Stakeholders issue a joint statement on access to innovative healthcare under the AI Act

Article summary

MedTech Europe and ten other stakeholders have announced their support of the proposed EU Artificial Intelligence (AI) Act. The regulation aims to provide individuals with the confidence to adopt AI-based solutions, including enabled digital health services and tools. The stakeholders have issued a joint statement highlighting the shared goal of improving health outcomes and healthcare systems and their support for the AI Act and its potential to transform healthcare across the EU. The statement notes that while existing AI solutions integrated into medical technologies are regulated by the Medical Devices Regulation (MDR), there will be further AI-enabled solutions as adoption grows and therefore the role of AI Act will be central in the delivery of innovative healthcare. The joint statement urges Member States and EU decision-makers to take into consideration the impact the proposal can have on the EU health system.