Dive Brief:

• A trade group for clinical decision support companies filed a petition opposing the Food and Drug Administration’s final guidance on clinical decision support tools.
• The September 2022 guidance broadens the FDA’s oversight over software tools, including those that provide a specific diagnostic or treatment suggestion, which had previously been exempted. 
• The Clinical Decision Support Coalition said the agency’s oversight violates Congress’ intent in enacting the 21st Century Cures Act. The trade group says the new regulations dissuade innovation by “imposing arbitrary rules on technology development.” 

Dive Insight:

Clinical decision support encompasses a wide variety of software tools used to support decision-making by doctors, nurses and other healthcare providers. They include alerts to flag potential cases of sepsis, medication interactions and care reminders.

Under the 21st Century Cures Act, some of these systems had been exempted from FDA regulation if healthcare providers could independently review the basis of the recommendations, and don’t rely on them to make a diagnostic or treatment decision. Under the regulator’s final guidance in September, more predictive tools would now be regulated as medical devices, including software that analyzes patient information to detect potential stroke or sepsis, and alerts a healthcare provider. 

Some companies said the clarity was helpful, including Bayesian Health, which makes sepsis detection software, and Mayo Clinic, which is developing algorithms to detect heart conditions using ECG data. 

Others, including the Clinical Decision Support Coalition, say the final guidance “is at odds with these other federal policies and congressional intent” and could dissuade innovators from developing these tools.

In the petition filed by Bradley Merrill Thompson, an attorney with Epstein Becker Green, the group asked the FDA to rescind the final guidance and amend it. Notably, they want the agency to clarify that CDS software can recommend a single diagnosis or treatment pathway, and the time-critical nature of the decision would not automatically result in it being regulated as a medical device.

The FDA has six months to respond to the petition.