Clinical UM Guideline

This document defines the general principles used to determine the medical necessity of practitioner-prescribed software applications for health management purposes when used on a mobile device (e.g., mobile phone, laptop, smartwatch, or tablet) with the intent to evaluate, diagnose or treat an illness, injury, disease or its symptoms.

Note: This document does not address:

• Mobile-based software applications (MSAs) that are used in the function or control of another US Food and Drug Administration (FDA)-cleared or approved stand-alone hardware medical device.
• MSAs that are accessible to the general public for download (including direct-to-consumer [DTC] or over-the-counter [OTC] applications), applications that promote general wellness, or applications operated by a healthcare practitioner in a clinical setting for remote health monitoring.

Note: Over-the-counter (OTC) and consumer wearable devices may be excluded from benefit plan coverage. This may include smart phone, smart watch, or other personal tracking devices, including any software or applications.

Note: Please see the following related document for additional information:

• CG-ANC-11 Selected Mobile Device-Based Health Management Applications
• CG-MED-102 Dichoptic Digital Therapy for Amblyopia

Note: For a high-level overview of this document, please see “Summary for Members and Families” below. 

Medically Necessary:

Mobile-based health management applications are considered medically necessary when all of the following criteria in I and II have been met:

1. Criteria to evaluate the mobile software application (MSA):
   1. The MSA has been approved or cleared by the Food and Drug Administration (FDA); and
   2. There is credible scientific evidence which permits reasonable conclusions regarding the impact of the MSA on health outcomes; and
   3. The MSA has been proven materially to improve the net health outcome or be as beneficial as any established alternative;
      and
2. Criteria to evaluate the appropriateness of the MSA for the individual:
   1. The MSA has been prescribed by a healthcare practitioner; and
   2. There is documentation supporting that the MSA was ordered for a covered purpose such as preventing, evaluating, diagnosing or treating an illness, injury, disease or its symptoms, and in accordance with generally accepted standards of medical practice;* and
   3. The requested MSA is not primarily for the convenience of the individual, prescribing clinician, caregiver, or other healthcare provider.

*Generally accepted standards of medical practice means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician specialty society recommendations and the views of physicians practicing in relevant clinical areas, and any other relevant factors.

Not Medically Necessary:

Mobile-based health management applications are considered not medically necessary when the criteria above have not been met.

This document describes clinical studies and expert recommendations, and explains when mobile device-based health management applications  are clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Mobile-based health management applications (“apps”) are software tools used on smartphones, tablets, or smartwatches to help manage, treat, or diagnose health conditions. These applications are sometimes prescribed by healthcare providers. These apps may collect health information, help manage symptoms, or provide information that may guide care. For these apps to be considered clinically appropriate, they must be approved or cleared by the FDA, show evidence of improving health, and be prescribed for a covered purpose like treating a specific illness or symptom. Apps that are used mainly for convenience or general wellness are not considered clinically appropriate.

What the Studies Show

While many health management apps are available, the relevant evidence from clinical trials does have limitations. Some apps, like those for diabetes or sleep management, show small improvements in health measures, but these improvements are often not large enough to improve health in a meaningful way. For example, some diabetes apps show a small drop in blood sugar levels, but not enough to improve symptoms or reduce complications caused by diabetes.

When are Mobile Device-Based Health Management Applications Clinically Appropriate?

A prescribed mobile-based health management application may be appropriate when all of these conditions are met:

• The app has been cleared or approved by the FDA; and
• Credible scientific studies allow reasonable conclusions about how the app affects health; and
• The app has been shown to meaningfully improve health or to work as well as an established option; and
• A healthcare provider has prescribed the app; and
• Records show that the app was ordered to prevent, evaluate, diagnose, or treat a health condition or its symptoms, using accepted medical practice; and
• The app is not mainly for the convenience of the person, caregiver, or healthcare provider.

Is this Clinically Appropriate?

A mobile-based health management application is not clinically appropriate when the criteria above are not met. For example, it is not appropriate when studies do not provide credible evidence about its effect on health or do not show that it improves health or works as well as an established option. It is also not appropriate when it has not been cleared or approved by the FDA, has not been prescribed for an appropriate medical purpose, or is mainly used for convenience.

