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
Solution
Solution
ProductAgenticHealth
On-premise AI for clinical research: source-cited research, draft study and quality documents, data redaction, with Compliance included: GDPR, NIS2 and AI Act registers for the provider. Research Use Only (RUO): it is not a medical device and does not support decisions on patient care; MDR pathway planned.
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
XRP Ledger: payment engine overflow and the role of AI
On 9 October XRPL disclosed an overflow in the xrpld payment engine that could have created spendable XRP beyond the total supply. Reported on 22 September by Cayden Liao and Veria AI, fixed on the 25th with an emergency release without an amendment. RippleX found no evidence of exploitation. What happened and what it means for anyone writing financial software.
Decree 179/2026: AI authorities, fines, work and training
The Italian Official Gazette of 8 October publishes Legislative Decree no. 179 of 7 October 2026 on the powers of the national AI authorities and on training. AgID is the notifying authority, ACN handles market surveillance and is the single point of contact, Banca d'Italia, CONSOB and IVASS cover high-risk systems in their sectors. Penalties up to €35 million or 7% of turnover, a regulatory sandbox, employment decisions reserved to a person. In force from 23 October.
Cyber Resilience Act: Italian decree, ACN and penalties
On 2 October the Italian Council of Ministers gave preliminary approval to the legislative decree adapting national law to Regulation (EU) 2024/2847. ACN is the notifying authority and the market surveillance authority and may rely on the Guardia di finanza; the AI authorities, Banca d'Italia, CONSOB, IVASS and the data protection authority supervise in their own areas. Consumer complaints go to CSIRT Italia, with an SME channel, proportionate fees and a regulatory sandbox, the Sandbox-CRA.
Frequently asked questions
Can you use AI on clinical data without letting it leave the hospital?
Yes, with AI installed on-premise at the healthcare provider: data stays local. agentichealth today works on the provider's research and quality documents (protocols, literature, procedures), with cited sources; FHIR connectors on pseudonymised data from a research cohort are on the roadmap. Research Use Only (RUO): it is not a medical device and does not support decisions on patient care. agentichealth includes Compliance: GDPR, NIS2 and AI Act for the provider as an organisation, with registers, deadlines, AI system classification and 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 today is Research Use Only (RUO): it is not a medical device and does not support decisions on patient care; the MDR pathway is planned. 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. agentichealth cites its sources, keeps the audit trail on-premise and includes Compliance for the AI Act, NIS2 and GDPR.