Research Use Only (RUO) – Intended Purpose, Limitations and Scientific Oversight
Binding framework for use of the current configuration solely for research, data governance and scientific orchestration, without replacing clinical judgement.
Regulatory and governance references
- Regulation (EU) 2017/745 (MDR)
- Regulation (EU) 2017/746 (IVDR)
- MDCG 2019-11 rev.1 (June 2025) on software qualification and classification
- Regulation (EU) 2024/1689 (AI Act)
- Regulation (EU) 2016/679 for personal-data processing
References indicate the design framework and must be verified against the current legislation, implementing measures, national law and the parties’ actual roles at implementation time.
1. Current Intended Purpose
The current UESE Precision Bio AI configuration is Research Use Only (RUO): it supports data governance, orchestration, traceability, research analyses and scientific review, but it is not intended to provide diagnosis, prognosis, prescriptions, treatment selection or autonomous clinical decisions. Actual use must remain consistent with that intended purpose and the approved scientific protocol.
The current intended purpose must be reflected in product materials, manuals and onboarding. Any change introducing a medical, diagnostic, prognostic, predictive or therapeutic purpose requires a new software qualification analysis and, where applicable, an MDR/IVDR pathway and reassessment under the AI Act.
RTO and RPO, if offered, must be expressly stated in the SLA and aligned with the architecture. Without executed values they cannot be inferred from public material; disaster recovery and application restoration should be tested periodically where required by the continuity plan.
For enterprise deployments, the decision should be translated into a RACI matrix, verifiable evidence, acceptance criteria, technical controls and periodic review; exceptions must be approved, reasoned, time-limited and traceable.
2. Meaning of Research Use Only
The current UESE Precision Bio AI configuration is Research Use Only (RUO): it supports data governance, orchestration, traceability, research analyses and scientific review, but it is not intended to provide diagnosis, prognosis, prescriptions, treatment selection or autonomous clinical decisions. Actual use must remain consistent with that intended purpose and the approved scientific protocol.
The current intended purpose must be reflected in product materials, manuals and onboarding. Any change introducing a medical, diagnostic, prognostic, predictive or therapeutic purpose requires a new software qualification analysis and, where applicable, an MDR/IVDR pathway and reassessment under the AI Act.
The project scientific lead should define inclusion criteria, sources, method versions and review arrangements. The platform makes activities traceable but does not certify the biological correctness of inputs, annotations or interpretations supplied by laboratories or external engines.
In healthcare or multi-centre projects, the requirement should be linked to the protocol, decision record, DPIA or security file where relevant, avoiding any assumption that a technical configuration replaces legal or scientific assessment.
3. Functions Within the RUO Scope
The current UESE Precision Bio AI configuration is Research Use Only (RUO): it supports data governance, orchestration, traceability, research analyses and scientific review, but it is not intended to provide diagnosis, prognosis, prescriptions, treatment selection or autonomous clinical decisions. Actual use must remain consistent with that intended purpose and the approved scientific protocol.
The current intended purpose must be reflected in product materials, manuals and onboarding. Any change introducing a medical, diagnostic, prognostic, predictive or therapeutic purpose requires a new software qualification analysis and, where applicable, an MDR/IVDR pathway and reassessment under the AI Act.
The project scientific lead should define inclusion criteria, sources, method versions and review arrangements. The platform makes activities traceable but does not certify the biological correctness of inputs, annotations or interpretations supplied by laboratories or external engines.
Compliance is continuous: changes to purpose, data, suppliers, engines, hosting, integrations or law require impact assessment and, where needed, updates to contracts, controls, instructions and documentation.
4. Functions Excluded from the Current Scope
The current UESE Precision Bio AI configuration is Research Use Only (RUO): it supports data governance, orchestration, traceability, research analyses and scientific review, but it is not intended to provide diagnosis, prognosis, prescriptions, treatment selection or autonomous clinical decisions. Actual use must remain consistent with that intended purpose and the approved scientific protocol.
The RUO configuration must not be used as a substitute for a medical device, IVD, validated report or healthcare professional judgement. Customers must prevent experimental outputs from being placed in clinical records or used for treatment without the necessary validation and regulatory pathway.
The project scientific lead should define inclusion criteria, sources, method versions and review arrangements. The platform makes activities traceable but does not certify the biological correctness of inputs, annotations or interpretations supplied by laboratories or external engines.
UESE retains evidence proportionate to function and risk. The customer organisation remains responsible for its authorisations, protocols, legal bases and healthcare or scientific decisions beyond the service scope entrusted to UESE.
5. No Diagnosis, Prescription or Therapeutic Decision
The current UESE Precision Bio AI configuration is Research Use Only (RUO): it supports data governance, orchestration, traceability, research analyses and scientific review, but it is not intended to provide diagnosis, prognosis, prescriptions, treatment selection or autonomous clinical decisions. Actual use must remain consistent with that intended purpose and the approved scientific protocol.