Mobile-based health management applications are not clinically appropriate in scenarios other than those listed above.

(Return to Description)

Coding edits for medical necessity review are not implemented for this guideline. Where a more specific policy or guideline exists, that document will take precedence and may include specific coding edits and/or instructions. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Summary

Practitioner-prescribed mobile software applications are used on mobile devices for health management purposes and are intended to evaluate, diagnose, or treat an illness, injury, disease, or its symptoms. Coverage is limited to applications that are FDA‑cleared or approved, prescribed by a healthcare practitioner, and supported by credible scientific evidence demonstrating a meaningful improvement in net health outcomes. Applications that are over‑the‑counter, direct‑to‑consumer, intended solely for general wellness, remote monitoring, or that function as accessories to stand‑alone hardware medical devices are excluded. Given the rapid growth of digital health technologies, this guideline applies a structured regulatory and evidence‑based framework to ensure clinical appropriateness and consistency with generally accepted standards of medical practice.

Discussion

More than 85% of U.S. adults own a smartphone (Pew Research Center, 2021). “Health-related mobile applications available to consumers on top app stores worldwide now surpass 350,000, with more than 90,000 digital health apps added in 2020 — an average of more than 250 apps per day.” (Institute for Human Data Science [IQVIA], 2021). Examples of medical mobile device software applications (MSAs) currently available include applications that purport to perform cognitive behavioral therapy, augment weight loss goals, identify suspicious nevi (mole), or even distinguish between normal cardiac sinus rhythm and potentially dangerous arrhythmias. Transforming a personal mobile device, such as a smartphone, into a medical device has the potential for far-reaching implications on the diagnosis and management of many diseases and disorders in addition to promoting general health and wellness. Despite the enormous effort to develop and disseminate digital health innovations, evidence of efficacy, or even a widely accepted framework for evaluation of efficacy, remains lacking. According to IQVIA (2021):

…independent organizations continue to highlight the need for larger and more robust randomized controlled trials (RCTs) that follow patients for longer times and report between-group differences in benefit, assessments of usability, and user-retention to determine the durability of their clinical effect, and evidence of cost-effectiveness that can be analyzed versus standard of care.

The FDA Center for Devices and Radiological Health (CDRH) is one of several groups leading development of a framework for evaluating the burgeoning number of MSAs anticipated to reach market as part of the expanding digital health innovation arena. The framework is detailed in their guideline entitled, “Policy for device software functions and mobile medical applications” (FDA, 2022).

The FDA’s regulatory oversight of software functions includes the following subsets:

1. Software functions that are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or analyzing medical device data.
   Examples of software functions that control medical devices include: software that provides the ability to control inflation and deflation of a blood pressure cuff through a mobile platform and mobile apps that control the delivery of insulin on an insulin pump by transmitting control signals to the pumps from the mobile platform.

Device software functions of these types are considered accessories to the connected device and not addressed by this document.

2. Software functions (typically, mobile apps) that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Software functions that use attachments, display screens, sensors, or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform.
   Examples of these types of software functions include: a software function that uses a mobile platform for medical device functions, such as attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter; or attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals; a software function that uses the built-in accelerometer on a mobile platform to collect motion information for monitoring sleep apnea; a software function that uses sensors (internal or external) on a mobile platform for creating an electronic stethoscope function is considered to transform the mobile platform into an electronic stethoscope; manufacturers of such a mobile app are required to follow the requirements of 21 CFR 870.1875(b) (Electronic stethoscope); and similarly, a software function that displays radiological images for diagnosis transforms the mobile platform into a medical image management and processing system under 21 CFR 892.2050.

Mobile software functions of this type are addressed by this document when the ancillary hardware device is intended to function solely in conjunction with the mobile device application.

3. Software functions that become a regulated medical device by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations. These types of functions are similar to or perform the same function as those types of software devices that have been previously cleared or approved.
   Examples of software functions that perform sophisticated analysis or interpret data (electronically collected or manually entered) from another medical device include: software functions that use patient-specific parameters and calculate dosage or create a dosage plan for radiation therapy; Computer Aided Detection software (CAD) image processing software; and radiation therapy treatment planning software.

