This library section is currently in development
We are curating and organizing key resources. Please check back soon or explore other sections of the Strategic Atlas.
Library
Curated references for decision‑makers: regulations, standards, guidance, and foundational reports across Digital Health, One Health, AI, and Sustainability.
EU AI Act — Horizontal Rules for AI Systems
Flagship EU regulation setting risk‑based requirements for AI systems, including governance, transparency, and market surveillance.
ISO/IEC 42001 — AI Management System (AIMS)
International standard specifying requirements for establishing and operating an AI management system across the lifecycle.
Medical Device Regulation (EU) 2017/745 — MDR
Core EU framework governing medical devices, including software, with requirements on safety, performance, and post‑market surveillance.
FDA Guidance — Clinical Decision Support Software
Explains when decision support software functions are considered medical devices under U.S. law and when they are not.
One Health High‑Level Expert Panel — Systems Approach
Foundational report framing integrated human‑animal‑environment health risks and collaborative governance.
OECD — Health Data Governance and Access
Policy principles for safe, trustworthy health data sharing to enable research and system performance.
MDCG 2021‑14 — Post‑Market Surveillance for SaMD
Operational guidance for planning and conducting post‑market surveillance activities for software medical devices.
Glossary — Venture & Policy Terms for Health
Concise definitions for investment and policy terminology used across Cobalt Oak’s analysis.