Clinical data under GDPR and MDR
Strict constraints on residency, audit trail, clinical validation, CE marking.
Healthcare
On-premise clinical AI, MDR, sovereign data.
Hospitals, health authorities, research hospitals (IRCCS), private clinics and biomedical research centres that want to use AI on clinical data without letting it leave the perimeter. noze comes from years of projects with Meyer, CNR and European research centres. Public bodies with no clinical activity will find their page under Public Administration.
Your challenges
Fragmented records
Reports, discharge letters, imaging, PDFs: data scattered and hard to query.
Decisions you can defend in an audit
AI has to support the clinician, cite its sources every time and leave a verifiable trail for every answer.
Post-discharge follow-up
Continuity of care hard to manage without dedicated tools.
How we can help
Product
Product
Product
Product
Solution
Solution
ProductAgenticHealth
Local clinical chatbot, RAG on FHIR/DICOM, digital twin, SaMD MDR pathway.
ProductDataGovern
GDPR and MDR on clinical data: gap analysis, AI risk classification and audit trail, on-premise.
ProductCyberAgent
Vulnerability assessment and pentest of the hospital network and medical devices.
ProductAdmina Enterprise
Clinical AI governance with Admina Enterprise: AI Act, NIS2 and sovereign health data.
SolutionDigital Health
Consulting on clinical roadmap, validation and CE pathway.
SolutionResearch & Development
25+ years of applied biomedical research, European projects.
Related projects
2019–2023
ALA (Advanced Laboratory Automation)
Joint R&D INPECO + BioRobotics Sant'Anna Pisa (EUR 3.5M, 30 researchers): automation and robotics for clinical labs, deep learning on skin lesions.
2008–2010ESCOGITARE: Collaborative Bioinformatics
noze system for ISTI-CNR: bioinformatics workflows on an existing computational grid, drag-and-drop Visual Workflow Designer and Web 2.0 CMS.
Insights
OpenAI and Hugging Face at Black Hat 2026: token forgery, Groovy plugin C2 and nine Artifactory CVEs
On 5 August 2026 two OpenAI staff presented their reconstruction of the July incident at Black Hat USA. Token forgery through a legacy refresh endpoint, a Groovy plugin used as a command-execution service, nine CVEs in JFrog Artifactory fixed in versions 7.161.15 and 7.146.34, and a communication channel between separate evaluation runs that appears in no written document from either company.
AI Act: the checklist for organisations from 2 August 2026
From 2 August 2026 the AI Act is generally applicable and supervisory authorities have full powers. The checklist of obligations already in force for providers and deployers of AI systems, the ones postponed by the Digital Omnibus and what you need to have ready.
Melanoma and early detection: why it is a robotics problem
A July 2026 post presents OpenDerm, an $8,500 robotic gantry that scans skin at 78 pixels per millimetre, and argues that the bottleneck in early detection is not the classifier but image acquisition. Three documented cases say the same thing: Thailand in 2019, surgical skin markings in dermoscopy, and the first AI software cleared to guide an ultrasound probe.
Frequently asked questions
Can you use AI on clinical data without letting it leave the hospital?
Yes. agentichealth is a local clinical chatbot with RAG on FHIR and DICOM: data stays inside the organisation's perimeter, on-premise. datagovern adds GDPR and MDR gap analysis, AI risk classification and an audit trail, all on-premise.
Does AI-based medical software need CE marking?
If it qualifies as a medical device, yes, and it has to follow the SaMD pathway under MDR. agentichealth is designed along the SaMD MDR pathway, and the healthcare consulting covers clinical roadmap, validation and the CE pathway.
How do you make a clinical AI answer defensible in an audit?
You need AI that supports the clinician, cites its sources every time and leaves a verifiable trail for every answer. Admina Enterprise brings clinical AI governance across the AI Act, NIS2 and sovereign health data; datagovern keeps the audit trail on-premise.