Around one year after the Sprint #1 workshop, we have kept our promise to organize in Brussels the second part of the series (Sprint #2), this time focusing on a very crucial topic, namely “Innovation uptake in eHealth with patient-centeredness and gamification. Regulatory challenges and opportunities“.
The workshop was held on 7th November 2018 with the scope to brainstorm the status of the regulatory and ethical scenario in the context of eHealth and expose the state of the art of three EU H2020 eHealth projects (COUCH, GOAL, vCare) discussing the process-to-market implications especially at the light of the Regulatory framework in the clinical research and uptake in the healthcare scenario.
The workshop was opened by Sofoklis Kyriazakos, the CEO of at Innovation Sprint, who welcomed the audience and set the goals of the day. The audience was consisting of speakers and attendees from many countries from diverse sectors, including medical industry, regulation, policy making, research, academia and SMEs. Following the welcome message, a keynote speech was given by Gianlugi Arialdi, CEO of the Brussels Life Sciences Incubator, who presented BLSI structure and activities that embrace eHealth startups in Brussels.
The first lecture was given by Ingrid Klingmann, President at the European Forum for Good Clinical Practice in Brussels, with the title “eHealth, Innovation and Patients’ Centredness”. Ingrid stressed the importance of patient centredness in clinical trials, however ensuring Goof Clinical Practice. The following lecture was given by Eric Klasen, Vice President Regulatory Affairs in Medtronic International Trading in Tolochenaz , who talked about “Innovation and (EU) Regulation: the Medical Device case”. Eric has given a focus on the 2020 regulation about medical devices; the challenges and the status of play.
After the first 2 lectures, Emilio Vandelli – Managing Director of Arithmos Srl in Verona, talked about “eHealth Innovation and Clinical Research”. In his presentation he presented the trends in clinical research and how Arithmos and is addressing them.
Following this presentation, Christina Kyriakopoulou – Directorate General for Research and Technological Development in the European Commission (Brussels), presented in her talk “Horizon Europe” the current and future Health related priorities and calls.
Having completed the above lectures and presentations, the workshop attempted to “crash test” the 3 EC projects (workshop co-organizers) about their status and the possible barriers they will have to break with regards to regulations in their exploitation activities. This was moderated by Alfredo Cesario, the Chief Scientific Officer in Innovation Sprint. In this context, Harm op den Akker, Senior Researcher in RRD in Enschede and coordinator of the COUCH project described the novelties and the next steps that involve advanced technologies on argumentation framework to realize mutli-avatar approach for virtual coaching. Furhtermore, Aristodemos Pnevmatikatis, Associate Professor in Athens Information Technology and coordinator of the GOAL project, presented the status and the final activities of the project, which is at the final stage and is executing commercialization activities in the area of gamification for behavioral change of elderlies.
Alfredo briefly presented vCare activities, which are focused on clinical pathways for virtual coaching in rehabilitation. Having concluded the 3 project presentations the morning speakers, Ingrid Klingmann, Eric Klasen and Emilio Vandelli, were raising questions to the presenters, in a constructive way for all to understand how critical is to address the regulatory challenges before the start of the exploitation, as this can even be a show stopper in R&D activities.
The last session included 3 speakers – one per project- that presented achievements, as well as best practices and lessons learned in EC projects. Lucia Pannese – CEO of IMAGINARY in Milan talked about “Savings and better QoL: Gamifying Rehab“ with her experience in R&D and commercialization activities in serious games.
Andrew Pomazanskyi, Senior Project Manager in NUROGAMES in Köln, described similar lessons learned with Lucia in his presentation “Problems of exploiting eHealth solutions from R&D projects“.
Finally, Marc Lange, Secretary General of EHTEL, presented the expected transition of vCare from R&D into the practice in “Virtual Rehabilitation Coach: a journey from the proof of concept to routine care“, Marc Lange.
The workshop was concluded by Sofoklis Kyriazakos, who explained that the outcomes of the workshop will be summarized in a White Paper and all partners should contribute, aiming to create impact for this critical point of regulation in R&D.