Compliance & Security · ONC Certification
ONC-Certified EHR:Elixir’s Certification Record in Full
Elixir is a certified Health IT Module under the ONC Health IT Certification Program, certified by an ONC-Authorized Certification Body against criteria adopted by the Secretary of Health and Human Services. The certificate number, the certified criteria, the cost disclosure and the real world testing documents are all published below, because certification is only worth anything if it can be checked.
- Health IT developer
- Mirketa Inc
- Product and version
- Elixir, Version 1
- Date certified
- 21 July 2023
- Certificate number
- 15.05.05.3165.MRKT.01.00.1.230721
- Certification body
- SLI Compliance, an ONC-Authorized Certification Body
- Relied upon software
- Salesforce, NewCrop, EMR Direct
- Criteria certified
- 21 criteria under 45 CFR 170.315
Certified, not self-declared
Tested and certified by an independent ONC-Authorized Certification Body, not asserted by the vendor.
Published criteria list
Every certified criterion named, with the capability it covers and the fees that apply to it.
Real world testing
Annual plan and results report, a Condition and Maintenance of Certification requirement.
Open API documentation
Business and technical API documentation published openly, with no registration, as the program requires.
Being precise
What ONC Certification Means for an EHR, and What It Does Not
Certification is a statement about tested capability against named criteria. It is not a security seal, and it is not a statement that one product is better than another.
- 3 Clinical capabilities
170.315(a) - 2 Care coordination and export
170.315(b) - 11 Privacy and security
170.315(d) - 5 Design, process and API
170.315(g)
This Health IT Module is compliant with the ONC Certification Criteria for Health IT and has been certified by an ONC-ACB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services.
Certification is granted criterion by criterion. The ONC Health IT Certification Program does not certify “an EHR” as a whole. It certifies a Health IT Module against specific criteria at 45 CFR 170.315, each one tested by an ONC-Authorized Certification Body against a published test procedure. A product is therefore certified to a list, and the honest way to present certification is to publish that list rather than a badge. Elixir’s list is immediately below.
Why it matters to a provider organization. Certified health IT is the basis of several federal programs. Eligible professionals and hospitals participating in the Medicare Promoting Interoperability Program and the Promoting Interoperability performance category of MIPS are required to use certified electronic health record technology, and the certification criteria a given program depends on are set by that program rather than by the vendor. If a federal or state program is part of why you are buying, confirm which criteria that program requires and check them against the list below before you sign anything.
What it is not. Certification is not an accreditation of your organization, not a HIPAA compliance certificate — there is no such thing — and not a security attestation. The security criteria in the (d) series are real and are listed below, but they test defined capabilities rather than the operating security of a deployment. For that side of the picture, see the HIPAA Compliance Center and the Salesforce security layer beneath Elixir.
Certification also carries continuing obligations. A certified developer is subject to the program’s Conditions and Maintenance of Certification, which include publishing API documentation openly, submitting an annual real world testing plan and results report, attestation requirements, and the information blocking condition. Those obligations sit with the developer, which is to say with us. The documents they produce are published on this page rather than supplied on request.
The record
Elixir’s Certified Criteria Under 45 CFR 170.315
Twenty-one criteria, grouped as the regulation groups them. The third column is the cost and fee disclosure required of certified developers, stated per criterion. Nothing in this table is optional disclosure; it is published because the program requires it.
Clinical capabilities · 170.315(a)
Recording and managing clinical information in the record.
| Criterion | Capability certified | Costs and fees |
|---|---|---|
(a)(1) | Computerized provider order entry — medications A user can record, change and access medication orders. | Included in the contract. No additional costs or fees. |
(a)(5) | Demographics A user can record each of a patient’s race, ethnicity, sex and preferred language. | Included in the contract. No additional costs or fees. |
(a)(14) | Implantable device list Unique device identifiers can be recorded for a patient’s implantable devices. | Included in the contract. No additional costs or fees. |
Care coordination and export · 170.315(b)
Moving a patient’s information out of the system in a standard form.
| Criterion | Capability certified | Costs and fees |
|---|---|---|
(b)(1) | Transitions of care Generation of a Consolidated CDA Continuity of Care Document and Referral Note for the ambulatory setting. | Included in the contract. No additional costs or fees. |
(b)(10) | Electronic health information export Timely creation of an export file containing all of a single patient’s electronic health information stored by the certified product. | Included in the contract. No additional costs or fees. |
Privacy and security · 170.315(d)
The eleven security criteria, certified as a set.
| Criterion | Capability certified | Costs and fees |
|---|---|---|
(d)(1) | Authentication, access control, authorization Users are authenticated and permitted access is established before health information can be read or changed. | Included in the contract. No additional costs or fees. |
(d)(2) | Auditable events and tamper resistance Actions on electronic health information are recorded. For each permissible action the audit log records date and time, patient identification, user identification, type of action, and identification of the patient data accessed. The log also records audit log status and encryption status. | Included in the contract. No additional costs or fees. |
(d)(3) | Audit report(s) Audit information is available to users and can be sorted by user, event time and event type. | Included in the contract. No additional costs or fees. |
(d)(4) | Amendments An accepted amendment can be appended to the record, and a denied amendment request recorded along with the denial, with a link indicating the location of the amendment. | Included in the contract. No additional costs or fees. |
(d)(5) | Automatic access time-out An authorized user configures a defined period of inactivity after which access times out automatically. | Included in the contract. No additional costs or fees. |
(d)(6) | Emergency access Emergency access to health information is enabled for a limited, identified set of users. | Included in the contract. No additional costs or fees. |
(d)(7) | End-user device encryption Electronic health information is not stored locally on the end-user device. Certified under the alternative that applies to products which do not write health information to the device. | Included in the contract. No additional costs or fees. |
(d)(8) | Integrity The product can generate a hash over a message containing health information, and can validate the message digest of health information it receives. | Included in the contract. No additional costs or fees. |
(d)(9) | Trusted connection Transport-level security is implemented, establishing a trusted connection in accordance with the standards at §170.210(a)(2) and §170.210(c)(2). | Included in the contract. No additional costs or fees. |
(d)(12) | Encrypt authentication credentials The developer makes an attestation as to the method by which authentication credentials are encrypted. | Included in the contract. No additional costs or fees. |
(d)(13) | Multi-factor authentication The developer makes an attestation as to the use of multi-factor authentication. | Included in the contract. No additional costs or fees. |
Design, process and API · 170.315(g)
How the product is designed, tested and documented, and how applications reach it.
