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ONC Health IT Certification Rule to Hold Vendors Accountable

According to industry players, the ONC Health IT Certification rule and its increased vendor accountability measures will help providers delivery quality care through technology.

By Sara Heath

The ONC Health IT Certification Rule makes great strides toward continuing to reward quality healthcare technology while holding accountable that which falls short, according to leaders from two prominent industry groups.

One was DirectTrust President & CEO David Kibbe.

“In general, and not speaking for all of our very diverse members, I am in favor of the new final rule, the so-called Oversight Rule, in part because it has maintained the oversight function I feel is of value, and also scaled back from the proposal in March,” Kibbe said.

In late August, Kibbe released a statement advocating for ONC health IT oversight, presenting an opinion contrary to many of his colleagues throughout the industry calling for a more limited role for the agency.

“This is for some an unpopular rule in the current anti-regulatory environment and coming near the end of the Meaningful Use era,” Kibbe said in a past statement. “However, it does beg the question whether EHR industry oversight by itself is going to be adequate to improve the usability and safety of EHR technologies in the coming months and years.”

According to Kibbe, the final rule meets these oversight needs. In technology’s infancy, the government has issued a considerable amount of reward for health IT adoption, mainly in issuing meaningful use payments to EHR vendors, Kibbe said. Up until now there has been little repercussion for those vendors who do not meet physician needs. This final rule is poised to put an end to that, the CEO said, and that is a good thing.

“There truly needs to be continuing oversight by ONC’s certification program to protect against the very few but potentially very damaging instances in which vendor conduct turns out to be improper after initial certification, or when vendors fail to perform their responsibilities as agreed to as part of the certification process,” Kibbe explained.

The final rule, which was released late last week, will hold health IT vendors accountable by first allowing ONC Authorized Certification Bodies (ACBs) to monitor and review technologies. Next, ACBs will publically publish surveillance findings each quarter, allowing end users to better assess the quality and safety of the tools they employ.

This rule is also set to lead the industry into a nationwide health IT system in which all stakeholders and up-to-date on key standards. These standards include both security standards and health data interoperability standards.

“In no area of health IT is it more important for vendors and their EHRs to stay in step than in conformity with the infrastructure that allows for electronic exchanges of health information,” Kibbe said. “This is because it is through the interoperable exchange of health information—across different organizations using different EHR vendors’ products—that we can eventually make the most progress in closing the gap between our health care system’s potential for quality improvements and the recognizably disappointing results to date.”

The American Hospital Association likewise offered its comments on the ONC Health IT Certification final rule, stating that it takes positive steps in improving transparency for end users about the quality and safety of technologies.

“The Office of the National Coordinator for Health Information Technology (ONC) took an important step to strengthen its oversight of certified health IT products,” AHA said in a public statement. “We applaud ONC’s commitment to provide greater transparency on the results of surveillance done by certification bodies and the agency itself. That information will be useful to providers as they evaluate and select products.”

The rule also establishes protocol for when the agency will decertify health IT, stating that it should only take that action if the developer is foregoing all corrective action plans.

According to AHA, this is a positive step because the coordinates these plans across all relevant federal agencies.

Going forward, the organization states that it will continue working with ONC to carry out key aspects of the final rule.

“The AHA is committed to working with ONC on its process for educating and providing notice to the provider community during investigations of how specific EHRs or other health IT products work in individual hospitals and physician offices,” AHA concluded.

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