Medical Device Nonvisual Accessibility Act of 2023
Impact
If enacted, the bill would mandate that all covered medical devices must meet specific non-visual accessibility standards before they can be marketed. These standards will ensure that user interfaces for such devices allow individuals with visual impairments to access information, engage with the devices, and enjoy services equally as those without disabilities. This legislative change aligns with broader efforts to improve healthcare accessibility and can potentially reduce reliance on caregivers for device operation, fostering greater independence among users.
Summary
House Bill 1328, known as the Medical Device Nonvisual Accessibility Act of 2023, aims to amend the Federal Food, Drug, and Cosmetic Act to establish accessibility standards specifically for medical devices with digital interfaces. The bill recognizes that many medical devices currently use complex visual interfaces that are inaccessible to individuals who are blind or have low vision. It emphasizes the need for these devices to be operable in a non-visual manner to ensure privacy and independent use by these consumers.
Contention
Notable points of contention surrounding HB1328 include concerns from manufacturers regarding the feasibility of implementing these accessibility standards. They may argue that meeting these standards could impose undue hardship on their operations or fundamentally alter the nature of their products. The bill allows for waivers under certain conditions; however, the criteria for waivers could lead to debates about whether the exemptions are being appropriately utilized.