FDA wants to make the home a healthcare hub

During the pandemic, the world became accustomed to carrying out more activities from the home, including healthcare needs. Ben Hargreaves explores the FDA’s announcement that it would create a vision of a home better suited to meeting the healthcare needs of those living with chronic diseases.

The pandemic was a catastrophic event for global public health. Yet, at the same time, the emergence of COVID-19 forced the healthcare industry to evolve and adapt at a rapid pace. There have been lasting benefits from this period: from greater adoption of decentralised trials, to increased use of digital health tools and a broader flexibility in attempts to tackle long-standing issues facing the industry.

One of these challenges is the necessity of reaching individuals needing healthcare support in their homes. This has been an on-going difficulty for the healthcare industry, particularly in regions and countries where access to support is complicated by distance or accessibility options. As part of its efforts to address this, the FDA recently announced that it would launch a ‘Health Care at Home’ initiative to advance health equity.

Home healthcare

In the press release describing the initiative, the FDA acknowledged that the way healthcare is delivered needs to change to ensure as many people as possible have their needs met. This means a shift from the traditional model, where healthcare has been primarily delivered at hospitals, clinics, providers, and payers, towards a more fluid and modern structure. The FDA noted that the existing healthcare system does not meet the needs of millions of people with limited or no access across the country, with racial and ethnic minorities, rural communities, and lower-income neighbourhoods losing out.

In response to this situation, the FDA wants to “reimagine the home environment” that will position people’s homes as an “integral part of the healthcare system”, stated the authors, Jeff Shuren, director of the FDA's Center for Devices and Radiological Health (CDRH), and Michelle Tarver, deputy director for transformation at CDRH. The authors identify that care providers are trying to make more use of the home as a clinical trial site, but that very few have considered the “structural and critical elements” of the home that are required for the transfer of care. Tarver was approached by pharmaphorum for more details on the project, in particular what is meant by the structural and critical elements of the home.

“The initiative focuses on the critical rooms in the home that are present in most housing units, whether a single-family home, mobile home, or an apartment,” Tarver responded. “In addition, how those rooms are constructed could impact the safe and effective use of medical devices in the home. The Home as a Health Care Hub initiative is examining opportunities to optimise how the home can integrate medical devices in healthcare, wellness, and evidence generation.”

AR/VR home prototype

A key part of the project will be the design of a home prototype that will tackle some of the issues facing delivering healthcare from the home. The dwelling will be designed by HKS Inc, an architectural firm, which will receive $1.2 million to build a virtual reality (VR) model of a home, stated Fierce Biotech.

Part of the firm’s remit will be to design a home where medical device developers and policymakers will be able to visualise how devices might work in a home environment through the use of VR and augmented reality (AR). “We envision that this prototype will be an idea lab, helping to inform the design or modification of medical devices that could work in the homes of individuals who may have limited resources,” Tarver said.

Beyond regulators and medical device developers, the project will also involve collaboration with patient groups and healthcare providers. According to the FDA, existing models that have examined care delivery at home have found improved patient satisfaction, good adherence, and potential cost savings to be brought to the healthcare system.

The project will begin with dwellings in rural locations and lower-income communities, with the initial prototype designed to advance health equity. The FDA stated that the home prototype is expected to be completed later in 2024.

Joined-up thinking

The home prototype will be designed for an individual living with diabetes. In terms of why this disease was chosen, the agency stated that over $300 billion was spent on medical costs for diabetes in the US in 2022. This represents a 35% increase over the past decade, which is disproportionately impacting underserved communities and communities of colour. The project could point a way forward to reducing the amount spent on this therapeutic area, and, more importantly, serving the needs of those most impacted.

Currently, the FDA stated that devices intended for use in the home tend to be operated in isolation, even if they are used for the same condition. “Someone living with diabetes, and the complications of their condition, may use multiple devices at home like a glucose monitor, an insulin pump, and a home dialysis machine. However, these devices may not all communicate with one another, may not be designed in a manner that encourages engagement, may not be customised to the person living with the condition, and may be identifiable by visitors to the home,” said Tarver.

The initiative aims to address these issues by placing personalised care with “people at the centre,” the agency stated. In shifting the care model in this manner, the agency believes that the healthcare system can deliver “scarce resources” to those with the most urgent and critical needs, tailoring personalised care for those managing chronic conditions.

The aim of the project is to begin conversations with medical device developers and providers to bring clinical trials and other evidence-generating processes to underrepresented communities through the home. Especially within clinical trials, the discussions over increased access, diversity, and equity are of increasing importance to the FDA, with the home prototype becoming a part of this broader effort. As the FDA outlines, the rise of chronic disease prevalence rates will necessitate greater care from the home setting in the future. Viewing houses as part of the medical healthcare system is one step to recognising the limits of the system within a traditional setting and into the model necessitated by the pandemic, where more functions can be carried out from the home.