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Actual and potential harm caused by medical software

A rapid literature review of safety and performance issues
16 July 2020
Download Actual and potential harm caused by medical software


The advent of widespread software resources, particularly those accessible through smart phones and smartphone apps has led to public expectations that digital health and medical information will be easy to access via apps and that such information will also be reliable. In 2018, over a third of adults were self-diagnosing health conditions by going online, and by 2020 over half a million health apps were available in major app stores. This is despite there being no way for consumers (or their healthcare providers) to verify the safety, accuracy or effectiveness of this software.

At the same time, the increasing adoption of digital health technologies and the enhancement of traditional medical software used in or as medical devices has increased its complexity and usage. This includes the rapidly developing software specialisation of artificial intelligence. The current COVID-19 pandemic is also thought to have accelerated the implementation and adoption of digital health, making remote consultations and diagnosis much more frequent, so consumers, medical professionals and patients will particularly need medical apps to be reliable and safe.


  1. Introduction
  2. Methods
  3. Software role in device recalls
  4. Software safety - summary of reviews and meta-analyses
  5. Issues with specific types of products
  6. Conclusion
  7. References

Version history
Version Description of change Author Effective date
V1.0 Original publication Devices Emerging Technology & Diagnostic July 2020

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