Dear Health 2.0 Amsterdammers,
As the summer has finally arrived, with enthusiasm and a smile on our faces we invite you to join us at the next Health 2.0 event to be held on Wednesday, July 24th from 18h30 till 20h30 under the theme of CE certification of medical apps.
As our usual DesignThinkers space is not available during the summer months, we have been invited by the team of IJsfontein to host our upcoming meetup at the beautiful building (see the picture below) just off Westerpark, located at Haarlemmerweg 4 in Amsterdam.
IJsfontein is a specialist in interactive communication and media production and you can see how to reach their office building by car and public transport here.
The use of medical apps appears promising for facilitating work of healthcare professionals, engaging patients in the management of their health and improving patient care. According to a recent study by a Dutch medical portal, Artsennet, that surveyed 554 doctors and medical students, 88 % percent of them indicated “sometimes prescribing apps to patients” (see the article here). With the rapid advances and widespread adoption of new technologies, it is expected that this number will be increasing with a growing emphasis on ensuring safety and quality of medically prescribed apps.
Artsennet organizes annual Health app award competitions to review medical apps while the Dutch Health Care Inspectorate, IGZ has recently announced that it requires all the apps classified as medical devices to be CE certified before January, 1st 2014. The CE marking indicates that medical devices meet the European requirements for safety, health, environmental and consumer protection and as European Commission reports “The CE marking indicates a product’s compliance with EU legislation and so enables the free movement of products within the European market. (…) However, not all products must bear the CE marking, only product categories mentioned in specific EU directives on the CE marking.” (source)
When does a medical app need CE mark? How does the CE certification process look like? And is CE marking sufficient to ensure the quality and safety of medical apps? If not, how can we facilitate medical doctors to choose what is best for their patients?
Join us next week to learn about medical apps and CE certification from a legal, regulatory and business perspective!
18:30 - Networking
18.45 - Introduction by Hans Luyckx (@luyckxh), IJsfontein, Operations Manager
19.00 - Sofie van der Meulen (@sofievdmeulen), Axon Lawyers, Attorney at Law
19:30 - Erik van der Zijden (@ErikvdZ), Synappz, CEO & Co-Founder
20:00 - Networking
Sofie van der Meulen is a lawyer working at Axon Lawyers in Amsterdam. Axon is fully focused on the life sciences sector including medical technology, pharmaceuticals, biotechnology, food and cosmetics. Sofie has gained broad experience in administrative law, both in business and in her consultancy work for several public administrations. She specializes in the legal and regulatory aspects of medical technology and is involved in the food sector through, among other things, the organization of the Food Law Academy (2012) and co-writing of the EU food law roadmap (Landkaart Levensmiddelenrecht). She lectures on administrative law and medical devices.
Sophie will be talking about when is an app a medical device, when is the CE-marking required and what are its consequences and benefits.
Erik van der Zijden is a co-founder of Synappz, previously active in several international roles in pharma, varying from business analysis, export sales, marketing and innovation. He started his own company, DigiRedo, in 2008 focusing on Web 2.0 and Enterprise 2.0 implementation. His change to mobile health in 2011 with the creation of Synappz was a logical step, given the passion in healthcare, digital and the challenging yet inspiring life of a start-up. Synappz wants to develop and market the best mobile technologies to bring back sense in healthcare communication.
Erik will be talking about the journey he and his team took to get their award winning app iP Voiding Diary through a CE-certification process. The challengers but, more importantly, the opportunities it gave for a start-up such as Synappz.
We are looking forward to seeing you next week! Since space is limited to 30 people, we kindly ask you to RSVP only if you can attend the event.
Lastly but not least, we decided to leave the feedback form online here to allow you to keep sharing your thoughts and ideas on the format, speakers, topics and venue. Thank you to those who have already done so and see you on the 24th!
Learn more about our summer event host, IJsfontein
IJsfontein is a specialist in interactive communication and media productions. Among the clients of the Amsterdam based company are broadcasting companies, museums, (consumer) brands, non-governmental organizations and healthcare institutes. IJsfontein also designs and develops serious games commissioned by several partners in Healthcare. Their games are being used as educational or training tools or are provided to the patient as part of their treatment.
Playful Solutions, Serious Communication