Has anyone any opinions (or official guidance) on whether medical transcription and/or translation software would be considered a medical device or not?
I'm thinking specifically software that takes an audio file and outputs a text file automatically, not software that helps a professional medical secretary to transcribe.
I'm also thinking of software that takes a text file of a medical record, transcription or instructions from a doctor to a patient and automatically translates it into another language.
Based on the MHRA guidance (https://assets.publishing.service.g...oftware_including_apps__including_IVDMDs_.pdf), I can see an argument that this is an administrative function, but also that is is providing information with a medical purpose and I'm wondering if anyone has seen anything more official from the MHRA on this or has a strong opinion one way or the other.
I'm thinking specifically software that takes an audio file and outputs a text file automatically, not software that helps a professional medical secretary to transcribe.
I'm also thinking of software that takes a text file of a medical record, transcription or instructions from a doctor to a patient and automatically translates it into another language.
Based on the MHRA guidance (https://assets.publishing.service.g...oftware_including_apps__including_IVDMDs_.pdf), I can see an argument that this is an administrative function, but also that is is providing information with a medical purpose and I'm wondering if anyone has seen anything more official from the MHRA on this or has a strong opinion one way or the other.