Patient records and findings
Health data is special-category data under Art. 9 GDPR, and medical confidentiality applies to everyone, including an AI provider. What patients entrust to you belongs in no outside data center.
LOKI in practices and labs
AI for practice and lab, without patient data leaving the building.
LOKI runs completely locally on your hardware, behind the practice’s firewall. It finds findings, logs, QM documents and inboxes with a single question. Every answer comes with its source.
Thursday’s the inspection. Where do I find the device inventory, the last STK for the ECG and the autoclave batches?
LOKI
The device inventory required by the German Medical Devices Operator Ordinance (MPBetreibV) is up to date, last amended in May [1]. The safety inspection (STK) of the ECG took place in March, the record is on file [2]. The autoclave’s batch documentation is complete with no gaps, including the validation report from 2025 [3].
3 sources used Device inventoryECG STK recordAutoclave batches
Next week’s the haematology EQA. What stood out last time, and what did we change afterwards?
LOKI
In autumn, one parameter sat at the edge of the tolerance range [1]. The corrective action: calibration brought forward and the control rule tightened, documented together with the effectiveness check [2]. Since then, all internal controls have been unremarkable [3].
3 sources used EQA certificateAction fileQC history
How does the DMP enrolment work here again? And which forms do I need?
LOKI
The procedure is a work instruction in the QM manual, last reviewed in January [1]. The forms, including a guide to filling them in, are in the templates folder [2]. And the team minutes from March record the agreement on who handles the follow-up documentation [3].
3 sources used QM manualTemplates folderTeam minutes
0 patient data in a third-party cloud
years retention of treatment documentation under Section 630f of the German Civil Code (BGB), evidenced in seconds
unlimited users in the license. Doctors, medical assistants, lab, administration
4 weeks to productive use, without touching your practice software (PVS) or lab system (LIS)
Selected customers
From family-run businesses to DAX corporations. Machine building, chemicals, and the public sector.
The stakes
This data must never leave your building.
Patients entrust it to you under the protection of medical confidentiality.
Lab evidence chains under accreditation
External quality assessment (EQA) under the German Medical Association’s lab-quality directive (RiliBÄK), control records, standard operating procedures: accreditation under DIN EN ISO 15189 checks whether you measure correctly, and just as much whether you can prove it without gaps. That chain must belong to you.
Billing and performance data
Billing code chains, quarterly figures, audit queries from the KV, the regional Association of Statutory Health Insurance Physicians: whoever reads them knows the financial position of the practice. None of it is anyone’s business outside the building.
The bottleneck
After consultation hours comes the second shift.
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Documentation with a ten-year memory
Treatment documentation must be retained for ten years under Section 630f BGB. Add the medical device log and the device inventory under the MPBetreibV, deadlines for safety and metrological checks (STK, MTK), and the batch and validation documentation of reprocessing. Keeping it all works. Finding it again is what costs.
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Inspections and audits come announced, or unannounced
The public health office inspects hygiene, the KV spot-checks your QM against the directive of the G-BA, Germany’s Federal Joint Committee, and in the lab the DAkkS, Germany’s national accreditation body, watches over the accreditation. And the RiliBÄK requires external quality assessment at fixed intervals. Anyone who first has to search for evidence loses days.
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Medical assistants are a shortage occupation
Medical assistants (MFA) have been on the Federal Employment Agency’s shortage list for years. The knowledge of your workflows lives in heads and sticky notes: who expects which preparation, how enrolment works, where the template sits. With every departure, part of it walks out the door.
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The telematics infrastructure delivers obligations, no search
eAU, eRezept, ePA, KIM: the channels go digital, the filing stays scattered: chart entry in the PVS, findings in the lab system, letter in the KIM inbox, fax as a scan, the rest in the paper archive. None of these systems can search the others.
The knowledge is in the building. It just sits in the PVS, the lab system, the QM folder, the KIM inbox and the paper archive all at once.
The solution
Four worlds, one question.
Your knowledge lives in four worlds that don’t know each other: chart entries in the PVS, findings and controls in the lab system, work instructions in the QM folder, letters and faxes in the inbox. LOKI lays one search across all four, with role-based access: whoever may not see patient data does not see it.
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Four worlds that don’t know each other
Chart entry, lab findings, QM document, mail thread.
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One index, behind your firewall
LOKI opens up all four, following your role-based access.
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One question, in plain language
No system knowledge, no file names, no folder hunting.
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One answer, with the source
Every statement carries the source it came from.
