Industry: Healthcare and life sciences

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The platform 1 page

Platform MapOperator 3D diagnostic of the KYE™ platform: every canonical component plotted on a rotatable dotted globe (longitude = lifecycle stage · shell = platform…

Products 8 pages

KYE™ Connector Profiles™KYE™ Connector Profiles™ make authority portable across 11 domain families — Commerce, Payment, Open Finance, Health, Pension, Agent Runtime, Security &…
KYE™ Sector PacksBrowse every KYE™ Authority Pack™ by sector — finance, health & life sciences, public sector, legal, industrial and cross-industry. Each pack governs an AI…
Agent Library™KYE™ Agent Library™ — 23 versioned, signed reference agents for 12 categories spanning banking, payments, insurance, healthcare, pharma, logistics, energy…
KYE™ Clinical Action Authority Agent™KYE™ Clinical Action Authority Agent™ — a bounded, single-purpose KYE™ Governed Agent™ that governed release/flag-triage/recommend/escalate/share. It is a…
KYE™ Clinical Trial Conduct Authority Agent™KYE™ Clinical Trial Conduct Authority Agent™ — a bounded, single-purpose KYE™ Governed Agent™ that governed…
KYE™ Genetic Sequencing Authority Agent™KYE™ Genetic Sequencing Authority Agent™ — a bounded, single-purpose KYE™ Governed Agent™ that synthesis-order/screening-disposition/data-release/clinical-resul…
KYE™ Pharmacovigilance Action Authority Agent™KYE™ Pharmacovigilance Action Authority Agent™ — a bounded, single-purpose KYE™ Governed Agent™ that governed ICSR filing, signal disposition, PSUR release…
KYE™ Canada-Health Authority Pilot™KYE™ Canada-Health Authority Pilot™ governs every AI-assisted action over personal health information at the boundary — lawful-purpose resolution, the…

By sector 14 pages

KYE™ for Clinical AIWhen AI shapes care, the authority chain must be provable before it is challenged. KYE Protocol™ is the identity, delegation, policy and evidence layer for…
KYE™ Biopharma Pharmacovigilance Authority Pack™The Biopharma Pharmacovigilance Authority Pack™ — a KYE™ Sector Pack Foundry™ expert-pack delivering Agentic Governance™ with Authority Finality™ for biopharma…
KYE™ Chatbot Authority Pack™The KYE™ Chatbot Authority Pack™ proves the authority and evidence of consumer chatbot safeguard actions at the moment an interaction occurs — under the…
KYE™ Clinical AI Governance Pack™The Clinical AI Governance Pack™ — a KYE™ Sector Pack Foundry™ expert-pack delivering the EU/UK governance and market-entry layer for AI clinical decision…
KYE™ Genomics-Biosecurity Authority Pack™The Genomics-Biosecurity Authority Pack™ — a KYE™ Sector Pack Foundry™ expert-pack governing AI-generated and AI-assisted genomic sequences at the action…
KYE™ HSE Authority Pack™The KYE™ HSE Authority Pack™ governs AI agents that author, interpret or approve safety-critical HSE documents — permits-to-work, risk assessments, method…
KYE™ ICH Authority Pack™The KYE™ ICH Authority Pack™ governs how AI-generated submission evidence under the ICH Q-series quality guidelines comes into existence at the action boundary…
KYE™ Laboratory & Testing Governance Pack™The KYE™ Laboratory & Testing Governance Pack™ governs AI-supported actions in laboratories of all types — testing, calibration, clinical / medical, and GLP…
One protocol, every sectorClick any sector — banking, payments, healthcare, pharma, maritime, energy, defense, RegTech, AI governance
KYE™ Governed Scientific AgentOpen skill libraries give a science agent capability — 148 skills across 17 scientific domains; KYE Protocol™ binds each consequential scientific action (an…
KYE™ Medical Device SaMD Authority Pack™The Medical Device SaMD Authority Pack™ — a KYE™ Sector Pack Foundry™ expert-pack delivering Agentic Governance™ with Authority Finality™ for Software as a…
KYE™ Medical Imaging Authority Pack™The Medical Imaging Authority Pack™ — a KYE™ Sector Pack Foundry™ expert-pack delivering Agentic Governance™ with Authority Finality™ for radiology and medical…
KYE™ Pharma AI Authority™Pharma teams run AI across R&D, clinical, safety and quality; KYE Protocol™ proves whether each pharma AI action — a synthesis order, a protocol decision, a…
Open Data & Data PortalsPublic-sector portals, regulator data portals, smart-city hubs, research catalogues, health data catalogues, NGO portals, infrastructure transparency…

