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Trade Body Call To Address Key Challenges Of The EHDS Regulation For Medtech

Executive Summary

The European Health Data Space Regulation is at the final trilogue negotiations stage, but the medtech industry is still calling for crucial changes.

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‘Deep Concerns’ Raised Over EHDS Regulation By Medtech Industry

Health stakeholder organizations including COCIR and MedTech Europe have issued a press statement outlining 10 fundamental issues with the European Health Data Space Regulation. The groups’ areas of focus include: legal clarity and member state harmonization; coordination and cooperation with existing infrastructures and stakeholders; and training.

EU Data Act Creates Complications For Medtech Manufacturers

Manufacturers of connected devices will now be required to give users direct access to data and share data with third parties, including competitors. Experts raise concerns over industry data governance, legislative interplay, and protection of intellectual property.

Will The European Health Data Space Succeed In Providing Benefit To The Medtech Industry?

The European Parliament's recent position creates points of contention with the Council of the EU. European Parliament aims to strike a balance between health data exchange and protecting citizen privacy. The medtech industry will not enjoy promised benefits if EHDS cannot deliver access to high-quality representative data.

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