Your practice · Your hardware PVS Charts & letters medatixx · CGM · tomedo Lab Findings & QC OPUS::L · GLIMS QM Manual & hygiene SOPs · MPBetreibV Inbox KIM & mail eArztbrief · fax scan LOKI One index on your hardware Answer With sources [1] [2] [3]
One question. Four systems. One answer that tells you where it knows it from.
Tuesday, 7:50 a.m. The public health office has announced the hygiene inspection, for Thursday.
Thursday’s the inspection. Where do I find the device inventory, the last STK for the ECG and the autoclave batches?
LOKI
The device inventory required by the German Medical Devices Operator Ordinance (MPBetreibV) is up to date, last amended in May [1]. The safety inspection (STK) of the ECG took place in March, the record is on file [2]. The autoclave’s batch documentation is complete with no gaps, including the validation report from 2025 [3].
3 sources used Device inventoryECG STK recordAutoclave batches
The evidence is gathered before consultation hours begin.
Compliance filter
Use external AI. Without data leaving the building.
Your team wants to work with the best models, and does so anyway, if need be around the official toolbox. LOKI turns that into an official path: you connect external models, and every request passes through a check first. Names, order numbers, part identifiers and amounts are detected and redacted before the prompt leaves the building.
Doctor’s letter to cardiology for H. Berger[PATIENT], born 12.03.1958[DATE OF BIRTH], status post myocardial infarction[DIAGNOSIS], for co-treatment.
Checking 3 found
Protokoll11:24 · Dr. Sommer · Claude Opus 4.8 · 3 findings redacted · sent
Detect
Name recognition and configurable patterns find what must not go out.
Decide
The user sees in the chat what was found and chooses: send anonymized, send unchanged, or cancel.
Prove
Every call is in the log, with user, model, time and the result of the check. Including the cancelled ones.
And this is what the switch looks like in the product: choose a cloud model and it tells you right above the input field.
That’s the difference between a ban that gets bypassed and a path you’re allowed to take.
Compliance
The regulators have already described this architecture.
We don’t have to vouch for the architecture ourselves. The conference of Germany’s data-protection authorities (DSK) described it before we built it.
Technically closed
The DSK’s guidance on AI and data protection states that technically closed systems are preferable from a data-protection perspective: in open systems, the input data leaves the users’ protected environment. With LOKI it doesn’t.
Where they technically work
Inside a language model itself there is no way to control who may see which information; the supervisory authorities state this explicitly. In the knowledge system in front of it, tenant separation and role-based access do work. That’s why LOKI is built this way. And that’s why individual entries can be deleted deliberately instead of disappearing into a model.
Medical confidentiality, Art. 9 GDPR and the documentation duties of the G-BA, MPBetreibV and RiliBÄK
Health data is special-category data, and medical confidentiality allows no exception for AI tools. A system that runs entirely inside the practice keeps patient data where it belongs, and at the same time opens up the evidence chains that the QM directive, the Medical Devices Operator Ordinance and the RiliBÄK demand. Who may see which record is decided by role-based access rather than by chance.
The regulators call this a mitigating measure, not a blanket solution, and name open questions around transparency and data-subject rights. We put it exactly the same way.
Data sources
We collect the knowledge where it already lives.
Without you changing your system landscape.
- Practice management
- medatixx, CGM MEDISTAR and TURBOMED, T2med, tomedo — document archives, letters, forms, GDT exports
- Lab IT
- OPUS::L, GLIMS, MOLIS, Swisslab — orders, findings, control records, LDT files
- Devices
- Measurement exports from the analyzers, ECG, lung-function and long-term blood-pressure reports, even as scans
- QM & hygiene
- QEP or ISO manuals, orgavision, roXtra, ConSense — work instructions, hygiene plans, training records
- Medical devices
- Device inventory and medical device log under the MPBetreibV, STK and MTK records, autoclave batches, validations
- Communication
- KIM inboxes, eArztbriefe, practice email, fax scans, paper archive
- Billing & contracts
- Quarterly filings, GOÄ invoices, HzV and selective care contracts, KV circulars, audit queries
LOKI replaces neither the PVS nor the lab system; they stay in charge. LOKI makes findable what lies between them. Who may see patient data is decided by role-based access.
In daily operations
Three tasks that cost an evening today.
Inspection
The hygiene inspection, announced for Thursday
LOKI compiles the hygiene plan, validation reports, batch documentation and the team’s training records, every document with its source.
The inspection cannot see whether you work cleanly. It can see whether you can prove it.
