Laws & regulations

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News • UK family doctor survey

AI in the GP office: study points out lack of clear work policies

ChatGPT has brought generative AI to the mainstream – and into many GP practices as well, a new study suggests. The work points out the risk of doctors using AI without clear guidance or policies.

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News • European Digital Healthcare Excellence Forum 2024

Effective Digitalisation in Hospitals and Healthcare Facilities

Managing Directors and C-level executives from hospitals, clinics, and healthcare facilities gather in Berlin to discuss the latest advances and strategies for the digitalisation of healthcare.

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News • Concerns about hurried adoption

Survey: Is medical AI taking over too quickly?

The pace of artificial intelligence (AI) adoption in personalised medicine is unsettling for great parts of the public. A new survey reflects the worried state of mind in the UK.

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News • A question of liability

Who’s to blame when AI makes a medical error?

Medical AI is advancing gastrointestinal endoscopy – but what happens when it contributes to a medical error? Legal experts are pioneering efforts to develop guidelines on medical AI liability.

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News • GMAI for cancer treatment

Generalist Medical AI: Experts propose legal guardrails

Generalist Medical Artificial Intelligence (GMAI) models pose a significant challenge to current regulatory frameworks. Experts discuss how regulation of these models could work in the future.

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News • Appeal for better approval conditions

AI in personalised cancer medicine: “A fundamental change is needed”

AI technology holds promise for personalised cancer therapies. However, rigid and slow approval requirements impede its introduction, say experts – and point out how this might be changed.

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Article • Sustainability

The challenge of "greening" medical technologies

Under the impulse of the European Commission, the in vitro diagnostic industry is developing emerging technologies to implement sustainable practices in medical laboratories. As sustainability has been a growing priority of the European Union (EU) in the last decade, ‘the medical technology sector, particularly the IVD sector, must comply with European legislation in this field like all other…

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Article • How to bring about better patient outcomes with health data

Propelling innovation in healthcare with the help of health data spaces

January 28 saw the celebration of the “Data Protection Day” as it is called in Europe, or respectively the “Privacy Day” as it is referred to outside of Europe. It marks the date on which the Council of Europe’s data protection convention, known as “Convention 108” was opened for signature back in 1981. According to the Council of Europe, it is the ‘only international,…

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Article • New EU regulation

Lab tests: Watch out! Conflict ahead

In May 2022 a shortage of several lab tests may come as many manufacturers struggle to comply with EU regulation requirements covering in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746). Even modified tests and laboratory-developed tests will present a problem for hospitals and labs as explained by Dr Thomas Streichert.

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Article • Cyberattacks and countermeasures

Healthcare cybersecurity in the EU and US: a technical, regulatory or political issue?

The pandemic has put a spotlight on the increasing role of cyberattacks and weaknesses in healthcare. In healthcare as in other industries, cybercrime does not stop at national borders. With this idea in mind, the US consulate general in Düsseldorf and the US embassy in Vienna recently invited interested parties to their Cybersecurity in Healthcare Briefing.

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News • Photon counting

Major CT advancement receives FDA clearance

The U.S. Food and Drug Administration (FDA) cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade. “Computed tomography is an important medical imaging tool that can aid in diagnosing disease, trauma or abnormality; planning and guiding interventional or therapeutic procedures; and monitoring the effectiveness of certain therapies,” said…

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