1.1 Is it considered a “medical device,” and if so, under what regulations?
Generally, the software within digital health apps may be qualified as a “medical device”, if it is intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
The definition of a medical device covers both standalone software and software that is used in combination with a device and is established by Technical Regulation No. 753 on Medical Devices.
All standalone and embedded software is currently regulated by Technical Regulation No. 753 on Medical Devices, save for in vitro diagnostics software, covered by Technical Regulation No. 754 on in vitro diagnostics Medical Devices, and any implantable devices software, covered by Technical Regulation No. 755 on active implantable Medical Devices.
1.2 Is it considered a “product” to which civil liability can attach, and if so, under what regulations?
Manifold definitions of “product” (including “an item of movable property, including electricity” in the product liability law, and “any substance, preparation or other product produced in the course of production activity” in the product safety, and conformity assessment laws), as well very little court practice of its application in general, and no known to us court practice of its application to software in particular, makes it currently unclear whether software within digital health apps alone would be qualified as a product.
In case of embedded software (used in combination with a device), the device along with software contained in it would be covered by general product liability rules.
1.3 If your response to (b) is yes, please state whether there are any exclusions/exemptions applicable with regard to liability, and/or whether those are applicable only under certain circumstances (e.g., for in-hospital use)?
No specific exceptions or exemptions to liability are provided for medical devices or software contained in such devices either by the relevant Technical Regulation or product liability legislation.
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