Digital Health Supporting Digital Wearables

There is already significant market potential being realised from wearable technology devices and the growth in this sector is undeniable. However, risks around liabilities that can be incurred have to be recognised however great the opportunities are.

All wearable devices are ‘smart’ and share three common technologies:

1. Sensor that monitor and capture the users
2. Microprocessors that convert the data digitally into a format that can be sent
3. Transmitters that send the data usually wirelessly for analyses or reporting or further processing

As with other areas of Digital Health, all participants and stakeholders in providing the service, including healthcare professionals, designers, technology and software developers and manufacturers are interlinked and there are significant liability risks for all those involved in providing such services.

The lines between the differing parties can be blurred when it comes to the question of liability and
accountability may not be clear between the separate parties. In the event of a mis-diagnosis or fault with the device, does this link to the technology and software that is involved or other partners in the chain who may be held liable for compensation for errors or omissions raised by user?

There are liability risks for those involved in providing such services.

• Companies that handle data collected from the device if part of the service. Those that are designing, developing, manufacturing and selling, examples include fitness trackers, head and eye mounted displays, smart jewellery and watches and more.
• Companies in a vendor capacity, i.e. software houses The range of examples is endless, from data security concerns i.e. hacking and theft of users details, through to the failure of software in a device causing an injury or worse.

As time moves on and the popularity of such wearable devices increases, there will be an emergence of new and evolving risks. A good insurance programme is of course a backstop for the potential financial impact of such risks.

Claims examples

1. Many wearables and healthcare devices are open to attack due to vulnerable data transfer protocols¹. This leaves personal data at risk of theft, and cyber-criminals
   could exploit issues around such data transfer.
2. The wearable device may provide telemedicine health counselling, based on feedback of a biological nature secured by the device. Where algorithm-bias on wearable devices leads to inappropriate medical advice, or if such data was being shared with a professional healthcare provider or GP, any mis-diagnosis or prescriptions provided would potentially leave the device designers, the software companies involved with the data captured and sent and the GP open to claims for resultant injury, bodily damage or death.

Examples of claims scenarios are not based on actual claims, but are highlighted and shared to evidence where claims may emanate, it should also be noted that insurance coverage provided is very much on a client by client basis so may not provide all the coverage for the examples shown in this ‘discussion document’.
 

¹ https://usa.kaspersky.com/about/press-releases/2022_33-vulnerabilities-found-in-the-data-transfer-protocol-for-wearablemedical-devices