FDA launches at-home patient monitoring challenge to reduce readmissions

At-home patient monitoring recently got a big boost from a five-year extension of the Medicare Hospital at Home Program. Now, the FDA is building on that momentum by launching a new challenge designed to accelerate innovation of the remote monitoring devices that make home-based post-acute care into a safe and effective option for clinically eligible populations. 

The Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge encourages innovators to submit proposals for medical device technologies that can be used to prevent 30-day readmissions – a key quality indicator for health systems participating in a variety of incentive programs. 

Thirty-day readmission rates for people with chronic conditions can be as high as 18.4%, the FDA notes, and more than half of these readmissions occur for reasons that differ from the original hospitalization. Meanwhile, for patients without chronic diseases, the 30-day readmission rate was 13.9% between 2016 and 2020. These readmissions cost about 12% more than the initial hospital stay, creating a costly and disruptive event for both patients and their care providers. 

Federal agencies including the FDA and CMS have been increasingly investing in programs and technologies that can transform the home into a health hub that is more deeply integrated into traditional clinical care. With analysts anticipating up to $265 billion worth of services for Medicare and Medicare Advantage beneficiaries shifting into the home, strengthening the remote monitoring ecosystem has become a priority. 

Providers have been generally on board with the idea, and have flocked to the Medicare Acute Hospital Care at Home program to avoid using up scarce inpatient beds on patients who can be safely monitored at home – and kept out of the hospital with the right technologies and support. 

The new READI-Home Challenge represents a further step in the evolution of home-based care, and will allow medical device innovators to experience early engagement with the FDA as they develop their products and systems.  

Interested parties can submit their applications until September 30, 2026, and the FDA will select participants for the “interaction phase” by December 4, 2026. Up to nine devices from will make the cut, with only one device per manufacturer selected. 

Successful applicants will showcase devices that are intended to address unmet or emerging health needs in the home or the community environment. The devices should be designed to be used by patients and/or caregivers themselves, as opposed to trained medical professionals. 

The FDA will require sufficient evidence to support that the device could be associated with the reduction or prevention of readmissions for the targeted population, as well as some degree of evidence of feasibility for the device to function in the real-world environment. 

Starting in early December of 2026, the FDA will conduct “sprint” discussions with the chosen participants to help refine the design or testing of devices. Developers will also have a chance to demonstrate their devices and technologies at FDA research facilities, which may provide valuable feedback for iterating on their offerings.  

Information on how to apply for the READI-Home model is available on the FDA’s website by clicking here. 

Jennifer Bresnick is a journalist and freelance content creator with a decade of experience in the health IT industry.  Her work has focused on leveraging innovative technology tools to create value, improve health equity, and achieve the promises of the learning health system.  She can be reached at [email protected].