Certification Companion Guide:
§ 170.405 Real World Testing

§ 170.405 Real World Testing.

1. Condition of Certification requirement. A health IT developer with one or more Health IT Module(s) certified to any one or more of the ONC Certification Criteria for Health IT in § 170.315(b), (c)(1) through (3), (e)(1), (f), (g)(7) through (10), (g)(31) through (33), (h), and (j)(20) and (21) 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.
2. 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.
      1. 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.
      2. The plan must include all health IT certified to any one or more of the criteria referenced in paragraph (a) 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.
      3. The plan must address the following for each of the certification criterion identified in paragraph (a) of this section that are included in each Health IT Module’s scope of certification:
         1. 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;
         2. 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;
         3. For any standards and implementation specifications referenced by the criterion that the developer has chosen to certify to National Coordinator-approved newer versions pursuant to paragraph (b)(8) or (9) of this section, a description of how the developer will test and demonstrate conformance to all requirements of the criterion using all versions of the adopted standards to which each Health IT Module was certified as of August 31 of the year in which the real world testing plan is due.
         4. A schedule of key real world testing milestones;
         5. A description of the expected outcomes of real world testing;
         6. At least one measurement/metric associated with the real world testing; and
         7. A justification for the health IT developer’s real world testing approach.
   2. Real world testing results reporting.
      1. If in the course of conducting real world testing the developer discovers one or more non-conformities with the full scope of any certification criterion under the Program, the developer must report that non-conformity to the ONC-ACB within 30 days.
      2. For real world testing activities conducted during the immediately preceding calendar year, a health IT developer must submit to its ONC-ACB an annual real world testing results report addressing each of its certified Health IT Modules that include certification criteria referenced in paragraph (a) of this section by a date determined by the ONC-ACB that enables the ONC-ACB to publish a publicly available hyperlink to the results report on CHPL no later than March 15 of each calendar year, beginning in 2023. For certified Health IT Modules included in paragraph (a) of this section that are updated using Inherited Certified Status after August 31 of the year in which the plan is submitted, a health IT developer must include the newer version of the certified Health IT Module(s) in its annual real world testing results report. The real world testing results must report the following for each of the certification criteria identified in paragraph (a) of this section that are included in the Health IT Module’s scope of certification:
         1. The method(s) that was used to demonstrate real world interoperability;
         2. The care setting(s) that was tested for real world interoperability;
         3. The voluntary updates to standards and implementation specifications that the National Coordinator has approved through the Standards Version Advancement Process.
         4. A list of the key milestones met during real world testing;
         5. The outcomes of real world testing including a description of any challenges encountered during real world testing; and
         6. At least one measurement/metric associated with the real world testing.
   3. [Reserved]
   4. [Reserved]
   5. [Reserved]
   6. [Reserved]
   7. [Reserved]
   8. Standards Version Advancement Process – voluntary updates of certified health IT to newer versions of standards and implementation specifications. A health IT developer subject to paragraph (b) of this section is permitted to update Health IT Module(s) certified to any one or more of the certification criteria referenced in paragraph (a) of this section to a newer version of any adopted standard or implementation specification included in the criterion, provided that newer version is approved by the National Coordinator for use in certifications issued under the ONC Health IT Certification Program. A developer that pursues such updates of its certified Health IT Module(s) must:
      8. Provide advance notice to all affected customers and its ONC-ACB-
         8. Expressing its intent to update the certified Health IT Module(s) to the National Coordinator-approved advanced version of the standard implementation specification;
         9. The developer’s expectations for how the update will affect real world interoperability for the Health IT Module(s);
         10. Whether the developer intends to continue to support the certificate(s) for the existing certified Health IT Module(s) version(s) for some period of time and how long or if the existing certified Health IT Module(s) version(s) will be deprecated; and
      9. Successfully demonstrate conformance with approved more recent versions of the standard(s) or implementation specification(s) included in each certification criterion under which the developer chooses to update its certified Health IT Module(s).
      10. Maintain the updated certified Health IT Module(s) in full conformance with all applicable Program requirements.
   9. Standards Version Advancement Process – voluntary certification to newer versions of standards and implementation specifications. A Health IT developer is permitted to seek certification for its Health IT Module(s) to any one or more of the certification criteria referenced in paragraph (a) of this section using a newer version of any adopted standard(s) or implementation specification(s) included in the criterion without first obtaining certification to the version of that adopted standard or implementation specification that is incorporated by reference in § 170.299, provided that the newer version is approved by the National Coordinator for use in certifications issued under the ONC Health IT Certification Program. Developers may, for each standard and implementation specification included in each criterion, choose on an itemized basis whether to seek certification to the version incorporated by reference in § 170.299, or to one or more newer version(s) approved by the National Coordinator for use in Health IT Module(s) certifications issued pursuant to section 3001(c)(5) of the Public Health Service Act, or to both.

