Digital health apps have seen an explosion in use in the past few years, as changing circumstances, evolving tastes, and a global pandemic make remote healthcare options more palatable. Mobile health apps offer new opportunities for patient care and monitoring, and help reduce the necessity of in-person visits. 

Historically, medical devices have always been defined as physical tools. Stethoscopes and scalpels, needles and forceps… these objects make sense as medical devices as they make a physical impact on a patient. But personal health apps are purely software, lines of code and programming. This makes them incredibly flexible and available to a wide number of people, as they can potentially be used by anyone who owns a smartphone or needs access to that via a medical computer (for example, a primary care provider).

In today’s article, we’ll examine the rise of software as medical devices, their common applications, and some of the challenges they face going forward. 

Defining Software as Medical Devices

According to the International Medical Device Regulators Forum, software as medical devices (SaMD) is “software intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device.” In other words, a SaMD program could function as a medical device even if it is installed on a standard consumer product, such as a smartphone. 

Also referred to as “stand-alone software” or “companion apps,” SaMD are frequently used for patient monitoring, capturing data like heart rate, blood pressure, and physical activity through connected devices. These mobile health apps can also be installed on medical devices to offer additional capabilities and services. 

Common Applications for Mobile Health Apps

  • Remote Monitoring: After surgery or treatment, patients are typically kept in the hospital ward so that healthcare providers can monitor their condition. Sending patients home earlier frees up hospital beds and reduces time in the ward, but providers still need a way to ensure the safety of their patients. Through a mobile health app, they can monitor their patient’s vital signs and receive alerts if there have been any complications. 
  • Telemedicine: Prior to COVID-19, telemedicine was already growing popular. However, the pandemic led to an explosion in its usage. Remote communication between providers and patients spares the latter a trip to the hospital or clinic. This is especially helpful for people living in remote or rural areas. It is also a boon to patients suffering from mobility issues or have limited transportation options. 
  • Personal fitness and health: Perhaps the most common use for mobile health apps is in helping with personal fitness and health goals. Consumers can use apps on their smartphones to track how many steps they take in a day, how many calories they eat, how long they take to run a mile, and other parameters. Because these apps do not handle personal health data like others, they are typically subject to less regulation. 

Implementation of AI in SaMD

Artificial intelligence is seeing increasing usage in the field of healthcare, and mobile health apps are no different. These apps are already collecting data for analysis by providers, so implementing data-powered AI is a natural fit. 

AI is primarily used for predictive analytics, as these algorithms can process large amounts of data to provide insights for both patients and doctors. For instance, an AI can look at a patient’s health records, medical history, and current condition as recorded by their mobile health app to predict if they will get better or worse in the future. 

Healthcare providers can also use AI for decision making by processing the enormous quantities of data that come from biomarkers during a patient’s remote monitoring. By being better informed as to their patient’s condition, they can make better decisions for the treatment of their patient. 

Growth and Regulation of SaMD

Both the European Union’s MDR and the United States’ FDA regulate the patient’s condition and the corresponding level of treatment or devices permitted. Mobile health apps fall under the FDA’s Class II category, as devices that pose a moderate risk to the patient if misused. According to GlobalData’s approval forecast, 70 new Class II mobile health apps are expected to be approved in 2023 alone. This accompanies GlobalData’s prediction that by 2030, the medical apps market will reach $12.1 billion by 2030

With such a massive potential for growth, it only makes sense that regulators are paying close attention to the sector. The introduction of AI in healthcare has only further highlighted the need for stronger guidelines concerning the use of clinical decision support software, not just for mobile apps, but all of the healthcare industry. 

Privacy is another concern. The question of whether mobile health apps are regulated by HIPAA are such a pressing concern that the FTC recently issued an interactive tool to help app developers determine if their app was subject to the law. 

Closing Thoughts

The adoption of software as medical devices and mobile health apps promises to reap benefits for both patients and healthcare providers. However, these advanced software programs will need equally-capable pieces of hardware to run on. While standard consumer devices can possibly fulfill this role, the ideal choice is a medical-grade tablet that providers can issue to their patients and securely transmit data back and forth over. 

If you’re looking for a trusted medical-grade tablet manufacturer, turn to the experts at Cybernet Manufacturing. Contact our team today – we’re more than happy to explain the advantages of our expertly-designed products and how they can support a variety of mobile health apps. 

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