Certain home medical devices would need controls usable without sight

Covered devices would need to offer blind and low-vision people comparable access, privacy, independence, and ease of use unless the health secretary grants a waiver. Only devices in federal classes II or III with screens or mobile apps would qualify. Devices intended solely for health care providers or solely for use outside the home would be excluded. Waivers would require clear and convincing evidence that compliance would make the device unusable, block an essential function, or cause significant difficulty or expense. Coverage would apply to devices cleared, authorized, or approved after the final rule takes effect, one year after its publication.

The health secretary would issue rules and train manufacturers to meet the accessibility standard. Training would cover manufacturers of covered devices and their screens or apps. The secretary would consult blind and low-vision people and the federal accessibility board when developing the standard and training. The secretary would also consult that board when issuing the rules. Proposed rules would be due within one year of enactment. The final rule would take effect one year after publication.