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.

Business colleagues reviewing documents in a board roomStandards 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 of the 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 of the EHR systems in which CDS 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 2023, the Workgroup will be focusing efforts on:

  • Developing an action plan, informed by an environmental scan, to address gaps in existing PC CDS standards and regulatory frameworks and advance PC CDS.
  • Developing a report of recommendations to improve interoperability of patient apps with the health IT ecosystem.
  • Compiling an action plan for standardizing the capture and use of patient preference data for PC CDS.

Workgroup Leadership:

Workgroup Products

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). 

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

Challenges and Opportunities for Advancing Patient-Centered Clinical Decision Support: Findings from a Horizon Scan
This May 2022 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. Click here to read the article.

Integrating a Patient Engagement App into an Electronic Health Record-Enabled Workflow Using Interoperability Standards
This December 2022 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. Click here to read the article.