2015 Edition Cures Frequently Asked Questions (FAQs)
Drummond’s service offerings for health IT testing and certification ensure a smooth transition for your organization in 2015 Edition’s next phase. To learn how to get started with the 2015 Edition Cures Updates, download our Decision Guide which outlines your next steps and puts you in contact with one of Drummond’s experts.
For a product already certified to the 2015 edition, a full recertification is not required to meet compliance to the Cures Act Final Rule. The updates are in place for existing 2015 certified criteria and a few new criteria. Recertification requirements will vary depending upon which criteria a developer is currently certified. Most developers already certified to 2015 Edition will only be required to live-test one criterion: (g.10) Standardized API for Patient and Population Services. This is only required for developers whose products are certified to the API criteria.
For all other new and revised Cures criteria, 2015 Edition certified developers may attest to meeting compliance and may not be required to conduct live-testing. A signed attestation form (provided by Drummond) will be required once the developer has self-tested the product and meets conformance to the Cures updates. The attestation form will be submitted directly to Drummond’s Certification Body and may be done via the quarterly attestation process or by registering to “change certified capabilities” using the online form here. In addition, please note that some changes, such as updating to USCDI, will require real-world testing along with the attestation. More details may be found on our Drummond Customer Portal under the “Real World Testing” section.
As noted above, this will vary depending upon which criteria a developer is already certified. The information listed includes general compliance timelines developers will need to meet. These requirements pertain to developers not yet certified to the Cures updates AND those that are already certified.
|Compliance Date||Conditions of Certification Requirement|
|April 5, 2021*|
§ Assurances: Ensure health IT conforms to full scope of certification criteria. See our related blog post titled: “Changes to your Costs and Limitations”
§ Communications: Prohibited from restricting user certain communications (refer to Cures Final Rule for more details)
|Beginning in 2021*||§ Communications: Notify all customers with contracts this condition of certification that communication restrictions will not be enforced. Annual customer notice required until contract(s) can be amended.|
|April 5, 2021*|
§ Information Blocking: Compliance with exceptions required, EHI definition limited to USCDI
§ Assurances: Comply by assuring will not take any action that constitutes info blocking
§ API Compliance: Update policies and revise existing API documentation to comply with section 170.404 of the Cures Final Rule.
|Nov. 15, 2021*||§ Real-World Test Plans: submit to Drummond before Dec. 15, 2021. Test plan will be based on testing to be conducted in 2022. Note the test results for 2022 real-world testing will not be due until March 2023.|
Conditions and Maintenance of Certification” were introduced as part of the ONC 21st Century Cures Act Final Rule. These are requirements that need to be met at initial certification and ongoing in order to maintain compliance. It includes a total of seven conditions, but the “EHR Reporting Criteria Submission” was not finalized. Therefore, the following six conditions below are required to meet compliance. Drummond clients may log into our Drummond Customer Portal for additional details regarding specific “maintenance” requirements and compliance timelines.
- Information Blocking: applies to all developers and their certified products
- Real-World Testing: applies to developers with products certified to 170.315(b.1-10), (c.1-3) (e.1), (f.1-7), (g.7-10) and (h.1-2)
- Assurances: applies to all developers and their certified products
- APIs: applies to developers with products certified to 170.315(g7-g10)
- Communications: applies to all developers
- Attestations: applies to all developers
Real world testing (RWT) is a condition of certification and requires all health IT developers with product(s) certified to 170.315(b.1-10), (c.1-3) (e.1), (f.1-7), (g.7-10) and (h.1-2) to successfully test the real-world use of the interoperability technology in the type of setting in which such technology would be marketed. Developers will be required to submit RWT test plans to their ONC-ACB for any applicable product certified to the criteria noted above by Aug. 31 of the year in which the test plan is required (first test plan due to Drummond on Nov. 15, 2021). Testing is expected to be conducted in 2022 and the first set of real-world test results will be due prior to March 15, 2023.
RWT test plans will be due annually by Nov. 15. RWT results also will be due annually beginning March 15, 2023.
The ONC is expected to release additional guidance for developers in 2021. As Drummond obtains more information, we will notify clients via our Drummond Customer Portal and other resources, including blogs and webinars.
Drummond also will be offering a new service line to assist developers with planning and executing real-world testing. Final details will be communicated to clients in a timely manner. For additional information about this optional service, please contact email@example.com.
If you are a previous client with Drummond, please log into our Customer Portal and click the “Support” tab to submit a question or request a phone call. For certification inquiries, you may email firstname.lastname@example.org. If you are new to Drummond, please contact us at EHR@drummondgroup.com.
*The ONC Interim Final Rule issued October 2020 extended the compliance timelines for conditions and maintenance of certification requirements as well as timelines for certifying new and revised criteria.