Standards and Certification Criteria to Support Meaningful Use of EHRs

Jan. 5, 2010

A Message from Dr. David Blumenthal, National Coordinator for Health Information Technology

As we look toward 2010, we can envision a transformation of our health system to improve health care quality, efficiency, equity, and safety through the use of health information technology (HIT), while providing the foundation for continued, measurable improvement in our nation’s health.  The adoption and meaningful use of information technology in health care is central to a necessary and overdue modernization of our health system. 

As required by the HITECH Act, the Secretary of the Department of Health and Human Services (HHS) has published an initial set of standards, implementation specifications, and certification criteria to enhance the interoperability, functionality, utility, and security of health information technology.  These criteria are outlined in the interim final rule (IFR) on Standards & Certification Criteria issued today by the Office of the National Coordinator for Health Information Technology (ONC).  

The IFR provides details on requirements for “certified” electronic health record (EHR) systems, and the technical specifications needed to support secure, interoperable, nationwide electronic exchange and meaningful use of health information. 

In a related announcement, the Centers for Medicare & Medicaid Services (CMS) issued a notice of proposed rulemaking (NPRM) that outlines provisions governing the Medicare and Medicaid EHR incentive programs, including a proposed definition for the central concept of “meaningful use” of EHR technology.  In order for professionals and hospitals to be eligible to receive payments under the incentive programs, provided through the Recovery Act, they must be able to demonstrate meaningful use of a certified EHR system.  The proposed standards and certification criteria in the IFR are fundamentally linked to and specifically designed to support the 2011 meaningful use criteria.

Great care was taken in the development of these criteria, with input from the public and federal advisory committees every step of the way.  The resulting standards and certification criteria in the IFR are organized into four categories as recommended by the HIT Policy Committee and HIT Standards Committee:

  • Content Exchange Standards (i.e., standards used to share clinical information such as clinical summaries, prescriptions, and structured electronic documents);
  • Vocabulary Standards (i.e., standard nomenclature used to describe clinical problems and procedures, medications, and allergies);
  • Transport Standards (i.e., standards used to establish the communication protocol between systems); and
  • Privacy and Security Standards (e.g., authentication, access control, transmission security/encryption) which relate to and span across all of the other types of standards.

While well-defined data and technical standards are the foundation for interoperability between systems – allowing for reliable, consistent, secure, and accurate information exchange – we recognize that a high-level of nationwide interoperability will take time and will occur at varying rates.  Therefore, our approach to the adoption of standards and certification criteria is pragmatic, yet forward looking.  The criteria are designed to be supportive of the staged meaningful use requirements, but at the same time lay the foundation for future growth in information exchange and technological innovation.

An incremental approach to standards adoption requires harmonization with current and future standards to come.  We will continue to be guided by recommendations from our federal advisory committees, public comment, industry readiness, and future meaningful use goals and objectives established for the Medicare and Medicaid EHR incentive programs.  We anticipate this ongoing evolution in standards and certification criteria development as meaningful use requirements become more demanding over time and as industry continues to spur adoption through its innovative offerings.

Now, we ask for your continued input to inform the final regulations due in 2010.