Findings
A systematic approach is needed to assess the quality and utility of digital biomarkers.
Challenges exist in ensuring patient privacy and autonomy with remote monitoring.
Evaluating the validity and fit-for-purpose of digital biomarkers is difficult due to the interplay among hardware, sensors, and algorithms.
Cybersecurity challenges pose risks to privacy and safety.
Transparency of algorithms and interoperability of components are necessary for a safe digital biomarker ecosystem.

Recommendations
Promote transparency of algorithms used in digital biomarkers.
Ensure interoperability of components with open interfaces.
Establish strong incentive structures for the safe and effective use of digital biomarkers.
Continuously collect data and handle modifications over time in a learning digital health system.
Encourage collaboration among industry, researchers, regulators, clinicians, and patients.

Regulatory Considerations
The FDA’s regulatory process can address modular components of digital biomarkers.
The FDA is piloting a pre-certification program for streamlined product approvals.
New frameworks are emerging for security, ethics, and informed consent challenges in digital phenotyping technologies.