What are Digital Biomarkers and Digital Health Technologies (DHT)?
Digital biomarkers are precise digital measurements that quantify health conditions and medical progress. They are generated by sensors and wearables and provide real-time data for clinical studies and medical research.
Digital Health Technologies (DHT) are advanced software applications and platforms that can collect, analyze and interpret health data. They range from telemedicine apps to wearables and enable seamless data collection and interaction with patients.
Why are they important?
The use of digital biomarkers and digital health technologies in clinical trials brings many advantages. These are for example:
Digital biomarkers and digital health technologies enable continuous monitoring of patient data in their natural environment. This allows for more accurate results.
These technologies also improve patient recruitment and retention. This is because digitalization has made study participation more convenient and appealing.
In addition, digital biomarkers and digital health technologies enable individualized medicine by providing precise data for each participant.
What is important in the development of digital biomarkers and digital health technologies?
Data security
Data security is the top priority during development, as the solutions must comply with data protection regulations and meet the relevant international and national regulations for clinical trials.
Interoperability, Usability and Scalability
These three factors are also crucial to ensure that the technologies can be seamlessly integrated into existing systems. With a reduced design control process, we ensure that the performance requirements for digital health technologies are met and documented for verification.