These Terms and Conditions are for the Publishing Organization (see Section C for Definitions of Key Terms), as accepted by the Publishing Organization Lead. They set out the expectations for submission of a Clinical Decision Support (CDS) resource or "CDS Artifact” to and its inclusion in the CDS Connect Repository, a national repository of CDS Artifacts. Publishing Organization Lead acceptance of these terms and conditions assures the submitted CDS Artifact will be reviewed for inclusion in the Repository in accordance with applicable criteria as set out in Section B but does not guarantee that the submitted CDS Artifact will be accepted for such inclusion. The Agency for Healthcare Research and Quality (AHRQ), the current Governing Organization of CDS Connect and its component tools, will make no claim of ownership or control of or any other interest in CDS Artifacts which are not accepted for inclusion.

The operation and purpose of CDS Connect is described on the CDS Connect website, while these Terms and Conditions are for the Publishing Organization to understand the expectations entailed in submitting CDS Artifacts to the Repository.

1. A CDS Artifact is developed for the CDS Connect Repository in one of two ways: 1) de novo development or 2) by using the CDS Authoring Tool development. The former provides the Publishing Organization Lead and any additional Authors the ability to create artifacts in different formats or with significant logical complexity. The latter is a tool within CDS Connect that provides the Publishing Organization Lead an interface for creating clinical decision support logic using simple forms and exporting it as a Health Level Seven (HL7) Clinical Quality Language (CQL) artifact using the HL7 Fast Healthcare Interoperability Resources (FHIR) data model for integration with Electronic Health Records (EHRs). See: Clinical Decision Support Authoring Tool.

2. A CDS Artifact is submitted to the Repository by first completing the registration process to create a user account, then agreeing to these Terms and Conditions. With a registered user account, the Publishing Organization’s named Lead and Authors can submit the developed CDS Artifact to the Governor for review ahead of posting to the Repository. The Governor’s review is based on the Experimental and Status selections of the CDS Artifact. The Governor reviews the evidence, metadata, value sets, and documentation, with Section 508 accessibility, as applicable to the CDS.

3. A CDS Artifact is included in the Repository after it is demonstrated that the Publishing Organization has, as applicable:

• Used best-in-class evidence-based source(s) (i.e., clinical practice guidelines, peer-reviewed articles, local best practices, and clinical quality measures)
• Populated required metadata fields
• Use best-in-class value set, ideally drawing from existing value set instead of creating a de novo value set representative of clinical concept
• Assured Section 508-accessible documentation files

If accepted for inclusion, then the Publishing Organization’s named Lead and Authors are advised to use the following citation to reference the CDS Artifact:

• LastName, FirstName. (Date published). Title. CDS Connect Repository. Available here: Insert Link.

4. A CDS Artifact that is accepted for inclusion in the repository shall be maintained by the Publishing Organization Lead through a regular review of the evidence, metadata, value sets, and documentation, as relevant to its combination of responses to Experimental and Status metadata fields. The objectives of reviewing a submission and maintaining a CDS artifact are to encourage the Governing Organization to build and maintain trust in the CDS through use of current clinical evidence and health IT standards.

• The notification process to ensure artifacts are maintained is as follows:
  • Governor will send email reminder to Publishing Organization’s named Lead and Authors if no content is reviewed/updated 9-months before the one-year mark.
  • Governor will send email reminder to Publishing Organization’s named Lead and Authors if no content is reviewed/updated 3-months before the one-year mark.
  • Governor will send email reminder to Publishing Organization’s named Lead and Authors if no content is reviewed/updated 1-month before the one-year mark.
  • Governor will notify Publishing Organization’s named Lead and Authors that the artifact(s) will be flagged starting the next day when the one-year mark is reached. The flagging will occur in the search results and detail to notify potential users that the material may be outdated.
• The specific review process is dependent upon the CDS Artifact’s Experimental and Status indications and is detailed on the CDS Connect website.

Author: contributor to creation and modification of a CDS Artifact, but not necessarily the Publishing Organization or its Lead, who are the stewards and responsible parties for the CDS Artifact.

Authoring Tool: tool to promote the creation and use of clinical decision support in everyday clinical settings through an interface for creating clinical decision support logic using simple forms and exporting it as Health Level Seven (HL7) Clinical Quality Language (CQL) artifacts using the HL7 Fast Healthcare Interoperability Resources (FHIR) data model for integration with electronic health records (EHRs).

Clinical Decision Support: CDS encompasses a variety of tools to enhance decision-making in the clinical workflow. It is a representation that provides clinicians, staff, patients or other individuals with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care.

CDS: See “Clinical Decision Support.”

CDS Artifact: actionable medical knowledge (e.g., clinical practice guidelines, peer-reviewed articles, local best practices, and clinical quality measures) translated into computable and interoperable decision support.

Governor: oversees and administers all activity within CDS Connect from a technical, process and systems perspective (currently The MITRE Corporation).

Governing Organization: organization that owns and oversees CDS Connect (currently AHRQ).

GO: See “Governing Organization”

Governing Organization Lead: represents the GO on all matters related to the CDS Connect resource.

Patient Centered Clinical Decision Support: CDS (See “clinical decision support”) for use by patients.

Patient Centered Outcomes Research: helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options.

PCOR: see “Patient Centered Outcome Research.”

Publishing Organization: legally owns and is responsible for a CDS Artifact from the clinical content perspective, including best efforts to review and maintain CDS Artifacts that are not Experimental and Active for clinical use. In some instances, an individual could be the Author, Publishing Organization Lead, and Publishing Organization.

Publishing Organization Lead: represents the publishing organization as the decision maker for all the organization’s activities within CDS Connect.

