In April, the U.S Food and Drug Administration (FDA) announced the launch of a new initiative, Home as a Health Care Hub.
The agency views the home as a key care setting that has the potential to drive health care equity forward.
That’s why it is seizing the moment, and creating room for experimentation with its current initiative, which will essentially serve as an idea lab that brings together device developers, policymakers, providers and much more.
To learn more about this initiative, Home Health Care News caught up with Dr. Michelle Tarver, deputy director for transformation at the FDA’s Center for Devices and Radiological Health (CDRH).
Prior to this, has the FDA ever done a big initiative around home-based care or health-at-home? If so, tell me more about these past initiatives and why the agency decided to launch this initiative now?
Tarver: It’s been over a decade that we’ve been discussing and exploring opportunities for people to have access to medical devices in the home. In fact, there was a workshop back in 2010 that talked about this very topic.
The COVID-19 public health emergency bubbled this back to the top. Everyone was forced to receive care at home. In many situations – because the health care system was overly taxed, overly stretched – it really did put, front and center, the importance of us considering what devices potentially need to be able to work in the home, and how we can integrate input from those devices, so that the providers can deliver good care.
The other important element that we saw during the public health emergency is that there were certain communities that really were bearing a great burden of poor health care outcomes. We were seeing deaths higher in certain segments of our society than in others. It inspired, to some extent, our strategic priority, which is advancing health equity. These two things kind of converged. We envision that by allowing health care to come into the home, we have the opportunity to allow people to receive care, right where they are, where they work, where they play, where they live. That can be enabled, partially, by technology, but also looking at ways that we can decrease some of the roadblocks to them potentially receiving care in those locations. As part of it, we opened the docket on home use devices in June of last year. Then we had a patient engagement advisory committee meeting where patients, caregivers and patient organization representatives discussed considerations around bringing devices into the home. One theme that emerged from the discussion is that no one’s talking about our homes. We’re talking about devices and these are siloed conversations, but can somebody tell us how our homes can be better prepared to receive these technologies? That was the inspiration behind us launching this initiative.
Can you give me an overview of the Home as a Health Care Hub? The FDA will be working with an architectural firm to design an Augmented Reality/Virtual Reality (AR/VR)-enabled home prototype. What will the prototype allow the FDA to accomplish?
The initiative will focus on the home, and understanding the homes of people who have the fewest amount of resources — starting with apartments, mobile homes, single family homes. The footprint of the home is the bedroom, the kitchen, the bathroom. Those are the areas we’re really focusing on.
We’re starting with the lower resourced communities, because it’s important that if we’re really trying to advance health equity, we start and intentionally design with health equity in mind. The prototype of the homes in those three different formats that I just alluded to, will be a virtual reality home. We’re hoping that device developers and other policymakers may be able to put on this virtual reality device and understand opportunities for devices to be developed that may meet the needs of patient populations, as well as inspire frameworks and other value-based care options that potentially can help communities that need it most. So it’s really going to be a home, but a prototype of a home, a virtual reality home that people can play with and use. That home will be publicly available, so we’re hoping that people will pick it up and play with it, and test it and modify it. We’re not proposing that this will be a finished final, never to change product again, but that it will be an iterative design that people can adjust and modify, as needed.
How does the FDA’s position allow the agency to tackle care at home in such an innovative way?
I think the FDA sits in a central position. We hear from patients, providers im the industry and payers and hospital systems. But there is always this linear kind of conversation. We very rarely talk to builders and home designers and furniture makers and general home appliance makers. By bringing this topic to the forefront, by creating a home prototype, we’re bringing all of these particular entities together to have a more integrated conversation. It becomes a crucible, where we can actually truly imagine, with input from all the different stakeholders, who would need to be part of that solution.
The initiative also includes partnerships with health care providers. How have these providers contributed to what the FDA is trying to accomplish?
They’ve been incredibly helpful. They have participated in our public meetings. They have provided comments on our docket, and they have sent emails to me directly wanting to talk with me about the initiative. We’ve had some very informative conversations, so that’s one way.
