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.
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.
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.
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.
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.
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.
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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.
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.
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.”
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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.
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.
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.
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.