Legal Advice on Wearables in Healthcare

What are wearables in healthcare?

Wearables, or tracking devices, are devices that continuously monitor vital signs to promote preventive health measures and are generally considered to be part of the Internet of Things. Common applications include ECGs, glucose monitors (CGM) or blood pressure monitors. Vital signs are usually measured using wristbands or watches, or biosensors in the form of patches.

What are the challenges facing developers and providers of health wearables?

• Privacy:
  The privacy requirements for processing health data are particularly high because of the sensitive nature of the data. Privacy by design and by default is particularly important.
• Information security:
  Providers will need to implement comprehensive cybersecurity measures to protect sensitive health data from cyber-attacks and unauthorised access.
• Consent management:
  Users must be able to give their consent to data processing in a targeted and transparent way. This is particularly difficult for wearables without an application interface.
• Data re-use:
  The processing of health data that has already been collected for research purposes or product improvement is subject to particularly strict regulations.
• Involvement of external service providers:
  Service providers involved in data collection, storage or processing must meet strict requirements and be contractually involved in data processing (e.g. order processing agreements).
• Interoperability:
  Developers and vendors must ensure that data can be transferred across devices and systems without altering the data.