No public information, classification, score or RUO output may be interpreted as individual medical advice. Diagnosis and treatment remain the exclusive responsibility of qualified healthcare professionals acting within their competence, authorisations and applicable clinical evidence.
The project scientific lead should define inclusion criteria, sources, method versions and review arrangements. The platform makes activities traceable but does not certify the biological correctness of inputs, annotations or interpretations supplied by laboratories or external engines.
For enterprise deployments, the decision should be translated into a RACI matrix, verifiable evidence, acceptance criteria, technical controls and periodic review; exceptions must be approved, reasoned, time-limited and traceable.
6. Local Baseline and Scientific Limitations
The current UESE Precision Bio AI configuration is Research Use Only (RUO): it supports data governance, orchestration, traceability, research analyses and scientific review, but it is not intended to provide diagnosis, prognosis, prescriptions, treatment selection or autonomous clinical decisions. Actual use must remain consistent with that intended purpose and the approved scientific protocol.
The local engine is a transparent research ranker based on metadata and does not predict HLA binding, antigen presentation, immunogenicity or treatment efficacy. Its scores are heuristic only and must not be presented as biological or clinical evidence.
Users must receive enough information to understand purpose, inputs, nature of scores, material limitations and non-use conditions. The required level of explanation is proportionate to risk and user role; a numerical score without context is not treated as adequate explanation.
In healthcare or multi-centre projects, the requirement should be linked to the protocol, decision record, DPIA or security file where relevant, avoiding any assumption that a technical configuration replaces legal or scientific assessment.
7. External Engines and Protocol Responsibility
The current UESE Precision Bio AI configuration is Research Use Only (RUO): it supports data governance, orchestration, traceability, research analyses and scientific review, but it is not intended to provide diagnosis, prognosis, prescriptions, treatment selection or autonomous clinical decisions. Actual use must remain consistent with that intended purpose and the approved scientific protocol.
An organisation connecting an external engine must document its identity, version, licence, intended purpose, dependencies, reference datasets and protocol validation. UESE orchestrates the call and records provenance, but does not warrant the scientific suitability of an engine selected by the customer or consortium.
The project scientific lead should define inclusion criteria, sources, method versions and review arrangements. The platform makes activities traceable but does not certify the biological correctness of inputs, annotations or interpretations supplied by laboratories or external engines.
Compliance is continuous: changes to purpose, data, suppliers, engines, hosting, integrations or law require impact assessment and, where needed, updates to contracts, controls, instructions and documentation.
8. Mandatory Human Scientific Review
The current UESE Precision Bio AI configuration is Research Use Only (RUO): it supports data governance, orchestration, traceability, research analyses and scientific review, but it is not intended to provide diagnosis, prognosis, prescriptions, treatment selection or autonomous clinical decisions. Actual use must remain consistent with that intended purpose and the approved scientific protocol.
RUO outputs require review by qualified personnel before they are accepted for research activity. Review must be attributable, reasoned and traceable; human oversight is not a formal rubber stamp and must be able to suspend, challenge or reject the result.
The project scientific lead should define inclusion criteria, sources, method versions and review arrangements. The platform makes activities traceable but does not certify the biological correctness of inputs, annotations or interpretations supplied by laboratories or external engines.
UESE retains evidence proportionate to function and risk. The customer organisation remains responsible for its authorisations, protocols, legal bases and healthcare or scientific decisions beyond the service scope entrusted to UESE.
9. Local Validation and Process Qualification
The current UESE Precision Bio AI configuration is Research Use Only (RUO): it supports data governance, orchestration, traceability, research analyses and scientific review, but it is not intended to provide diagnosis, prognosis, prescriptions, treatment selection or autonomous clinical decisions. Actual use must remain consistent with that intended purpose and the approved scientific protocol.
Validation must be proportionate to purpose: test data, acceptance criteria, software and dependency versions, reproducibility and change control should be documented. Platform validation does not replace validation of the analytical method, laboratory or scientific protocol.
The project scientific lead should define inclusion criteria, sources, method versions and review arrangements. The platform makes activities traceable but does not certify the biological correctness of inputs, annotations or interpretations supplied by laboratories or external engines.
For enterprise deployments, the decision should be translated into a RACI matrix, verifiable evidence, acceptance criteria, technical controls and periodic review; exceptions must be approved, reasoned, time-limited and traceable.
10. Research Data and Source Quality
The current UESE Precision Bio AI configuration is Research Use Only (RUO): it supports data governance, orchestration, traceability, research analyses and scientific review, but it is not intended to provide diagnosis, prognosis, prescriptions, treatment selection or autonomous clinical decisions. Actual use must remain consistent with that intended purpose and the approved scientific protocol.
