The U.S. Food and Drug Administration (FDA) has taken a significant step in advancing health equity by soliciting public input on the transition to at-home care and how it can support enabling technologies. In an effort to facilitate access to medical devices outside of traditional clinical settings, the FDA’s Center for Devices and Radiological Health (CDRH) has posed a series of questions to the industry and the public. This move aligns with the FDA’s commitment to ensuring that all patients have access to safe, effective, and high-quality medical devices. Through gathering insights from diverse stakeholders, the FDA aims to better understand the challenges and opportunities associated with at-home care.
Expanding Access to Non-Clinical Care Settings
The development of remote patient-monitoring devices and other connected medical technologies has opened up new possibilities for treating patients at home. By leveraging these technologies, healthcare providers can potentially reduce costs and risks associated with traditional healthcare facilities, while also alleviating burdens on patients. The COVID-19 pandemic has further accelerated the adoption of telehealth and remote monitoring, underscoring the importance of at-home care in modern healthcare systems.
To support the transition to non-clinical care settings, the FDA is seeking feedback on various aspects of home-based healthcare. One key area of inquiry is how digital health technologies can contribute to and enhance home-based healthcare. This includes understanding the design attributes that facilitate the use of devices outside of clinical settings. By soliciting input on these topics, the FDA aims to gather insights that can inform regulatory reviews and ultimately lead to the development of safer and more effective medical technologies for use in the home.
Promoting Health Equity and Inclusivity
The FDA’s call for public feedback also reflects its commitment to advancing health equity. The agency recognizes that diverse patient populations may have unique needs and considerations when it comes to utilizing medical technologies outside of clinical settings. Consequently, the FDA is interested in learning how digital health technology design attributes can be improved to better facilitate their use by these populations. In particular, the FDA seeks insights that can enhance acceptance and usability among older adults, non-English speakers, and individuals with lower literacy levels.
The FDA acknowledges the importance of accessibility to medical technologies in remote locations. Recognizing that some individuals may be unable or unwilling to access care in traditional clinical settings, the FDA aims to identify strategies for enabling the use of medical technologies in non-clinical settings. By understanding the barriers and challenges associated with accessing care in remote locations, the FDA can develop policies and guidelines that ensure equitable access to medical devices for all individuals, regardless of their geographic location.
Driving Innovation and Evidence Generation
The FDA’s solicitation of public feedback is not only about gathering insights on patient care in non-clinical settings, but also about driving innovation and evidence generation. The agency is keen to explore the potential methods and strategies for generating evidence and analyzing data that can facilitate the regulatory review of medical technologies intended for use outside of traditional clinical settings. By streamlining the regulatory process and ensuring the availability of robust evidence, the FDA aims to foster a more efficient and effective path to market for these devices.
Additionally, the FDA is interested in identifying medical procedures and diagnostics that are ideal for transitioning from hospital and healthcare settings to non-clinical care settings. This includes exploring the medical technologies that could be best suited for use in non-clinical settings and considering any necessary modifications to optimize their performance outside of traditional healthcare facilities.
Questions for Public Feedback:
- How can the FDA support the development of medical technologies, including digital health technologies and diagnostics, for use in non-clinical care settings, such as at home?
- What factors should be considered to effectively institute patient care that includes home-based care?
- What are ways that digital health technologies can (a) foster the conduct of clinical trials remotely and (b) support local or home-based healthcare models?
- How can the FDA facilitate individuals accessing medical technologies in remote locations when they are unable or unwilling to access care in clinical settings?
- What processes and medical procedures, including diagnostics, do you believe would be ideal for transitioning from a hospital and/or healthcare setting to non-clinical care settings, for example, home use or school/work use?
- What medical technologies could be ideal to transition to use in non-clinical settings? What aspects of those technologies could potentially benefit from modifications to optimize use in non-clinical settings?
- What design attributes and user needs would facilitate the use of medical technologies, including diagnostic and therapeutic devices, for use in a non-clinical setting, for example home use?
- For digital health technologies, what design attributes could better facilitate their use by diverse patient populations outside of a clinical setting? What other factors are important to consider which may improve use and acceptance of different digital health technologies by diverse patient populations (for example, older adults, non-English speakers, lower literacy)?
- What potential methods and strategies for evidence generation and data analysis could facilitate the regulatory review of medical technologies intended to be used in non-clinical settings, for example home use or school/work use?
People are encouraged to provide their feedback to the FDA before the end of August.
