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Healthcare: patient contact, minimal data, no clinical advice.

Future controlled cohort · not accepting first-launch healthcare deployments

Patient contact is the hardest ordinary use of a voice agent. Almost every call touches special-category data the moment a reason is mentioned, a share of callers are distressed or confused, and the one thing the agent must never do is answer a clinical question. Audact is built around those three constraints: collect only what the call needs, refuse what belongs to a clinician, and leave a record of both. We do not put this sector in the first launch. Health data is a special category under Article 9 GDPR and pulls in the impact assessment of Article 35; that assessment is a condition of onboarding here, not paperwork afterwards. Healthcare opens as a later controlled cohort, and this page is the reference in the meantime.

What the law requires

A person interacting with an AI system must be told so, unless it is obvious from the circumstances.
Regulation (EU) 2024/1689, Art. 50(1)
Health data is a special category. Processing needs a ground under Art. 9(2), for healthcare purposes typically Art. 9(2)(h), alongside a basis under Art. 6.
Regulation (EU) 2016/679, Art. 9(1) and 9(2)(h)
Personal data must be adequate, relevant and limited to what is necessary for the purpose.
Regulation (EU) 2016/679, Art. 5(1)(c)
Software is a medical device only where the manufacturer intends it for a medical purpose such as diagnosis, prevention, monitoring or treatment.
Regulation (EU) 2017/745, Art. 2(1)
From 9 December 2026, anyone who puts their own name on a product is treated as its manufacturer. Software, AI systems included, is a product.
Directive (EU) 2024/2853, Art. 4(1) and Art. 8(1); a directive, so transposition runs per member state

What Audact does about it

Scope limits enforced while the call runs: clinical questions are refused and routed to “a clinician will call you back”, patent-pending (UK IPO).
In controlled testing
PHI compartmentalisation: sensitive turns are kept out of general retention, patent-pending (UK IPO).
In development
Vulnerable-person handling: the pacing and the routing change when a caller shows distress or confusion, and the call goes to a person.
In development
The Article 50 disclosure spoken in every call, and a receipt recording that it happened.
In controlled testing
Primary application hosting: Frankfurt. The subprocessor list and the transfer basis are in the Trust Center.
Working today
Write-back into practice-management and EHR systems.
On the roadmap

Three constraints

What makes healthcare different is not the volume. It is the failure modes.

The first is drift into advice. A caller asks whether they should keep taking something, whether a symptom can wait, whether the dose sounds right. A general-purpose assistant answers, because answering is what it optimises for. Audact refuses that class of question at run time and moves to what it may do: book, take a callback note, escalate. The refusal is recorded.

The second is data. Article 5(1)(c) says collect what is necessary and no more, and a conversational interface makes over-collection easy: people volunteer detail nobody asked for. PHI compartmentalisation keeps those turns out of general retention rather than relying on later deletion.

The third is the caller who is not coping. Distress, confusion, a voice that does not follow the script — a phone system that treats those calls like any other is the one that produces the complaint. Vulnerable-person handling changes the pacing and the routing instead of pressing on; it is listed above with the status the rest of the call runtime carries.

The medical-device question

Intended purpose is what decides it, not the technology.

Under Article 2(1) of Regulation (EU) 2017/745, software is a medical device when its manufacturer intends it for a medical purpose: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation. Scheduling, confirming, informing about opening hours and handing a clinical question to a person is not that purpose, which is one practical reason the scope boundary is enforced rather than encouraged.

Where a deployment does have a medical purpose, it is the client's regulatory route that governs it, not the telephony layer underneath. Audact does not hold a medical-device certification and does not present itself as one. This page is general information, not legal advice.

Questions

Will the agent ever give medical advice?
No. Clinical questions are refused at run time. A transfer to a person, triggered by the agent, is in controlled testing; automatic hand-off on red-flag signals is in development. The refusal is recorded on the receipt for that call, so the boundary is checkable afterwards rather than assumed.
What happens to a recording that contains health data?
Sensitive turns are compartmentalised so they stay out of general retention, and retention, access and deletion are configured per tenant. Primary application hosting is Frankfurt; the full subprocessor list and the transfer basis are in the Trust Center.
Does the agent handle a caller who is distressed?
It changes the pacing and the routing; a transfer to a person, triggered by the agent, is in controlled testing rather than continuing as an ordinary IVR would. That handling is listed above with the status the rest of the call runtime carries, and no healthcare deployment has run on it.

Refusal is a feature, and it is recorded

What keeps a healthcare agent safe is what it declines to do, applied while the call runs. See how the engine decides what may be said and what must be handed to a person.

How Control works

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