Code of Federal Regulations Title 45. Public Welfare § 45.170.550 Health IT Module certification

(1)Section 170.315(g)(3) if the Health IT Module is presented for certification to one or more listed certification criteria in § 170.315(g)(3);

(2)Section 170.315(g)(4);

(3)Section 170.315(g)(5);  and

(4)Section 170.315(g)(6) if the Health IT Module is presented for certification with C–CDA creation capabilities within its scope. If the scope of certification sought includes multiple certification criteria that require C–CDA creation, § 170.315(g)(6) need only be tested in association with one of those certification criteria and would not be expected or required to be tested for each. If the scope of certification sought includes multiple certification criteria that require C–CDA creation, § 170.315(g)(6) need only be tested in association with one of those certification criteria and would not be expected or required to be tested for each so long as all applicable C–CDA document templates have been evaluated as part of § 170.315(g)(6) for the scope of the certification sought.

(5)Section 170.315(b)(10) when a health IT developer presents a Health IT Module for certification that can store electronic health information at the time of certification by the product, of which the Health IT Module is a part.

(1) General rule. When certifying a Health IT Module to the 2015 Edition health IT certification criteria, an ONC–ACB can only issue a certification to a Health IT Module if the privacy and security certification criteria in paragraphs (h)(3)(i) through (ix) of this section have also been met (and are included within the scope of the certification).

(2) Testing. In order to be issued a certification, a Health IT Module would only need to be tested once to each applicable privacy and security criterion in paragraphs (h)(3)(i) through (ix) of this section so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification, except for the following:

(3) Applicability.

(1) Before granting certified status to a newer version of a previously certified Health IT Module(s), an ONC–ACB must review an attestation submitted by the developer(s) of the Health IT Module(s) to determine whether any change in the newer version has adversely affected the Health IT Module(s)' capabilities for which certification criteria have been adopted.

(2) An ONC–ACB may grant certified status to a newer version of a previously certified Health IT Module(s) if it determines that the capabilities for which certification criteria have been adopted have not been adversely affected.

(1)Section 170.315(a)(10) and (13) and § 170.315(e)(2) for the period before January 1, 2022.

(2)Section 170.315(b)(6) for the period before December 31, 2023.

(3)Section 170.315(g)(8) for the period before December 31, 2022.