In a recent position paper, the European Consumer Organisation (BEUC) comes back on the potentially serious risks for consumers entailed by mobile health applications and devices. To reverse the trend, it formulates several recommendations to be taken at the European Union level:
1. Clearly define ‘mhealth’
A more effective regulatory framework should cover all mhealth solutions. This would
oblige manufacturers to play by the same rules and provide the same high quality level
of information to consumers. At the moment, only a minority of tools is covered by
specific laws, i.e. those regulating medical devices and in vitro diagnostic devices.
2. Ensure legal accountability and right to redress
Bad quality mhealth solutions may harm consumers. But who is responsible? Liability
should be clear for all mhealth solutions, not just for medical devices and in vitro
diagnostic. Consumers should also be given tools to claim redress.
3. Guarantee privacy and data protection
Consumers have the right to data protection, especially when related to their health.
Privacy settings should be embedded from the manufacturing stage. As for data
collection, it should be limited to the essential functioning of the device.
4. Set simple and fair Terms and Conditions
Consumers can effectively understand and take decisions only if terms and conditions are
clear and transparent.
5. Ensure security at all stages
Mhealth solutions should embed specific safeguards at each stage of data processing.
This should include the encryption of patients’ data and authentication mechanisms to
beef up protection.
6. Label apps’ target audience
Some apps are intended for consumers while others aim to support healthcare
professionals. To prevent consumer misuse, developers should specify the target
audience of each app.
7. Ensure mhealth does not widen gaps in access to care
The uptake of mhealth goes hand in hand with mobile internet availability, which is
unequal from one country to another. To prevent health disparities within the EU,
Member States need to promote digital and health literacy before promoting mhealth.
Read the full position paper: