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eHealth HUB Storybox | Legal Support Stories and cases from the European market

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eHealth HUB Storybox | Legal Support 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 | Legal Support 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. Lean Entries: the view of a regulatory expert “ “ Digital Regulatory Runways at Lean Entries Heikki Pitkänen, CEO https://www.leanentries.com/ Finland Regulatory guidance and eHealth HUB Platform. “The creation of a network of quality and easily identifiable legal and regulatory experts and digital services can be considered a good practise and will facilitate the access to this type of expertise. The emergence of digital regulatory services provides an opportunity to cut down costs and increase efficiency in compliance for the SMEs. In this sense, the eHealth HUB platform is very useful by providing a digital tool where SMEs can easily find regulatory experts. For us, it can serve for identifying potential clients as well. Ultimately, it raises awareness about the importance of the matter, helping SMEs to understand that is a key factor for success” The importance of the legal and regulatory aspects is not perceived by SMEs as compliance is considered non-affordable and is not well understood due to its complexity. Non-compliance creates a high risk for market entry for the SMEs. Start-ups should see this as an investment due to the importance of the matter, since no regulatory compliance ultimately means no commercialization. My challenges eHealth HUB support Lean Entries Ltd. is a group of regulatory compliance professionals with decades worth of know-how from the medical device sector. The company started in 2016 with a mission to light the way into compliance for every medtech developer around the world. The Entries platform was born for turning the piles of regulatory requirements into minutes of clarity for the developers. The company The importance of the legal and regulatory aspects is inestimable. It is, therefore, definitely useful to a have a directory as the eHealth HUB Platform where SMEs can find regulatory experts providing services specially designed for this sector.
  3. 3. Learning points “Start-ups should see getting advice as an investment due to the importance of the matter, since no regulatory compliance ultimately means no commercialization.”. Heikki Pitkänen, Founder and CEO Digital Regulatory Runways at Lean Entries eHealth HUB services eHealth HUB platform The eHealth HUB platform (platform.ehealth-hub.eu) is the map of European digital health. An online catalogue that identifies the key players to enhance transparency in the sector and encourage stakeholders’ interaction 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. Actual: affordable legal advice for startups Clemence and her team helped us at Actual during the launch of the first version of the company, when we were learning the basics of European startup law and had only a very limited budget. We would recommend to anyone in a similar situation looking for quality advice to seek out their services! “ “Actual Anna Gat, Co-founder http://actual.chat United Kingdom Legal Guidance. We received advice on the main changes that the GDPR made and how to implement them. The advice provided guidance on the seven over-arching principles that must be met in order to be in compliance, the obligations of a data controller, processing sensitive personal data and legal liability regarding encryption. We received general advice on how to draft a privacy policy, and what to include. Since Actual uses artificial intelligence, we were advised to identify precisely which parts of the programme include automated individual decision making and to include this information in the privacy policy. Understanding how to comply with the General Data Protection Regulation (GDPR), specifically, how to monitor and analyse conversations on an app in order to improve the app’s performance. Besides, as a startup we had a very limited budget and were concerned about the affordability of these type of legal services as sometimes they are expensive. My challenges eHealth HUB support Actual is an AI-mediated chat app for meaningful conversations. A messaging app which aims to promote conflict-free conversation. Artificial intelligence within the chat application acts as a mediator during the discussion. The artificial intelligence looks for things like mood, the speed of the conversation and whether either party is misunderstanding the other. It then makes a suggestion on how to neutralise the conversation. The company
  5. 5. The project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under Grant Agreement No727683. Learning points qLegal excellent pro bono work provided us with the necessary information, and self-confidence, to embark upon the exciting and often complicated journey of building a great company. Anna Gat, Co-founder Actual 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.
  6. 6. Medimaat We received advice on the legal implications of our way of working: which regulations apply to us and liability. Additionally, we received advice on data protection: data that can be used on our platform. “ “ Medimaat Philip Croon, Managing partner https://www.medimaat.nl/ Netherlands Legal guidance. “Clinic's free legal advice service has taught me the importance of legal compliance. As a startup founder, you are hesitant to involve lawyers because your focus is on the product and cash is limited. What often happens is that entrepreneurs start drawing up the legal documents themselves on the basis of (free) formats on the internet. These can be incomplete and contain errors, which ultimately costs more time and money to fix than previously thought. A good legal basis is extremely important. It can bring many benefits in the future and prevent many problems.“ • Understanding data protection laws • Understanding medical liability regulation • Limited resources to devote to consultancy services My challenges eHealth HUB support Medimaat is about empowering patients. Medimaat connects medical students to patients and helps them before, during and after visiting a doctor. The company
  7. 7. The project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under Grant Agreement No727683. Learning points “The memo they provided is a solid base to further evaluate the legal issues of MediMaat. It is both professional yet easy to read and understand, which is important for me since my knowledge of law is poor. I know I gave them a hard case but they did an excellent job.” Philip Croon, Managing partner 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.
  8. 8. M’Care: protecting IPR Not being able to access legal advice can mean losing real opportunities. Before my appointment with qLegal I didn’t know what information we should keep quiet about, and how to navigate the business environment.” “ “ M’Care Opeoluwa Adetayo CEO & Founder https://m.care/ Nigeria Legal guidance. “We were advised on what a patent is, the extent to which it is applicable to software patents in certain European countries, the application process and key considerations when making an application. We were provided with advice in relation to other intellectual property rights including, copyright, trade marks and design rights. We were provided with advice in relation to non-disclosure agreements including its purpose, key terms to incorporate and considerations when operating in several countries.” • Understanding how to protect intellectual property rights • Understanding confidentiality when working with others and non- disclosure My challenges eHealth HUB support M’Care is about empowering local community health workers by providing an on time decision support system via SMS. M’Care also improves diagnostics and treatment outcomes for patients in rural areas. The company
  9. 9. The project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under Grant Agreement No727683. Learning points “When we were trying to raise funds, we almost released information about our technologies to all the people we were meeting in order to convince them to invest in us. Attending a qLegal webinar and then teleconference advice session certainly helped us realise we should not. If you want to patent the software, you need to make sure it hasn’t been publically released. It was important for the sustainability of the business to get a patent first.” Opeoluwa Adetayo, CEO of M’Care 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.
  10. 10. Immersive Rehab I really appreciate all the attention from qLegal and would definitely recommend your services to any startups, as a good source of quick, easy and accessible professional legal advice. “ “ Immersive Rehab Isabel Van De Keere Founder & CEO https://immersiverehab.com/ Legal guidance. We were provided with an overview on intellectual property rights including trademarks, patents, copyright and design rights in the UK. The advice detailed the subject matter, key considerations and process with respect to these rights. We were advised on entering into Non-Disclosure Agreements when developing products with external collaborators. Additionally, the advice contained guidance on data protection laws including the responsibilities of a data controller and processor as well as drafting a Privacy Policy. • Understanding how to protect VR games with different intellectual property rights. • Understanding how to comply with data protection laws, specifically in relation to the implications of collecting and storing data on the cloud. My challenges eHealth HUB support Immersive Rehab develops interactive games in Virtual Reality. With these programmes, Immersive Rehab intends to improve the effectiveness of physical rehabilitation, by providing a motivating solution to people who have neurological limitations. The company United Kingdom
  11. 11. The project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under Grant Agreement No727683. Learning points “The advice letter provided me with advanced information regarding my business’ current demands and went even into more detail than I was expecting. Everything was very well written and I plan on going back to consulting the letter from time to time, when facing any issues again. Isabel Van De Keere, Founder & CEO 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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