How The European Health Data Space Is Game-Changer For Digital Device Assessment

The EHDS’ pivotal role in generating real-world evidence and capturing patient-reported outcomes will be a bonus for health technology assessment, especially in digital health.

Digital Health
Explosion Of Available Digital Health Data Will Help Scrutinize Digital Device Safety (Shutterstock)

The European Health Data Space is set to be a game-changer for health policy in Europe, providing the necessary high-quality and standardized data infrastructure to support comprehensive and consistent assessments of health technologies and improve patient access and outcomes across the continent.

That is the view of the EU-funded European Digital Health Technology Assessment (EDiHTA) project whose role is to establish criteria...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Medtech Insight

More from Policy & Regulation

MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation

 
• By 

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By 

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?