Who checks the eye? Independent oversight of optical implants
The final report of the scoping study with Frothly. It recommended independent pre-release evaluation of perception software, firmware escrow for discontinued devices and wider adoption of open service interfaces, and that the Independent Implant Register, which predates the study, be given funding that cannot be cut mid-term.
Optical implants are medical devices, computers and, increasingly, perception systems that decide what their wearers see. This scoping study asked who, if anyone, independently checks each of those things, and what a sensible system of oversight would look like.
We reviewed regulation in twelve countries, interviewed regulators, makers, clinicians and wearers, and compared optical implants with other devices that update their own software, such as insulin pumps and cardiac devices.
Key findings
- Medical device regulators check that implants are safe as devices; nobody routinely checks how their perception software behaves.
- No country of the twelve reviewed requires a maker to say, before sale, how long a device will be supported.
- Recommended independent pre-release evaluation of perception software, firmware escrow for discontinued devices, wider adoption of open service interfaces, and secure multi-year funding for the Independent Implant Register.
- Kiroshi Opticals agreed in October 2023 to submit its perception models to Frothly’s Blackwall programme before release.
How to cite
Chiba Centre for Visual Science and Frothly (2023). Who checks the eye? Independent oversight of optical implants. KF-R-2023-02. Tokyo: Kiroshi Foundation. kiroshi.org/research/publications/kf-r-2023-02/
Download the full report (PDF). For other formats, write to research@kiroshi.org.