COCIR本周发布信息

Medical technology industry’s input to the XpanDH industry X-net

The European Health Data Space (EHDS) regulation is a groundbreaking initiative designed to enable secure, interoperable, and efficient health data exchange across the EU. This effort holds the potential to transform healthcare delivery, foster innovation, and enhance patient access to critical health information.

In partnership with the XpanDH project, MedTech Europe and COCIR affirm their commitment to supporting the successful implementation of the EHDS by addressing key challenges, particularly those related to the regulation's broad definition of Electronic Health Record (EHR) systems.

This paper will address three pivotal topics: the need for use-case-driven guidance for interpreting requirements across digital health product categories, scaling testing frameworks for EHDS interoperability, and ensuring the separation of exchanged content and transport transactions within a simplified interoperability architecture.

MedTech Europe本周发布信息

Medical technology industry’s input to the XpanDH industry X-net

The European Health Data Space (EHDS) regulation is a groundbreaking initiative designed to enable secure, interoperable, and efficient health data exchange across the EU. This effort holds the potential to transform healthcare delivery, foster innovation, and enhance patient access to critical health information.

In partnership with the XpanDH project, MedTech Europe and COCIR affirm their commitment to supporting the successful implementation of the EHDS by addressing key challenges, particularly those related to the regulation’s broad definition of Electronic Health Record (EHR) systems.

This medical technology position emphasises the importance of leveraging established testing frameworks, to validate interoperability and ensure compliance with EHDS requirements. These frameworks, built on decades of industry experience, provide a robust foundation for achieving readiness and maintaining consistency across diverse jurisdictions.

This paper addresses three pivotal topics:

The need for use-case-driven guidance for interpreting requirements across digital health product categories

Scaling testing frameworks for EHDS interoperability

Ensuring the separation of exchanged content and transport transactions within a simplified interoperability architecture

The medical technology sector’s extensive expertise in large-scale eHealth deployment is offering invaluable insights to navigate the complexities of the EHDS regulation. Together, we advocate for a collaborative approach involving policymakers, industry leaders, and healthcare stakeholders to develop clear and actionable guidance for applying EHDS requirements across varied digital health solutions.

Through this expertise, we want to ensure that the EHDS fulfils its transformative promise—enabling seamless cross-border health data exchange while addressing industry concerns and fostering innovation.

BfArm本周发布信息

Field Corrective Actions

MHRA本周发布信息

Guidance

Medical devices: UK approved bodies

UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

21 January 2025

Updated 'DEKRA Certification UK Ltd medical devices scope '

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