§ 170.556 In-the-field surveillance and maintenance of certification for Health IT.

(a) In-the-field surveillance. Consistent with its accreditation under 170.523(a) to ISO/IEC 17065 and the requirements of this subpart, an ONC–ACB must initiate surveillance “in the field” as necessary to assess whether a certified Health IT Module continues to conform to the requirements in subparts A, B, C and E of this part once the certified Health IT Module has been implemented and is in use in a production environment.

(1) Production environment. An ONC–ACB's assessment of a certified capability in the field must be based on the use of the capability in a production environment, which means a live environment in which the capability has been implemented and is in use.

(2) Production data. An ONC–ACB's assessment of a certified capability in the field must be based on the use of the capability with production data unless the use of test data is specifically approved by the National Coordinator.

(b) Reactive surveillance. An ONC–ACB must initiate surveillance (including, as necessary, in-the-field surveillance required by paragraph (a) of this section) whenever it becomes aware of facts or circumstances that would cause a reasonable person to question a certified Health IT Module's continued conformity to the requirements of its certification.

(1) Review of required disclosures. When an ONC–ACB performs reactive surveillance under this paragraph, it must verify that the requirements of § 170.523(k)(1) have been followed as applicable to the issued certification.

(2) [Reserved]

(c) Randomized surveillance. During each calendar year surveillance period, an ONC–ACB may conduct in-the-field surveillance for certain randomly selected Health IT Modules to which it has issued a certification.