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MedTech Forum 2023: Why The Commission Must Not ‘Shoot For The Moon’ With EHDS Plans

 
• By Eliza Slawther

EU policymakers have ambitious goals to enable greater sharing of electronic health data through the creation of a European Health Data Space, but experts at the MedTech Forum conference urged the commission to ensure its regulation is implementable.

MedTech Forum 2023
Left to right: Marjolijn Klaver, Jelena Malinina, Ronan Cahill, Wim Vandenberghe • Source: MedTech Forum 2023, MedTech Europe, Dublin

The European Health Data Space (EHDS), announced in May 2022, is among several new digital legislations recently proposed by the European Commission. Its main purpose is to facilitate the sharing of health data from patients between EU health systems, research organizations and industry players.

While huge benefits could arise from the initiative for both patients and medtech companies, three experts agreed during a panel discussion at the MedTech Forum 2023 last week that the commission must avoid casting the net

“I think the most important piece is scope,” said Marjolijn Klaver, vice president for strategy and market development at J&J, in response to a question about how

More from Europe

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
• By Amanda Maxwell

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

Will NICE’s New Medtech Evaluation Plans Hit the Target for Patients and Industry?

 
• By Ashley Yeo

One year after the UK mooted the Rules-Based Pathway to give medtechs clarity on what can be expected from an evaluation, the devices industry says UK healthtech assessment and adoption processes are still failing to meet the needs of innovators and patients.

The Value Of Consumer Wearables Within The Clinic Is Currently Unknown, Says Cardiologist

 
• By Natasha Barrow

“It’s quite likely [consumer wearable manufacturers] are changing the sensitivity and specificity based on consumer feedback, but not for medical reasons,” said Dipak Kotecha, a University of Birmingham professor of cardiology. Often, self-reported performance evidence from manufacturers is “low quality and biased.”

More from Geography

Beyond The Bladder: Incontinence Impacts Mental Health

 
• By Brian Bossetta

In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.

AI Rollout Aims To Accelerate FDA’s Product Review Process

 
• By Elizabeth Orr

The FDA plans to implement artificial intelligence in its scientific review process by 30 June, following a successful pilot. The agency hopes the tool will reduce nonproductive tasks for reviewers amid recent staff cuts. A Chief AI Officer will oversee the rollout and integration.

Access To Library Tools Being Restored At US FDA

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals and laid off librarians have not been reinstated.