[License-review] Request for approval by license steward: Tidepool Open Access to Health Data Software License

Howard Look howard at tidepool.org
Sat Oct 5 18:58:36 UTC 2013


== Overview ==

My name is Howard Look. I am President/CEO of Tidepool Project. We are a non-profit, (soon to be) open source project creating an open platform and applications to help reduce the burden on people with Type 1 Diabetes. We are proposing that we a new create a new license, the Tidepool Open Access to Health Data Software License.

Our company and efforts are described here:

Our rationale and proposed license strategy is detailed here: 

The draft license is here (and in plain text below):

FAQ is here:

== Rationale ==

We want to require applications, devices and services to keep health data open and accessible to patients, their designated caregivers.

We could not find a source license that included an open data provision. Various open data licenses were close (see http://opendefinition.org/licenses/), but they covered the data and not the software or devices creating the data. They also require open access to everyone, which is not appropriate for private health data where the patient should choose who has access to their data.

We intend for the Tidepool license to be reusable by others. Our initial intent is to license the code created by the Tidepool project, which makes it easier to gather data from various diabetes devices, and to analyze that data in intuitive and actionable ways.

== Distinguish ==

The Tidepool license is permissive as to source code, and "copyleft" as to the open data requirement. The license is most similar to the Apache v2 license, though with the addition of the open data provision.

== Legal Review ==

The license was drafted by Heather Meeker of Greenberg Traurig, who also participated in the creation of the Mozilla licenses.

We have asked for legal review from institutions that we hope to collaborate with, so far UCSF and Stanford, as well as from medical device companies such as Medtronic and Dexcom.

UCSF has concerns about the patent provision and it's broad reach across the UC system. We are awaiting further clarification about whether this is a unique to the Tidepool license, or whether they have similar concerns about they Apache license, for example.

We have not received any other legal review.

== Other Feedback ==

So far, the feedback on our plan falls into these rough buckets:
0 - Only use GPLv3. Truly free and open software is the only way to go for medical devices and therapy software.
1 - Steer clear of GPL at all costs. It's a third rail and will cause enterprises to not look at your code. Not worth it.
2 - The dual-license approach is way more confusing than it's worth.
3 - Doing a new permissive license is more confusing than it's worth. Just release it under MIT/BSD/Apache and let it speak for itself.
4 - We love that you are doing a new permissive license and totally agree that patients must own and have access to their own health data.

== Proliferation category ==

We hope that the Tidepool license is reusable, and put it in the category of "Special purpose licenses." We hope that it is reusable by other projects delivering hardware and software medical technology. We discussed this, for example, with members of the Implanted Cardiac Defibrillator community, who have similar desires as the diabetes community for open patient access to data.

Please let me know if you have any further questions. Thanks in advance for your feedback and consideration.


[DRAFT - This draft is open for public review and comment. Please email your comments to legal at tidepool.org or comment on the associated blog post at http://tidepool.org/blog/2013/9/17/wheres-the-code... published September 17, 2013.]


This license governs the use of the software to which this license notice is applied (“Software”). You are not required to accept these license terms; however, nothing else grants you permission to modify or distribute the Software or its derivative works.  The purpose of this license is to ensure that any use of this Software is conditioned upon making Health Data collected or processed by the Software Open to the Data Owner or any party authorized by the Data Owner, and this license should be interpreted in service of that purpose.  

1. Definitions.  As used in this license, the following terms have the following meanings.

A “Contribution” is the Software, or any modification or addition to the Software made available under this license.  

A “Contributor” is any person or entity that makes available any Contribution under this license.  

“Data Owner” means the natural person to whom the Health Data applies.

“Distribute” means to distribute, transfer a copy of, or otherwise make available (including via network access).

“Health Data” means data pertaining to the physiological functions of a natural person, including any information or data specific to understanding the operation, safety or efficacy of a device or service that accompanies, is assistive in understanding, or generates such data.

“Licensed Claims” are all claims in issued patents or pending patent applications owned or controlled by any Contributor or any of its Subsidiaries, now or in the future, having claims that, absent the license granted in Section 2(B), would be infringed by the making, having made, use, sale or other exploitation of that Contributor’s Contribution, or by the combination of the Contribution with the remainder of the Software (where such infringement would not arise based on the Software standing alone without the Contribution).

“Open” as applied to Health Data will have the meaning ascribed to such term by the Open Definition promulgated at opendefinition.org, version 1.1 and any later version; provided, however, that no condition of attribution will be applied to use of Health Data and the Health Data need not be made available or accessible to any party other than the Data Owner or parties authorized by the Data Owner.  For avoidance of doubt, as applied to Health Data under this license, “Open” means that in the event you apply any encryption or obfuscation to the Health Data using the Software, you must provide the Data Owner with any encryption keys or other suitable means, free of charge, to access such Health Data, in a manner sufficient to allow a Data Owner with ordinary skill and knowledge to extract and store the Health Data in a non-proprietary format, in both human-readable and machine-accessible forms. When you provide Health Data in machine-accessible forms, you must also provide data format descriptors suitable for other programs to read the Health Data.

Any reference to the “Software” includes the Software, in whole or in part, in any medium or any format (such as binary or source code).

A “Subsidiary” is an entity that is controlled, directly or indirectly, by a Contributor.

In this license, “you” refers to any recipient of the Software.

2. Grant of Rights

(A) Copyright Grant. Subject to the license conditions and limitations in section 3, each Contributor hereby grants you a non-exclusive, perpetual, irrevocable, worldwide, fully paid-up, royalty-free copyright license to reproduce, prepare derivative works of, and Distribute its Contribution, in whole or in part, or any derivative works thereof that you may create under the foregoing license grant.

(B) Patent Grant. Subject to the license conditions and limitations in section 3, each Contributor hereby grants you a non-exclusive, worldwide, royalty-free license under the Licensed Claims to make, have made, use, sell, offer for sale, import, and otherwise dispose of its Contribution, and to practice any method embodied therein.

(C) No Sublicense.  This license does not grant you the right to sublicense the rights granted to you in this license.  Each time you Distribute the Software, the recipient automatically receives a license directly from the Contributors, subject to the terms of this License.

3. Conditions

(A) License Notice. If you Distribute the Software, whether in source code or binary format, you must provide the recipient with a copy of this license, which will govern the Software.  Such notice may be delivered via any reasonable means that gives the recipient effective notice.

(B) Defensive Termination.  If you bring a claim against any Contributor alleging that the Software directly or indirectly infringes any patent claim, the patent license granted to you under Section 2(B) will automatically terminate.

(C) Open Health Data.  You must ensure that the Health Data remains Open to its Data Owner for a period of three years after the Health Data is first generated.  

(D) Notices.  If you Distribute the Software, you must retain all copyright notices that are present in the Software.

(E) Source Code Distribution.  If you Distribute the Software or any derivative work thereof in source code form, you may do so only under this license by including a complete copy of this license with your distribution.  For clarity, any source code file that does not contain any portion of the Software (other than interface definitions as necessary to interoperate with the Software) is not considered a derivative work of the Software. You may Distribute the Software in binary form under terms of your choice, so long as any license to redistribute the Software includes all of the conditions in this Section 3.  For clarity, this license does not require you to deliver any source code to any recipient, except to the extent it may be necessary to comply with the conditions regarding Open Health Data in Section 3(C).

(F) Disclaimer.  The Software is provided "as-is." All Contributors hereby disclaim, to the maximum extent possible under law, any and all warranties, guarantees or conditions, express or implied.

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