Proposed rule for EHR certification released by ONC


On Feb. 24, the Office of the National Coordinator for Health IT (ONC) released its proposed rule for the certification of electronic health record systems.

In its 184-page document, ONC lays out the standards that vendors and providers must adopt, technical specifications that describe how to deploy the standards, certification criteria and the establishment of certification programs for certified EHRs.

Under the proposed rule, vendors must make sure their EHR supports functions such as providing patients online access to their health information and electronic health information exchange between providers to enable care coordination, patient engagement, security and safety.

Among its requirements, vendors and providers have a single standard instead of options to communicate information in certain transactions. These include Health Level 7 2.51 for lab results, syndromic surveillance and immunizations.

The Consolidated Clinical Document Architecture (CDA) is now the single standard for communicating the summary of care because the template can accommodate the formatting of a summary care record that includes all data elements that the Centers for Medicare & Medicaid Services (CMS) proposes providers give their patients after office visits.

The CDA is based on components of the Continuity of Care Record (CCR) and the CDA specification of the Continuity of Care Document (CCD) standard formats, both of which were previously required for certified EHRs.

The ONC proposed rule, called the 2014 Edition EHR certification criteria, supports and enables the functions called for in the proposed rule for meaningful use Stage 2 that CMS released Feb. 23. ONC will publish its proposed rule March 7 in the Federal Register. The public may comment for 60 days, after which ONC will publish its final rule sometime in the summer.

To transport the summary of care record, ONC proposes that EHRs be able to use both the Direct Project’s protocols, the SMTP and SMIME secure messaging standards.

“We believe the use of these standards is a critical first step in achieving a common means of transporting health information to support meaningful use and future exchange needs,” ONC said.

It also proposed that EHRs be capable of using the SOAP-based secure transport industry standard, as well as Direct, which was developed under the nationwide health information network (NwHIN) Exchange program.

“We intend to monitor innovation around transport and would consider including additional transport standards,” ONC added.

ONC proposed eight new certification criteria for both office and inpatient settings, including the ability to record clinician electronic notes in patient records with search functions for both free text and data fields, and to be able to electronically and directly access imaging results and information.

Providers will have to supply for patients the ability to view online, download and transmit their health information or summary of care, including to a third party or personal health record if they choose. For physicians, that must be within four business days of the data being available to them.

Also in the proposed regulation, ONC will retire its temporary certification program and move to its permanent program on the effective date of the final rule, expected in late summer this year. ONC also plans to make publicly available the results of tests used to certify EHRs to increase transparency and clarity around the health IT technology that has been approved.

In addition to describing requirements, ONC seeks feedback on a number of questions, including on proposed certification criteria intended to improve patient and EHR safety through the application of user-centered design processes and adherence to quality system principles.

ONC also wants to hear from the public about methods to improve data portability for providers, including the migration from one EHR to another, and about how far to push price transparency, including whether vendors should disclose the full cost of a certified EHR or module.