Data & Technical Standards: Standards and Recognition

Executive Order and Recognition

The Executive Order issued on August 22, 2006 stated that HHS and all federal agencies shall ensure that internal programs and external contracts implement relevant HHS recognized interoperability standards. This requirement applies to the implementation, acquisition and upgrade of health information technology systems consistent with Executive Order: Promoting Quality and Efficient Health Care in Federal Government Administered or Sponsored Health Care Programs.

Certification of Recognized Standards

All recognized certification bodies (see Health IT certification) are required to include interoperability standards recognized by the Secretary of Health and Human Services in their certification processes.

Certification will be the process by which IT systems of federal health contractors are established to have met interoperability standards referenced in the Executive Order: “Promoting Quality and Efficient Health Care in Federal Government Administered or Sponsored Health Care Programs”.

Acceptance and Recognition

Recognition by the Secretary of HHS is critical to advancing both federal and private sector use of health IT standards as specified above. In order to ensure that software developers have adequate time to implement recognized standards in their software, Secretary Leavitt has established a two step process for his recognition of interoperability standards. First, the Secretary publicly “accepts” standards recommended to him by the American Health Information Community and then, one year after his “acceptance,” the Secretary has committed to formal “recognition” of these standards.

The intervening year between “acceptance” and “recognition” of interoperability standards allows software developers time to test the implementation of standards and allows the Health Information Technology Standards Panel to refine the implementation guidance for how the standards need to be implemented based on feedback from actual software implementation. Only minimal changes of any kind may be implemented in the final six months before recognition, to ensure that software developers have a clear and stable target for their implementation efforts.

Standards Implementation

The interoperability and operation of Health IT systems is a complex challenge. Data and technical standards are critical elements for overcoming this challenge, but at times there are several ways that systems can implement standards and still achieve needed outcomes. As an example, one way to share very specific, standardized data is to only use data that are recorded, stored, processed and exchanged in that very specific, standardized format. Another way to achieve a comparable outcome, is to record and store data in one format and then convert those data into the very specific, standardized format when it is time to process or exchange them.

Because systems are at difference stages of standards implementation, the national health IT agenda and its processes strive to be minimally prescriptive of how organizations and software systems will implement standards. The principal focus of standards harmonization, certification and Executive Order implementation is where organizations need to exchange data and interoperate. A lesser focus is in areas where systems interoperate inside of organizations. This latter setting will only be a focus when it is critical to achieving specific capabilities. Restraint in focusing on systems inside of organizations will allow as much flexibility as possible for different implementation approaches.

Recognition Status

At the American Health Information Community (AHIC) meeting held on October 31, 2006, the HITSP presented three sets of Interoperability Specifications (Version 1.2), based on use cases previously approved by the Community in the areas of Electronic Health Records - Lab Results; Biosurveillance - Connecting to Clinical Care; and Consumer Empowerment - Registration and Medication History.

The Interoperability Specifications can be retrieved from the HITSP Web site using the following links:

• Electronic Health Record-Laboratory Results Reporting (HITSP/IS-01)
• Biosurveillance-Connecting to Clinical Care (HITSP/IS-02)
• Consumer Empowerment-Registration and Medication History (HITSP/IS-03)

The Secretary of Health and Human Services has “accepted” these standards and indicated that he intends to “recognize” these standards and Version 2 of their implementation guidance in December of 2007.