Heidi Health is committed to ensuring the ongoing safety, quality, and performance of the Heidi AI Scribe medical device. To support this, we have established a clear process for users to report medical device complaints and potential serious incidents.
Examples of a medical device complaint that may be relevant to the Heidi AI Scribe include:
The scribe adds incorrect clinical information (“hallucination”) that was not stated during the consultation - for example, introducing an inaccurate diagnosis, medication, or symptom.
The scribe omits key clinical details such as medications, allergies, vital signs, or other items of the patient history that were discussed.
The scribe summarises inaccurately or incompletely, resulting in a meaning change or potential misunderstanding of clinical facts.
A serious incident refers to any event that led, might have led, or could lead to the death or serious deterioration in the health of a patient, user, or other person.
Note: A complaint may relate to a serious incident.
How to report an issue
If you believe you have encountered a potential complaint, device-related error, or possible serious incident:
Open the Help icon within the Heidi product.
Send us a message describing the issue and any relevant context.
Our system will triage your message, If the concern is a complaint, it will be escalated to our Medical Knowledge and Regulatory teams for assessment.
What happens after you report an issue
Once your message is received, our Medical Knowledge and Regulatory teams will:
Review and investigate the issue
Confirm whether it meets the definition of a medical device complaint
Assess any safety impact and whether the event is reportable to regulators
Implement corrective and preventive actions, where required
This process supports our Post-Market Surveillance obligations and ensures compliance with medical device vigilance requirements in the UK.
For general support queries
If you have a routine question or need technical assistance, click the help button from within Heidi apps, or email us at [email protected]