Authored by: Laura Kanov, Senior Vice President, Product Strategy
In case you missed the update[1], the FDA is now looking more closely at predictive analytics software to classify as a medical device and therefore fall under the regulations associated with other medical devices, which can include both pre-market and post-market compliance.
The concern they have is that AI technology may provide prescriptive or diagnostic advice or strong implication without having a clinical professional review those implications or have insight into what was driving those implications – therefore putting the patient/individual at risk.
Be sure the predictive analytics you choose is either excluded from the new definition of a medical device, or approved by the FDA under this new scrutiny. Those not meeting either of those criteria will incur a future burden to meet and maintain the guidelines which may impact their abilities to innovate or serve existing clients, or withdraw from the market altogether.
HBI Spotlight Analytics truly supports the health care professional without replacing their clinical judgement. Learn how we can support your acute, readmission/transition or population risk needs now.
[1] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software