Skip to content

Tidepool documents and disclosures

As an open nonprofit organization, we share everything. We hope it helps.


Regarding Tidepool Loop

Continuing our commitment to openness and transparency, we are making Google Doc versions of some of these documents available for public review and comment. Tidepool genuinely values your feedback and questions on our regulatory process and submissions. The original versions submitted to the FDA are available as linked PDFs.

Tidepool Loop, Clearance Received January 23, 2023

FDA Q-Submission Meeting, Submitted June 12, 2020

  • Tidepool Human Factors Bolus Calculator iCGM RFF (Public Google Doc)
  • Tidepool Loop Background for Human Factors Reviewers (Public Google Doc)
  • Tidepool Loop Human Factors Protocol Draft (Public Google Doc)
  • Tidepool Loop Use-related Risk Analysis (PDF)
  • Tidepool Loop Bolus Recommendation Tool (Public Google Doc)
  • Plan for Assessing Loops Decision Making under iCGM Constraints v2 (Public Google Doc)
  • Assumptions Underlying the iCGM Sensor Simulator (Public Google Doc)
  • Details of Simple Diabetes Metabolism Model Insulin and Carb Only (PDF)
  • Documents Tidepool Intends to Submit in Support of Tidepool Loop 510k Pre-market Notification (Public Google Doc)
  • Written feedback from FDA, received August 21, 2020 (PDF)
  • Meeting Minutes from August 27 call. Submitted to the FDA on September 11, 2020. Approved on October 14, 2020. (PDF)
  • Response to Tidepool Loop Human Factors Protocol Feedback (Public Google Doc)

FDA Q-Submission Meeting, February 13, 2020

JAEB Observational Study of DIY Loop users, 6 month readout — ATTD 2020 Shared with permission from the JAEB Center for Health Research, first shared on February 21, 2020

FDA Q-Submission Supplement, Submitted December 11, 2019

FDA Pre-submission Meeting, June 17, 2019

Jaeb Observational Study Protocol, November 29, 2018

  • Observational Study Protocol, v2.0 (PDF)

FDA Pre-submission Meeting, January 10, 2019

FDA Pre-submission Meeting, August 27, 2018

FDA Pre-submission Meeting, May 4, 2018

Regarding Tidepool Project

Tidepool Public Comment on Federal Register 2023-14624, issued July 13, 2023 CMS Proposed Rules (PDF)

Tidepool Public Comments on FDA Cybersecurity Draft Guidance, July 6, 2022 (Public Google Doc)

FDA Workshop, November 13, 2014

FDA Pre-submission Meeting, March 3, 2016

FDA Pre-submission Meeting, June 2, 2015

FDA Pre-submission Meeting, October 14, 2014

More information about our Regulatory Quality System can be found here.


Annual report
Original strategy document


Tax returns and financial information

TY2017 FY2018

  • IRS Form 990

  • Audited Financial Statements not required by CA Law*

TY2015 FY2016

  • IRS Form 990

  • Audited Financial Statements not required by CA Law*

TY2013 FY2014

  • IRS Form 990

  • Audited Financial Statements not required by CA Law*

TY2012 FY2013

  • IRS Form 990

  • Audited Financial Statements not required by CA Law*

The State of California only requires audited financials in years that exceed $2M in gross revenue, which is why some years have them and some don’t.

Tax-exempt status


Privacy Policy and Terms of Use

Previous, updated January 1, 2020

Contact information


Mailing address:
Tidepool Project, Attn: Legal
555 Bryant St., #429
Palo Alto, CA 94301


Tidepool takes the privacy and security of the information we store very seriously. Here are references and links to documents that may help you understand our security practices and policies.

For clinics

Business Associate Agreement

Tidepool provides a standard Software Service Agreement and Business Associate Agreement for participating clinics and health systems that wish to use Tidepool’s Base Platform at no cost. Please fill out our Business Associate Agreement and return it to to get the Agreement countersigned.

Redlines to either document will be entertained as part of a Tidepool+ Essential or Tidepool+ Professional contract. Please see or contact for additional details about these Tidepool+ offerings.

Security practices

If you’re interested in a Business Associate Agreement, you may also want to read these documents to get a complete understanding of how Tidepool operates.

Website content

Creative Commons

Unless otherwise indicated, the text, documents, and images on this website are available under the Creative Commons Attribution Share-Alike 4.0 Unported license, or any later version.

Creative Commons (CC) Some rights reserved

A summary of the terms of this license is available, as well as its detailed terms.
The rights in the trademarks, logos, and service marks of the Tidepool Project, are not licensed under the Creative Commons license, and to the extent they are works of authorship (like logos and graphic design), they are not included in the work that is licensed under those terms.

If you use the text of documents, and wish to also use any of these rights, or if you have any other questions about complying with our licensing terms for this collection, you should email

(This page was modeled after this page.)

Tools and services

We'd like to give a special thanks to these organizations that provide their tools or services to us pro bono or at a discounted rate: