Can Software be Regarded as a Medical Device?

For many years, software has been a great part of our lives right from the operating systems on our computers, up to the phones. They generally make our lives easier. They enable the user to communicate with the machines more effectively and allow automation.

IBM’s 360 was the first software system ever developed with the capability of running different applications at the same time.  And as many will agree, advancements in software since IBM’s 360 up until the 21st Century, has seen some of the fastest growth metrics. We are now even beginning the new age of artificial intelligence.   

But I’ve always wondered to myself, “What exactly is Software as a Medical Device (SaMD)?”

 “Is there even such a thing as software being regarded as a device?”

Well, the US FDA published a draft guidance document on Software as a Medical Device (SaMD) in August of 2016. In that document, it defined SaMD as:

“Any apparatus, appliance, software, material, or other article intended by manufacturer to be used for human beings for the purpose of:

Diagnosis, prevention, monitoring, treatment or alleviation of disease;

Medical Software

Diagnosis, monitoring, treatment, alleviation, or compensation for an injury or handicap;

Investigation, replacement, or modification of the anatomy or of a physiological progress;

Control of conception; and which does not achieve is principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which maybe in its function by such means.”

From the above definition, it seems quite clear that the US FDA regards Software in hospitals and medical centers as a medical device.

The big question right now is; do medical industry players in Uganda share the same opinion? And does it really matter whether software in a hospital is a medical device?  


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