Software as a Medical Device and its Evolving Role in Healthcare

Software is a critical part of our everyday lives. It fuels the apps that help us order on-demand rides and take-out, access music and movies, power the wearables that monitor our physical activity, and in general, make our lives easier. Modern healthcare also relies a great deal on software to keep the wheels in motion—from data analysis to EHRs and medication dose monitoring, software continues to transform the industry.

The role of software in healthcare is ever-changing—particularly in its expanding role as a medical device. The FDA is now working with the International Medical Device Regulators Forum (IMDRF) and have released guidelines around software as a medical device, due to the rapid development and innovation taking place in the market and its multiple applications in clinical care.

Spotlighting the issue recently was the buzz created from the FDA inviting Apple to join a working group within the IMDRF (which Apple enthusiastically accepted) to offer input on drafting guidelines for regulating medical software. Furthermore, the AMA recently “approved a list of principles to guide coverage and payment policies that support the use of mobile health apps and devices.”

Given its widening reach and the profile of stakeholders taking notice, the conversation surrounding software as a medical device (SaMD) is gaining momentum and prompting a closer look at the role it plays in healthcare and its impact on patients.

Gaining momentum

The regulation of SaMD, which includes apps, is still a work in progress but as an international panel of medical device regulators, scientists, legal experts and physicians continue to streamline how best to regulate different types of software, a framework to help define the term is emerging. The proposed guidelines look at “whether the device informs care, drives care, or treats/diagnoses and whether the condition in question is non-serious, serious, or critical” and would have a major impact on how many products that fit this criteria are categorized and potentially regulated—including those made in the future by Apple.

Apple is currently working with the FDA on a FDA-regulated app aimed at diagnosing Parkinson’s disease. Maureen Phillips, global clinical trials manager at Great Lakes NeuroTechnologies, which makes wearable devices for Parkinson’s management, told MobiHealthNews, “It seems like the market is finally starting to grow a lot and people are starting to realize that wearables and [mobile health] apps really have a place in clinical care. We’re going to continue to see more and more companies pop up with potential resources or apps that can be used in that application. So it’s just a part of this technology being on the market and people realizing the importance of it.”

Currently there are no definitive regulations on apps. While recognizing the mass potential of apps and devices, the AMA cautioned for patients and physicians to hedge their enthusiasm by acknowledging that not all apps and devices are created equal.

The patient’s critical role

On one end of the spectrum, some SaMDcan be accessed only by prescription, such as Voluntis’ type 2 diabetes management app, Insulia, which is a mobile app with an algorithm that optimizes glucose doses. On the other end, another type of SaMD laid out in the IMDRF guidelines is software that helps identify and triage early signs of a disease or condition. Under this definition, patient lifestyle interventions like digital diabetes prevention programs could also fall under the domain of software as a medical device.

With the range of SaMD’s role in healthcare and its various contexts, providers and patients need to be realistic about software’s capabilities and ultimately, limitations. People can start to view software as a silver bullet that solves serious health issues by pressing a button or downloading an app. Yet we know that for significant health challenges, like chronic disease, where the benchmark for improving health begins with significant lifestyle and behavior changes, individuals will need to play a greater role in the process.

Software’s use in healthcare

While SaMD is an exciting area of growth for digital health, it is not the only place where technology can play a key role in healthcare. The FDA also recognizes and defines what are known as “Medical Device Data Systems,” meaning “hardware or software products that transfer, store, convert formats, and display medical device data.” Thus, this includes tools that enhance care team workflow and communication both within the health care team and between care teams and patients. Chronic care management also includes critical components, such as health coaching, that rely on efficient and effective ways of reinforcing the patient-provider relationship for ongoing education and support.

By providing patients the tools to manage health that include education, patient-provider communication, tracking and coaching, technology can help people be more informed and proactive with self care. Moreover, with complex chronic diseases, software that can help power the coaching relationships that supports patients for sustained lifestyle changes will have the most impact on improving health outcomes.