Should we be wary of wearable data?
The devices used and data generated are not governed under the Medical Device Regulation as they are not classified as ‘medical grade’.
And in fact, this form of technology isn’t regulated...or even standardised...but what does this mean?
Firstly, does the data generated meet the requirements for clinical use? If devices aren’t being produced in a coherent fashion, then maybe what one device tracks for one trial, would be captured and interpreted differently in another clinical trial.
Additionally, if these devices aren’t being qualified/validated for the purpose of each clinical trial, then this raises questions concerning the reliability of the subsequent data.
Data must be verified for it to be meaningful.
“Securing wearable data is important but how good is the data itself?
Although wearables are increasingly gaining some degree of clearance or approval by the FDA, doctors may dismiss the data since consumer wearable companies are not held to the kinds of safety and liability standards that medical providers are5."
Could the lack of clarity and rules diminish trial outcomes as well as question the data’s reliability?
Red Flags
- What data is being collected and for what purpose?
- Is over-collection of data happening? If so, what happens to this data?
- How is this data being analysed, transferred and archived in a way that ensure integrity remains intact?
- Is the data encrypted? Secure?
- If it’s being collecting via a mobile app, how secure is the network or connectivity that is being used?
These raise ethical, technical and data integrity concerns. If these devices and their data aren’t governed by regulatory rules, then it goes to follow that data management guidelines also are unlikely to be closely adhered to. This leaves the door open for potential security threats, unconvincing data results, lack of integrity and many more concerns.
Data security and privacy are crucial elements of the long-term data strategy which must be considered.