About You
Tell us about yourself so MHRA can follow up if needed. Contact details are optional but helpful.
About the AI/Software
Tell us about the AI or software involved in the incident. If you don't know some details, that's okay.
What Happened
Describe the incident in as much detail as you can. This helps MHRA understand what went wrong.
Impact and Outcome
Tell us about the impact of the incident. "Near misses" where harm could have occurred are also important to report.
Patient Information
This section is optional. If the incident involved a patient, providing basic demographics helps MHRA with their analysis. Please do not include any information that could identify the patient.
Review Your Report
Please review the information below. You can go back to any section to make changes.
About You Edit
AI/Software Details Edit
Incident Details Edit
Impact and Outcome Edit
Patient Information Edit
Your Report is Ready
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What to do next:
- Click "Copy to Clipboard" to copy your report
- Go to yellowcard.mhra.gov.uk and select "Standalone software and medical device Apps"
- Paste your information into the relevant fields
Alternatively: email your report directly to aic@mhra.gov.uk
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