Accreditation
The ISO 15189 surveillance audit
Standard operating procedures, device histories, EQA results, staff qualifications: LOKI finds the status of every record and shows the gaps before the audit.
Accreditation hangs on the chain of evidence rather than on the measurement technology.
Team
The medical assistant leaves, the knowledge stays
How practice supplies are ordered, which preparation each physician expects, how consent for self-pay services (IGeL) is documented: LOKI finds the work instruction, the team minutes and the email where it was last clarified.
Onboarding from the records instead of from memory.
Also: answering KV audit queries with the quarter’s supporting notes · keeping STK and MTK deadlines in view · keeping the QM manual current and documenting changes · onboarding new colleagues · making contracts and KV circulars searchable
What convinced our customers.
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With our locally installed AI assistant from IGNAITE, our employees can access company knowledge much faster. For example, information from past projects. This enables higher productivity and, above all, more comprehensive knowledge sharing.
Rainer Braun Managing Director, bonGroup -
In our collaboration with IGNAITE, we built a practical, high-performance computer-vision solution that has sustainably improved our incoming-materials processes. What particularly convinced us was the structured approach, the deep process understanding, and the ability to translate complex requirements into pragmatic solutions.
Dr. Philipp Reisert CEO, C.Hafner · Computer vision project
And when you measure
Where no file exists, MINERVA creates one.
LOKI opens up what was written down. But much of what happens in practice and lab never makes it into a document: the temperature of the vaccine fridge, the room climate in the storage area, device runtimes. MINERVA captures them, with its own boards on your own network, and turns them into sources LOKI can cite. The fridge temperature curve becomes evidence with a source.
Extendable with MINERVABoth products follow the same principles: sovereign, source-based, local. You start with one and add the other when you need it.
How it works
Three steps to sovereign AI.
From signing to productive operation in under four weeks — without touching the PVS or lab system.
Intro call, 30 minutes
We look at where your records live (PVS, lab system, QM folders, inboxes) and tell you honestly what LOKI can open up from them.
Installation on site
The hardware goes behind your firewall. We connect archives, exports and inboxes, without touching the PVS or lab system. Role-based access is set up together before launch.
Onboarding and training
We hand over only once it runs production-ready. The EU AI Act has required you since February 2025 to train your staff in the competent use of AI; we deliver that training.
Frequent questions
What every intro call asks about.
Is patient data even allowed in an AI?
With a cloud AI, that is exactly the right concern: health data enjoys special protection, and medical confidentiality also applies to service providers. That is why LOKI runs entirely on your hardware: no upload, no API call to OpenAI, Anthropic or Google, no training by third parties. And role-based access governs who may see which record.
Can LOKI read our PVS? We’re on medatixx.
We open up the relevant content: document archives, letters, forms, GDT and LDT exports, and PDF collections including scans. We make no attempt to replace the PVS; the aim is to answer the question “Where does it say that?” in seconds. What is concretely possible in your landscape is something we clarify before installation.
Does everyone on the team see everything then?
No. LOKI only shows sources the person asking is authorized for: billing sees no findings, the lab sees no charts. Role-based access is set up together with you before the rollout.
Our old findings are scanned PDFs and faxes. Useless?
No. Scanned documents are processed with text recognition. With handwritten entries the hit rate drops. We tell you that up front instead of promising otherwise.
What if LOKI makes something up? In medicine that would be fatal.
LOKI answers from sources and names the document behind every statement, checkable before anything goes into a letter or a record. And we draw one line deliberately: LOKI is a knowledge assistant for administration, QM and research. It is not a medical device. It finds; diagnosis and treatment decisions stay with you.
We’re accredited under ISO 15189. Does LOKI help there, or does it get in the way?
It helps with the part that costs time: keeping evidence findable. Standard operating procedures, device histories, EQA results, training records: LOKI finds the current status and its location. Your QM system stays in charge; LOKI changes nothing about it, it makes it searchable.
How is it licensed?
A fixed monthly price plus a one-time setup fee that includes the server hardware. The license covers unlimited users. There are three packages that differ in hardware sizing. Operation, maintenance, updates and support are included. We’ll give you the specific price in the intro call.
Other industries
Your industry isn’t here?
The industry pages show LOKI in the everyday work of individual industries. If yours is missing, that only means we haven’t written it up yet.
NEXT STEP
Request an intro call.
30 minutes, an honest assessment. No slides, no sales pressure. We’ll also tell you if LOKI isn’t the right step for your data situation yet.