Our Priorities Digital Health

Health Data

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For digital health to reach its full potential, we need to unlock the benefits of health data. Medical technology companies are at the heart of the health data ecosystem* as they need to process health data, both when developing new technologies, and as part of their roll-out to healthcare systems.

Harnessing the power of #DataForHealth

Health data is generated everywhere. From visits to hospitals and doctor’s practices to smartwatches and connected medical devices (devices that are connected to the internet or other devices), that help manage your health. Making this data accessible for healthcare professionals and researchers is valuable to optimise/personalise the provision of healthcare and to improve patient outcomes.

Explore the great potential of health data for care delivery and innovation. Find here more information and be part of the campaign #DataForHealth

 

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Data Act

The European Commission’s proposed Data Act aims at ensuring fairer value allocation from data and fostering increased access to, and use of, data. MedTech Europe would like to highlight the need to preserve incentives for industry to invest in methods of generating value through data, in a balanced and proportionate way. In particular, the Data Act should: 

  • Recognise the complexity of the healthcare sector  
  • Provide precise definitions and a clear scope
  • Take existing legislation into account, especially the rules outlined under Medical Devices Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and General Data Protection Regulation (GDPR)
  • Avoid the erosion of the protection granted by IP rights and trade secrets 

Regulation on the European Health Data Space (EHDS)

MedTech Europe welcomes the Commission’s goal of creating an environment which fosters access to health data and health data sharing across the European Union. As the voice of the medical technology industry, it is our view that the EHDS is a pioneering initiative and has the potential to empower patients and accelerate the European Single Market for digital health and data by tackling barriers to cross-border data sharing. While the proposal represents a tangible first step toward a European health data ecosystem, we see areas for improvements. A truly enabling EHDS should meet several key criteria:  

  • Maintain a reasoned and logical scope to achieve its intended objectives 
  • Have clear and consistent requirements and provisions  
  • Enable and encourage access to good quality data for secondary use while ensuring compliance with the General Data Protection Regulation (GDPR) by, for example, providing additional clarifications 
  • Ensure consistency with the existing EU regulatory environment, in particular with sectoral legislation

 

* Source: Big Data to See Explosive Growth, Challenging Healthcare Organizations, Health Analytics. Find the article here.