Compliance, conformance & certification 22 pages

Compliance frameworksPer-framework reference: which KYE Protocol™ controls map to which obligation, with framework scope, official source, and the canonical KYE™ Compliance…
NIST 800-53 Rev 5 hub (universal control taxonomy)NIST 800-53 Rev 5 is the universal control taxonomy KYE Protocol™ uses as the hub for every regulatory crosswalk. 20 control families, 25 headline controls…
CDSCO Medical Devices Rules 2017CDSCO Medical Devices Rules 2017 coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
CLIACLIA — US Clinical Laboratory Improvement Amendments (42 CFR Part 493) coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that…
COSHHCOSHH — Control of Substances Hazardous to Health Regulations 2002 (UK) coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact…
HAARFHAARF — Healthcare AI Agents Regulatory Framework coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
ICH Q1ICH Q1 — Stability Testing coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
ICH Q10ICH Q10 — Pharmaceutical Quality System coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
ICH Q2(R2)ICH Q2(R2) — Validation of Analytical Procedures coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
ICH Q3ICH Q3 — Impurities coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
ICH Q5ICH Q5 — Quality of Biotechnological Products coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
ICH Q6ICH Q6 — Specifications coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
ICH Q7ICH Q7 — Good Manufacturing Practice for Active Pharmaceutical Ingredients coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact…
ICH Q8(R2)ICH Q8(R2) — Pharmaceutical Development coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
ICH Q9(R1)ICH Q9(R1) — Quality Risk Management coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
ISO 15189:2022ISO 15189:2022 — Medical laboratories — Requirements for quality and competence coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™…
ISO 45001ISO 45001 — Occupational Health & Safety Management Systems coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces…
MHRA Medical Devices Regulations 2002MHRA Medical Devices Regulations 2002 coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.
MSHAMSHA — Mine Safety and Health Administration standards (30 CFR) coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that…
OECD Good Laboratory Practice (Principles, 1998) + FDA 21 CFR Part 58OECD Good Laboratory Practice (Principles, 1998) + FDA 21 CFR Part 58 — non-clinical lab data integrity coverage by KYE Protocol™ — every requirement…
PHIPA (Ontario)PHIPA (Ontario) — Personal Health Information Protection Act, 2004 coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that…
PMDA Software-as-a-Medical-Device (SaMD) PathwayPMDA Software-as-a-Medical-Device (SaMD) Pathway coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.

Solutions 4 pages

Use casesNine real-world KYE Protocol™ use cases — high-value payments, custody break-glass, EU AI Act docs, HIPAA chart review, NIS2 incident response, FedRAMP…
KYE Protocol™ for CanadaRuntime authority and signed evidence for Canadian AI — bijection-mapped to PIPEDA, PHIPA, Health Canada SaMD, HC AI/ML Action Plan 2023, OSFI and FINTRAC.…
KYE Protocol™ for the United StatesRuntime authority and signed evidence for US AI — bijection-mapped to HIPAA, HITECH, FDA SaMD, 21 CFR Part 11, HITRUST CSF, OCC Heightened Standards, NYDFS…
KYE Protocol™ for JapanRuntime authority and signed evidence for Japanese AI — bijection-mapped to the APPI (PPC), the FSA's AI / model-governance expectations and the PMDA…

Resources 4 pages

Roadmap to AI Adoption in HealthcareHealthcare organisations are adopting AI into clinical and operational decisions — triage, diagnosis support, documentation, scheduling, prior authorisation…
HIPAA §164.312HIPAA §164.312 — Technical safeguards: — Technical safeguards
KYE™ Semantic Authority Mapper™KYE™ Semantic Authority Mapper™: Maps OAuth scopes, IAM roles, payment mandates, legal delegations, healthcare consents, API permissions and sector terms into…
MHRA SaMD & AIMHRA SaMD & AI: UK Medicines and Healthcare products Regulatory Agency Software-as-a-Medical-Device regime.