The FDA's 2024 Report on Risks and Benefits to Health of Non-Device Software Functions outlines categories of software that fall under the statutory exemptions outlined in Section 520(o)(1) of the FD&C Act. These include general wellness tools, software limited to administrative or data transfer functions, and certain clinical decision support tools that do not provide automated diagnostic or treatment output. Applications in these exempt categories are not regulated as medical devices by the FDA (FDA, 2024). This document addresses software applications only when they operate on a mobile device, have received FDA clearance or approval, are clinician-prescribed, and are intended to evaluate, diagnose or treat an illness, injury, disease or its symptoms.

In 2025, Lakhan conducted a cross-sectional study, which systematically reviewed all FDA-cleared, prescription-only digital therapeutics (PDTs [for example, MSAs]) as of May 2025 to characterize patterns in regulatory pathways, sponsor geography, labeled indications, and therapeutic language. In total, 13 PDTs were identified, 8 of which were cleared via the 510(k) pathway and 5 via the De Novo classification pathway. All products were cleared under the CDRH, and sponsors were exclusively U.S.-based. The study found that FDA labeling varied meaningfully in terms of therapeutic claims. Although 11 of 13 PDTs included the word “treat” in their indication for use, many were accompanied by qualifiers such as “aid in the management” or “help improve symptoms.” Only 1 product, CT-132 for migraine, received a treatment indication without modifiers, representing a “clean” treatment label and 2 products, EndeavorRx and reSET-O, were labeled not as treatments but as tools to improve attention function or retention in treatment, respectively. These distinctions in language may impact how PDTs are interpreted. The study concluded that labeling language plays a central role in determining therapeutic scope and regulatory positioning and has direct implications for adoption and use in clinical care.

Mobile application (mobile app): Software application that can be executed (run) on a mobile platform (i.e., a handheld commercial off-the-shelf computing platform, with or without wireless connectivity), or a web-based software application that is tailored to a mobile platform but is executed on a server.

Mobile platform: Commercial off-the-shelf (COTS) computing platforms, with or without wireless connectivity, that are handheld in nature (e.g., mobile computers such as smart phones, tablet computers, or other portable computers).

Off-the-self: As purchased or as commonly available, without modification or customization.

Over-the-counter: Non-prescription therapeutic device, test, software, or other product.

Software: A set of instructions, data or programs used to operate a computing device and execute specific tasks; a generic term used to refer to applications, scripts and programs.

Peer Reviewed Publications:

