Whether the digital mental health app is grounded in established clinical evidence or recovery-oriented principles that align with its stated purpose or therapeutic claims. A valid clinical or recovery foundation means the app’s design, features, and functions are:
- Based on evidence-based practices, such as Cognitive Behavioral Therapy (CBT), Dialectical Behavior Therapy (DBT), or peer-supported recovery frameworks;
- Supported by published literature, clinical guidelines, or expert consensus;
- Designed to facilitate clinically meaningful outcomes, such as symptom reduction, improved functioning, or enhanced recovery;
- Appropriate to the app’s intended population and use case, such as mood tracking for depression, exposure exercises for anxiety, or peer support for substance use recovery.
Source: Torous, J., Lipschitz, J., Ng, M., & Firth, J. (2021). Dropout, Engagement, and Effectiveness of Mobile Health Interventions for Mental Health: Systematic Review. NPJ Digital Medicine, 4(1), 13. https://doi.org/10.1038/s41746-020-00350-0
Percentage of patients or participants who remain engaged in a clinical program, treatment regimen, or clinical trial over a specified period.
Risks associated with health IT systems that could lead to patient harm. Clinical safety harms refer to adverse outcomes resulting from failures in health information technology (health IT) systems or clinical workflows, particularly when these failures impede timely and appropriate responses to suicide risk or the implementation of evidence-based treatments. These harms may include:
- Failure to flag or act on suicide risk due to missing alerts, documentation gaps, or decision support errors.
- Delays or omissions in delivering guideline-concordant care (e.g., not initiating CBT or pharmacotherapy for depression due to system configuration or user error).
- Fragmented data that prevent coordination across providers and settings, increasing the risk for patient deterioration or crisis.
Source: Singh, H., & Sittig, D. F. (2016). A Sociotechnical Framework for Safety-Related EHR Research Using Real-World Data. Journal of Biomedical Informatics, 59, 14–24. https://doi.org/10.1016/j.jbi.2015.11.006
Data health tools are digital systems or platforms used to collect, store, analyze, or visualize health-related information. These tools help clinicians, researchers, or patients make sense of data from apps, electronic health records (EHRs), or wearable devices. Examples include:
- Dashboards for tracking symptoms or outcomes
- Data visualization platforms
- Analytics software for monitoring trends or risk scores
- Tools that integrate data from multiple sources to support clinical decision-making
Source: Mandel, J. C., Kreda, D. A., Mandl, K. D., Kohane, I. S., & Ramoni, R. B. (2016). SMART on FHIR: A standards-based, interoperable apps platform for electronic health records. Journal of the American Medical Informatics Association, 23(5), 899–908. https://doi.org/10.1093/jamia/ocv189
A distinctive characteristic or functionality of a system or product, which can be used to satisfy a requirement or provide value to the user.
Low bandwidth or offline environments refer to settings where internet connectivity is limited, slow, unreliable, or completely unavailable. These conditions can affect how digital health apps or tools function, especially those that rely on real-time data exchange, cloud storage, or video features.
Source: Agarwal, S., LeFevre, A. E., Lee, J., L'Engle, K., Mehl, G., Sinha, C., & Labrique, A. (2016). Guidelines for reporting of health interventions using mobile phones: Mobile health (mHealth) evidence reporting and assessment (mERA) checklist. BMJ, 352, i1174. https://doi.org/10.1136/bmj.i1174
Modes of engagement refer to the ways users interact with the app’s features or content to support their health or well-being. This includes the types of activities, prompts, or tools the app uses to encourage participation, behavior change, or self-monitoring. Examples include:
- Active engagement: Completing daily check-ins, tracking symptoms, setting goals
- Passive engagement: Receiving notifications, reminders, or educational content
- Interactive features: Chatbots, games, or peer forums
- Therapeutic exercises: Guided meditations, CBT modules, journaling prompts
- Behavioral nudges: Motivational messages, push alerts, streak tracking
Source: Baumel, A., Muench, F., Edan, S., & Kane, J. M. (2019). Objective user engagement with mental health apps: Systematic search and panel-based usage analysis. Journal of Medical Internet Research, 21(9), e14567. https://doi.org/10.2196/14567
Procedural and organizational actions taken by manufacturers or supporting parties (such as communication, documentation, education, and update notifications) that assist users in securing and managing IoT devices across their lifecycle.
Source: https://nvlpubs.nist.gov/nistpubs/ir/2021/NIST.IR.8259B.pdf
Low bandwidth or offline environments refer to settings where internet connectivity is limited, slow, unreliable, or completely unavailable. These conditions can affect how digital health apps or tools function, especially those that rely on real-time data exchange, cloud storage, or video features.
Source: Agarwal, S., LeFevre, A. E., Lee, J., L'Engle, K., Mehl, G., Sinha, C., & Labrique, A. (2016). Guidelines for reporting of health interventions using mobile phones: Mobile health (mHealth) evidence reporting and assessment (mERA) checklist. BMJ, 352, i1174. https://doi.org/10.1136/bmj.i1174
Any information about health status, provision of health care, or payment for health care that can be linked to an individual. This includes medical records, lab results, prescriptions, and any other information that identifies the individual or can be used to identify them in a healthcare context.
Source: https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-160/subpart-A/section-160.103
Commonly shortened as tech support, is a customer service provided to customers to resolve issues, commonly with consumer electronics. This is commonly provided via call centers, online chat and email.
Entities external to the organization that handle or process information on its behalf. Third parties in the context of an app refer to external organizations, services, or software tools that are not part of the app’s core development team but are integrated into the app or receive user data. These third parties may support various functions, such as analytics, advertising, data storage, or clinical services.
Source: https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-171r3.pdf
The specific individual, group, or organization for whom a mobile application is designed, and who is expected to directly engage with its features to achieve the app’s intended purpose