ONC Expanding HIT Certification Beyond Meaningful Use

Seeking to accelerate health information technology interoperability among providers not eligible for the electronic health records meaningful use program is the focus of a newly proposed rule from the Office of the National Coordinator for HIT.


Seeking to accelerate health information technology interoperability among providers not eligible for the electronic health records meaningful use program is the focus of a newly proposed rule from the Office of the National Coordinator for HIT.

ONC released the rule on March 20, the same day that the Centers for Medicare and Medicaid Services released a proposed rule for Stage 3 of the meaningful use program.

The ONC rule establishes new and voluntary 2015 Edition certification criteria for other health information systems, called Health IT Modules. A proposed Base EHR definition specific to the 2015 Edition would include fewer measures to report and targets care settings beyond the ambulatory and inpatient environments, such as long-term post-acute care, behavioral health and pediatrics.

The goal is to ease the path to expanded use of HIT and data exchange for ancillary providers by creating a market what will incent vendors to offer interoperability capabilities to these providers. “It incorporates changes that are designed to spur innovation, open new market opportunities and more choices to providers when it comes to electronic health information exchange,” according to the rule.

Consequently, a certification program for vendors of laboratory information systems, other ancillary systems, health information service providers and health information exchanges would enable them to receive appropriate recognition of their abilities to support interoperability.  In particular, vendors would be assessed on the ability of their products demonstrate application programming interface (API) functionality to support the exchange of a standard summary of care (C-CDA version 1.1 and 2.0.), using a new Common Clinical Data Set.

Among other capabilities, vendors would be required under the ONC Health IT certification program to enable their products seeking certification to collect social, psychological and behavioral health data to aid stakeholders in better understanding and addressing health disparities. Other criteria includes consistent identification of patients, design principles to prevent errors, reporting by certifying bodies to ONC of complaints received about certified products, proper identification of health information documents for users such as advance directives and birth plans, and eased consumer access to their own electronic health information.

ONC also asks for comment on several other possible requirements, such as if real-time formulary benefit checking should be part of the certification criteria. The agency also proposes early steps to begin development of baseline functionality to use and exchange unique device identifiers, with the goal of proposing requirements in future rulemaking.

The proposed voluntary 2015 Edition for certifying Health IT Modules also has scaled-down requirements for privacy and security to account for the more limited uses and functionalities of ancillary systems compared with a complete EHR. “In essence, we identify the privacy and security certification criteria that would be applicable to a Health IT Module presented for certification based on the other capabilities included in the Health IT Module and for which certification is sought,” according to the rule. “Under the proposed approach, a health IT developer would know exactly what is needed to do in order to get its Health IT Module certified and a purchaser of a Health IT Module would know exactly what privacy and security functionality against which the Health IT Module had to be tested in order to be certified.”

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