Digital biomarkers explained: from wearable devices to NHS apps

Learn about digital biomarkers, their types, and how they are used in remote monitoring with devices like Apple Watch, Fitbit, and Oura

Digital biomarkers are physiologicalbehavioralor passive indicators of a person’s health, typically collected through wearable devices or mobile apps. These biomarkers can provide valuable insights into an individual’s health status, enabling early intervention and personalized care.

The use of digital biomarkers is becoming increasingly relevant in healthcare, as it allows for remote monitoring and early detection of potential health issues.

Wearable devices like Apple Watch, Fitbit, and Oura are popular examples of how digital biomarkers are being used to track various aspects of health, including physical activity, sleep patterns, and heart rate.

Digital biomarker types

There are three main types of digital biomarkers: physiologicalbehavioraland passive.

Physiological biomarkers measure physical characteristics, such as heart rate or blood pressure. Behavioral biomarkers track lifestyle habits, like exercise or diet. Passive biomarkers collect data without requiring direct user input, such as location tracking or environmental monitoring.

Remote monitoring with wearable devices

Wearable devices like Apple Watch, Fitbit, and Oura are equipped with sensors that collect data on various aspects of health, including physical activity, sleep patterns, and heart rate. This data can be shared with healthcare providers through mobile apps, enabling remote monitoring and personalized care. The NHS App, for example, allows users to share their health data with healthcare providers, facilitating more effective care and treatment.

Data protection and GDPR

The use of digital biomarkers raises important concerns about <em:data protection and privacy. The General Data Protection Regulation (GDPR) sets strict guidelines for the collection, storage, and use of personal data, including health data. Healthcare providers and device manufacturers must ensure that they comply with these regulations to protect users’ sensitive information. The NHS Digital Technology Assessment Criteria (DTAC) also provides a framework for evaluating the safety and effectiveness of digital health technologies, including those that use digital biomarkers.

Medical device claims and MHRA guidance

When making claims about the health benefits of digital biomarkers or wearable devices, it is essential to follow the guidance set by regulatory bodies like the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA provides guidelines for the evaluation and approval of medical devices, including those that use digital biomarkers. Manufacturers must ensure that their claims are supported by robust evidence and comply with regulatory requirements to avoid misleading advertising or unsubstantiated claims.