None. 

Clarifications:

• While developers are not required to test their certified health IT in each and every setting in which it is intended for use, it is expected a developer’s Real World Testing plan will address each type of clinical setting for which its health IT is marketed.
• Enforcement Discretion: In accordance with Executive Order 14192, “Unleashing Prosperity Through Deregulation” released on June 30, 2025, ASTP/ONC is exercising enforcement discretion related to certain Real World Testing requirements to reduce regulatory burden for Certified Health IT developers. For calendar year (CY) 2025, a developer is not expected to submit an annual Real World Testing plan to its ONC-Authorized Certification Body (ONC-ACB) for the 2026 Real World Testing year. For CY 2026, ASTP/ONC only expects a developer with a Health IT Module(s) certified to the (g)(7) through (10) certification criteria, as of August 31, 2024, to submit a CY 2025 Real World Testing results report to its ONC-ACB by March 2026. This enforcement discretion will be in effect immediately, and will remain in effect until December 31, 2026, or until the Department of Health and Human Services completes deregulatory action, whichever comes first. Please read the full notice outlining the details of the Real World Testing enforcement discretion.

Clarifications:

• Certified Health IT Developers(s) must submit an annual Real World Testing plan to its ONC Authorized Certification Body (ONC-ACB) by a date determined by the ONC Authorized Certification Body (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. Initial Real World Testing plans may be posted through December 15, 2021.
• Refer to the ASTP/ONC Enforcement Discretion Notice released on June 30, 2025, for impacts on calendar year 2025 and 2026 plan submission requirements. For CY 2025, a developer is not expected to submit an annual Real World Testing plan to its ONC-Authorized Certification Body (ONC-ACB) for the 2026 real world testing year.

Clarifications:

• If a developer discovers one or more non-conformities with the full scope of any certification criterion, the developer must report that non-conformity to the ONC-ACB within 30 days of identifying the non-conformity.

Clarifications:

• A developer must post an annual Real World Testing results report to its ONC-ACB by a date that enables the ONC-ACB to publish a publicly available hyperlink to the results report on CHPL no later than March 15 of each calendar year. Initial Real World Testing from the 2022 performance year may be posted up through March 15, 2023.
• The Real World Testing results report must address each of its Certified Health IT Module(s) that meet applicable certification criteria.
• Many health IT developers update their certified Health IT Module(s) on a regular basis, leveraging the flexibility provided through ONC’s Inherited Certified Status (ICS) [PDF – 275 KB].  Because of the way that ONC issues certification identifiers, this updating can cause an existing certified Health IT Module to be recognized as new within the Program. Regular updating, especially on a frequent basis (such as quarterly or semi-annually), creates an anomaly that could result in existing certified Health IT Modules being inadvertently excluded from the real world testing reporting requirements (88 FR 23753). ONC has eliminated this anomaly by requiring health IT developers to include in their real world testing results report the newer version of those certified Health IT Module(s) that are updated using ICS after August 31 of the year in which the plan is submitted. [see 89 FR 1198]
• Refer to the ASTP/ONC Enforcement Discretion Notice released on June 30, 2025, for impacts on calendar year 2025 and 2026 results submission requirements. For CY 2026, ASTP/ONC only expects a developer with a Health IT Module(s) certified to the (g)(7) through (10) certification criteria, as of August 31, 2024, to submit a CY 2025 Real World Testing results report to its ONC-ACB by March 2026.

Clarifications:

• A developer that intends to update to its Certified Health IT Module(s) under the Standards Version Advancement Process (SVAP) must provide advance notice to all affected customers and its ONC-ACB.
• The Real World Testing enforcement discretion issued on June 30, 2025 does not impact the Standards Version Advancement Process (SVAP) and associated developer requirements beyond not requiring developers to report Real World Testing results for certification criteria outlined in 170.405(a) except for 170.315(g)(7-10); nor does this enforcement discretion result in added SVAP requirements. For more information, please see the SVAP section in the Real World Testing resource guide.