Findings
Sites must establish effective data privacy and security plans, especially considering regional and global regulations like GDPR.
Risk mitigation is critical, including plans to address unanticipated issues and potential patient disengagement due to technology challenges.
Budgeting and contracting often involve additional considerations, such as storage, training, and technical support requirements for connected devices.
Sites require adequate training to ensure staff and patients are prepared to use connected devices efficiently.
Companion applications or services often play an essential role in device functionality and data transmission.

Recommendations
Develop a clear plan for data pathways, including storage, security, and regulatory compliance.
Establish detailed risk mitigation and management strategies to handle unexpected challenges.
Ensure comprehensive training programs for site staff and patients to enhance device usability.
Incorporate device storage and resource allocation into budgeting and contracting processes.
Facilitate effective communication with sponsors and vendors to resolve operational and technical issues promptly.

Regulatory Considerations
Ensure connected devices comply with CFR 21, Part 11, and other relevant data collection and transmission regulations.
Understand and adhere to local and regional data privacy laws, such as GDPR, when managing patient data.
Verify that appropriate licenses and regulatory approvals are in place for device data transmission and storage.
Assess and address shipping and handling regulations for devices, ensuring safe and compliant transportation.