Patient risks and benefits associated with non-medical device software

Every couple of years the FDA publishes report that lists patient risks and benefits associated with non-medical device software (i.e. software that is not regulated by the FDA).

Examples of non-device software:

• Administrative support of health care facilities.

• Encouraging a healthy lifestyle.

• Serving as electronic patient records.

• Transferring, storing, converting formats, or display of data.

• Providing limited clinical decision support.

Examples of patient risks associated with non-device software per 2022 report:

• Electronic Patient Records – an incorrect patient selection for medication refill

• Transferring, storing, converting formats, or display of data – a system displayed the wrong patient data and the wrong time the test was done

Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles | FDA