Training and evaluation data must be relevant to the population and use case. Bias, drift, under-representation and annotation quality should be monitored; where evidence is insufficient the limitation must be disclosed and the model must not be extended beyond the validated scope.
The project scientific lead should define inclusion criteria, sources, method versions and review arrangements. The platform makes activities traceable but does not certify the biological correctness of inputs, annotations or interpretations supplied by laboratories or external engines.
In healthcare or multi-centre projects, the requirement should be linked to the protocol, decision record, DPIA or security file where relevant, avoiding any assumption that a technical configuration replaces legal or scientific assessment.
11. Interpretation of Outputs
The current UESE Precision Bio AI configuration is Research Use Only (RUO): it supports data governance, orchestration, traceability, research analyses and scientific review, but it is not intended to provide diagnosis, prognosis, prescriptions, treatment selection or autonomous clinical decisions. Actual use must remain consistent with that intended purpose and the approved scientific protocol.
The project scientific lead should define inclusion criteria, sources, method versions and review arrangements. The platform makes activities traceable but does not certify the biological correctness of inputs, annotations or interpretations supplied by laboratories or external engines.
Compliance is continuous: changes to purpose, data, suppliers, engines, hosting, integrations or law require impact assessment and, where needed, updates to contracts, controls, instructions and documentation.
12. Publications, Communications and Reproducibility
The current UESE Precision Bio AI configuration is Research Use Only (RUO): it supports data governance, orchestration, traceability, research analyses and scientific review, but it is not intended to provide diagnosis, prognosis, prescriptions, treatment selection or autonomous clinical decisions. Actual use must remain consistent with that intended purpose and the approved scientific protocol.
Publications using platform outputs should identify version, configuration, datasets and engines sufficiently to support reproducibility. External communications must not convert preliminary research findings into unsupported clinical or commercial claims.
The project scientific lead should define inclusion criteria, sources, method versions and review arrangements. The platform makes activities traceable but does not certify the biological correctness of inputs, annotations or interpretations supplied by laboratories or external engines.
UESE retains evidence proportionate to function and risk. The customer organisation remains responsible for its authorisations, protocols, legal bases and healthcare or scientific decisions beyond the service scope entrusted to UESE.
13. Evolution Toward Regulated Medical Functions
The current UESE Precision Bio AI configuration is Research Use Only (RUO): it supports data governance, orchestration, traceability, research analyses and scientific review, but it is not intended to provide diagnosis, prognosis, prescriptions, treatment selection or autonomous clinical decisions. Actual use must remain consistent with that intended purpose and the approved scientific protocol.
The project scientific lead should define inclusion criteria, sources, method versions and review arrangements. The platform makes activities traceable but does not certify the biological correctness of inputs, annotations or interpretations supplied by laboratories or external engines.
For enterprise deployments, the decision should be translated into a RACI matrix, verifiable evidence, acceptance criteria, technical controls and periodic review; exceptions must be approved, reasoned, time-limited and traceable.
14. Reporting Misuse
The current UESE Precision Bio AI configuration is Research Use Only (RUO): it supports data governance, orchestration, traceability, research analyses and scientific review, but it is not intended to provide diagnosis, prognosis, prescriptions, treatment selection or autonomous clinical decisions. Actual use must remain consistent with that intended purpose and the approved scientific protocol.
The project scientific lead should define inclusion criteria, sources, method versions and review arrangements. The platform makes activities traceable but does not certify the biological correctness of inputs, annotations or interpretations supplied by laboratories or external engines.
In healthcare or multi-centre projects, the requirement should be linked to the protocol, decision record, DPIA or security file where relevant, avoiding any assumption that a technical configuration replaces legal or scientific assessment.
15. Acceptance of the RUO Scope
The current UESE Precision Bio AI configuration is Research Use Only (RUO): it supports data governance, orchestration, traceability, research analyses and scientific review, but it is not intended to provide diagnosis, prognosis, prescriptions, treatment selection or autonomous clinical decisions. Actual use must remain consistent with that intended purpose and the approved scientific protocol.
The current intended purpose must be reflected in product materials, manuals and onboarding. Any change introducing a medical, diagnostic, prognostic, predictive or therapeutic purpose requires a new software qualification analysis and, where applicable, an MDR/IVDR pathway and reassessment under the AI Act.
The project scientific lead should define inclusion criteria, sources, method versions and review arrangements. The platform makes activities traceable but does not certify the biological correctness of inputs, annotations or interpretations supplied by laboratories or external engines.
Compliance is continuous: changes to purpose, data, suppliers, engines, hosting, integrations or law require impact assessment and, where needed, updates to contracts, controls, instructions and documentation.
For requests concerning data processed within a customer project, UESE may need to direct the data subject to the competent controller. For commercial or technical enquiries, use the dedicated stakeholder form and do not submit patient data.
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