coordination process.
For additional observations on the NPRMs, please go to the May issue of Standards Insight available on the HIMSS member page.