Can my phone be my doctor? Regulated vs. Unregulated applications

To optimize the benefits of technology for your health, it's important to distinguish between unregulated health apps and those classified as SaMD.

To optimize the benefits of technology for your health, it's important to distinguish between unregulated health apps and those classified as SaMD.

Bailey Pearlman

3 minutes

Health applications on our phones, smartwatches, and computers have become a daily part of our lives. Designed to help users monitor their health, keep track of their fitness goals, and manage chronic conditions, it’s easy to rely on them to keep track of the little details that have a big impact on our future health. But how do you know which ones you can trust? 

Software as a Medical Device (SaMD) has become increasingly popular in the field of healthcare and mobile health apps, which can be used for a variety of medical purposes, including monitoring chronic conditions, tracking medication adherence, and providing telehealth services. 

Many unregulated health apps are joining the expansion of accessible health services. It can be difficult to distinguish from their regulated partners, especially when both are trying to achieve the same outcome: better human health. 

How can a medical device be on my phone? 

To determine whether an app meets the definition of a medical device, the FDA considers factors such as the intended use of the app, the patient population for which it is intended, and the app's functionality. If the app is intended for a medical purpose and its functionality meets the definition of a medical device, then it is labeled SaMD.

The regulatory requirements for SaMD apply to all software platforms. Mobile apps that meet the medical device definition are subject to the same regulatory requirements as other SaMD, including: 

  1. Pre-Market Evaluation: SaMD must undergo a pre-market evaluation to determine its safety and effectiveness, including a review of the software's intended use, its design, its performance, and its clinical validation.

  1. Design and Development Controls: SaMD must be designed and developed under a set of controls, including software validation, verification, and risk management, to ensure that it meets its intended purpose. 

  1. Clinical Validation: Regulated software must undergo clinical validation to ensure that it performs as intended and is safe and effective. This process includes testing the software in a clinical setting to evaluate its performance, safety, and efficacy.

  1. Post-Market Surveillance: Monitoring for safety and effectiveness after software is released into the market includes ongoing monitoring of adverse events, software updates, and feedback from users.

  1. Labeling and Instructions for Use: Clear and concise labeling and instructions for use to ensure that software is used properly by clinicians and patients.

  1. Quality Management System: A quality management system must be used when manufacturing and distributing SaMD to ensure that it fulfills its intended purpose consistently and safely. 

Not all apps are created equal

It’s important to understand that unregulated health applications are not all created equal. While some of them are developed by reputable companies and have undergone rigorous testing, others have not. This means that there is a wide variation in the quality and accuracy of the information that users are receiving. Unfortunately, it’s up to you to tell the difference to protect your medical privacy and your health. 

At first glance, a calorie tracking app with over 1.5 million reviews that claims to be a personal trainer, dietitian, and nutrition coach all in one sounds like the perfect tool. However, a closer look at the user agreement section reveals that the data harvesting for marketing purposes includes any diagnostic information you enter into the app.

One of the issues that occurs with unchecked health applications is when users start to rely on them too heavily. While these apps can be a useful tool for monitoring health, they should not be used as a substitute for professional medical advice. There is no way to know whether the methods these unregulated applications use to reach conclusions are tried and tested. What’s more, the health advice could be provided without having a complete picture of your health. These factors and more potential risks are what an app developed in a regulated environment would account for. 

Apps that meet the definition of SaMD are subject to the same regulatory requirements as any other medical device, and these requirements help to ensure that regulated apps are safe, effective, and reliable in clinical settings. But don’t throw away your smart watch or delete your favorite app just yet—know that if these apps get you to choose water over coffee once a day or have you going for a walk for the first time in years, you might not want to dismiss them too quickly. Keeping the risks in mind is a better approach when considering your health and how your mobile applications play a role.