Tidepool documents and disclosures
As an open nonprofit organization, we share everything. We hope it helps.
Regulatory
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
- Substantial Equivalence Notification (PDF)
- 510(k) Summary (PDF)
- Indications for Use (PDF)
- An Observational Study of Individuals with Type 1 Diabetes Using the Loop System for Automated Insulin Delivery - Public Dataset, JAEB Center for Health Research
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
- Proposed Teleconference Meeting Agenda (Public Google Doc)
- Exposure time in the Loop Study - Updated February 10, 2020 (PDF)
- Teleconference Meeting Minutes — Submitted to FDA, Approved April 15, 2020 (Public Google Doc)
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
- Request for Information: Tidepool Loop Observational Study Exposure Targets (PDF)
- Exposure Time in the Loop Observational Study (PDF)
- Written feedback from FDA, received Feburary 7, 2020
FDA Pre-submission Meeting, June 17, 2019
- Proposed In-person Meeting Agenda and Misc Questions (Public Google Doc) (PDF)
- Plan for Demonstrating Safety of Tidepool Loop 1.0 (Public Google Doc) (PDF)
- Tidepool Loop Statistical Analysis Plan (Public Google Doc) (PDF)
- Jaeb Loop Statistical Analysis Plan (PDF)
- Plan for Assessing Loop’s Decision Making under iCGM Constraints (Public Google Doc) (PDF)
- Human Factors and Usability Testing Outline for Tidepool Loop 1.0 (Public Google Doc) (PDF)
- Tidepool Loop 1.0: Anticipated Changes to DIY Loop (Public Google Doc) (PDF)
- Analysis of DIY Loop GitHub Issues and Resolutions (Public Google Doc) (PDF)
- Proposal for Ongoing Beta Test Program for Tidepool Loop (Public Google Doc) (PDF)
- Tidepool Loop Quality Assurance Strategy (Public Google Doc) (PDF)
- Tidepool Approach to Online Documentation and Training (Public Google Doc) (PDF)
- Cybersecurity Strategy for Tidepool Loop 1.0 (Public Google Doc) (PDF)
- Wireless Test Strategy for Tidepool Loop 1.0 (Public Google Doc) (PDF)
- Meeting Minutes. Submitted to the FDA on July 2, 2019. Approved by FDA. (Public Google Doc) (PDF)
Jaeb Observational Study Protocol, November 29, 2018
- Observational Study Protocol, v2.0 (PDF)
FDA Pre-submission Meeting, January 10, 2019
- In-person agenda (PDF)
- Tidepool and DIY Loop Functionality Narrative (Public Google Doc) (PDF)
- Tidepool Loop: Proposed iController Definition and Special Controls (Public Google Doc) (PDF)
- Loop Algorithm Documentation (Public Google Doc) (PDF)
- Approved Meeting Minutes from January 10 In-Person Meeting (PDF)
FDA Pre-submission Meeting, August 27, 2018
- Observational Study Protocol Meeting (Public Google Doc)
- Approved Meeting Minutes (PDF)
FDA Pre-submission Meeting, May 4, 2018
- In-person agenda (Public Google Doc) (PDF)
- Approved Meeting Minutes (PDF)
Regarding Tidepool Project
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
- Pre-submission Informational Meeting Full Presentation about Tidepool Project updates (PDF)
- Approved Meeting Minutes (PDF)
FDA Pre-submission Meeting, June 2, 2015
- Pre-submission Informational Meeting Full Presentation about Regulatory Quality System (PDF)
- Approved Meeting Minutes (PDF)
FDA Pre-submission Meeting, October 14, 2014
- Pre-submission Cover Letter and agenda (PDF)
- Pre-submission Informational Meeting Full Presentation (PDF)
- Approved Meeting Minutes (PDF)
More information about our Regulatory Quality System can be found here.
Disclosure
Governance
Articles of incorporation of GreenDot Diabetes. Note that our non-profit entity, Tidepool Project, was originally incorporated as GreenDot Diabetes. This and some other early documents refer to the organization by that name.
Annual report
Original strategy document
Financial
Tax returns and financial information
TY2022 FY2023
TY2021 FY2022
TY2020 FY2021
TY2019 FY2020
TY2018 FY2019
TY2017 FY2018
Audited Financial Statements not required by CA Law*
TY2016 FY2017
TY2015 FY2016
Audited Financial Statements not required by CA Law*
TY2014 FY2015
TY2013 FY2014
Audited Financial Statements not required by CA Law*
TY2012 FY2013
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
IRS Form 1023, Application for 501(c)(3) tax-exempt status. Filed June, 2013.
IRS 501(c)(3) Determination Letter; Received June, 2014.
Legal
Privacy Policy and Terms of Use
Current, updated March 11, 2022
Previous, updated January 10, 2022
Previous, updated January 1, 2020
Previous, updated May 22, 2018
Previous, updated April 24, 2017
Previous, updated November 2, 2015
Contact information
Email: legal@tidepool.org
Mailing address:
Tidepool Project, Attn: Legal
555 Bryant St., #429
Palo Alto, CA 94301
Security
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.
Tidepool Security, Privacy, and Regulatory Technical Documentation
Tidepool’s Privacy Policy, Terms of Use and other legal info
Responsible Disclosure Policy: Tidepool’s Terms of Use include a Responsible Disclosure Policy. If you believe you have found a security vulnerability in any of Tidepool’s App, Tidepool’s source code or Tidepool’s other systems or network security, we encourage you to let us know right away by submitting a report to security@tidepool.org.
Chief Privacy and Security Officer: Howard Look
Email: security@tidepool.org
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 legal@tidepool.org to get the Agreement countersigned.
Redlines to either document will be entertained as part of a Tidepool+ Essential or Tidepool+ Professional contract. Please see tidepool.org/providers or contact clinic@tidepool.org 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.
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 legal@tidepool.org.
(This page was modeled after this Mozilla.org 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:
1Password | Secure Password Management
Adobe Systems | Design Tools & Services
Amazon Web Services | Cloud Computing Services
Atlassian | Project Management Services
Axosoft GitKraken | Source Code Management Tools
Barrel NY | Website Design
Contentful | Website Services
Conveyor | Security Questionnaire Processing
dQ&A | Research Services
Early Growth Financial Services | Financial Services
EWK Consulting | Regulatory Services
Headway | Release Notes
GitHub | Open Source Code Repository
GitLab | DevOps Services
Kelly Dern Designs | Design Services
LifeOmic JupiterOne | Cloud Security Services
Microsoft | Operating Systems & Office Software
Mitch Robbin, The Anthony Michael Group | Recruiting services
Monday | Project Management Services
Hogan Lovells US LLP | Legal Services
SJR Associates | Regulatory Services
Slack | Communication Services
Snyk | Software Security Services
Solo.io | Cloud Computing Tools
Stoplight | API Design & Documentation Services
Webflow | Website Services
Wilson Marshall & Taylor | Legal Services
Winifred Paper, Inc & Monkrobot | Website Development
Zoom | Video Conferencing Services
