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An app as a medical device?

The use of apps as medical devices can be advantageous for both patients and care providers, on condition that these products are thoroughly investigated and conform to the requirements for medical devices. The study discussed in this Ge-Bu article concerns the use of a smartwatch app to screen for atrial fibrillation, and illustrates the possibilities and limitations of research into new technologies. The study collected cardiac rhythm data using an app for smartwatch, and then used these data to detect possible atrial fibrillation.

  • The authors of the Apple Heart Study conclude that smartwatch messages signalling an arrhythmia in the wearer are predictive of atrial fibrillation in 70% of cases.
  • The shortcomings of the study preclude a definitive conclusion that the app is suitable to screen for atrial fibrillation.
  • Care providers will in the future be more frequently faced with patients with a smartwatch-based diagnosis, as the manufacturers of such apps refer patients to them.
  • Without accurate information about the value and mode of operation of the app, it is difficult to estimate the health risks associated with an app message.
  • In addition to the danger of medicalisation, there is a risk that patients with morbidity are unjustly reassured by the absence of app messages.

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  • Anton J.F.A. Kerst, dr
  • Peter H.Th.J. Slee
  • Marielle A.E. Nieuwhof, pharmacist