Passive Health Monitoring: Collecting Patient Data at Home

Trial Better: A Clinical Trials Podcast

Introduction

We welcome Nicholas Conn from Heart Health Intelligence and Jean-Phillippe Couderc from VPG Medical as he joins Trial Better to discuss passive health monitoring and the smart toilet seat.

What is the Heart Seat and what does it do?

The Heart Seat is a cardiovascular monitoring system integrated into a toilet seat. This allows you to monitor a comprehensive set of measurements in the home without requiring patients to change their behavior at all. The Heart Seat automatically starts downloading data when the user sits down; that data is then uploaded to the cloud. It can measure over nine clinically relevant cardiac parameters including blood pressure and cardiac output.

What is the user experience of the Heart Seat like?

The seat has the same standard hinge mounting as a regular toilet seat. It’s as simple as popping off the old toilet seat and replacing it with the Heart Seat, which is completely battery powered. The version coming to market will have full cellular and WiFi capabilities built into it.

What’s the timeline and process for bringing the Heart Seat to market?

Right now, Heart Health Intelligence is working through the required regulatory processes to bring the Heart Seat to market. They anticipate finishing development and submitting for final FDA approval by 2021, and are targeting the end of 2021 for the initial product launch.

Is there anything different that needs to be done to achieve regulatory approval for passive monitoring devices versus achieving approval for new drug therapies?

Companies seeking approval for passive monitoring devices must prove that high quality data can be collected using the device. So far, nobody has gotten approval from the FDA for these types of devices. While the FDA is interested in understanding the impact the device and passive acquiring procedures can have on data, they also want to ensure passive monitoring devices can produce robust data.

How can the introduction of passive health monitoring devices impact clinical trials?

Integrating passive monitoring into clinical trials will make participating in trials less burdensome for patients. One would expect that this type of technology will not only lead to more data but will also increase patient compliance and enrollment in clinical trials. Passive health monitoring can also be looked at as a trigger for virtual clinical trials.

Besides regulatory approval, what other challenges might passive health monitoring devices like Heart Seat face?

One of the big challenges with adopting any in-home monitoring technology is how it ends up being used in clinical practice. Passive health monitoring devices put massive amounts of data in the hands of providers and study teams that are already extremely busy. Producers of passive health monitoring devices are also digital services companies that have a responsibility to figure out how to reduce this burden in order to achieve widespread adoption.

How can we ensure patients are compliant with these devices?

These devices require much less effort from the patient in order to achieve compliance. The point of these devices is that patients don’t need to change their behavior in order to provide the data that sponsors need.

Do you have any final thoughts on the future of passive health monitoring?

One of the most exciting things about these technologies is that we don’t know what we’ll discover when we capture data at such a high frequency and with such high levels of adherence. It may enable us to develop better, safer medications and make improvements in the quality of care. There are also opportunities for advancements through machine learning. These devices and the data that they capture can be used for other purposes and applications that we can’t yet imagine.