In recent years, the line between consumer technology and medical devices has blurred, with many mobile applications now classified as Software as a Medical Device (SaMD), a subset of medical device software. These applications are designed to perform one or more medical functions without being part of a hardware medical device.

For instance, some apps can monitor heart rhythms using the phone’s sensors or connected devices, providing users with real-time health data that can be shared with healthcare providers.

Beyond entertainment

When it comes to mobile apps that are classified as SaMD, this means that your smartphone can host applications that perform functions like diagnosing diseases, monitoring patient health, or providing therapeutic interventions. 

Mobile apps have become an integral part of healthcare, offering functionality that can significantly impact patient outcomes and even save lives. For instance, these apps can track heart rate or blood glucose levels and alert users and healthcare providers to irregularities, allowing for timely intervention.

The safety of SaMD apps on mobiles is governed by regulatory frameworks such as those from the US Food and Drug Administration (FDA), the European Commission, and other national health authorities.

These bodies ensure that apps meet stringent safety, efficacy, and quality standards before they can be marketed. This regulatory oversight helps to protect users from potential harm due to software errors, malfunctions, or use errors.

The regulatory angle

An app is considered a medical device if it is intended for use in the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This intention is often determined by the app’s functionality and the claims made by its developers regarding its use. This is what differentiates a general wellness app from a medical device. 

So, if an app claims to diagnose, treat, or prevent a specific medical condition, it is likely to be considered a medical device, whereas apps that promote general health and fitness without specific medical claims are usually not classified as such.

Regulatory bodies have specific criteria for classifying an app as a medical device. These criteria focus on the app’s intended use and its potential impact on patient health and safety.

Why some apps require medical device approval

Some apps require medical device approval because they perform functions that can significantly impact a user’s health. These functions might include diagnosing conditions, providing treatment recommendations, or monitoring vital signs. As such, they are classified as software as medical devices (SaMD) and need to meet stringent safety and efficacy standards to ensure they do not cause harm.

The approval process ensures that apps claiming to be medical devices are reliable and accurate. This is particularly important for apps that collect and analyse health data, as inaccuracies could lead to misdiagnosis or inappropriate treatment. Approval processes typically involve rigorous testing and validation to confirm the app’s performance under various conditions.

This testing includes conducting risk assessments, implementing robust quality management systems, completing clinical evaluations, and conducting clinical investigations to demonstrate that the app is safe and effective for its intended use. Regular updates and maintenance are also crucial to address any emerging safety issues or vulnerabilities.

User data privacy and security are also critical components of SaMD safety. These apps often handle sensitive health information, so developers must ensure compliance with data protection regulations like the General Data Protection Regulation (GDPR) in the EU or the Health Insurance Portability and Accountability Act (HIPAA) in the US. This involves implementing strong encryption, secure data storage, and clear user consent protocols.

Your pocket doctor

Some apps, initially designed for general wellness, have evolved to meet criteria that classify them as medical devices.

• Natural Cycles – contraceptive app. One notable example of an everyday health app that is classified as a medical device is Natural Cycles. This is a certified contraceptive app that uses body temperature data to predict fertility. The app uses a sophisticated algorithm to analyse basal body temperature and menstrual cycle data to predict fertile and non-fertile days, thus allowing users to plan or prevent pregnancy. The app’s classification as a medical device underscores its reliance on scientific methods and its potential impact on users’ health decisions.
• BlueStar – living with diabetes. The BlueStar app is another health app that is classified as a medical device. It is specifically designed to assist individuals with diabetes in managing their condition more effectively. By providing personalised guidance and real-time feedback, BlueStar aims to improve the daily management of diabetes.
• Propeller Health – managing asthma and COPD. Along with the Propeller Health app, which connects with inhalers to help manage asthma and COPD, these apps are just a few in a growing trend where mobile technology is leveraged to provide healthcare solutions that are accessible and convenient.

More surprising apps with diagnostic capabilities

Several mobile apps have been developed with diagnostic capabilities, transforming smartphones into powerful medical tools. These apps often utilise the phone’s built-in sensors or connect with external devices to gather health data, which can then be analysed to provide diagnostic insights.

• SkinVision – capture skin leasons. For instance, some apps, such as the SkinVision app, use the phone’s camera to capture images of skin lesions, which are then assessed using artificial intelligence algorithms to detect potential skin cancers or other dermatological conditions.
• Kardia app – detect irregular heartbeats. Another category of diagnostic apps includes those that monitor heart health. These apps can work in conjunction with wearable devices or use the phone’s sensors to record heart rate and rhythm. For example, Kardia app is capable of detecting irregular heartbeats or atrial fibrillation, providing users with early warnings that can prompt further medical evaluation. This type of app often offers the ability to generate electrocardiograms (ECGs) that can be shared with healthcare professionals for detailed analysis.
• ResAppDX – analyse breathing patterns. There are also apps designed for respiratory health diagnostics. Apps, such as ResAppDx, can analyse breathing patterns and sounds to identify conditions such as asthma or chronic obstructive pulmonary disease (COPD). By using the phone’s microphone, these apps can record and evaluate coughs or breathing sounds, offering insights that can aid in the management of respiratory conditions.

These are just some examples of apps that are classified as medical devices, and we are sure to see many more in the years to come.

As we wrap up our exploration of this digital revolution, one thing is clear: the world of mobile apps has expanded beyond simple convenience to embrace profound medical utility. Mobile medical apps are now essential tools in everyday life around the world.

Julian Carter, a psychology graduate from the University of Hertfordshire, has a keen interest in the fields of mental health, wellness, and lifestyle.