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PRODID:-//Microsoft Corporation//Outlook 11.0 MIMEDIR//EN
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TZID:Europe/Brussels
UID:20260507T141322-511561292@ehtel.eu
DTSTART:20260528T120000Z
DTEND:20260528T133000Z
DTSTAMP:20260507T141322Z
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:  Evidence and innovative digital health services: a square in a circle                                      \nThis series of webinars explores how people living with dementia are currently supported and what short-term or medium-term opportunities - including the use of digital technologies - can be seized to improve the well-being of both themselves and their carers.\nIn the EU, dementia prevalence in people over 60 increased from 5.9 million in 2000 to about 9.1 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 would thus require a personalised approach to his or her needs. Starting with the patients, we will explore the solutions proposed and viewpoints of all the main actors who can make a difference: social and healthcare professionals, industry, policymakers, and researchers.\nA previous CCF webinar has explored the type of technologies and products which are currently used or tested in the context of ageing and dementia. It has been observed that they were mainly proposed as Class 1 medical devices; this is partially related to the lower the regulatory barriers for their entry, as opposed to Class 2a. \nKey requirements include technical documentation, a Quality Management System (QMS), clinical evaluation, and registration with regulatory authorities.  The drawback for these Class 1 applications- often more related to lifestyle in the dementia and frailty context - is the lack of integration in clinical workflows and the absence (or rarity) of reimbursement. This limit therefore their uptake even when innovative business models are developed.\nClass 2a applications and products usually offer a better perspective of integration in clinical workflows since they contribute to diagnosis, monitoring, or treatment of conditions. Those applications are still considered low/medium-risk but the related Regulatory obligations are more rigorous, requiring proactive Notified Body involvement, extensive technical documentation, and a functioning quality system. AI is also increasingly incorporated in innovative applications, extending significatively the number of class2a or 2b (medium/high risk) applications which need to collect additional evidence to comply with the AI Act regulation. \nIn all cases, innovators are confronted with the challenge to collect the evidence to demonstrate the safety, efficacy and cost-efficiency of the solutions developed, be it for legal/regulatory compliance or possible qualification for reimbursement. The production of this evidence is both time and resources intensive as it requires a wide scale testing. This “time to evidence” also increases the risk to see new and more advanced products arriving on the market. Nowadays, the cycle of innovation has indeed be shortened.\nIn this webinar, we wish to explore if production of evidence is stimulating adoption. And if yes, which evidence is mostly required and which strategies can be implemented to produce the evidence needed to allow innovative products (and in particular Class 2a (and above) products to be used quicker and more extensively.\nIn this webinar we want to analyse some of the possible strategies to rapidly collect the evidence such as:\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:\n\n Hear lessons learnt from existing schemes to apply for early access / pilot reimbursement schemes \n Hear from innovators successful and less successful stories\n
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