(a) Condition of Certification requirement. A health IT developer, or its authorized representative that is capable of binding the health IT developer, must provide the Secretary an attestation of compliance with the following Conditions and Maintenance of Certification requirements:

(1) Section 170.401;

(2) Section 170.402, but only for § 170.402(a)(4) and (b)(2) if the health IT developer certified a Health IT Module(s) that is part of a health IT product which can store electronic health information;

(3) Section 170.403;

(4) Section 170.404 if the health IT developer has a Health IT Module(s) certified to any of the certification criteria adopted in § 170.315(g)(7) through (10); and such health IT developer must also ensure that health IT allows for health information to be exchanged, accessed, and used, in the manner described in § 170.404; and

(5) Section 170.405 if a health IT developer has a Health IT Module(s) certified to any one or more ONC Certification Criteria for Health IT in § 170.315(b), (c)(1) through (3), (e)(1), (f), (g)(7) through (10), and (h).

(b) Maintenance of Certification requirement. (1) A health IT developer, or its authorized representative that is capable of binding the health IT developer, must provide the attestation specified in paragraph (a) of this section semiannually for any Health IT Modules that have or have had an active certification at any time under the ONC Health IT Certification Program during the prior six months.

(2) [Reserved] [85 FR 25945, May 1, 2020, as amended at 89 FR 8549, Feb. 8, 2024]