The Ohio State University: Wexner Medical Center

Mobile Health Application Privacy Policy

Mobile Health Application Privacy Policy

ACHIEVE study mobile health application

App ID: (mhealth61636869657665)

Updated: 05-19-2024

 

  1. Introduction

Welcome to the ACHIEVE study mobile health application, developed to support the Achieve study focused on pregnant women living with type 2 diabetes. We are committed to protecting your privacy and ensuring that your personal information is handled in a safe and responsible manner.

 

  1. Purpose of the Study

The Achieve study aims to evaluate the effectiveness of Continuous Glucose Monitors (CGM) in managing blood glucose levels in Medicaid-enrolled pregnant women on insulin treatment. Participants will be randomly assigned to receive either the DEXCOM G7 CGM or standard care. The study involves the collection of health data through surveys, blood samples, and medical records. The mobile health application is currently only available to patient eligible participants seen at The Ohio State University Medical Center and screened by a clinical research associate at the Department of Maternal Fetal Medicine.

 

  1. Information Collection

As part of the Achieve study, the mobile application will collect the following types of information:

– Personal identifiers (e.g., name, contact information)

– Medical records (e.g., diagnosis, treatment, height, weight)

– Blood glucose levels and CGM data

– Survey responses about diabetes management, social needs, and medication adherence

– Physical activity information like your total steps

 

  1. How We Use Your Information

The information collected is used to:

– Conduct the study and analyze results

– Monitor and improve your health management

– Ensure compliance with research protocols

– Communicate with you and provide necessary support

 

  1. Data Sharing and Disclosure

Your data may be shared with:

– Study staff and researchers involved in the Achieve study

– Healthcare providers managing your care

– Regulatory authorities (e.g., FDA, OHRP)

– Study sponsors and their agents

– The Ohio State University Institutional Review Board

 

We will take all necessary measures to protect your data from unauthorized access and will only share your information as required by law or for the purposes of the study.

 

  1. Data Security

We implement appropriate technical and organizational measures to safeguard your information against loss, theft, and unauthorized access. This includes storing your data in a secure, HIPAA-compliant environment.

 

  1. Your Rights

You have the right to:

– Access your personal information and request corrections

– Withdraw from the study at any time without penalty and delete your account upon discussion with a study member

– Receive a copy of this privacy policy

– Be informed about any new information that may affect your participation in the study

 

  1. Data Retention

Your information will be retained for the duration of the study and for as long as necessary to comply with legal and regulatory requirements. There is no specific end date for the retention of your information, as it may be analyzed for many years.

 

  1. Contact Information

For questions or concerns about your privacy, please contact:

– Achievestudy@osumc.edu

– HIPAA Privacy Officer Kathleen Ojala: 614-293-6482

For questions about your rights as a study participant, contact the Office of Responsible Research Practices at 1-800-678-6251.

 

  1. Changes to This Privacy Policy

We may update this privacy policy periodically. Any changes will be posted within the ACHIEVE study mobile health application, and we will notify you of significant changes.

 

Consent

By using the ACHIEVE study mobile health application and participating in the Achieve study, you agree to the collection and use of your information as described in this privacy policy. If you do not agree with the terms, please do not use the application or participate in the study.