EU Public Health & Health Emergencies, HERA Regulations & European Health Data Space
Follow HERA medical countermeasure procurement, Regulation (EU) 2022/2371 on serious cross-border health threats, European Health Data Space (EHDS) rules, and ECDC surveillance mandates.
Public Health, Crisis Preparedness & HERA Regulatory Landscape & Compliance Overview
Official IntelligencePolicyIndex indexes real-time gazette notifications, policy orders, tariff determinations, and compliance circulars issued across the Public Health, Crisis Preparedness & HERA sector. Regulatory intelligence is aggregated across central ministries, state regulatory commissions, and statutory authorities.
Statutory Directives
Official Extraordinary Gazettes, S.O. & G.S.R. orders, and executive notifications.
Compliance Mandates
Sector-specific regulatory obligations, licensing norms, and statutory filing guidelines.
Other Verticals in Healthcare, Pharmaceuticals & Life Sciences
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Official Public Health, Crisis Preparedness & HERA Gazettes & Notifications
Frequently Asked Questions on Public Health, Crisis Preparedness & HERA Regulations
What is the European Health Data Space (EHDS)?
The EHDS is a health-specific ecosystem comprising rules, common standards, and infrastructures enabling citizens to access electronic health data across borders (primary use) and facilitating health research, innovation, and policy-making under strict privacy controls (secondary use).
What is Regulation (EU) 2022/2371 on serious cross-border health threats?
This regulation replaces Decision 1082/2013/EU, establishing a reinforced legal framework for epidemiological surveillance, early warning through the EWRS, joint procurement of medical countermeasures, recognition of public health emergencies at EU level, and coordinated response measures between Member States and the Commission.
How does HERA operate in preparedness versus crisis mode?
In preparedness mode, HERA conducts threat assessments, invests in R&D for medical countermeasures, builds strategic stockpiles (rescEU medical reserve), and pre-negotiates advance purchase agreements. In crisis mode (activated by Council implementing act), HERA gains emergency procurement powers, can mandate production, and coordinates deployment of countermeasures.