CDS Standards and Regulatory Frameworks Workgroup

What is needed to advance the adoption and use of standards for the development of patient-centered clinical decision support (PC CDS)? The CDS Standards and Regulatory Frameworks Workgroup is identifying and promoting the adoption of standards that support developers in creating PC CDS that can be used across systems and sites.

Standards are agreed-upon methods for connecting systems together and may pertain to security, data transport, data format or structure, or the meanings of codes or terms. CDS standards allow CDS tools to be shared, integrated, and implemented in various systems, including electronic health record (EHR) systems. Without standards, consistency and interoperability would be impossible, as many healthcare systems work in siloed health IT systems, often with different computing languages or standards. While many standards are available, new innovations in PC CDS, such as the use of data directly from patients and the use of artificial intelligence, may require additional standards development. There are numerous regulatory considerations for PC CDS as well, including the Food and Drug Administration’s (FDA’s) regulatory approach to CDS, the Centers for Medicare & Medicaid Services (CMS) Promoting Interoperability Rules, and the Office of the National Coordinator for Health IT certification standards for the EHR systems in which CDS tools are integrated. The Standards and Regulatory Frameworks Workgroup is identifying, monitoring, and promoting standards for the development of PC CDS and examining the current state of the regulatory environment that influences how PC CDS is developed and used. The Workgroup is working to recommend ways to enhance existing standards and identify areas where new standards and regulatory frameworks are needed. The reports, resources, ands tools developed by the Workgroup will support the creation of standards-based PC CDS that can be scaled across systems to support patients and clinicians in making evidence-informed healthcare decisions. Through Fall of 2024, the Workgroup will be focusing efforts on:

Developing a taxonomy of reasons for which PC CDS recommendations may be dismissed, or “overridden”, to advance research into reasons for PC CDS override and, ultimately, the development of more useful PC CDS.
Convening patients and other PC CDS experts in a multi-stakeholder roundtable to prioritize patient preference domains/sub-domains for standardization that will inform an action plan for the incorporation of this data into PC CDS.

Workgroup Products

Standards and Regulatory Frameworks Workgroup: Prioritizing Patient Preferences for Standardization to Support PC CDS

This report explores the standardization of patient preference information for inclusion in patient-centered clinical decision support.

CDS Standards and Regulatory Frameworks Workgroup: An Initial Taxonomy of Override Reasons for Patient-Centered Clinical Decision Support (PC CDS) Recommendations

This taxonomy provides a shared set of override domains that can be used by developers and researchers when analyzing why users do not accept patient-centered clinical decision support guidance.

An Overview of Standards for Patient-Centered Clinical Decision Support

This factsheet describes available standards and future opportunities for the patient-centered clinical decision support technical landscape.

Standards and Regulatory Frameworks Workgroup: Improving Interoperability of Patient Apps with the Health IT Ecosystem

This report identifies opportunities for improving patient app interoperability to advance patient-centered clinical decision support.

Standards and Regulatory Frameworks Workgroup: Improving Interoperability of Patient Apps with the Health IT Ecosystem

This report identifies opportunities for improving patient app interoperability to advance patient-centered clinical decision support.

Standards and Regulatory Frameworks Workgroup: Advancing Standardized Representations for Patient Preferences to Support Patient-Centered Clinical Decision Support

This report describes standards for patient-preferences data.

Standards and Regulatory Frameworks Workgroup: Environmental Scan

This environmental scan reveals opportunities to evolve standards and regulatory frameworks to advance patient-centered clinical decision support.

Related Resources

Infographic: Patient-Centered Clinical Decision Support Explained

The Clinical Decision Support Innovation Collaborative (CDSiC) created this infographic to explain the definition of patient-centered clinical decision support (PC CDS).

Challenges and Opportunities for Advancing Patient-Centered Clinical Decision Support: Findings from a Horizon Scan

This article published in the Journal of the American Medical Informatics Association (JAMIA) shares findings from a horizon scan conducted to identify challenges in patient-centered clinical decision support (PC CDS) and identify future directions for PC CDS.

Integrating a Patient Engagement App into an Electronic Health Record-Enabled Workflow Using Interoperability Standards

This article published in Applied Clinical Informatics (ACI) describes the process of using interoperability standards to integrate a COVID-19 Tracker mobile application within an EHR.

CDSiC CDS Standards and Regulatory Frameworks Workgroup Charters

CDSiC CDS Standards and Regulatory Frameworks Workgroup Charter - Option Year 2

The CDS Standards and Regulatory Frameworks Workgroup Option Year 2 Charter is a document that describes the purpose, goals, and key activities of the Workgroup under the CDSiC Stakeholder Community and Outreach Center.

CDSiC CDS Standards and Regulatory Frameworks Workgroup Charter - Option Year 1

The CDS Standards and Regulatory Frameworks Workgroup Option Year 1 Charter is a document that describes the purpose, goals, and key activities of the Workgroup under the CDSiC Stakeholder Community and Outreach Center.

CDSiC CDS Standards and Regulatory Frameworks Workgroup Charter - Base Period

The CDS Standards and Regulatory Frameworks Workgroup Base Period Charter is a document that describes the purpose, goals, and key activities of the Workgroup under the CDSiC Stakeholder Community and Outreach Center.