1. Abbas H, Garberson F, Glover E, Wall DP. Machine learning approach for early detection of autism by combining questionnaire and home video screening. J Am Med Inform Assoc. 2018; 25(8):1000-1007.
2. Abbas H, Garberson F, Liu-Mayo S, et al. Multi-modular AI approach to streamline autism diagnosis in young children. Sci Rep. 2020; 10(1):5014.
3. Bae H, Shin H, Ji HG, et al. App-based interventions for moderate to severe depression: a systematic review and meta-analysis. JAMA Netw Open. 2023; 6(11):e2344120.
4. Batterham PJ, Christensen H, Mackinnon AJ, et al. Trajectories of change and long-term outcomes in a randomised controlled trial of internet-based insomnia treatment to prevent depression. BJPsych Open. 2017; 3(5):228-235.
5. Beukes E, Andersson G, Fagelson M, Manchaiah V. Internet-based audiologist-guided cognitive behavioral therapy for tinnitus: randomized controlled trial. J Med Internet Res. 2022; 24(2):e27584.
6. Catalá-López F, Hutton B, Núñez-Beltrán A, et al. The pharmacological and non-pharmacological treatment of attention deficit hyperactivity disorder in children and adolescents: a systematic review with network meta-analyses of randomised trials. PLoS One. 2017; 12(7):e0180355.
7. Kumar A, Ross JS, Patel NA, et al. Studies of prescription digital therapeutics often lack rigor and inclusivity. Health Aff (Millwood). 2023; 42(11):1559-1567.
8. Lakhan SE. Decoding FDA labeling of prescription digital therapeutics: a cross-sectional regulatory study. Cureus. 2025; 17(5):e84468.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Agency for Healthcare Research and Quality (AHRQ). May 20, 2022. Evaluation of mental health mobile applications. Available at: https://effectivehealthcare.ahrq.gov/products/mental-health-apps/report. Accessed on July 24, 2026. 
2. American Medical Association. Integration of Mobile Health Applications and Devices into Practice H-480.943. Last modified 2024. Available at: H-480.943 Integration of Mobile Health Applications and Devices | AMA. Accessed on July 24, 2026.
3. Institute for Clinical and Economic Review (ICER). Digital health technologies as an adjunct to medication assisted therapy for opioid use disorder. December 11, 2020. Available at: https://icer.org/wp-content/uploads/2020/08/ICER_Digital_Therapeutics_for_OUD_Evidence_Report.pdf. Accessed on July 24, 2026.
4. Institute for Human Data Science (IQVIA). Digital Health Trends 2021: innovation, evidence, regulation and adoption. Available at: https://www.iqvia.com/insights/the-iqvia-institute/reports/digital-health-trends-2021. Accessed on July 24, 2026.
5. Institute for Human Data Science (IQVIA). Digital health trends 2024: implications for research and patient care. Available at: https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/digital-health-trends-2024. Accessed on July 24, 2026.
6. U.S. Food and Drug Administration (FDA). Developing a software precertification program: a working model (V1.0). January 2019. Available at: https://www.fda.gov/media/119722/download. Accessed on July 24, 2026.
7. U.S. Food and Drug Administration (FDA). Developing the software precertification program: summary of learnings and ongoing activities: 2020 Update. September 2022. Available at: https://www.fda.gov/media/142107/download. Accessed on July 24, 2026.
8. U.S. Food and Drug Administration (FDA). Digital Health Center of Excellence. July 22, 2026. Available at: https://www.fda.gov/medical-devices/digital-health-center-excellence. Accessed on July 24, 2026.
9. U.S. Food and Drug Administration (FDA). Policy for device software functions and mobile medical applications. September 28, 2022. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications. Accessed on July 8, 2026.
10. U.S. Food and Drug Administration (FDA). Report on risks and benefits to health of non-device software function. December 2024. Available at: https://www.fda.gov/media/184083/download?utm_medium=email&utm_source=govdelivery. Accessed on July 24, 2026.   
11. U.S. Food and Drug Administration (FDA). Software pre-cert pilot program. September 2022. Available at: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program. Accessed on July 24, 2026.
12. World Health Organization. Recommendations on digital interventions for health system strengthening. April 2019. Available at: https://apps.who.int/iris/bitstream/handle/10665/311941/9789241550505-eng.pdf?ua=1. Accessed on July 24, 2026.

1. American Psychiatric Association (APA). App Advisor. Available at: https://www.psychiatry.org/psychiatrists/practice/mental-health-apps. Accessed on July 24, 2026.
2. Pew Research Center. Mobile fact sheet. November 20, 2025. Available at: https://www.pewresearch.org/internet/fact-sheet/mobile/. Accessed on July 24, 2026.
3. U.S. Food and Drug Administration (FDA).
   • Digital Health Policy Navigator. December 14, 2022. Available at: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-policy-navigator. Accessed on July 24, 2026.
   • Examples of device software functions the FDA regulates. Updated May 21, 2026. Available at: https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-device-software-functions-fda-regulates. Accessed on July 24, 2026.

Federal and State law, as well as contract language, and Medical Policy take precedence over Clinical UM Guidelines. We reserve the right to review and update Clinical UM Guidelines periodically. Clinical guidelines approved by the Medical Policy & Technology Assessment Committee are available for general adoption by plans or lines of business for consistent review of the medical necessity of services related to the clinical guideline when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the member's card.

Alternatively, commercial or FEP plans or lines of business which determine there is not a need to adopt the guideline to review services generally across all providers delivering services to Plan’s or line of business’s members may instead use the clinical guideline for provider education and/or to review the medical necessity of services for any provider who has been notified that his/her/its claims will be reviewed for medical necessity due to billing practices or claims that are not consistent with other providers, in terms of frequency or in some other manner.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

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