Privacy Policy

This Privacy Policy explains how NuRelm Inc. and the University of Pittsburgh research team ("We" or "Us") handle information collected through the FIT Scale Mobile App. This app is intended only for participants in the "Fast In-Bed Tracking (FIT) System Lifestyle Intervention" clinical trial.

1. The App and the Research Study

The FIT Scale Mobile App is an integral part of the Fast In-Bed Tracking (FIT) System, which is an under-the-bed weight monitoring system used in a controlled clinical trial funded by the National Institutes of Health (NIH). The app's primary purpose is to facilitate the use of the FIT scale system and is not intended for general public use.

2. Information We Collect

The app is designed to primarily handle de-identified or coded research data.

  • Coded Health Data: Daily weight measurements from the FIT scale.
    • Purpose: To provide a weight readout via the app and for the research study's primary objectives of weight monitoring.
  • Algorithmic Data: De-identified algorithmic data from the scale sensors.
    • Purpose: To refine the weight calculation process and the overall FIT system.
  • Study ID/Login: A specific study ID (e.g., "FIT001") and a predetermined password.
    • Purpose: Used to register and secure the app for authorized study participants.

Data We DO NOT Collect Through the App

As outlined in the IRB documents, the FIT Scale Mobile App is not designed to collect, store, or transmit any identifiable or sensitive personal information. Specifically, the app does not access or collect:

  • Identifiable Data: No names, addresses, or un-coded personal information.
  • Sensitive Data: No sensitive health data beyond coded weight data.
  • Device Functionality: No access to device features such as your location, contacts, or notifications.
  • Data Storage on Device: App data is not stored on your device for any period of time.

3. How We Use the Information

The limited data collected via the app is used strictly for the purposes of the clinical trial and the functionality of the FIT system:

  • Scale Configuration: The app transmits data to the scale system located in the participant's home for the initial and ongoing configuration of the scale.
  • Research and Monitoring: The coded weight data is securely sent to the project's AWS cloud hosting account for storage and long-term monitoring by the authorized research team.
  • System Refinement: Algorithmic data is transmitted to NuRelm Inc. for the purposes of refinement of the algorithmic process in weight calculation.

4. Data Storage, Security, and Retention

Data Retention

All collected data (coded health data and algorithmic data) will be retained for the duration of the "Fast In-Bed Tracking (FIT) System Lifestyle Intervention" clinical trial and for a period of seven (7) years following the trial's completion or the publication of the results, as required by the protocols of the University of Pittsburgh Institutional Review Board (IRB) and the National Institutes of Health (NIH). After the required retention period, data will be permanently deleted or further de-identified for future research purposes, in compliance with IRB protocols.

Security Measures

  • App Access: Access to the FIT scale app is secured by a required password/PIN, which is encrypted.
  • Data Transmission: Weight data is transmitted securely using industry-standard encryption protocols (SSL/TLS) to the project's cloud hosting account.
  • Data at Rest: All coded data is stored in a secure, compliant cloud hosting environment with access restricted to authorized research personnel.
  • De-Identification: All participant data within the research records is coded and identified only by a case number (e.g., study ID), with the information linking the case numbers to identity kept separate from the research records and stored in secure systems.

Third-Party Service Providers

Data is stored and processed using Amazon Web Services (AWS) for secure cloud hosting. AWS acts as a data processor for the University of Pittsburgh research team. We ensure that any third-party service provider, including NuRelm Inc. (for algorithmic refinement), is contractually obligated to maintain the confidentiality and security of the data in compliance with the study’s requirements.

Data Sharing and Disclosure

The information collected by the app (coded health data, algorithmic data) is shared exclusively among the authorized members of the research team and their oversight bodies for the purpose of conducting the clinical trial:

  • Research Team: Data is shared with the Principal Investigator (Dr. Pearlman), the Co-Investigators, and other authorized staff from the University of Pittsburgh, NuRelm Inc., and Craig Hospital (for the GLB-AIM intervention).
  • Oversight Bodies: Data may be reviewed by authorized representatives of the University of Pittsburgh Office of Research Protections, the National Institutes of Health (NIH) (the study sponsor), and the U.S. Food and Drug Administration (FDA) for monitoring the appropriate conduct of the trial.
  • Future Research: De-identified data (data that has all personal identifiers removed) may be used for future research studies.

5. Your Privacy Rights and Contact Information

Your Rights as a Participant

Because the data collected is coded and de-identified, we are generally unable to link it back to an individual outside of the secure research key held separately by the Principal Investigator. However, as a study participant, you have the right to:

  • Request Access: Request information about the coded data collected under your Study ID.
  • Request Correction: Request the correction of any coded data errors.
  • Request Withdrawal & Deletion: Withdraw from the study and request the deletion of your coded data. Please note that data already used in a study analysis or required for regulatory compliance (NIH/FDA) may be subject to retention requirements.