HHS Issues Final Health IT Rule, Not All Satisfied With Results

By Christine Kern, contributing writer

Some healthcare stakeholders are concerned about the new oversight rule.

The U.S. Department of Health and Human Services (HHS) Office of the national Coordinator for Health IT (ONC) has issued a final rule designed to “enhance the reliability, transparency, accountability, and safety of certified health information technology,” according to an HHS release.

The ONCE Health IT Certification Program: Enhanced Oversight and Accountability final rule is designed to allow the ONC Health IT Certification Program to better support healthcare providers and institutions using certified electronic health records (EHRs) and adapting to the fast pace of innovation in the health information technology (health IT) market. “More transparency and accountability in health IT is good for consumers, physicians, and hospitals,” said Vindell Washington, M.D., M.H.C.M., national coordinator for health IT. “Today’s final rule strengthens the program by ensuring that certified health IT helps clinicians and individuals use and exchange electronic health information safely and reliably.”

Yet, not all healthcare stakeholders are convinced. In a statement, Robert Horne, Executive Director of Health IT Now, wrote, “We are very disappointed that ONC has decided to move in this direction. Health IT Now is reviewing these rules. However, our chief concern is the potential for negative consequences from the ONC final rule. Simply put, the Office of the National Coordinator for Health IT was not created by Congress to be a regulator like the Food and Drug Administration (FDA).”

Horne underscored Health IT Now’s objection to the new rule, arguing, “ONC is clearly overstepping its statutory authority by moving forward with direct review of uncertified functionalities and products, in addition to certified products. By focusing on safety issues, ONC is encroaching on the regulatory functions of other federal agencies like the FDA.

“The FDA, Congress, and other stakeholders have been working for many years to strike an appropriate balance between supporting innovation and regulatory clarity for health IT products. Much progress has been made, with more work needing to be done. This ONC action has the potential to negatively impact those efforts, create confusion in the marketplace, slow innovation, and adversely affect patient safety by impeding access to health IT products.” 

The statement closed with a call to President Obama and the White house to reconsider this final rule. It also urged Congress to block the implementation of the rule. According to HHS, there are three areas of focus for the final rule:

• Direct Review. The rule creates a regulatory framework for ONC to directly review certified health IT products and take action when potential risks to public health and safety or circumstances presenting practical challenges to ONC- Authorized Certification Bodies arise.
• Consistent Authorization and Oversight. The rule establishes an authorization and oversight process for accredited testing laboratories to align with ONC’s existing oversight of ONC-ACBs and facilitates the efficient attention to testing and performance issues by ONC.
• Increased Transparency and Accountability. This rule also publishes identifiable surveillance results of certified health IT to improve transparency and provide users with critical information about the performance of certified health IT.

More information on the final rule can be found here and on the ONC Health IT Certification Program here.