Regulatory Framework for Clinical Decision Support Software: Present Uncertainty and Prospective Proposition

Area of Science:

• Health Informatics
• Regulatory Science
• Medical Device Regulation

Background:

• Clinical decision support (CDS) software lacks clear regulatory guidance in the US.
• Distinguishing between regulated medical devices and health management software with patient care impact is ambiguous.

Purpose of the Study:

• To advocate for regulatory clarity in US clinical decision support (CDS) software.
• To propose criteria for differentiating regulated CDS from unregulated software.

Main Methods:

• Analysis of current US regulatory landscape for CDS.
• Review of potential frameworks for future CDS regulation.

Main Results:

• Current US regulatory guidance for CDS is insufficient.
• Ambiguity exists regarding the classification of CDS software.

Conclusions:

• Urgent clarification is needed to define regulated medical devices versus health management software.
• Establishing simple, detailed criteria for CDS regulation is crucial for safety and innovation.
• The "substantial dependence" standard should be considered for the US CDS regulatory framework.