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PRODID:-//Microsoft Corporation//Outlook 11.0 MIMEDIR//EN
VERSION:2.0
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TZID:Europe/Brussels
UID:20260510T142215-1954957854@ehtel.eu
DTSTART:20260526T120000Z
DTEND:20260526T133000Z
DTSTAMP:20260510T142215Z
SUMMARY:Evidence and innovative digital health services: a square in a circle
DESCRIPTION: COMFORTage CCF TA1: Dementia and Frailty Service Delivery Models for affected patients and their carers\nWebinar 5:&nbsp; Evidence and innovative digital health services - a square in a circle&nbsp; &nbsp; &nbsp; &nbsp;\n\nThis series of webinars explores how people living with dementia are supported and what short-term or medium-term opportunities - including the use of digital technologies - can improve the well-being of themselves and their carers.\nIn the EU, dementia prevalence in people over 60 increased from 5.9 million in 2000 to over 9 million in 2018. However, behind the words “dementia” and “frailty”, are very different clinical conditions. Furthermore, the personal and social environments play critical roles. Every person with dementia is unique and needs a personalised approach to his or her needs. Starting with the patients, COMFORTage explores the solutions proposed and viewpoints of all the main actors who can make a difference: social and healthcare professionals, industry, policymakers, and researchers.\nA focus on AI, technologies and evidence collection\n<a href="https://www.ehtel.eu/activities/webinars/2025-transforming-care-delivery-assessing-interventions-supported-by-digital-health-technologies.html" target="_blank" rel="noopener">A previous CCF webinar</a> explored the types of technologies and products&nbsp;currently used or tested in ageing and dementia. They were mainly proposed as Class 1 medical devices (this is partially related to their lower regulatory barriers, as opposed to Class 2a devices). \nClass 1 devices’ key requirements include technical documentation, a Quality Management System (QMS), clinical evaluation, and registration with regulatory authorities.&nbsp;\nThey are, however, often more related to lifestyle in the dementia and frailty context. Their drawback is their lack of integration into clinical workflows and the absence (or rarity) of reimbursement. This limits their uptake even when innovative business models are developed.\nClass 2a applications and products usually offer better integration into clinical workflows since they contribute to diagnosis, monitoring, or treatment of conditions. These applications are still considered low/medium-risk. The related regulatory obligations are more rigorous, requiring proactive Notified Body involvement, extensive technical documentation, and a functioning quality system.\nAI is increasingly incorporated in innovative applications, extending significatively the number of Class 2a or 2b (medium/high risk) applications which need to collect additional evidence to comply with the AI Act regulation.&nbsp;\nIn all cases, innovators are confronted with the challenge to collect the evidence needed to demonstrate the safety, efficacy and cost-efficiency of the solutions developed (be it for legal/regulatory compliance or qualification for reimbursement). The production of this evidence is time- and resource-intensive as it requires wide-scale testing. This “time to evidence” also increases the risk of not seeing new and more advanced products arriving on the market. Today, instead, the innovation cycle has to be shortened.\nWhat’s in this webinar?\nIn this webinar, we:\n\nExplore whether the production of evidence is stimulating adoption. If yes, what evidence is most required? Which strategies can be implemented to produce the evidence needed to allow innovative products to be used more quickly and extensively (in particular, Class 2a – and above - devices)?\nAnalyse some possible strategies to collect evidence rapidly.&nbsp;\n\n\nRapid evidence collection strategies include:\n\nDesigning the app to be a data collection tool from day one:\nPartnering early with healthcare systems and Healthcare Professionals\nRunning pragmatic trials instead of “pure” RCTs\nUsing adaptive and hybrid study designs\nThinking “evidence lifecycle,” not “one-time study”\n\n\nPeople attending the webinar will hear about:\n\nLessons learnt from existing schemes to apply for early access / pilot reimbursement schemes \nStories from innovators' successful and less successful experiences\n
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