P3-NEURO: v2.0 Non-Clinical Evidence-Gate Proposal
Documentation-only v2.0 non-clinical evidence-gate proposal in the existing P3-NEURO version family. The newly original English PDF separates technical performance, person-relevant benefit, cybersecurity and risk, user rights and recoverability, and data provenance. Its arithmetic example is synthetic. No device, patient population, clinical study, deployed system or real dataset is specified or tested here; consequently no medical safety, efficacy, regulatory compliance or personal benefit is established. FDA guidance is cited as applicable reference material, not as an approval of P3. Only this explanatory PDF is uploaded; no patient data, earlier code, archive or third-party figure is included. Earlier versions: https://doi.org/10.5281/zenodo.22171365 and https://doi.org/10.5281/zenodo.22151763 . CC BY 4.0 applies only to this newly original PDF, not to earlier materials or cited works. Computational and AI assistance is disclosed; Riccardo Giudici is responsible for the presentation as an independent systems orchestrator. No institutional endorsement is claimed.
Authors
- Riccardo Giudici (ORCID: https://orcid.org/0000-0002-2202-6194)
Publication Details
- Journal
- Zenodo (CERN European Organization for Nuclear Research)
- Published
- 2026-10-03
- DOI
- https://doi.org/10.5281/zenodo.23112876
- Primary Topic
- Healthcare Technology and Patient Monitoring
- Type
- preprint