As we come to the end of 2017, I’m proud of the significant progress the FDA’s digital health team has made on the Action Plan. We launched the Pre-Cert pilot and selected nine diverse companies to participate. We also have invested in hiring additional talent for our digital health team, including announcing the Entrepreneurs in Residence program. Yet, we recognize there’s more work to do.

Today, we’re announcing three new guidances – two draft and one final – that address, in part, important provisions of the 21st Century Cures Act (“Cures Act”), that offer additional clarity about where the FDA sees its role in digital health, and importantly, where we don’t see a need for FDA involvement. We’ve taken the instructions Congress gave us under the Cures Act and are building on these provisions to make sure that we’re adopting the full spirit of the goals we were entrusted with by Congress.


The first draft guidance, “Clinical and Patient Decision Support Software,” outlines our approach to clinical decision support software (CDS). CDS has many uses, including helping providers, and ultimately patients, identify the most appropriate treatment plan for their disease or condition. For example, such software can include programs that compare patient-specific signs, symptoms or results with available clinical guidelines to recommend diagnostic tests, investigations or therapy. This type of technology has the potential to enable providers and patients to fully leverage digital tools to improve decision making. We want to encourage developers to create, adapt and expand the functionalities of their software to aid providers in diagnosing and treating old and new medical maladies.

This draft guidance is intended to make clear what types of CDS would no longer be defined as a medical device, and thus would not be regulated by the agency. For example, generally, CDS that allows for the provider to independently review the basis for the recommendations are excluded from the FDA’s regulation. This type of CDS can include software that suggests a provider order liver function tests before starting statin medication, consistent with clinical guidelines and approved drug labeling.

However, the FDA will continue to enforce oversight of software programs that are intended to process or analyze medical images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations, as these remain medical devices under the Cures Act. For example, we would continue to oversee software that analyzes data from a patient’s spinal fluid test to diagnose tuberculosis meningitis or viral meningitis. These are areas in which the information provided in the clinical decision software, if not accurate, has the potential for significant patient harm, and the FDA plays an important role in ensuring the safety and effectiveness of these products.

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