1. What are the safety and effectiveness concerns when a digital health device provides a diagnosis (e.g., a computer-assisted diagnosis for screening diabetic
retinopathy by adding on software to fundus camera images) in comparison to when a digital health device provides information as an aid for diagnosis to the eye care provider?
2. What are the important safety and effectiveness concerns for an ophthalmic digital health device (e.g., a metamorphopsia detection application for screening or monitoring progression of macular disease; or a visual field assessment application for screening or monitoring glaucoma) used in the following settings?
a. An eye care clinical environment
b. A non-eye care clinical environment
c. Non-clinical environment (e.g., at home, school, workplace)
3. What are the most effective methods of mitigating risks for an ophthalmic digital health device?
a. Safeguards built into the software;
b. Safeguards built into the hardware such as:
i. Light standards for light sources
ii. Electrical and EMC standards
c. Methods to limit the intended users
d. Labelling for patient use
e. Training modules and tutorials
4. What are the assets, threats, and vulnerabilities that should be considered and identified as a threat to the privacy of a patient by ophthalmic digital health device developers?
a. Transmission of information to electronic medical records or other databases
b. Storage of information on the personal device or cloud devices
c. Monitoring patient behavior and location