As seen on App Store
- Last update
a year ago
Current version 1.7.1
English and British English
United Arab Emirates, Armenia, Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Estonia, Egypt, Spain, Finland, France, UK, Georgia, Greece, Hong Kong, Croatia, Hungary, Indonesia, Israel, India, Italy, Japan, South Korea, Lebanon, Lithuania, Latvia, Mexico, Malaysia, Nigeria, Netherlands, Norway, New Zealand, Peru, Philippines, Poland, Portugal, Romania, Serbia, Russia, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Turkey, Taiwan, Ukraine, US, Vietnam, and South Africa
TherAppX Review Guidance v2022.10
Review update 2023-03-17
Context informing the intended clinical use of the app based on the targeted health conditions and included features.
Covered health conditions
The developer claims to offer features targeting these health conditions.
Features that facilitate health data generation, collection, sharing and interpretation by patients.
- Automatic monitoring
- Patients can use a device to automatically record information about their health (e.g. blood glucose sensors, step trackers, etc).
Features that promote self-care and self-management of conditions.
- Auto-generated feedback
- Patients may receive feedback based on their recorded actions to achieve their health goals.
- Guided self-care activities
- Patients may access guided exercises or activities to perform actions and achieve their health goals.
263 Summer Street, 5th Floor Boston, MA 02210
The app must show relevance of its clinical underpinnings as determined by scientific evidence and support from clinicians or reputable organizations.
Evidence of acceptability or feasibility
A point is provided to this app if there is at least one peer-reviewed study demonstrating the app's acceptability, as found on a research database (e.g. Pubmed, Medline). The evidence is in the form of a clinical trial, a feasibility study, a review, a survey or other published evidence.
No evidence found
Licensed by a regulatory organization
A point is provided to this app if it is licensed by at least one regulatory organization (e.g. FDA, European Union, Health Canada). A regulatory decision means that a regulatory body has approved marketing for medical purposes after assessing supporting evidence and the tool's safety.
- Food and Drug Administration - Class II
- Device for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device.
Developed by a clinician
A point is provided to this app if health professionals are involved in its development.
Recommended by an independent organization
A point is provided to this app if it is recommended by at least one independent non-regulatory organization, such as health technology assessment agencies, government, clinical association or research institution.
No recommendation found
Clinical value demonstrated by a peer-reviewed study
A point is provided to this app if there is at least one peer-reviewed study proving the app's clinical value, as found in a research database (e.g. Pubmed, Medline). The evidence is in the form of a clinical trial or other published clinical evidence.
Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial.
- Obstet Gynecol, 2022-03-10
- Weinstein MM, Dunivan G, Guaderrama NM, Richter HE
Economic value demonstrated by a peer-reviewed study
A point is provided to this app if there is at least one peer-reviewed study proving the app's economic value, as found in a research database (e.g. Pubmed, Medline). The evidence is in the form of an economic study such as a cost-effectiveness analysis.
No demonstration found
Other study of interest
Other studies providing additional context that may be considered for decision-making. This information does not affect the clinical robutness score.
Development of a wireless accelerometer-based Intravaginal device to detect pelvic floor motion for evaluation of pelvic floor dysfunction.
- Biomed Microdevices, 2020-03-19
- Bohorquez J, McKinney J, Keyser L, Sutherland R, Pulliam SJ
The app must not disclose personal information from users. Score is based on public information. A high score does not guarantee absence of issues with privacy.
Restricted access to accounts
A point is provided to this app if it does not give information about other apps installed on the device (creator, name, type of account, etc.).
Restricted access to unique device identification
A point is provided to this app if it does not give information about the device's hardware components, which could be used to track the user on different web services.
Restricted access to the phone subscriber identity (SIM)
A point is provided to this app if it does not give information about the mobile phone services and provider, which could be used to track the user on different messaging and phone services.
Restricted access to phone number
A point is provided to this app if it does not give information on the phone number, which could be used to follow the user on services that use this data or to attack using spam, phishing or two-factor authentication (2FA) tactics.
Right to be forgotten
Data privacy officer contact available
Data privacy legislation
- CalOPPA (United States)
- HIPAA (United States)
This information does not affect the privacy score.
This app requests access to some features of your device. Make sure that each of these accesses is relevant to you. This information does not affect the privacy score.
- Allows the app to search for nearby devices and initiate connection.
- Can give access to fine location in the background.
The app must not be exposed to external security threats. Score is based on public information. A high score does not guarantee absence of issues with security.
A point is provided to this app if it has been updated at least 1 time in the last 6 months, significantly reducing technical vulnerability and associated risks.
Restricted access to device administrator privileges
A point is provided to this app if it cannot gain administrator access to your device.
Restricted access to device debugging details
A point is provided to this app if it cannot gain debugging access to your device, which could expose privileged details and sensitive information.
Compliant to one or more security certification
A point is provided to this app if it declares compliance with one or more security certifications (e.g. ISO/IEC 27017, ISO 27001, PCI, SOC 2, HITRUST, MASVS).
No certification found
Easy to understand
A point is provided to this app if it is easy to understand (grade level below 8) as defined by the Automated Readability Index (ARI) readability tool.
User satisfaction on App Store
A point is provided to this app if user satisfaction averaged at least 4 out of 5 stars on App Store.
- App Store
Free of distracting ads
A point is provided to this app if it is free of unrelated ads during app use.
Sufficient support section
A point is provided to this app if it provides appropriate resources to adequately help users who experience problems with the app (e.g. support section, knowledge base, FAQs).
Compliant to a design standard
A point is provided if the app manufacturer declares compliance with one or more design standard(s) related to accessibility, usability, and inclusivity (e.g. ISO 9241, WCAG, ADA, etc.).
No design standard found