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eHealth HUB Storybox | Regulatory Guidance Stories and cases from the European market.

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eHealth HUB Storybox | Regulatory Guidance Stories and cases from the European market. Discover how eHealth HUB initiative can support digital health startups and SMEs in Europe.

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eHealth HUB Storybox | Regulatory Guidance Stories and cases from the European market.

  1. 1. The project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under Grant Agreement No727683. Learning points “The lean startup strategy is the best move to start a project like this, it saves time on unnecessary aspects. And time is money! Quentin Pedron, social psychologist and CPO eHealth HUB services Lean Startup Academy The Lean Startup Academy provides eHealth SMEs with the opportunity to mature their business by systematically testing their ideas against the market. Business Model Clinic The Business Model Clinic supports the best promising entrepreneurs and startups offering personalized coaching on business proposition, customers and go-to-market strategies. The project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under Grant Agreement No727683. Learning points “The lean startup strategy is the best move to start a project like this, it saves time on unnecessary aspects. And time is money! Quentin Pedron, social psychologist and CPO eHealth HUB services Lean Startup Academy The Lean Startup Academy provides eHealth SMEs with the opportunity to mature their business by systematically testing their ideas against the market. Business Model Clinic The Business Model Clinic supports the best promising entrepreneurs and startups offering personalized coaching on business proposition, customers and go-to-market strategies.
  2. 2. Naru: adapting the product design to regulatory standards It was really important for us to have this workshop in the early development stage of our product and we can recommend to other startups to receive advice on CE certification as early as possible “ “ Naru Intelligence Solutions Eider Sanchez, CEO and co-founder www.naruintelligenc e.com Spain Regulatory Guidance [July 2017]. eHealth HUB help us to obtain the very valuable support from CEplus as an expert of the Regulatory Network. It included an internal face-to-face workshop and follow-up advice which helped us to better understand the regulatory requirements and the limits of our system. After the workshop with CEplus we decided to change the architecture and technical development of our product to make it more scalable in the future. It was very convenient for us to have the workshop at a very initial point of the project, so that the architecture change suited correctly under our timeline. Our product STEP is a system to predict Severe Adverse Events in cancer patients, so that oncologists can personalize the follow up to improve results. We integrate clinical information with patient reported data that we gather from a mobile app. Our proprietary algorithms in our cloud platform analyse the data and generate the predictions. We wanted to know if our product or some parts of it are a medical device and how to classify them. We also wanted to understand which are the steps required to obtain the CE certification. My challenges eHealth HUB support Naru Intelligence develops Artificial Intelligence systems for oncology. We are focused on improving outcomes of every patient and optimizing hospital performance and clinical research. We specialize in the development of machine learning algorithms that integrate Real World Data in order to support and enhance clinical decisions. Our main objective is to improve personalized care through the analysis of each patient’s experience. The company
  3. 3. The project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under Grant Agreement No727683. Learning points “We were really satisfied with the support from CEplus. At the moment we are focusing on launching our product and are working on the CE marking process together with CEplus”. Eider Sanchez, CEO and co-founder eHealth HUB services Regulatory Guidance eHealth Hub Regulatory Network helps European eHealth SMEs to be compliant with regulatory requirements and develop reimbursement strategies across the European Union.
  4. 4. Lean On Me: legal guidance for expanding internationally The assistance provided by the qLegal clinic was absolutely invaluable in helping us understand how to bring our operations abroad. The team presented a clean big-picture view of the legal landscape and concretely recommended next steps for us to take “ “ Lean On Me Daniel Mirny, CEO https://lean0n.me/ Legal guidance. We were aadvised on the conditions for processing sensitive personal data and how to fulfil such conditions. The advice provided guidance with regards to breaches and safeguarding measures including anonymisation and pseudonymisation. Since the transfer of personal data outside the European Economic Area necessitates additional requirements, we were advised on such. We were made aware of the different types of charity structures available in the UK. We were advised to consider adopting a CIO or a charitable company limited by guarantee, understanding the main advantages and disadvantages of establishing a charity in the UK as well as the process and requirements in order to do so. While fielding requests from UK-based communities to expand our service, we realised that we had a very poor understanding of the legal barriers (anonymity, data protection, liability, and crisis support) associated with bringing a volunteer-based mental health service such as Lean On Me to the United Kingdom. My challenges eHealth HUB support Lean On Me strengthens communities by providing peer-to-peer text lines that allow for easy access to confidential non-crisis support. Lean On Me envisions a world where anyone can seek and receive emotional support. The company US
  5. 5. The project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under Grant Agreement No727683. Learning points “We’re grateful to the qLegal team and their partners for all of their help, and strongly recommend qLegal to other nonprofits seeking legal counsel that is as professional and thorough as it is warm and respectful.” Daniel Mirny, CEO Lean On Me eHealth HUB services Legal Support eHealth Hub Legal Network offers good quality, affordable legal advice for eHealth SMEs as well as free workshops detailing current legal issues of eHealth SMEs interest.

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