Johns Hopkins App Solutions
To support Johns Hopkins stakeholders, the University and The Johns Hopkins Health System Corporation have implemented a process that standardizes the review, posting and hosting of mobile or web applications (“apps”). This process aims to address the complex issues presented by apps in a coordinated, efficient manner that maximizes impact and minimizes risk.
This process applies to anyone (personnel and students at all 9 schools of the university and JHHS entities) wishing to:
- Post an app to the Hopkins app store OR
- Brand the app with the Hopkins name OR
- Use an app for Hopkins activities (e.g. patient care, student evaluation, marketing).
One exception: Apps used in research must be disclosed to, and reviewed by, the responsible Institutional Review Board (IRB) IRB committee.
In this process, apps are reviewed for technical appropriateness, compliance, regulatory issues, and branding. An App Review Committee (”Committee”) reviews submissions at a monthly meeting and works with stakeholders to arrange for additional reviews / modifications as needed. Following committee confirmation to move ahead with branding/posting/use of the app, the Technology Innovation Center (TIC) performs technical diligence prior to publishing. A $3,000 fee is charged annually to cover the costs associated with posting and maintenance of Apps on the Hopkins store.
Note on existing apps: Apps that predate the implementation of the ARC process have until January 1, 2019 to comply with the university app policy. Please contact the TIC at email@example.com to coordinate this process.
The Process in Detail
The Committee accepts submissions through a convenient online form App Submission Form. A JHED ID is required to complete the form.
Each month, the Committee meets on the 3rd Friday to review recent submissions. The Committee asks that you plan ahead by making submissions at the beginning of the month to ensure that your submission is considered in a given cycle. Depending on the complexity of the issues presented, the Committee may recommend additional review, which may take a number of weeks. Please provide as much information as possible in order to facilitate an efficient review.
Below is an outline of the steps in the review process:
- The App Review Committee web form will take 20 minutes to complete and will ask questions about the app, the development stage, the use case / target audience, privacy and data implications, and the marketing plan.
- If applicable, please have the following materials ready at the time of your application:
- The invention disclosure
- Any documentation on the app that will help the committee understand its intended use
- The application’s source code
- Application and architecture diagrams
- Any additional documentation related to the application’s design, build, testing or deployment
- In reviewing your submission the Committee will consider the following factors:
- Intellectual Property – Intellectual property developed with JHU and/or JHHS support is owned by the supporting institution. To protect University IP, please contact Johns Hopkins Technology Ventures by completing a disclosure form.
- Risk management – The amount of review that an app will be required to undergo before public offering is directly correlated to the risk level of the app.
- Branding – Any proposed branding of an app which includes the “Hopkins” name will be reviewed for compliance with the current Johns Hopkins Branding Guidelines and will be submitted for further review by the Use of Name Committee.
- FDA approval – Certain apps intended to be used in a health care setting may be FDA-regulated devices. If an app to be placed on the Hopkins App store or branded as a Hopkins App could be deemed as an FDA-regulated device, the app will need to undergo extensive review.
- Regulatory – The Committee considers all other regulatory parameters that might apply.
- The Committee will determine next steps and communicate back to the app lead based on contact information provided in the online submission form. The Committee will communicate with you throughout any additional reviews.
- Note that if the intent is to publish on the Johns Hopkins’ App store, the app must undergo technical TIC review.
- There may be risks inherent in using a mobile app for clinical, educational or commercial purposes. Apps that will be used in a clinical setting may require review by the Clinical IT Review Committee. Apps that will be used for educational purposes may be subject to review by the Provost’s Office.
The Johns Hopkins App Store
- Notice on Fees: An annual administrative fee of $3,000 is charged by TIC to host an app. This fee funds the team that provides technical support for the store, as well as the project management involved in posting and maintaining apps (i.e. incorporating updates). JHU investigators may want to plan for these fees when budgeting grant proposals.
- Revenue: When an app involves user charges, any associated revenue will be distributed according to the university IP policy.
- App Development: For apps that have not been developed, TIC provides development services, at a subsidized cost. Please visit the TIC website for more information about these services.
- Tools for App Creators
- Regulatory Guidance: For information regarding FDA regulation of apps please visit https://www.fda.gov/medicaldevices/digitalhealth/
- IRB Guidance: The Institutional Review Board Quick Guide provides an overview of the IRB process at the university.
About The Johns Hopkins Medical and Research Apps Committee
The Johns Hopkins App Review Committee aims to ensure that apps posted by, used by, or branded with Hopkins support the mission of Johns Hopkins University. The committee is comprised of representatives from Marketing & Communications, Information Technology, Johns Hopkins Technology Ventures, and the Office of the General Counsel.