Removal of Criteria from ONC 2015 Edition Program (June 30, 2020)
The following criteria will no longer be supported in the program and will be listed as “Removed” on the CHPL:
- 170.315(a)(6) Problem List
- 170.315(a)(7) Medication List
- 170.315(a)(8) Medication allergy list
- 170.315(a)(11) Smoking Status
- 170.315(b)(4) Common Clinical Data Set summary record – create
- 170.315(b)(5) Common Clinical Data Set summary record – receive
New Criteria Added to the ONC 2015 Edition Program
As of June 30, 2020, all new and updated certifications require attestations to the following 2 new criteria, and all current certifications must be updated to include these by April 30, 2022:
170.315(d)(12) Encrypt authentication credentials
170.315(d)(13) Multi-factor authentication
New criterion added to the ONC 2015 Edition Program [Update within 24 months (by April 30, 2022) – replaces (g)(8)]
170.315(g)(10) Standardized API for patient and population service
ONC has adopted a new secure, standards-based API certification criterion in § 170.315(g)(10) to implement the 21st Century Cures Act’s requirement that developers of certified health IT publish APIs that can be used “without special effort.” This new certification criterion requires standardized API access for single patient and population services and is limited to API-enabled “read” services using the HL7® Fast Healthcare Interoperability Resources (FHIR®) standard Release 4. The FHIR standard, in addition to a set of adopted implementation specifications, provides known and consistent technical requirements for software developers.
New criterion added to the ONC 2015 Edition Program [Update within 36 months of final Rule (by April 30, 2023)]
170.315(b)(10) EHI export
Revised Criteria to the ONC 2015 Edition Program
Update to USCDI/C-CDA companion guide by April 30, 2022
- 170.315(b)(1) Transitions of care
- 170.315(b)(2) Clinical information reconciliation and incorporation
- 170.315(b)(9) Care plan
- 170.315(e)(1) View, download, and transmit to 3rd party
- 170.315(f)(5) Transmission to public health agencies — electronic case reporting
- 170.315(g)(6) Consolidated CDA creation performance
- 170.315(g)(9) Application access — all data request
Update standard by April 30, 2022
- 170.315(b)(3) Electronic prescribing
- 170.315(b)(7) Data segmentation for privacy – send
- 170.315(b)(8) Data segmentation for privacy – receive
- 170.315(g)(3) Safety-enhanced design
HL7 QRDA standard requirements removed as of June 30, 2020 – update to support the CMS QRDA Implementation Guide (IGs) instead of the HL7 IGs by April 30, 2022
- 170.315(c)(3) Clinical quality measures (CQMs) — report
Update to new ASTM standard by April 30, 2022
- 170.315(d)(2) Auditable events and tamper-resistance
- 170.315(d)(3) Audit report(s)
- 170.315(d)(10) Auditing actions on health information
Time Limited Criteria to the ONC 2015 Edition
ONC-ACBs only permitted to issue certificates for these criteria until the specified dates and any certifications will expire after those dates
- 170.315(a)(10) Drug-formulary and preferred drug list checks (1/1/2022)
- 170.315(a)(13) Patient-specific education resources (1/1/2022)
- 170.315(b)(6) Data export (4/30/2023)
- 170.315(e)(2) Secure messaging (1/1/2022)
- 170.315(g)(8) Application access — data category request (4/30/2022)
ONC-ACB Certified Products
June 30, 2020 (or soon thereafter): The limitations language (but not the additional costs language) must be removed from disclosures about 2015 Edition certified products. We will send a message to all clients with the details.
June 30, 2020: 2014 Edition certifications are retired. Developers may no longer use the ONC Mark or the SLI Mark associated with 2014 Edition certified products or claim a 2014 Edition Certification. If you have a 2014 Edition certification, please inform all users of the retirement of this certification.
June 30, 2020: Attestation period begins for the attestation window that opens in April 2021.
June 30, 2020: The initial Removed criteria (see above) must be removed from Mandatory Disclosures URLs. Please do this as soon as possible after June 30.
June 30, 2020: If any current contracts with your clients forbid certain types of communications about the health IT, you are required to stop enforcing those clauses – more info re contracts below. Regarding new contracts: 170.403(b)(2) (i) requires that a developer may not include provisions that contravene the Communications Condition of Certification requirements in any new contract as of the effective date of the final rule.
July 1, 2020, or soon thereafter: The CHPL will identify specific criteria that are certified as 2015 Edition Cures Rule update criteria, in addition to the “original” 2015 Edition criteria.
July 2020: Please inform us at email@example.com when you have updated your mandatory disclosures URL to remove the limitations language and the initially removed 2015 criteria listed above.
Approx. August 1, 2020: We highly recommend you start planning for your first round of Real World Testing, covering 2015 Edition certified products*. The test plans must be reviewed for completeness by the ACBs, any modifications must be made, and the plans provided to the ONC by March 15, 2021. Therefore, we will ask you to provide these by January 15, 2021 and will welcome them even earlier so there is time to complete the process. (The first cycle of testing must be done during 2021 and reported in early 2022.) Note that in future years, plans must be provided to ONC 3 months earlier, by Dec. 15.
*Certified to any 1 or more of the following: b (any), c1-3, e1, f (any), g7-10, h (any) as of August 31 of the year the plan is due – August 31, 2020 for testing to be done in 2021
Approx. Sept 1, 2020: If your contracts with any clients prohibit communications about certain aspects of the products, you must actively inform your clients that you will not enforce those provisions of the contract at least once per calendar year until those contracts are changed to remove all non-allowed prohibitions. (Per to the ONC’s enforcement discretion timeline, notice can be made until March 31, 2021 for the 2020 calendar year. The 2021 notice must be given during 2021.) See slides 8-12 here:
ONC Cures Rule Update FAQs
SLI Compliance will update our FAQs at the address below as questions arise: