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D. Future Updates to Standards, Implementation Specifications, and Certification Criteria
The initial set of standards, implementation specifications, and certification criteria adopted in this interim final rule marks the beginning of what we expect to be an iterative approach to enhancing the interoperability, functionality, utility, and security of HIT.
A number of factors including maturity, prevalence in the market, and implementation complexity informed our adoption of the standards, implementation specifications, and certification criteria included in this interim final rule.
Our approach to the adoption of standards, implementation specifications, and certification criteria is pragmatic, but forward looking.
While a high-level of interoperability nationwide will take time and be challenging, we believe that the HITECH Act has generated a significant amount of momentum and interest in meeting the challenges that lie ahead.
We recognize that interoperability and standardization can occur at many different levels.
For example, one organization may use an information model to describe patient demographic information as (PatientAge, PatientSex, StreetAddress), while another may describe similar demographic information in a different way (DateOfBirth, Gender, City/State).
To achieve interoperability at this information level, these information models would need to be harmonized into a consistent representation.
In other cases, organizations may use the same information model, but use different vocabularies or code sets (for example, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT {registered trademark}) or ICD9-CM) within those information models.
To achieve interoperability at this level, standardizing vocabularies, or mapping between different vocabularies (using tools like Unified Medical Language System (UMLS)) may be necessary.
For some levels, (such as the network transport protocol), an industry standard that is widely used (e.g., Transmission Control Protocol (TCP) and the Internet Protocol (IP), (TCP/IP)) will likely be the most appropriate.
Ultimately, to achieve semantic interoperability, we anticipate that multiple layers--network transportation protocols, data and services descriptions, information models, and vocabularies and code sets--will need to be standardized and/or harmonized to produce an inclusive, consistent representation of the interoperability requirements.
We anticipate using a harmonization process that will integrate different representations of health care information into a consistent representation and maintain and update that consistent representation over time.
For an information model, this process could include merging related concepts, adding new concepts, and mapping concepts from one representation of health care information to another.
Similar processes to support standardization of data and services descriptions and vocabularies and codes sets may also be needed.
We also recognize that a sustainable and incremental approach to the adoption of standards will require processes for harmonizing both current and future standards.
This will allow us to incrementally update our initial set of standards, implementation specifications, and certification criteria and provide a framework to maintain them.
Our decision to adopt such updates will be informed and guided by recommendations from the HIT Policy Committee, HIT Standards Committee, public comment, industry readiness, and future meaningful use goals and objectives established for the Medicare and Medicaid EHR Incentive Programs.
As a result, we expect, unless otherwise necessary, to adopt standards, implementation specifications, and certification criteria synchronously with and to support a transition to the next stage of meaningful use in the Medicare and Medicaid EHR Incentive Programs.
In doing so, we also anticipate increasing the level of specificity we provide related to standards, implementation specifications, and certification criteria as well as phasing out certain alternative standards that have been adopted in this initial set.
Furthermore, we anticipate that the requirements for meaningful use will become more demanding over time, and consequently that Certified EHR Technology will need to include greater capabilities as well as the ability to exchange electronic health information in a variety of circumstances with many different types of health information technology.
Finally, as will be discussed in more detail in the HIT Certification Programs proposed rule, it is possible that the certification programs established by the National Coordinator could certify other types of HIT, perhaps related to certain specialty products and personal health records.
In order for that to occur, specific standards, implementation specifications, and certification criteria related to those types of HIT would need to be developed and adopted.
