On Feb. 26, the Office of the National Coordinator for Health IT released a Notice of Proposed Rule Making to develop a Voluntary 2015 Edition Electronic Health Record Certification Program and update its previous certification criteria and rules.

Just the word "voluntary" in the title may suggest to IT leaders and EHR vendors that this NPRM only pertains to optional EHR functionalities, so they need not pay it much notice. However, in a closer look at the NPRM, not only are there proposed changes that affect EHRs seeking 2015 Edition certification, but there also are more than 100 topics under consideration that if finalized will very likely affect IT leaders including their infrastructure, vocabulary management, clinical documentation and clinician workflow.

Part of the federal rule making process is the mandatory "public comment" period soliciting stakeholder comments on proposed changes. Those comments are required to be resolved in the final rule. So now is your time as a stakeholder to "speak up" and be heard. This is also an opportunity to give additional input on topics for future rulemaking (i.e., Stage 3 of meaningful use, although those comments on which will be resolved in later rulemaking). 

Overview of NPRM

This proposed voluntary 2015 Edition certification NPRM from ONC is the first non-meaningful use-dependent certification program update. ONC offers this incremental approach between certification Editions as a way to signal which functionalities it intends to require and to establish a high proportion of revised or unchanged criteria with each released rule.

In the NPRM, ONC details a methodology to release proposed rules every 12 to 18 months to show the industry the direction it will take for required and optional functionality, which will help EHR vendors better predict where to spend their development resources. Meanwhile, IT leaders can use these proposals to glean insights into possible meaningful use Stage 3 objectives.  

In addition to the proposed voluntary 2015 Edition, ONC also requests feedback on several possible approaches to the meaningful use Stage 3-aligned 2017 Edition NPRM, which is expected in late 2014.

How the NPRM Could Affect EHR Vendors

In the 2015 NPRM, approximately 60% of certification criteria are unchanged from the previous rule and are eligible for "gap certification" by those vendors certified to the equivalent module.

The remaining 40% of certification criteria fall into four categories:

• Clarifying revisions;
• Standards updates;
• Restructuring to make certification criteria clearer; and
• New certification criteria proposals.

The new certification criteria pertain to:

• Functionality providers use for the Transitions of Care meaningful use objective (§170.314[h][1-4]);
• Clinical quality measures (§170.314[c][4]);
• Non-percentage-based meaningful use measure reporting (§170.314[g][5]); and
• A non-meaningful use-related function to record and display a unique device identifier and other information about a patient’s implantable devices (§170.314[a][20]).

How the NPRM Could Affect IT Leaders

Among the changes proposed are the collection of new demographic data such as disability status, gender identity, sexual orientation, work and occupation, and military service.

ONC specifically seeks comment on capabilities that would prevent duplicate patient records, assist in disaster preparedness, and aid entry and maintenance of provider directories.

Additionally, proposed changes in the NPRM may assist IT leaders to identify particular types of EHRs meant for specific types of health care settings. IT leaders in search of a specialty-specific EHR may have an additional source of information to add to their acquisition process if ONC finalizes a certification program for use in those specific domains (e.g., pediatrics).

ONC also proposes to create a certification avenue for EHR systems used primarily in settings where providers are not eligible for meaningful use (e.g., long-term post-acute care, behavioral health). A certification option for those systems would provide IT leaders a set of criteria with which to compare systems under consideration. 

Public Comment Opportunity

IT leaders and EHR vendors should read the NPRM in its entirety. For public convenience, please see our bookmarked version of this NPRM to pinpoint the "seek comments" portions.

Meanwhile, the Advisory Board's publicly available tool, "2015 Edition Detailed Comment Reference Tool," lets stakeholders review requests for comment.

IT leaders and EHR vendors should be proactive and help shape the direction of what is yet to come in meaningful use Stage 3, and the 2015 and 2017 Editions of ONC EHR certification criteria. This public comment time is your opportunity to provide feedback on many new functionalities and standards ONC has under consideration for both the 2015 and 2017 Editions, both shaping the path to Stage 3 of meaningful use.

ONC provides a template that can be used use to collect comments to be uploaded to www.regulations.gov. Comments are due no later than 5 p.m. ET on Monday, April 28.