Prescribing wearable tech.

Area of Science:

• Health Informatics
• Regulatory Science
• Digital Health

Background:

• Wearable devices (smartwatches, fitness bands) are increasingly proposed for healthcare applications.
• Governments in the USA, UK, and globally are interested in their potential to improve treatment and reduce costs.
• The transition of wearables from consumer to health contexts introduces complex regulatory challenges.

Purpose of the Study:

• To examine the regulatory challenges associated with using wearable devices in healthcare.
• To investigate the adequacy of current data protection regulations for health-related wearable data.
• To explore alternative regulatory models for public healthcare systems using wearables.

Main Methods:

• Exploratory analysis of regulatory challenges.
• Empirical research based on a Freedom of Information request to 37 UK National Health Service Hospital Trusts.
• Examination of existing regulations such as the EU General Data Protection Regulation 2018 and the UK Data Protection Act 2018.

Main Results:

• Wearable device data generation poses significant data protection, privacy, and surveillance concerns.
• Empirical research casts doubt on the appropriateness of individual consent for data processing in healthcare settings with unequal power dynamics.
• Existing regulations based on consent may be insufficient for the complexities of health wearables.

Conclusions:

• Current regulatory frameworks may not adequately address the unique challenges of health data from wearable devices.
• Alternative models like open data and data sovereignty should be considered.
• Protecting patient trust and confidence is paramount for the successful integration of wearables into public healthcare systems.