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Session 6 - Digital health solutions: From innovation to prescription

This session explored digital health solutions in more detail. Insights were offered into three different stages when preparing greater use of digital health solutions: the next steps needed once an innovative solution has been developed; how to obtain a CE Mark; and what are the challenges to scale up mHealth apps ecosystem.


The work of European project, vCare, was outlined by project coordinator Hannes Schlieter of TUD (Germany). He outlined all the challenges that need to be addressed – like gathering evidence and ensuring certifications – before digital solutions can be moved onto the market. A general overview of vCare’s work features in the project’s brochure and short videos. Marco Benedetto of Kelyon (Italy) drilled deeper into one specific challenge: certification. The audience heard all about how to certify products for CE Marking, so that they are ready for sale on the European market. Prescribing digital health solutions was also highlighted: indeed, there is probably a need for an organisation that operates in a similar way to medicines approval. Lloyd Humphreys of ORCHA (England) examined therefore how a digital solution can receive an official recommendation so that it can be used by patients (and hence usage be covered or reimbursed). Lloyd also spotlight the importance of raising the quality of digital health, driving its adoption, and “turbo-charging” its adoption.


✅ ePoll: Attendees were asked to rank what they thought could be the top three actions to take to incentivise European health and care professionals to prescribe CE-marked digital health solutions. The top three votes were for:

  • Evidence on effectiveness and impact.
  • Integration of digital health solutions in usual care pathways.
  • Financing of the use of digital health solutions.

A very close fourth ranking was for the data integration of digital health solutions with electronic medical records or electronic health records.

🗣️ Discussions: Conversations ran far and wide around the practical details of scaling-up the use of digital health solutions, and doing so – through training – with both healthcare professionals and patients. Discussants were keen to move beyond digital therapeutics to the whole range of health apps and other digital clinical services. There was great interest in what is happening in Germany in terms of the DiGA Act and the forthcoming DiPA Act on applications which will relate to social care. Registering an app as a medical device can clearly be a long and complex procedure, and the notified bodies – which check out submissions for approvals of apps – are under pressure until at least 2023. Attendees commented on many further “myriad frameworks” that currently cover the certification of mobile apps in diverse ways. Overall, they showed keen enthusiasm for a globalised approach to app classification and review.


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