The US Food and Drug Administration (FDA) assesses food and tobacco products, supplements, drugs and medical devices and authorizes their sale in the US. Due to their potential impact on patient health, some mobile health apps are considered medical devices and must therefore be approved by the FDA.
Medical Device, defined in the Food and Drugs Act, covers various health tools used to treat, diagnose, or prevent a disease or medical condition. This definition includes the software intended to be used for medical purposes, such as health apps. (1)
Health apps can give users more control over their health by providing easy access to health information anytime, anywhere and tools to manage their health. Users can take an active role in their health by making decisions and acting to improve their health outcomes. This can help patients to manage their health more efficiently and effectively.
The apps considered medical devices must go through the appropriate FDA review process before marketing. This rigorous process is designed to ensure products are effective and safe for patients.(1)
It is important to clarify that not all health-related apps are considered medical devices. Apps that provide general health and wellness information, track exercise or nutrition, or provide tips for healthy living may not meet the criteria for medical device classification and would not have to be reviewed by a regulator such as the FDA.(1)
The FDA has recently approved several new prescription apps entering the US market and may make their way to other countries, including Canada. In this article, you will learn more about some of these apps and the FDA process they went through.
Although this article focuses on FDA scope and processes, it should be noted that regulators in other countries provide similar oversight. For instance, in Canada, Health Canada is responsible for approving health software considered a medical device.
What are the criteria for an app to be approved by the FDA?
The FDA regulates and approves various products, including medical devices, apps, drugs, and food products. To gain FDA approval, an app must be classified as a medical device and meet specific criteria. The main ones are:
Risk assessment: The FDA assesses the level of risk associated with the app. The greater the potential risk to patient safety, the more rigorous the FDA's review process will be. The FDA classifies medical devices into three categories: Class I, II, and III. The classification of a health application depends on its intended use and risk level.
Medical objective: The FDA evaluates the intended use of the app to determine if it is intended to diagnose, treat, mitigate, or prevent disease.
Functionality and performance: The app must perform a medical function, such as measuring vital signs, monitoring symptoms, or providing diagnostic assistance. In addition, the FDA evaluates the app's performance to determine if it meets its intended purpose and if it is safe and effective for use.
Valid scientific evidence: The FDA reviews the scientific evidence supporting the safety and effectiveness of the app.
User friendly: The FDA assesses the user interface to determine if it is easy to use and understand, especially for healthcare professionals who may use the app to make clinical decisions.
Data privacy and security: The FDA evaluates the app's data privacy and security protocols to ensure that the app protects the patient's privacy and personal health information.
Quality system: The FDA evaluates the quality system of health application developers to ensure that they have a system in place to ensure that their products meet regulatory requirements and are safe and effective for their intended use.
Overall, the FDA seeks to ensure that medical apps are safe and effective for patients and that healthcare professionals can rely on the app's results to make clinical decisions. (1)
What does this mean for patients?
Approval of apps by the FDA means that US patients can access an expanding set of tools to help manage their disease. These apps can be prescribed just like a drug or a medical device. They may be used as a standalone modality or to connect with and analyze data from a portable sensor or other devices. Some apps may represent a significant step forward in terms of patient care and have a positive impact on people's health.
These apps can be beneficial for patients who want to manage their health actively. They provide valuable resources to help people better understand their condition and make informed decisions about their treatment. In addition to this, some apps allow clinicians access to the patient's data. Sharing health data can help inform clinical decisions promptly. The FDA ensures that the data is shared securely.
Which conditions can be treated using FDA-approved apps?
Various diseases and conditions can be treated using an FDA-approved app.
Regulated apps include software tools developed for treating diabetes, COPD, hypertension, mental illness, hypercholesterolemia, or cancer, among other diseases. Robust, regulated apps are becoming essential tools for the clinician and patient as they allow better disease management and compliance with therapeutic objectives.
