FAQ: How will my data be used in the Levels Research?
This article provides an overview of how your data will be collected, protected, used, and accessed during Levels Research.
In this Article:
- What data will be collected?
- How will my data be protected?
Who will have access to my data?
How may my data be used?
What data will be collected?
As part of this study certain health data may be collected and used for the purpose described in this form. The health data collected may include:
- Contact information such as name, address and phone number
- Demographic data such as age, date of birth and gender
- Glucose data using a CGM
- App data (for example, Apple Health or Fitbit) such as activity related information, sleep, or other health data
- Survey data such as weight, height, current medications, medical history
- Laboratory and other test results
- Levels App data such as food logs, etc.
This data may include data that occurred or were recorded prior to study enrollment, for example shared lab results that were collected prior to the study enrollment. This data may also include data that occurred or were recorded before or after you finish using a CGM.
How will my data will be protected?
Summary of Levels data storage practices:
- Levels uses a HIPAA-compliant cloud platform, Aptible, to manage our server and database infrastructure.
- Aptible manages and audits security best practices, including ensuring that data is encrypted via AES-256 industry standards at rest and End-to-end Encryption in transit. Traffic is encrypted all the way from endpoints to app and database containers using strong Transport Layer Security (TLS) ciphers.
- Databases are not publicly accessible, all access is controlled and audited, two-factor authentication is used for all devices, and backups are performed and encrypted at regular intervals. Internal Data access is strictly controlled. We maintain an audit log for administrator access.
Who will have access to my data?
Sponsor (Levels Health, Inc.) and authorized users will have access to your data, including the following:
- Designee of Levels Health, Inc., such as research organizations
- Service providers and CGM manufacturers supporting the study
- Government agencies, such as with the U.S. Food and Drug Administration
- Advarra Institutional Review Board that reviewed this research
- Outside individuals and companies, such as laboratories and data storage companies, that work with the researchers and sponsor and need to access your information to conduct this study
- Other researchers and medical centers participating in this study, if applicable
- A data safety monitoring board which oversees this study, if applicable
- For research, publication and development purposes, we will keep your name and other identifying information confidential and will only share the coded study data with authorized users
How will my data be used?
By consenting to the study, you agree to allow the Sponsor (Levels Health, Inc.) and authorized users to collect, store, use, or disclose your study data for the following purposes:
- To support, carry out or oversee the study
- To contact you about the study
- To contact you about other studies you may be eligible for
- To design or improve future studies
- To combine or compare the results of this study with other studies or data sets
- For research and publication of study findings
- For development, design, approval, improvement, production, publication, sale and support of products and services