Findings
Lack of security and confidence in digital health technologies hampers adoption.
Absence of suitable guidance for selecting BioMeTs based on clinical requirements.
BioMeTs (DHTs) and algorithms are often created without expert guidance and transparency.
No standardized evaluation resources for testing, verifying, and validating BioMeTs.
Inconsistencies in algorithm application across different cohorts.
Recommendations
Develop a standardized BioMeT and algorithm evaluation framework.
Create professionally tailored standardized guidelines for BioMeT use.
Implement a framework with unique identifiers for BioMeTs and algorithms.
Establish mechanisms for dynamic updates of hardware or software.
Use systematic reviews and Delphi processes to inform framework development.
Regulatory Considerations
Assign unique identifier numbers to BioMeTs and algorithms.
Provide mechanisms for dynamic hardware or software updates.
Ensure robust deployment through standardized evaluation protocols.