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.
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.
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.
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.
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.