DAY 2 | 1 December 2021 | 14:15 CET (GMT +01:00)
Session prepared with Shahram Sharif, Founder of Lindacare and Director of the EHTEL Board
In partnership with the vCare project
📝 Session abstract
The “Everywhere with digital health” health and care paradigm shift aims at transferring, where possible, the place of care from an acute environment to a home environment and even to people directly when they are on the move. Digital Health Services – including mHealth and Digital Therapeutics – are becoming critical enablers. By using these services, patients become key actors in the care they receive.
To be integrated well into the digital health infrastructure and become mainstream in care pathways and hybrid models of care, digital health services and products needs to be assessed before being prescribed by health professionals. Examples of what needs to be assessed include their safety, usability, clinical efficiency, and economic value. Progress has been achieved at European level with the Medical Device Regulation. It is also in the process of moving ahead with the EC proposal for an AI Act. The ISO standard on Quality and Reliability of Health and Wellness Apps is another solid step in this direction.
This session will start from a use case where innovators are starting to reflect on the certification needed by the digital health services they are developing, and explore how another innovator has also addressed this challenge. It will then expand the conversation to cover the additional conditions that need to be fulfilled in order for health services to be prescribed and possibly reimbursed.
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✋ Do you want to have an impact on the future of the European Health Data Space (EHDS)? This session relates to an action in the EHTEL position paper on the EHDS consultations: "Digital health services and products". |
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🕑 Session Programme
► 14:15 CET Session Introduction
Shahram Sharif, Founder of Lindacare and Director of the EHTEL Board
This session will start from a use case where innovators are starting to reflect on the certification needed by the digital health services they are developing and explore how another innovator has addressed this challenge. It will then report on how a healthcare system is considering the prescription of digital health services. Conversations will follow which cover the additional conditions that need to be fulfilled for health services to be prescribed and possibly reimbursed.
► 14:20 CET vCare`s journey from innovation to prescription – an intermediate assessment
Hannes Schlieter, Technische Universität Dresden
The vCare project addresses the shortcomings of home-based rehabilitation by an intelligent digital coach that reminds, engages, and educates the patients in their daily lives. As digital innovation, vCare is the result of a European project consortium. In this presentation, the hurdles to be taken will be outlined when building value for European citizens by exploiting vCare`s solution.
► 14:30 CET Advantages and drawbacks of the new Medical Device Regulation: new challenges for a digital health company
Marco Benedetto, Bioengineer, Kelyon
The new EU Medical Device Regulation (MDR) 217/745 marks the beginning of a new scenario for companies operating in the medical device sector. The organisational processes for the production and marketing of medical devices need to be reviewed. The debate is an open one. How has the new regulation affected software medical device manufacturers? What has changed for software certification as a medical device? The presentation will focus on what experiences a digital health company may undergo behind the scenes.
► 14:40 CET Mind the gap: Digital health without infrastructure isn’t working
Lloyd Humphreys, MD, ORCHA
With over 365 000 digital health products available and more than 5 million downloads per day, why are we not realising the full potential of the digital revolution? It remains a separate pathway to traditional care and physicians are not recommending ('prescribing') at the rate needed to effect change in healthcare delivery. We need to support the high quality digital health products with the right infrastructure. Standards and accreditation for digital technologies is a start, but is simply only the beginning. The presentation will reflect on the various ways to raise the quality, drive adoption and reflect on how we might turbo-charge digital health as an integrated approach to healthcare.
- Authorising the prescription of a digital health service or product on the basis of which criteria?
- Which financing and reimbursement models for digital health services?
- From prescription authorisation to prescription-making and use: what are the issues?