1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

European Health Data Space Regulation: Hurdles Ahead As Negotiations Intensify

 
• By Natasha Barrow

As the European Health Data Space Regulation heads towards a more intense discussion phase, EU member states still have concerns over patient data autonomy, data storage, and resources for developing national health data platforms.

EUDS
• Source: Shutterstock

Trilogue negotiations between the European Parliament, Council of the EU and European Commission on the European Health Data Space Regulation could start before the end of 2023, with the aim of reaching a political agreement before the mid-2024 European Parliament elections, European Commissioner Stella Kyriakides told the recent EPSCO Council Meeting.

During the Employment, Social, Policy, Health and Consumer Affairs (EPSCO) Council on 30 November, commissioner Kyriakides stated that "the availability...

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
Start Free Trial

Already a subscriber?

More from Regulation

More from Policy & Regulation

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

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?

 
• By Brian Bossetta

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?

US FDA Unveils Plans To Consolidate Support Services

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.