The second way is we have health care providers that are part of the research committee, and are sharing their insights as we are developing the prototype. The other way is there are focus groups that we are going to be using as we’re developing the prototype with the health care provider community. Lastly, we will be having a public meeting where anyone from the public can share their thoughts and perspectives with the agency, as we are developing this prototype. We’re using all the vehicles we can think of, in order to garner input from the public about the effort.
Is the FDA working with any home-based care providers on this? If yes, how so?
Not necessarily the organizations, but nurses, the community health workers, and the therapists will be part of those groups that we will be getting feedback from. We will be getting their insights. There is someone that sits on our steering committee for the initiative, who is part of the American Occupational Therapy Association. They are very aware of how to deliver care in the home and some of the considerations there. We have clinicians, nurses and wound care folks that we’ve been talking with. A lot of different [health care professionals] are sharing their insights, as we are moving along this development process.
We’ve also talked to a number of different companies that are developing different types of solutions that they envision being in the home. Some of them are consumer technology, some of them are regulated medical devices. We are open to conversations from both stakeholders. One of the things that I have talked with a lot of the industry members about is the importance of considering how people engage with technology. It’s one thing to say, ‘I’m designing something to go in the home,’ it’s another thing for a person to engage with that and use it to improve their health. There is this blending of some of the consumer technology opportunities with the medical device opportunities, so that we actually can have patients use the devices in the home and improve their health care outcomes.
As you mentioned, advancing health equity is a big part of this initiative. How does care in the home allow you to do this?
There are a number of hospitals that have been closing in rural areas, and there are a number of care providers that are retiring from delivering clinical care. We’re not repopulating that provider pool at the same rate as they’re leaving. It’s more and more difficult to find specialists in certain segments of our nation, and the cost of delivering care is rising. With all of those challenges, it’s compounded by the fact that there are certain groups in the United States that have trust issues with the health care system. All this will result in people not utilizing systems, not getting care that they need, and potentially experiencing worse health care outcomes. The home itself is convenient, it’s accessible, and it may allow for the building of more trusted relationships and may improve the ability for people to get their health care needs met because they don’t have to take time away from work, or find additional childcare options in order to just get clinical care. By focusing on where people are, it doesn’t require them to go to something. We are bringing it to them, and I think this will play a huge role in advancing health equity.
The FDA is using diabetes as an example health condition for the hub. Talk about why, and what other conditions the agency is hoping to address?
We chose diabetes because it’s a condition that currently plagues about 30 million people, or more, of all ages in the United States. Children are challenged by it, as well as adults. We see disparities in certain racial and ethnic groups, including American Indian and Alaskan Natives, Black, Hispanic, and Asian populations, rural residents, as well as those who have lower education, and those who have fewer resources. It is, by definition, a condition that we see significant health disparities in. It also is a huge cost of the health care system, it costs over $300 billion in medical costs.
What makes diabetes an interesting condition to start with, in this particular imagining exercise, is that the natural history of diabetes impacts so many different organ systems. It’s the leading cause of blindness in the United States, it’s the leading cause of amputations in the United States, and one of the top causes of end stage kidney disease. It’s associated with significant morbidity and disability. As a result, those things have impacts on independence, have impacts on the ability to navigate around one’s home and live your daily life. We don’t think that it is going to be the only condition that we will encourage the community to consider, but it’s a good starting place, because it allows us to imagine what a home needs to look like for all those different scenarios, which may touch on scenarios that are relevant for other conditions.
What does the agency want the ultimate impact of the Home as a Health Care Hub to be?
We hope it opens up the opportunity to truly center care on the people that are most impacted by their conditions. The folks who are patients in our health care system, and consider them as people instead of patients. By just changing our frame of focus, we can help to imagine a health care system that is democratized in a way that people can get access to it, and that by its very design exudes empathy. It’s not the finish line starting point, it’s an idea, it’s an experiment. We hope that it’ll start a conversation that will lead to novel solutioning.
