Insight

Feb 10, 2025, 10:52

Tanja Obradovic: How current FDA policy can affect advances in AI

Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared a post on LinkedIn about a paper by Scott Gottlieb published in JAMA Health Forum:

“Very insightful and important article today by Scott Gottlieb on how current FDA policy can affect advances in AI and possible hurdles when it comes to novel AI tools that synthesize complex clinical information from distinct sources such as those integrated into electronic medical record (EMR) software that may automatically be classified as medical devices, regardless of their intended use.

Several points to highlight:

AI tools in the realm of clinical decision support software (CDSS) are classified as a ‘device’, under FDA oversight unless they offer nonmandatory, informational recommendations to clinicians without overriding their clinical judgment.
AI functionality that is integrated into an EMR (and possibly EMR itself) can fall under FDA premarket review when software integrates data from multiple sources (such as imaging, consultation reports, and clinical laboratory results) since data condensation/reasoning is not transparent to clinicians. As a consequenceAI decision tools CDSS are developed as add-ons outside of EMR that limits use and full potential of the novel powerful AI tools.
Possible solution commented is following intent of established policies under the 21st Century Cures Act and updates to focus on regulating presentation to clinicians and emphasis on the point that CDSS AI are decision-aid tools rather than autonomous definitive decision-making resources.

It remains to been seen if important comment about future is considered by FDA allowing EMR providers to come to market with properly designed and validated tools but mandate real-world evidence (RWE) studies in the postmarket setting to verify if these tools genuinely enhance the quality of medical decision-making.

This debate remains critical for all stakeholders as healthcare and Pharma community ultimately need to realize full potential of AI advances toward increasing patient benefit and quality of care.”

“New FDA Policies Could Limit the Full Value of AI in Medicine”

Author: Scott Gottlieb

Tanja Obradovic: How current FDA policy can affect advances in AI