The American Medical Association has praised the ONC Health IT Certification final rule for its emphasis on technology oversight, testing, and transparency, according to a statement from the group.
The final rule, which was released late last week, foremost serves patients and providers who directly use these technologies. Through ONC Authorized Certification Bodies (ACBs), the agency is approved to test and certify certain digital health technologies based upon patient safety and public health.
According to Steven J. Stack, MD, the immediate past president of AMA, the final rule is good news for physicians, who will be able to access better information about the reliability and quality of their technologies.
"These rules will promote health IT developers' accountability for the performance, reliability, and safety of certified health IT," Stack said. "Physicians are captive to the IT products, and these steps will give regulatory certainty to them. Increasing the accountability and transparency of health IT certification will give assurances to physicians as they modernize their practices.”
This increased oversight is likely to promote better accountability among health IT developers.
“While we do not expect a large number of non-conformity instances or adjustments to vendors' health IT certification, we agree more emphasis must be placed on supporting the physician as an end-user and furthering their consumer power,” Stack explained.
Prior to the final rule’s publication, AMA was among many that provided feedback to ONC regarding health IT certification. The organization suggested ONC adhere to the following key principles:
- ONC authority should pertain directly to patient safety and health data security
- ONC ACB reviews should be conducted transparently and solutions should be made public
- Health IT certification termination should be used as a last resort, only employed if health IT developers ignore corrective action plans
- ONC and CMS should work together to protect patients and providers from the adverse effects of terminating health IT certification
Ultimately, the health IT certification final rule includes three areas: direct review, consistent authorization and oversight, and increased transparency and accountability.
The direct review section describes specifically how ACBs will review health IT, emphasizing patient safety and field reliability. Health IT developers will play a role in developing these standards.
The direct review section will also include the development of corrective action plans.
The authorization and oversight section describes how ONC will accredit health IT testing laboratories. This process will reportedly be similar to how the agency accredits ACBs.
The final section requires all ACBs to report surveillance results publically on a quarterly basis.
According to Stack, these provisions meet several of AMA’s suggestions. For those that do not, he says the organization will work with ONC to refine the final rule.
The College of Healthcare Information Management Executives (CHIME) also released a statement praising the final rule.
“CHIME appreciates that steps that the agency is taking to increase transparency of health IT performance,” said CHIME Vice President of Federal Affairs Mari Savickis. “Hospitals and clinicians must have confidence that the products they purchase work as intended and do not pose a significant risk to patient safety or public health.”
Health IT quality and reliability is especially important given its role in federal payment programs. Providers are required to use certified health IT while attesting to meaningful use.
Eligible clinicians will likewise need to use certified health IT while participating in the Merit-based Incentive Payment System or an Advanced Alternative Payment Model under the Quality Payment Program. With the Quality Payment Program beginning in January, 2017, it will be important for all industry stakeholders to work to ensure accountability and transparency in health IT.