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A Guide to Clinically Testing Health Apps



Mobile health (often referred to as mHealth) is an increasingly popular facet of the healthcare field that involves the use of mobile devices, such as smartphones and tablets, to support healthcare delivery and health-related activities. One of the most common forms of mHealth is health and wellness apps, which can be used for a wide range of purposes, from providing mindfulness practice prompts and tracking fitness goals to managing chronic conditions.


Many tech brands are now launching health apps, and pursuing clinical testing in order to assess the safety and effectiveness of their apps. For new brands, this consumer testing can feel a bit daunting as it differs somewhat from pharmaceutical or consumable clinical testing but must still maintain some kind of medical rigor. To make the process clearer for brands creating health apps, we have compiled some of the ways that health apps are clinically tested:


1. Usability Testing

Usability testing is exactly what it sounds like; this type of clinical testing focuses on the app's user interface, user experience, and overall ease of use. The goal of usability testing is to ensure that the app is intuitive, easy to navigate, and does not create any unnecessary barriers to its use by the average consumer. This type of testing usually involves a small group of users who are asked to complete specific tasks using the app while either directly being observed by researchers or reporting their progress digitally.


2. Feasibility Testing

Feasibility testing is used to determine whether an app is feasible in a clinical setting. This can involve testing the app's functionality and compatibility with existing clinical systems. For example, a health app designed to monitor blood glucose levels would need to be compatible with the devices used to measure blood glucose levels and the electronic health record system used by the patient's healthcare provider.


3. Pilot Studies

Pilot studies are small-scale studies that evaluate the feasibility and potential effectiveness of the app. These studies may involve a small group of patients or healthy volunteers using the app for a short period of time. Pilot studies can help identify any issues with the app's design or functionality before it is used on a larger scale or with more vulnerable participants.


4. Randomized Controlled Trials (RCTs)

As with any other kind of clinical research, randomized controlled trials (RCTs) are considered the gold standard for evaluating the effectiveness of health apps. RCTs involve randomly assigning participants to either an intervention group (using the app) or a control group (not using the app or instead using a non-clinical placebo app) and comparing outcomes between the two groups. As RCTs are the most rigorous form of clinical testing, they are often required by regulatory agencies before an app can be marketed as an official medical device or treatment aid.


5. Observational Studies

Observational studies can be used to evaluate the real-world effectiveness of a health or wellness app. These studies may involve collecting data from patients or volunteers who are using the app in a clinical setting. Observational studies are less rigorous than RCTs but can provide valuable information about the app's effectiveness in a real-world setting.


6. Post-Market Surveillance

Once an app is on the market, ongoing monitoring can be conducted to identify potential adverse events or other issues that may arise. This can involve collecting live data from users through self-report and automatic data collection or monitoring user reviews and feedback. Post-market surveillance is vital to ensure that health apps continue to be safe and effective after they have been released to the public, as well as to attend to any technical issues that may arise and affect user experience.


Wrapping Up

In general, the clinical testing process for health apps may involve a combination of these methods, depending on the app's intended use and regulatory requirements. It's important to note that health apps should all undergo clinical testing and brands should be sure to make sure that their product complies with all necessary regulations before releasing it to consumers.

When choosing a health app, consumers look for apps that have been rigorously tested and evaluated for safety and effectiveness, and having clinical research behind your app will help it to stand out in a crowded marketplace.


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