When you're ready to release, the university can help you with intellectual property, privacy and distribution details. Also, check here for issues specific to medical apps.Disclosure and Considerations
Distribution and Spotlight
Medical Mobile Apps
Disclosure and Considerations
Invention Disclosure/Intellectual Property
University-owned apps are apps developed by university faculty, staff, grad students and other employees and contractors. The Office of Technology Transfer has the responsibility of distributing
OTT will work with you to ensure that your app meets the standards for branding requirements, appropriate end user license agreements and privacy policies, encryption technology for export control and royalty distribution if the app is sold. OTT publishes the application through the official
Once the app has been published, the developer team is expected to have a plan for maintenance of the app to provide ongoing support and updates. OTT reserves the right to check apps offered under the official University account and remove any apps that do not work for the latest version of the mobile operating system.
Please see the OTT mobile app website for more details.
Does your mobile app collect any information from the user, including deidentified information? Is there any communication with a backend server?
If your app collects information with a medical application, please consult the Medical Mobile App Guidelines for additional information.
Please see the Graphics and Logo Considerations section in Design.
It is essential that all apps that use, access, contain, implement or incorporate encryption in any form comply with US export regulations as well as international import regulations as applicable. This includes https, native keychain use, and any embedded encryption.
At the time of submitting an app, developers are required to answer trade compliance questions regarding encryption in the app. It is essential that these questions are answered accurately as you—the app developer—are responsible for the trade compliance for your app. Non-Compliance with government regulations is subject to penalties by the relevant government.
Distribution and Spotlight
For university apps developed by faculty, staff, other employees and contractors, contact Jessica Soulliere in the Office of Technology Transfer for distribution information. These U-M-owned applications are distributed through U-M's corporate license on the iTunes Store, managed by OTT. This does not usually apply to student-owned applications. Any student/staff/faculty-developed application can be distributed to the U-M community through our Enterprise license.
The Apple licensing options are detailed here:
Standard - Personal License:
Registered Apple Developers receive access to the iPhone Software Development Kit (SDK), including Xcode, and the iPhone Simulator. To test a device or distribute your app via the iTunes Store, you must be registered with Apple as a developer and pay a $99 registration fee. If this is an app built by an employee of the University of Michigan, then you may need to utilize the Corporate Agreement or Enterprise Agreement listed below. For more information, visit the Apple iPhone Developer Program website.
Corporate Agreement (Standard) U-M License:
To distribute official University of Michigan apps on the iTunes App Store, there is only one U-M license of this type that is administered centrally by U-M. University-owned apps are apps developed by university faculty, staff and other employees and contractors. For more information, contact Jessica Soulliere in the Office of Technology Transfer.
Enterprise Agreement U-M License:
This license is for limited, internal distribution of free apps to current faculty, staff and students. Registration is open to current university faculty and staff developers and allows for testing on university-owned devices. Apps using the Enterprise License are reviewed by U-M and are not available directly from the iTunes App Store. For more information, contact the ITS Service Center at 734-764-4357 (4-HELP) or 4HELP@umich.edu
University Developer U-M License:
This license allows faculty and instructors to develop in class with up to 200 students per calendar year. Students and instructors can share apps for presentations and grading, but apps cannot be distributed through the iTunes App Store. For more information, contact the ITS Service Center at 734-764-4357 (4-HELP) or 4HELP@umich.edu
U-M on iTunes U License:
This license is not used to distribute apps. It is used for distribution of educational audio and video, lectures, lessons and podcasts. For more information, visit the U-M iTunes U website.
U-M Apps Spotlight
Medical Mobile Apps
There are several special considerations for apps that are related to medical applications. The following checklist provides a high level overview:
- Submit invention report
Comply with FDA assessment
- Answer FDA assessment questions and provide applicable screenshots
- Review FDA assessment when complete
- Provide IRB HUM number/status
- Verify HIPAA compliance (e.g., data must be stored on a HIPAA compliant infrastructure)
- Provide details on app access restrictions (e.g., username/login, etc.)
- Provide answers to mobile publishing questions
Guidelines for Release via the App Store or Google Market
- For apps with FDA considerations or those associated with an IRB study: access must be restricted via login. A user must be presented with a login screen when opening the app.
- Username creation or registration must happen outside of the app.
- Username/password information should be stored on approved infrastructure.
A disclaimer must be accepted when a user is registering for the app.
- This disclaimer is in addition to the IRB consent. This is a double opt-in.
- The disclaimer must be emailed to the participant upon registration to demonstrate the double opt-in.
- The disclaimer must be accepted with each material/functional modification to the application within the application (i.e. via a pop-up).
FDA Regulation Considerations
Some medical mobile apps may be regulated by the FDA - please consider the following questions for discussion with OTT:
- Who is the user? (e.g., Physician, nurse, patient)
- What is the purpose of the app? (Provide a 1 paragraph description)
- Is it intended for a specific disease or condition? If so, what?
- Is it intended to be used to screen for or diagnose a disease or condition? If so, describe.
- What are the inputs to the app? Be specific.
- What are the outputs of the app? Be specific.
- If the app provides a recommendation for patient treatment, briefly describe the scientific basis for the algorithm used to generate the treatment recommendations.
- What is the hardware platform?
- How will the software be provided? (e.g, downloaded from app store, pre-installed on hardware platform).
TechTransfer Presentation on Mobile App FDA Considerations at Mobile Developer Community Meeting.