Lack of regulation
One of the main findings of the paper is that the divide between "wellness" devices that encourage a healthy lifestyle (for example the Apple Watch or Fitbit) and medical devices are beginning to blur. A good example of this is that recent series of the Apple Watch have received medical approval to monitor atrial fibrillation - a heart condition that causes an irregular and often abnormally fast heart rate.
However, there is currently a lack of regulation for wellness devices. One example of this is that no current legislation exists to stop companies from collecting data from each user, which can be used in targeted advertisements and product development. If future wearables can monitor more about us, then this lack of regulation could lead to more and more personal data being susceptible to misuse.
Panel discussion
In a joint event between IMSE and The Forum, representatives from the Medicines and Healthcare products Regulatory Agency (MHRA), the Information Commisioner's Office and researchers from Imperial discussed how clear guidance on wellness devices is needed now.
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