| Criterion | Capability certified | Costs and fees |
|---|---|---|
(g)(3) | Safety-enhanced design The NISTIR 7741 user-centered design process is applied during design and development for the capabilities to which the criterion applies. | Included in the contract. No additional costs or fees. |
(g)(4) | Quality management system A quality management system is identified for the development, testing, implementation and maintenance of each certified capability. | Included in the contract. No additional costs or fees. |
(g)(5) | Accessibility-centered design The developer identifies, for each certified capability, any accessibility-centered design standard applied. | Included in the contract. No additional costs or fees. |
(g)(6) | Consolidated CDA creation performance A C-CDA file can be created in accordance with the HL7 C-CDA Release 2.1 implementation guide for each document template. | Included in the contract. No additional costs or fees. |
(g)(7) | Application access — patient selection Published API documentation covering syntax, function names, required and optional parameters and their data types, return variables and their types and structures, exceptions, and exception-handling methods and their returns. | Included in the contract. No additional costs or fees. |
Costs and limitations disclosure
Elixir is licensed as a web-based solution under a contractual agreement covering the functionality set out in the contract. The following fee types apply:
- A one-time implementation fee for the functionality set out in the contract.
- Annual recurring fees for support and hosting.
- An additional one-time fee for data import or migration, where the client requires it.
Beyond those, the certified capabilities listed above are included in the contract and carry no additional costs or fees. Known material limitations: the certified capabilities depend on the relied-upon software named above — Salesforce, NewCrop and EMR Direct — and the scope of certification is the criteria listed above and no others.
Conditions of certification
Real World Testing: Plan and Results
Real world testing is an annual Condition and Maintenance of Certification requirement for Health IT Modules certified to certain interoperability criteria. The developer submits a plan before the testing year and a results report after it, and both are public. Ours are below.
PDF · Plan
Real World Testing Plan 2025
The measures, care settings and methodology submitted for the 2025 testing year. Plan Report ID Number
20241003mir.
PDF · Results
Real World Testing Results Report CY 2025
The outcome of the 2025 testing year against the plan: what was measured, what the measurements showed, and any non-conformities or challenges encountered.
The authoritative record for any certified product is the Certified Health IT Product List, which is maintained by the certification program rather than by the developer. Elixir’s listing can be found there by searching the certificate number above.
Published documentation
The Documents Certification Requires Us to Publish
Certification is not only a test that was passed once. It carries continuing obligations to publish, openly and without preconditions, the documentation a customer or an integrator would otherwise have to ask for. Each of these is a separate published artifact rather than a marketing page, and each has its own permanent address.
170.315(g)(7)API Developer Portal
The complete business and technical API documentation: OAuth 2.0 authentication, fourteen FHIR-formatted resource endpoints, the C-CDA all-data request, HTTP status codes and exception handling, software requirements and terms of use.
Published with no registration, no form and no agreement, because the API Condition of Certification requires any person to be able to reach it directly.
170.315(b)(10)Patient EHI Export
The format documentation for the electronic health information export — the file a customer can generate containing all of a single patient’s electronic health information held by the certified product.
170.315(d)(13)Multi-Factor Authentication
The authentication use cases supported by Elixir, which the criterion requires the developer to attest to — direct login, single sign-on, API access, authenticator applications, hardware security keys, one-time passwords and source-IP restrictions.
Real world testing plans and results are published above. Together these are the documents a security reviewer, an integration engineer or a procurement team would otherwise have to request — which is the point of publishing them.
For evaluators
How to Verify Any of This Independently
Everything on this page is verifiable without asking us, which is the point of publishing it. If you are putting together a vendor evaluation, these are the checks worth making — of any vendor, not only this one.
Check the product list, not the website
The Certified Health IT Product List is the authoritative record. Search the certificate number and confirm the product, version, criteria and status there rather than taking a vendor page at face value.
Match the criteria to your program
Ask which criteria your federal or state program actually requires, then read them off the list. A certified product can be certified to criteria that do not include the one you need.
Read the real world testing results
The results report says what was measured and what the measurements showed. It is the one document in the set that reports outcomes rather than intentions.
Ask about the relied-upon software
Where certification relies on third-party software, that dependency is part of what you are buying. Confirm what each component does and what happens if one changes.
Separate certification from security
Certification is not a security attestation. Ask for the security documentation and the Business Associate Agreement separately, and read them separately.
Confirm the version
Certification attaches to a named product and version. Confirm that the version being quoted to you is the version on the listing.
For evaluation teams
Certification is the floor, not the argument
A certified product tells you what was tested. Whether it fits your programs is a separate question, and a better one. We are happy to walk the certified criteria against your requirements and tell you plainly where Elixir does and does not reach.