Date
July 10, 2023
A recent review article in the International Journal of Medical Informatics reviewed current and changing regulations related to the use of apps in healthcare.
Three topics were discussed: 1) the relevant European legislation and its enforcement, 2) the responsibilities and liability of the medical professional when using these apps, and 3) an overview of the most practical considerations medical professionals should know when using or building a medical app.
The review concluded that the important guidelines for manufacturers to comply with the Medical Devices Regulation are ISO 13485, ISO 17021, ISO 14971 and ISO/TS 82304–2.
The article also provided a comprehensive checklist for anyone wanting to start using or building medical apps.
The full article can be viewed here: https://www.sciencedirect.com/science/article/pii/S1386505623001594
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