FDA’s Approach on Remote Patient Monitoring Devices
When it comes to checking our health, we are no longer dependent on scheduling a bunch of appointments and sit in waiting rooms. Remote patient monitoring devices enable us to keep an eye on our health right from our living room. Whether it’s a smart watch that tracks our heart rate or a little gadget that measures our blood sugar, these devices make it super easy to stay on top of things. However, while the convenience of remote patient monitoring devices is undeniable, it’s essential to address the data privacy concerns that come along with them.
In the USA, the FDA was quick in recognizing the transformative potential of remote patient monitoring devices and at the same time agile to respond to the critical importance of data privacy in this new context.
Traditionally, the Food and Drug Administration (FDA) classified devices based on their risk levels, with strict requirements for higher-risk devices. However, the rapid growth of telehealth and RPM has prompted the FDA to adapt its guidelines to facilitate innovation while ensuring patient safety. But is this a diplomatic way of saying that in this case data privacy is compromised in favor of innovation? Let’s find out below how the FDA’s approach to data protection for RPM is impacting both patients and health care professionals.
As RPM devices collect and transmit sensitive health data, the FDA emphasizes on the importance of interoperability and data security. The agency encourages manufacturers to design devices that can integrate with electronic health records (EHRs) and other health information systems while ensuring solid cybersecurity measures to protect patient data.
In cases where the RPMs qualify as SaMD, the FDA has issued guidance which outlines the criteria for determining whether the software is subject to FDA regulations. The criteria focuses on the SaMD’s intended use and the risks associated with its functionality. Post-market surveillance of RPM devices in order to monitor their performance and safety once they are in use is also on the FDA’s radar. What’s interesting to highlight is the manufacturer’s obligation to use real-world data as a way to identify potential issues and continously improve the RPM’s safety over time. At the same time, the FDA recognizes the importance of patient engagement in the development and evaluation of RPM devices. By incorporating patient feedback and preferences, the FDA aims to ensure that devices are not only effective but also user-friendly and accessible.
So it would be safe to say that the Emergency Use Authorizations (EUAs) issued by the FDA during the pandemic was an exception which allowed RPM devices that had not yet received full FDA approval, to expedite their availability in unprecedented times.