App Operability Guidelines & Survey
Please read through the guidelines below and provide feedback using the brief survey at the end.
App Operability (OP) Guideline
Operability will assess whether a mobile health app installs, loads, and runs in a manner that provides a reasonable user experience on mobile and web platforms.
Guideline OP1 On-Boarding
The app installs, launches, and runs consistently on the target device(s) and target operating system(s) for that app.
Requirements for Guideline OP1
- 01 The app downloads and installs on the target device(s) and target operating system(s) as confirmed by user notification.
- 02 The app launches and runs on the target device(s) that it is installed upon and, if it does not, the user is notified of the potential problem (e.g., to restart the app, Bluetooth, OS, etc.).
- 03 The app runs on a defined & current version of the intended OS. The app documentation must state clearly what versions are supported. (e.g. Android versions).
- 04 If the app requires that it be connected to a network, the app can connect and operates on the intended domestic and global carriers, Local Area Network (LAN) and Personal Area Network (PAN) and informs the user that the app is connected to a network and which network they are connected.
- 05 The app functions as intended when not connected to a network. The user shall be informed of any differences between the apps functioning when connected or not connected to a network.
Guideline OP2 Connectivity
If applicable, the app connects consistently to any and all peripheral or accessory devices (e.g., NFC, Bluetooth, Continua), third party mobile application or software, regulated or unregulated, required for operation and/or marketed for use in conjunction with such app.
Requirements for Guideline OP2
- 01 The app connects to the peripheral device(s) and operates consistently.
- 02 The app has a mechanism to notify the user if the app fails to connect to any and all peripheral or accessory devices. The app needs to notify when data has been collected and not transmitted, if required.
- 03 The app connects consistently to all third party mobile applications, software, and online user accounts, but such connection shall only occur after: (i) notifying user; (ii) requesting permission; and (iii) receiving consent from the user.
- 04 The app has a mechanism to notify user of all updates applicable or necessary for the app to connect to any such device, application, software or online user accounts.
Guideline OP3 Access to App Publisher
A method for contacting the app publisher and technical support is provided.
Requirements for Guideline OP3
- 01 The app publisher’s contact information―including but not limited to, mailing address, email address, or other clearly identified method (e.g. IM, Skype) for support and general inquiries, web address and/or DNS address—is provided within the app, or the app provides a link to a webpage that contains the same information.
- 02 The app provides a method for users to submit feedback to the app publisher for purposes of improving the user experience, including without limitation, any technical issues, bugs, and errors detected by users.
Guideline OP4 Documenting & Detailing Releases
The app publisher shall document the feature detail and include a historical view of prior releases.
Requirements for Guideline OP4
- 01 The app should have a history of updates including details of changes over time.
Guideline OP5 Operability with EHR
Electronic Health Record (EHR) systems optimized for mobile devices or apps for certified EHRs (EHRs that have been certified by a Federally-designated Authorized Testing and Certification Body) maintain secure and operable data exchange. Certified EHRs may consist of complete EHRs or EHR modules.
Requirements for Guideline OP5
- 01 The app operates in accordance with the documented functionality provided by the Certified EHR.
- 02 Documentation is provided regarding any relevant EHR certification received.
- 03 The EHR systems with which the app connects are specifically enumerated and documentation of the interoperability with each specified EHR is provided.
- 04 The details and description of the data fields that the app saves, sends to, and/or receives from each specified EHR system regarding patient information is provided.
- 05 The app maintains (at rest) and transmits (in motion) patient information in a secure, HIPAA-compliant manner, as applicable (see Guidelines S2, S3, and S4).
Guideline OP6 Connectivity with PHR
An app that is intended to connect to a Personal Health Record (PHR) enables users to send and retrieve patient information between a mobile device and the PHR and does so in a secure manner.
Requirements for Guideline OP6
- 01 The PHR systems with which the app connects (e.g. Microsoft HealthVault, Blue Button etc.) are specifically enumerated and documentation of the interoperability with each specified PHR is provided.
- 02 The details and description of the data fields that the app saves, sends to, and/or receives from each specified PHR system regarding patient information (e.g., medical history, diagnoses, treatment plan, medications, laboratory results, radiology images, etc.) is provided.
Guideline OP7 Medical Device Status
If applicable, the app publisher certifies that it is not a medical device, or certifies that the app constitutes a medical device as defined by the U.S. Food and Drug Administration (FDA), has ascertained its correct classification, and either certifies that the app complies with all applicable FDA regulatory requirements.
Requirements for Guideline OP7
- 01 The app publisher has ascertained that the app, including any and all peripheral devices required or intended for operation and/or marketed for use in conjunction with such peripheral devices, is an MDDS, Class I, II or III medical device.
- 02 The app publisher provides documentation demonstrating that the app complies with all applicable FDA requirements, including but not limited to: Establishment registration; Medical Device Listing; Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA); Investigational Device Exemption (IDE) for clinical studies; Quality System (QS) regulation; Labeling requirements; and Medical Device Reporting (MDR).
- 03 The app publisher has a mechanism to immediately notify all users about an FDA-approved app that is recalled, the subject of an FDA advisory, or similar status that calls the app’s safety and/or effectiveness into question.
- 04 If the app does not constitute a medical device as defined by the FDA, the App publisher certifies that the app is not a medical device by written attestation on the Alliance Submission Form.
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