Let's talk about some of the FDA-approved apps that have clinical relevance and are also approved for use in Canada
Dexcom G6 mg/dL DXCM2
The Dexcom G6 Continuous Glucose Monitoring (CGM) System is a tool that provides real-time glucose readings for patients with type 1 or type 2 diabetes every five minutes. The app provides personalized trend alerts on your smart device and lets you see when your glucose levels are too low or too high, so you can better manage your diabetes. (4)
FreeStyle Libre 2 – CA
FreeStyle Libre 2 is a sensor-based glucose monitoring system that makes diabetes management more effortless. The system provides a small and discreet sensor that can be worn for up to 14 days, allows high accuracy for adults and children, and provides customizable, live glucose alarms that alert you of highs and lows. You can also get detailed reports, including your time in range, to understand your glucose patterns better, stay connected to your healthcare professional with LibreView and share data with family and friends using the LibreLinkUp app.(5)
Kardia works with the FDA-cleared KardiaMobile, KardiaMobile 6L, or KardiaBand personal EKG devices to detect arrhythmias (irregular heartbeats) in 30 seconds. The Kardia app makes it easy to manage heart care from home, with features like EKG recording, remote sharing of heart data with doctors, and health history tracking. (2)
Qardio heart health
L'application Qardio peut être utilisée pour suivre une gamme de données de santé, y compris la pression artérielle, la fréquence cardiaque, le poids et les niveaux d'activité, en se connectant à des capteurs portables. L'application fournit aux utilisateurs des visualisations de leurs données, leur permettant de voir facilement les tendances et les changements de leur santé au fil du temps. Il permet également aux utilisateurs de définir des objectifs et des rappels pour les aider à rester sur la bonne voie avec leurs objectifs de santé.
These next apps are only marketed in the US but may become available in Canada at a later time
reSET is a 12-week prescription digital therapeutic for patients with substance use disorder who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is the first FDA-authorized treatment shown to increase abstinence and retention over the 12-week trial duration.
reSET lets you continue your recovery work on your smartphone or tablet, so you can build new skills and get support—anytime, anywhere. reSET is not intended to be used as a stand-alone therapy for substance use disorder (SUD) and does not replace care by your provider.
Somryst is an FDA-approved digital therapeutic app for treating chronic insomnia in adults. The app combines cognitive behavioural therapy for insomnia (CBT-I) with digital therapeutics to provide a personalized treatment plan for users. (3) It requires a prescription from a health professional and is intended to be used as part of a comprehensive treatment plan for chronic insomnia.
Apps you can trust
Health professionals and patients can trust apps approved by the FDA and other regulators, such as Health Canada, because they are considered effective and safe according to scientific evidence and meet quality standards. The proven usefulness and robustness of these new tools to help prevent or treat diseases mean that patients can confidently use them for their conditions.
In conclusion, the use of FDA-approved apps may have a positive impact on the health of patients through the following:
Robust clinical effectiveness: Patients can expect tangible, consistent and predictable health benefits from these apps.
Improved accuracy and earlier diagnosis: Fewer health problems will go undetected and untreated.
Increased patient engagement: Patients can become more engaged in their healthcare and take a more active role in managing their conditions.
Enhanced safety: FDA-approved applications are subject to rigorous safety standards, which can help to ensure that patients are not exposed to unnecessary risks or harm.
More efficient healthcare delivery: These applications can help to streamline healthcare delivery by reducing the need for in-person visits and enabling doctors to monitor their patients remotely.
Overall, using regulated apps is a great way to ensure the apps are safely designed, improve the quality of care, increase patient satisfaction, and promote better health outcomes for individuals. Still, it does not guarantee that these apps fit your lifestyle or healthcare needs. If you feel the need to, for example, if you have difficulty choosing an app or don't feel safe using such tools, feel free to ask your health professional for help with choosing or using these apps.
Shuren, J., Patel, B., & Gottlieb, S. (2018). FDA Regulation of Mobile Medical Apps. JAMA, 320(4), 337‑338. https://doi.org/10.1001/jama.2018.8832
Cullen, J., Reed, M. J., Muir, A., Murphy, R., Pollard, V., Zangana, G., Krupej, S., Askham, S., Holdsworth, P., & Davies, L. (2021). Experience of a smartphone ambulatory ECG clinic for emergency department patients with palpitation : A single-centre cohort study. European Journal of Emergency Medicine: Official Journal of the European Society for Emergency Medicine, 28(6), 463‑468. https://doi.org/10.1097/MEJ.0000000000000859
Dreyer, R. P., Berkowitz, A., Yaggi, H. K., Schneeberg, L., Shah, N. D., Emanuel, L., Kolla, B., Jeffery, M. M., Deeg, M., Ervin, K., Thorndike, F., & Ross, J. S. (2022). PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I) : A protocol for a pragmatic randomised controlled trial. BMJ Open, 12(8), e062041. https://doi.org/10.1136/bmjopen-2022-062041
FDA Advisory Panel Votes to Recommend Non-Adjunctive Use of Dexcom G5 Mobile CGM. (2016). Diabetes Technology & Therapeutics, 18(8), 512‑516. https://doi.org/10.1089/dia.2016.07252.mr
Heller, A., & Feldman, B. (2010). Electrochemistry in diabetes management. Accounts of Chemical Research, 43(7), 963‑973.https://doi.org/10.1021/ar9002015
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