Repository: includes CDS Artifacts.

Section 508: section 508 requires that all website content be accessible to people with disabilities: https://www.hhs.gov/web/section-508/index.html.

The following expectations apply to all Publishing Organizations of CDS Artifacts to the Repository and are acknowledged by the Publishing Organization Lead to promote trust in the content posted to the Repository.

1. Publishing Organization acknowledges that execution of these terms and conditions is a condition of inclusion of one or more CDS Artifacts to the Repository.
2. Eligibility to Submit CDS Artifacts. See the specific review process that is dependent upon the CDS Artifact’s Experimental and Status indications and is detailed on the CDS Connect website
3. Publishing Organization acknowledges that the sole purpose of restricting eligibility to submit artifacts to the Repository is to identify entities qualified to develop and maintain CDS Artifacts to assure Repository users can trust the content.
4. Publishing Organization acknowledges and accepts the criteria and standards set out at Section B (above) for development, submission, inclusion, and maintenance of CDS artifacts included in the Repository.
5. Publishing Organization acknowledges that the Governor makes the final decision as to inclusion and retention of a CDS Artifact or Artifacts in the Repository and that there is no process for protesting or appealing the outcomes of that decision, aside from resubmission.
6. Publishing Organization acknowledges that Governor support for an Author extends only to provision of the Repository and resources necessary to submit CDS Artifacts for inclusion in the Repository and to perform review of CDS Artifacts in connection with the process for maintenance of such artifacts in accordance with Section B above.
7. Publishing Organization Lead acknowledges that CDS Connect is not a part of the AHRQ grants process and that acceptance of an CDS Artifact contributed to the Repository is not the award of or equivalent to a grant but results only in the placement of the CDS Artifact in question in the Repository and neither guarantees nor restricts eligibility or qualification for future awards.
8. Intellectual Property - Publishing Organization acknowledges that the basic purpose of CDS Connect is to advance evidence into practice through CDS and to make CDS shareable, standards-based, and publicly available and further understands and agrees that, as a condition of acceptance for inclusion in the Repository,. Publishing Organization will grant to Governing Organization a limited license authorizing public dissemination of the CDS artifact and providing other permissions necessary to use and maintain the CDS artifact in accordance with the terms and conditions of this website. Publishing Organization Lead acknowledges the requirements of U.S Copyright Law, including the FAQ with procedures for Copyright Complaints.
9. Publishing Organization acknowledges that the Governing Organization reserves the right to modify the above-described Develop, Submit, Include and Maintain processes in Section B.
10. Publishing Organization acknowledges that the Governing Organization reserves the right to revise this Terms & Conditions document to conform its provisions to changes, if any, in either the governance structure or the processes identified in Section B.
11. Publishing Organization acknowledges that all documents submitted with a CDS Artifact, regardless of Experimental or Status responses, will be assessed by the Governor for 508 accessibility and the Publishing Organization will be responsible for creating an accessible document, as per AHRQ’s 508 accessibility guidelines.
12. Publishing Organization acknowledges at least one email address will be posted with a CDS Artifact to allow users to contact the Publishing Organization about the CDS Artifact. The Publishing Organization may include additional Author emails at its discretion. The Governor will make reasonable efforts to prevent Spam being sent to the posted email.
13. The Author and Publisher acknowledge that by accepting an artifact for inclusion in the Repository the Governing Organization is representing only that the artifact has met the requirements set out in Section C above. The Author and Publisher further acknowledge the disclaimer information at https://cds.ahrq.gov/disclaimer.
14. Security – CDS artifacts must comply with federal security laws that include, but are not limited to, the HHS Information Security and Privacy Policy (IS2P); the AHRQ Information Security and Privacy Policy/Management Operations Manual (MOM) Instruction; Federal Information Security Modernization Act (FISMA) of 2014, (44 U.S.C. 101); National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53, Security and Privacy Controls for Federal Information Systems and Organizations; Office of Management and Budget (OMB) Circular A-130, Managing Information as a Strategic Resource; and other applicable federal laws, regulations, NIST guidance, and Agency policies. Developers of CDS artifact computer software shall ensure IT applications are designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges. Contractors shall follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP), which will limit system software vulnerability exploits. Contractors shall ensure that computer software developed on behalf of HHS or tailored from an open-source product is fully functional and operates correctly on systems configured in accordance with government policy and federal configuration standards. Contractors shall test applicable products and versions with all relevant and current updates and patches updated prior to installing in the HHS/AHRQ environment. No sensitive data shall be used during software testing. Contractors shall protect information that is deemed sensitive from unauthorized disclosure to persons, organizations, or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably-available information, is deemed sensitive or proprietary by HHS/AHRQ shall be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. The CDS artifacts applications must: (1) preserve confidentiality, i.e. authorized restrictions on access and disclosure, protect personal privacy and proprietary information; protect against disclosure of PII information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual; and protect against storage, processing transmittal and disclosure of sensitive information in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution; (2) preserve integrity, i.e. guard against improper information modification or destruction, and ensure information non-repudiation and authenticity; and (3) preserve availability, i.e. ensure timely and reliable access to and use of information. Also, the CDS artifact application must ensure use of, as applicable via public website access, Hypertext Transfer Protocol Secure (HTTPS), using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. Also, the system, as appropriate, should implement FIPS 140-2 validated encryption that provides for origin authentication, data integrity, and signer non-repudiation.

Publisher and Author/s acknowledge that submission of a CDS artifact to the Repository constitutes acceptance of these terms and conditions. See a workflow of the governance process at: https://cds.ahrq.gov/cdsconnect/governance.