In our first article about medical apps, we already explored the question: App or medical device? Today we would like to extend the app by a device …
The idea of mobile ECG measurement is not entirely new (attention, advertising!) Nevertheless, the topic of wearable and medicine was recently reignited by the presentation of the Apple Watch 4.
We don’t want to give an assessment here, there have been enough articles about this. Instead, we will take a look at the FDA’s statement on classification and the associated positioning and classification options for medical devices:
The product does not claim to make a diagnosis, but simply gives the medical professional more objective assessment options than if the patient merely describes his symptoms.
Despite this limitation of purpose, the far-reaching context in which such products are developed and approved becomes apparent. Even such large companies as Apple have to go through the time-consuming approval procedures and the associated verification – a binding statement on the availability for the new function in Germany is still pending.
On the one hand, there are the classic areas of clinical data, usability, labeling, software verification & validation and risk management, and on the other hand, there are the more recent topics such as data protection, data security, cloud computing and cyber security that challenge manufacturers.
We would be happy to reveal in a personal discussion how products can be approved “smartly” without too many restrictions through a clever approval strategy, and how documentation can still retain a slim figure.
Further information and opinions on this topic can be found here:
Stanford Medicine Apple Heart Study
DGK press release on the Apple Watch (press release DGK 09/2018).
Please note that all data and listings do not claim to be complete, are without guarantee and serve purely for information purposes.
