Privacy Policy

Last updated: [DATE]

Who we are

SPARC-XP is an IRB-approved research study (Protocol #2025P001508) at Massachusetts General Hospital, in collaboration with Vanderbilt University Medical Center, and funded by the National Institutes of Health (1UF1MH141632-01). This application is used only by authorized study staff to collect research data from enrolled, consented participants. It is not a consumer product and is not publicly available.

What data this application accesses

With participant consent, the application uses the Google Health API to retrieve wearable-device data generated by a study-issued Fitbit Inspire 3 worn by an enrolled child for a seven-day period. The data accessed consists of physical activity and sleep measurements, which may include steps, distance, activity intensity, heart rate, heart rate variability, oxygen saturation, respiratory rate, skin temperature, and sleep stages.

The application accesses this data using study-managed accounts created by study staff that contain no identifying personal information about the child or parent. The retrieved data is associated only with a study-assigned code. The application requests read-only access and does not modify or write data.

How we use the data

The data is used solely for the research purposes of the SPARC-XP study — to assess activity and sleep patterns as potential correlates of childhood developmental outcomes. It is not used for any other purpose.

How we store and protect the data

Retrieved activity and sleep data is extracted and imported into REDCap, a secure data-capture platform hosted behind the Mass General Brigham firewall. Data in transit is protected using Transport Layer Security (TLS). Only deidentified data associated with a study-assigned code is stored, and access is limited to authorized study staff. The study holds a federal Certificate of Confidentiality providing additional protection for participant information.

How we share the data

We do not sell the data, and we do not transfer it to third parties for advertising, retargeting, credit assessment, or any commercial purpose. Data obtained through the Google Health API is used only by the authorized study team for the research described here.

Deidentified study data may be shared with study collaborators under approved data-use agreements, and certain deidentified phenotypic study data is deposited with the NIH NIMH Data Archive (NDA) as required by funding.

Data retention and deletion

The study-managed accounts used to collect this data are deleted by study staff after the data-collection period ends and study programmers have finished extracting the data.

Limited Use

This application's use of information received from Google APIs adheres to the Google API Services User Data Policy, including the Limited Use requirements. The data is used only to provide the research functionality described here and is not transferred or used except as described.

Human access to data

Authorized study staff access the deidentified wearable data as a necessary part of conducting the research the participant consented to, consistent with the study's IRB-approved protocol.

Your choices

Participation in the wearable-device component is voluntary, as described in the study consent form. Participants may withdraw from the study and may contact the study team to withdraw their data at any time.

Contact

Massachusetts General Hospital
Principal Investigator: Andrea G. Edlow, MD, MSc
Study contact: mghcqh@mgh.harvard.edu
Mass General Brigham IRB: 857-282-1900