§ 170.405 Real world testing.

(a) Condition of Certification requirement. A health IT developer with Health IT Module(s) certified to any one or more 2015 Edition certification criteria in § 170.315(b), (c)(1) through (3), (e)(1), (f), (g)(7) through (10), and (h) must successfully test the real world use of those Health IT Module(s) for interoperability (as defined in 42 U.S.C.300jj(9) and § 170.102) in the type of setting in which such Health IT Module(s) would be/is marketed.

(b) Maintenance of Certification requirements—(1) Real world testing plan submission. A health IT developer with Health IT Module(s) certified to any one or more of the criteria referenced in paragraph (a) of this section must submit to its ONC–ACB an annual real world testing plan addressing each of those certified Health IT Modules by a date determined by the ONC–ACB that enables the ONC–ACB to publish a publicly available hyperlink to the plan on CHPL no later than December 15 of each calendar year, beginning in 2021.

(i) The plan must be approved by a health IT developer authorized representative capable of binding the health IT developer for execution of the plan and include the representative's contact information.

(ii) The plan must include all health IT certified to any one or more of the criteria referenced in paragraph (a) of this section as of August 31 of the year in which the plan is submitted, and address the real world testing to be conducted in the calendar year immediately following plan submission.

(iii) The plan must address the following for each of the certification criteria identified in paragraph (a) of this section that are included in each Health IT Module's scope of certification:

(A) The testing method(s)/methodology(ies) that will be used to demonstrate real world interoperability and conformance to the full scope of the certification criterion's requirements, including scenario- and use case-focused testing;

(B) The care setting(s) that will be tested for real world interoperability and an explanation for the health IT developer's choice of care setting(s) to test;