"> 2015 Edition Final Cures FAQs – Drummond Group

2015 Edition Final Cures 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.

  • Health IT developers should start by reviewing the ONC’s 21st Century Cures Act Final Rule and the associated information and resources found on the ONC Cures Rule page. Additionally, Drummond hosted a series of Cures-related webinars available for viewing and downloading here. For Drummond clients, please also log in to our Drummond Customer Portal and click the 21st Century Cures Resources page for more information.

  • For a product already certified to the 2015 edition, full recertification is not required to meet compliance with the Cures Final Rule. Rather, these are updates to 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 which is (g.10) Standardized API for Patient and Population Services. This criterion 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 (provided by Drummond) will be required once the developer has self-tested the product and believes the product 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 registering to “change certified capabilities” using our 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.

    Below are some general compliance timelines developers will need to meet. These requirements pertain to both developers not yet certified to the Cures updates and those that are.

    Compliance Date Conditions of Certification Requirement

    Effective Date of Rule

    June 30, 2020*

    § Assurances: Ensure health IT conforms to the 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 2020* § Communications: Notify all customers with contracts this condition of certification that communication restrictions will not be enforced.  Annual customer notice required until a contract(s) can be amended.

    6 months after publication

    Nov. 2, 2020*

    § 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.

    Dec. 15, 2020* § Real-World Test Plans: submit to Drummond by Dec. 15. The test plan will be based on testing to be conducted in 2021. Note the test results for 2021 real-world testing will not be due until March 2022.
    *Enforcement Discretion applies (up to 3 months after the compliance timeframe)
  • “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. There are a total of seven conditions, but the “EHR Reporting Criteria Submission” is not finalized. Therefore, the following six conditions below are required to meet compliance. For Drummond clients, please log into our Drummond Customer Portal for additional details regarding specific “maintenance” requirements and compliance timelines.

    1. Information Blocking: applies to all developers and their certified products
    2. 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)
    3. Assurances: applies to all developers and their certified products
    4. APIs: applies to developers with products certified to 170.315(g7-g10)
    5. Communications: applies to all developers
    6. 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 Dec. 15, 2020). Testing is expected to be conducted in 2021 and the first set of real-world test results will be prior to March 15, 2022.

    Note that this condition of certification is ongoing. RWT test plans will be due annually beginning December 15, 2020. RWT results also will be due annually prior to March 15, 2022.

    The ONC is expected to release additional guidance for developers later this year. As Drummond obtains more information, we will notify clients via our Drummond Customer Portal and new webinars.

    Drummond also will be offering a new service line to assist developers with planning and executing real-world testing. Details will be finalized soon and communicated to clients. For additional information about this optional service, please contact certification@drummondgroup.com.

  • Due to the impact of COVID-19 on the healthcare community, the ONC instituted an Enforcement Discretion Policy allowing health IT developers an additional three months to comply with Cures requirements, if additional time is needed. Drummond anticipates providing a means for developers to indicate if the enforcement discretion will be exercised and will provide details as they are released by the ONC.

  • If you are a previous Drummond client, 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 contact certification@drummondgroup.com. If you are new to Drummond, please contact us at EHR@drummondgroup.com.

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