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 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:

• Aziz Boxwala, MD, PhD
• Rachel Richesson, PhD, MS, MPH