This past spring, the Office of the National Coordinator for Health IT announced the 2015 Edition Health IT Certification Criteria proposed rule, along with the proposed rule for Stage 3 of the EHR incentive program.

[See also: Stage 3 meaningful use proposed rule and certification criteria released]

Vendors immediately began weeding their way through those hundreds of pages to prepare official comments and to understand the potential implications for product development.

According to ONC, the 2015 Edition seeks to "enable a more flexible certification program that supports developer innovation" and "incorporates changes to foster innovation, open new market opportunities, and provide more choices to the care community when it comes to electronic health information exchange."

[See also: CMS makes meaningful use modifications]

Despite ONC's lofty objectives, many EHR vendors are concerned that the scope of the proposed rule is too broad with too many requirements, including certain standards that have yet to be fully vetted by the industry. One consistent criticism is that the proposed rule includes a considerable number of criteria that are not specifically tied to the meaningful use program – nor to other HHS programs.

"In all previous rules, the ONC certification requirements were tied to a meaningful use objective," explained Stephanie Zaremba, senior manager of government and regulatory affairs for athenahealth. "The rules have now been decoupled and about half of what is in the ONC rule are requirements for functionalities that are not necessary to succeed in meaningful use."

Joe Wall, supervisor of federal initiatives for MEDITECH, shared similar concerns: "We really wanted to see ONC focus on the meaningful use regulatory aspect," said Wall. "The proposed certification rule included requirements that are not necessarily tied to any specific meaningful use objectives, but still place a burden on EHR vendors to develop, test, certify, and implement by the 2017 optional year."

Other vendors, including Allscripts, concur that the breadth of requirements, given the proposed timeline, presents a challenge.

"We certainly understand the thinking behind a lot of the suggestions, but believe the scope of what ultimately was presented was really too significant, particularly within the scope of time they allowed for the work to be done," said Leigh Burchell, vice president of policy and government affairs for Allscripts. "If we have to devote resources for all these requirements, we have to use resources that could be innovating elsewhere."

It is, she says, "an industry-wide drain on innovation."

Another area of concern is the inclusion of criteria based on new or immature standards which may have been conditionally piloted, but not fully tested and validated.

"As a vendor, we are concerned that before we adopt standards into our system they are mature, well-vetted, and well-tested – rather than the latest and greatest," said Wall.

Burchell theorizes that the ONC's inclusion of certain proposed standards was an attempt to give vendors more room to innovate. "What may have happened is that they went down the road of inclusion of more immature standards in order to broaden the list of available standards you can use towards certification," said Burchell.

"Unfortunately the way the standards showed up is not hitting the goal they were going for," said Burchell. "The reality is that if standards aren't ready, it isn't going to be something we are going to be confident in including in our products."

While vendors applauded the ONC's efforts to engage stakeholders, improve flexibility and usability, and support innovation, the general consensus is that overall the proposed rule mixed the mark.

"In trying to move away from their typically overly-prescriptive approach, ONC didn't hit the right balance," noted Zaremba. "They are still being pretty specific and prescriptive in what vendors need to do for some things.

[See also: CMS lays out vision for Stage 3 meaningful use]

"Our overall comment is that ONC should actually take a step back and let the market figure out what is needed and let vendors work with their clients to meet their demands. If they want to create an environment for innovation in health IT, 500 pages of regulation is probably not the way to do it."

Regardless of the final certification rule, the major vendors appear committed to developing whatever functionality is required. They predict, however, that some smaller organizations may struggle to comply.

"We will certainly meet all the demands for industry regulation and do what is necessary," said Wall. "But, the certification process will pose a challenge to smaller vendors because what they put in the certification rule is very large and the technology demands are immense."

Burchell agrees: "You can expect most of the larger companies to move forward with whatever is in the final rule. We have already seen some of the smaller organizations show up less in the Stage 2 attestation data, so that may be exacerbated if all these requirements to go into effect."