Table 2.

How pharmaceutical companies can implement digital biomarkers and account for environmental context

Barriers to implementation	Considerations
1 Accuracy thresholds and validity	Establish guidelines for how novel digital biomarker technology should be validated; for example, methodologies to compare objective measures to more traditional self-report measures can help increase the uptake of new technologies by researchers and clinicians
2 User adoption and user experience	Excessive and continuous tracking may negatively impact user experience and result in lower engagement; prioritizing the patient experience by measuring only what matters can help reduce the measurement burden
3 Technological platforms	Consumer-facing technology (e.g., smartphones, direct to consumer wearables) may be updated regularly, forcing revalidation studies; new hardware or use of case-specific hardware can help ensure technology consistency over time
4 Regulatory concerns	A more agile regulatory framework can support innovation while ensuring safety; FDA's Digital Health Program is a step in the right direction; however, multiple stakeholders should participate
5 Privacy and security	As person-generated health data continues to grow, the risk of data breaches becomes more significant; alleviating privacy and security concerns by establishing best practices, adhering to privacy guidelines, and ensuring patients are well informed of the risks can help increase comfort of participation
6 Pharmaceutical company organization	Introducing novel technology and concepts (e.g., role of environment) into routine business operations requires top-level senior executive support and clear delineation of where such efforts live within the organization (commercial, R&D, etc.); further, ensuring that innovation efforts are tied to clear business metrics will help to better position internal efforts amongst staff