E9-31216 I C 2

2. HITECH Act Requirements for the Adoption of Standards,

Implementation Specifications, and Certification Criteria

With the passage of the HITECH Act, two new Federal advisory committees, the HIT Policy Committee and the HIT Standards Committee, were established as specified in the new sections of the PHSA, 3002 and 3003, respectively.

Both are responsible for advising the National Coordinator on different aspects of standards, implementation specifications, and certification criteria and consequently they both have the potential to impact how and when standards, implementation specifications, and certification criteria are adopted by the Secretary.

The HIT Policy Committee is responsible for, among other duties, recommending priorities for standards, implementation specifications, and certification criteria while the HIT Standards Committee is responsible for recommending standards, implementation specifications, and certification criteria for adoption under section 3004 of the PHSA.

Section 3002 of the PHSA directs the HIT Policy Committee to ``make policy recommendations to the National Coordinator relating to the implementation of a nationwide health information technology infrastructure.``

Section 3002(b) further specifies the type of policy recommendations expected of the HIT Policy Committee by requiring that the committee focus on ``specific areas of standards development`` and in so doing ``recommend the areas in which standards, implementation specifications, and certification criteria are needed for the electronic exchange and use of health information for purposes of adoption under section 3004.``

Section 3002(b) also requires the HIT Policy Committee, after determining the areas where standards, implementation specifications, and certification criteria are needed (a process and analysis that are likely to occur on a periodic basis), to ``recommend an order of priority for the development, harmonization, and recognition of such standards, specifications, and certification criteria among the areas so recommended.``

After receipt of a recommendation related to a priority order, the National Coordinator is expected to review the priorities identified by the HIT Policy Committee and generally will either accept them as submitted, request adjustments, or reject the priority order in whole or in part.

Once the National Coordinator accepts a recommendation for the priority order of standards, implementation specifications, and certification criteria, such priorities will be communicated to the HIT Standards Committee to guide its work.

The HIT Policy Committee is charged with making recommendations in at least the following eight areas as specified in section 3002(b)(2)(B) of the PHSA:

(1) Technologies that protect the privacy of health information and promote security in a qualified electronic health Record, including for the segmentation and protection from disclosure of specific and sensitive individually identifiable health information with the goal of minimizing the reluctance of patients to seek care (or disclose information about a condition) because of privacy concerns, in accordance with applicable law, and for the use and disclosure of limited data sets of such information;

(2) A nationwide health information technology infrastructure that allows for the electronic use and accurate exchange of health information;

(3) The utilization of a certified electronic health Record for each person in the United States by 2014;

(4) Technologies that as a part of a qualified electronic health Record allow for an accounting of disclosures made by a covered entity (as defined for purposes of regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996) for purposes of Treatment, payment, and health care operations (as such terms are defined for purposes of such regulations);

(5) The use of certified electronic health Records to improve the quality of health care, such as by promoting the coordination of health care and improving continuity of health care among health care providers, by reducing medical errors, by improving population health, by reducing health disparities, by reducing chronic disease, and by advancing research and education;

(6) Technologies that allow individually identifiable health information to be rendered unusable, unreadable, or indecipherable to unauthorized individuals when such information is transmitted in the nationwide health information network or physically transported outside of the secured, physical perimeter of a health care provider, health plan, or health care clearinghouse;

(7) The use of electronic systems to ensure the comprehensive collection of patient demographic data, including, at a minimum, race, ethnicity, primary language, and gender information; and

(8) Technologies that address the needs of children and other vulnerable populations.

The HIT Policy Committee is also authorized at 3002(b)(2)(C) to consider other areas to make recommendations such as the ``appropriate uses of a nationwide health information infrastructure, including [for] * * * collection of quality data and public reporting,`` ``telemedicine,`` and ``technologies that help reduce medical errors.``

Section 3003 of the PHSA directs the HIT Standards Committee to ``recommend to the National Coordinator standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of adoption under section 3004.``

It also established that the HIT Standards Committee must recommend standards, implementation specifications, and certification criteria they have developed, harmonized, or recognized.

We note that in section 3003(b)(2), the HIT Standards Committee is also expressly permitted to recognize harmonized or updated standards from other entities and as a result, we expect the HIT Standards Committee to, where appropriate, consider the standards, implementation specifications, and certification criteria from various entities for recommendation to the National Coordinator.

We expect that in determining whether to recognize harmonized or updated standards from other entities, the HIT Standards Committee will look to entities such as HITSP and the National Quality Forum (NQF).

Additionally, section 3003(a) requires the HIT Standards Committee to focus on and make recommendations to the National Coordinator on the eight areas in section 3002(b)(2)(B) listed above.

The HIT Standards Committee is required to update their recommendations and make new recommendations as appropriate, including in response to a notification sent under section 3004(a)(2)(B) of the PHSA.

Section 3004 of the PHSA redefines how the Secretary adopts standards, implementation specifications, and certification criteria.

Section 3004(b)(1) of the PHSA requires a one-time Action by the Secretary to adopt an initial set of standards, implementation specifications, and certification criteria.

This interim final rule has been published to meet the requirements in section 3004(b)(1).

Section 3004(a) of the PHSA defines a process whereby an obligation is imposed on the Secretary to review standards, implementation specifications, and certification criteria and identifies the procedures for the Secretary to follow to determine whether to adopt any grouping of standards, implementation specifications, or certification criteria included within National Coordinator-endorsed recommendations.

The specific elements of the process related to section 3004(a) will be described in greater detail below.

Section 3004(b)(3) of the PHSA entitled ``subsequent standards activity`` states that the ``Secretary shall adopt additional standards, implementation specifications, and certification criteria as necessary and consistent`` with the schedule published by the HIT Standards Committee.

While we intend to consistently seek the insights and recommendations of the HIT Standards Committee, we note that section 3004(b)(3) provides the Secretary with the authority and discretion to adopt standards, implementation specifications, and certification criteria without having first received a National Coordinator-endorsed HIT Standards Committee recommendation.

Under section 3004(a) when a recommendation regarding a standard, implementation specification, or certification criterion is made by the HIT Standards Committee to the National Coordinator, a time limited statutory process is triggered.

First, after receiving a recommendation from the HIT Standards Committee, the National Coordinator must review and determine whether to endorse the recommendation as well as report such determination to the Secretary.

Upon receipt of an ``endorsed recommendation,`` the Secretary is required to consult with representatives of other relevant Federal agencies to review the standards, implementation specifications, or certification criteria and determine whether to propose their adoption.

The Secretary is required to publish all determinations in the Federal Register.

If the Secretary determines to propose the adoption of standards, implementation specifications, or certification criteria, the Secretary is permitted to adopt any grouping of standards, implementation specifications, or certification criteria.

On the other hand, if the Secretary determines not to propose the adoption of any grouping of standards, implementation specifications, or certification criteria, the Secretary must notify the National Coordinator and the HIT Standards Committee in writing of such determination and the reasons for not proposing their adoption.

The HIT Standards Committee issued recommendations to the National Coordinator on August 20, 2009, and updated those recommendations on September 15, 2009.

In fulfilling the duties under section 3001(c)(1)(A) and (B), the National Coordinator reviewed the recommendations made by the HIT Standards Committee and issued a determination endorsing several recommendations for the Secretary's consideration.

As specified in section 3004(a)(3), this interim final rule also serves as the Secretary's formal publication of the determinations made regarding the National Coordinator-endorsed recommendations.