Regulatory disclosures
Tidepool's Terms of Use and Privacy Policy are compliant with the Health Insurance Portability and Accountability Act (HIPAA) and the requirements of the EU General Data Protection Regulation (GDPR).
US FDA
Tidepool is registered and listed with the FDA as follows:
FDA Entity Registration: Tidepool Project, Registration # 3012128418
Tidepool Platform and Tidepool Uploader
Classification: Medical Data Display System
Product Code: OUG
Regulation: 880.6310
Tidepool Web, and Tidepool Mobile (formerly known as Blip and Blip Notes)
Classification: Continuous Glucose Monitor Data Management System
Product Code: PHV
Regulation: 862.2120
More detailed registration and listing documentation can be found here: DOC-0006 US FDA Regulatory Strategy – Tidepool Software.
Tidepool's entire regulatory quality system is openly available here.
All documentation shared with US FDA during Q-Submission meetings, including approved meeting minutes, can be found at tidepool.org/documents.
International
Use of Tidepool's software outside of the US may not comply with local law or with our Terms of Use or Privacy Policy.
Tidepool is not marketed outside of the US. Tidepool does not currently have CE marking or ISO 13485 certification.
Tidepool's Terms of Use state:
You understand that to register as a User of Tidepool Apps you must be in the United States. We make no claims that Tidepool Apps are accessible or appropriate outside of the United States. Access to Tidepool Apps may not be legal by certain persons or in certain countries. If you access Tidepool Apps from outside the United States, you do so on your own initiative and are responsible for compliance with local laws.
The content of the Tidepool Technical Documentation is licensed under a Creative Commons CC0 1.0 Universal (CC0 1.0) Public Domain Dedication.