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HHS Proposes Rule to Increase ONC Review and Oversight of Certified Health IT

The U.S. Department of Health and Human Services and the Office of the National Coordinator for Health Information Technology (ONC) recently proposed a rule to enhance ONC oversight and accreditation of health IT.  Under the rule, the ONC’s primary goal would be to work with health IT developers to remedy any non-conformities with certified health IT.  The proposed rule focuses on three areas:

ONC Direct Review of Certified Health IT:  The rule would grant ONC broad authority to conduct direct reviews of health IT certified under the ONC Health IT Certification Program.  This review would be in addition to reviews already conducted by the ONC Authorized Certification Body (ONC-ACB).  Direct reviews would occur when ONC becomes aware of information that indicates that certified health IT leads to medical errors or breaches in patient information, or otherwise does not meet the standards of its certification.

ONC-Authorized Testing Laboratories:  The rule would grant ONC direct oversight of testing labs under the Health IT Certification Program, in order to ensure that uniform oversight is applied at all stages of the Program.  Currently, ONC has no direct oversight over testing laboratories, as it has over ONC-ACBs. The rule would require some previously-accredited laboratories to apply to become ONC-Authorized Testing Labs.  The ONC estimates this accreditation process to cost a testing lab approximately $56,000 annually.

Transparency and Availability of Surveillance Results:  The rule would require ONC-ACBs to make identifiable surveillance results publicly available on their websites on a quarterly basis.  This would provide customers and users with valuable information about the performance and safety of health information technology.

The comment period closes on May 2, 2016.  A copy of the proposed rule can be found here.

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About this Author

Shruti Barker, Covington Burling, Healthcare attorney

Shruti Barker is an associate in the firm’s Washington, DC office, where she practices in the areas of health care, federal-state programs, and employee benefits. Ms. Barker advises state agencies, providers, food manufacturers, and other clients on issues related to government-sponsored health care programs. Ms. Barker has experience with an array of healthcare statutes and regulations, including Medicare, Medicaid, Women, Infants, and Children (“WIC”), and the Supplemental Nutrition Assistance Program.