FDA launches ‘Home as a Health Care Hub’ initiative

Over the last few years and especially during the Covid-19 pandemic, healthcare systems in all parts of the world have faced many challenges, such as a shortage of professionals, rising costs, higher prevalence of chronic diseases and population longevity. Against this backdrop, the US Food and Drug Administration (FDA) is announcing the Home as a Health Care Hub initiative to help reimagine the home environment as an integral part of healthcare.

Although many places are already adopting the home as a small virtual clinic, few are considering the structural and critical elements of the home needed to absorb this migration. In addition, devices intended for home use are often designed to work in isolation rather than in an integrated environment. This creates other challenges, but also many opportunities for medical device suppliers with customisable technologies.

The FDA’s Center for Devices and Radiological Health (CDRH) has contracted an architectural firm that designs innovative buildings with health and equity criteria in mind to consider the needs of model homes and customised solutions with opportunities to adapt and evolve in complexity and scale. The hub will be designed as a prototype home prepared to work with Virtual Reality and Augmented Reality and should be completed later this year.

The work will include collaboration with patient groups, clinical and medical service providers and the medical equipment industry to build a home as a healthcare centre. The prototype will serve as a think tank, not only to establish connections with population groups most affected by health inequality, but also for medical device manufacturers, politicians and suppliers to start developing home-based solutions.

The FDA will take diabetes as an example of a health condition in the hub prototype, because of the long-term impacts of patients living with this condition. According to the US Centers for Disease Control and Prevention, more than $300 billion a year will be spent on medical costs for diabetes in the country by 2022, an increase of 35% in the last decade and something disproportionate when it comes to underserved and black communities. Diabetes affects many of the major organs and can result in early mortality and significant morbidity, including cardiovascular disease, kidney failure, blindness and amputations.

The Home as a Health Care Hub prototype aims to help medical device developers consider new design approaches and opportunities to educate patients and thus broaden care options. It will also motivate discussions to break down paradigms associated with medical care. Lessons learned from the initiative could inform future regulations involving technologies used in hospital at home programmes.

Although the FDA has been working to ensure the safety of home healthcare solutions for almost a decade and a half, Krista Drobac, executive director of the Moving Health Home group, told the Fierce Healthcare  website that the agency is probably trying with the new initiative to better understand the extent of the use of home medical equipment and software, which has evolved rapidly in recent years.

Moving Health Home (MHH) is an association working to change federal and state policies in the United States to allow homes to become a place for clinical care. Before the pandemic, some groups of innovators sought to bring more health care into homes, but political priorities, debates over health insurance coverage and payment made it difficult to move forward with the initiatives.

According to the article on the Fierce Healthcare website, the FDA had difficulty understanding the indications for use of at least one important software solution for hospitals used in home environments at the time of the pandemic.

On a page dedicated to medical devices for home use, the FDA states that the CDRH regulates medical devices, but regulatory authority alone is not enough to ensure that devices are safe and effective when used in the home. According to the page, the CDRH has received an increasing number of adverse event reports about medical devices used in the home.

Who knows the new hub could help change that.