COMMISSION STAFF WORKING DOCUMENT Accompanying the document COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society
Date: 2018-04-25
Institutions: Directorate-General for Communications Networks, Content and Technology, European Commission
Subjects: cross-frontier data flow, data protection, digital single market, digitisation, disclosure of information, e-Health, exchange of information, organisation of health care, personal data, technical specification

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 25.4.2018 SWD(2018) 126 final  COMMISSION STAFF WORKING DOCUMENT Accompanying the document COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society  {COM(2018) 233 final}  
 
 
Contents 

1. INTRODUCTION 
1.1. Policy Context 
1.2. State of Play 
1.3. New Developments and Challenges 

1.3.1. Citizens' access to personal data concerning health 
1.3.2. Cross-border access to data for research and personalised medicine 
1.3.3. Security of communication infrastructure and networks  

2. CITIZEN'S SECURE ACCESS TO ELECTRONIC HEALTH RECORDS AND THE POSSIBILITY TO 
SHARE HEALTH DATA ACROSS BORDERS 
2.1. Electronic Health Record (EHR) and digital access to personal health data 
2.2. State of Play 

2.2.1. Lack of Electronic Health Records (EHR) interoperability 
2.2.2.  Citizens'  access  to  EHRs  and  cross-border  exchange  of  health  data  amongst 

professionals 
2.3. Remaining challenges at the EU-level 

3.  BETTER  DATA  TO  ADVANCE  RESEARCH,  DISEASE  PREVENTION  AND  PERSONALISED 
MEDICINE 
3.1. Fragmented data and computing capacity 
3.2. State of Play 

3.2.1. Digital infrastructure to support research and personalised medicine 
3.2.2. National and international initiatives on personalised medicine 
3.2.3. Initial areas of application 

3.3. Remaining challenges at the EU-level 

4. DIGITAL TOOLS FOR CITIZEN EMPOWERMENT AND PERSON-CENTRED CARE  
4.1. Challenges for health systems and the strive for affordable innovative solutions 

4.1.1. Coping with an epidemic of chronic conditions 
4.1.2. People at the heart of reformed health and social care models  
4.1.3 The role of digital solutions 

4.2. State of Play 

4.2.1 Relevant initiatives and evidence 
4.2.2. Low uptake of digital health from pilot to large-scale deployment 
4.2.3  Market  fragmentation  and  challenges  to  European  enterprises  integrating 

innovations into the health and care systems 

4.2.4 From start-up to scale-up 
4.2.5. Lack of strategic approaches to investments 

4.3. Remaining challenges at the EU-level 

1 

 
 
 
 
 
 
 
 
1. INTRODUCTION 

1.1.  Policy Context 

Europe faces a major challenge with the sustainability and quality of healthcare provision, as 
a consequence of demographic change, increased longevity and rising prevalence of chronic 
conditions1. Public expenditure on health and long-term care has been increasing over the last 
decades in all EU Member States, and is expected to rise even further. In 2015, it accounted 
for 8.5% of GDP in the EU and could reach up to 12.5% of GDP in 20602.  

Despite  increased  spending  in  health  and  long-term  care,  and  advances  in  medical  science, 
those extra years of life gained through increased longevity are not necessarily spent in good 
health. Healthy life years  indicate the amount of life spent in a healthy state, rather than the 
length  of  life,  and  are  an  important  measure  of  the  relative  health  and  quality  of  life  of 
populations. Between 2010 and 2014, there have been virtually no gains in healthy life years 
in many EU countries. This suggests that greater efforts may be needed to prevent illness and 
disability  and  to  improve  the  management  of  chronic  conditions  to  reduce  their  disabling 
effects3. 

The  Commission  Communication  on  effective,  accessible  and  resilient  health  systems4 
concluded that Member States’ future ability to provide high quality care to all will depend on 
making  health  systems  more  resilient,  more  capable  of  coping  with  the  challenges  that  lie 
ahead.  And  they  must  achieve  this  while  remaining  cost-effective  and  fiscally  sustainable. 
These needs have been recognised by policy makers5,6.  

In particular, the Council Conclusions on the Economic Policy Committee - Commission Joint 
Report on health care and long-term care in the EU7 identified a number of reform measures 
to  address  policy  challenges  in  health  and  long-term  care  systems,  including:  strengthening 
health promotion and disease prevention; moving healthcare out of the hospital sector towards 
more cost-effective primary and ambulatory care services; and promoting integrated care.  

1 With an average age of 44 years, Europe will be the ‘oldest’ region by 2030 — more than double the average 
age of 21 in Sub-Saharan Africa. People over 65 will account for close to 23 % of the European Union’s 
population, compared with 16 % today (Rand Europe report to ESPAS 2013). 

2 According to the European Commission's Joint Report on Health Care and Long-term Care Systems and Fiscal 

Sustainability (7 October 2016) 

3 OECD/EU (2016), Health at a Glance: Europe 2016 – State of Health in the EU Cycle, OECD Publishing, 

Paris. http://dx.doi.org/10.1787/9789264265592-en  

4 COM(2014) 215 final 
5 Council Conclusions: Towards modern, responsive and sustainable health systems, OJ C 202, 8.7.2011, p. 10–

12  

6 Ministerial Statement, OECD Health Ministerial Meeting, "The next generation of health reforms", 2017, 

http://www.oecd.org/health/ministerial/ministerial-statement-2017.pdf 

7 Council Conclusions on the EPC- Commission Joint Report on health care and long-term care in the EU, 8 

November 2016, http://data.consilium.europa.eu/doc/document/ST-14182-2016-INIT/en/pdf  

2 

 
 
 
                                                            
Innovative solutions that make use of digital technologies can, if designed purposefully and 
implemented in a cost-effective way, provide the means to support such reform measures in 
health and long-term care systems. 

eHealth, telemedicine and other digital technologies such as 4G/5G mobile communications, 
artificial  intelligence  and  supercomputing  offer  new  opportunities  to  transform  healthcare 
systems8.  They  allow  the  capture,  management  and  processing  of  large  volumes  of  diverse 
data generated from multiple sources to create new knowledge. They enable new approaches 
to  personalised  medicine,  accelerating  scientific  progress,  early  diagnosis  and  prevention  of 
diseases  and  more  effective  treatments.  Furthermore,  digital  tools  can  assist  in  addressing 
shortages in health and care staff in rural areas and certain specialties. They can also connect 
the various actors across the health and social care sectors, thus ensuring effective sharing of 
data  and  collaboration,  in  more  effective  care  models.  In  addition,  digital  technologies  can 
enable citizens to access information about health risk factors and well-being measures, and 
help them engage in healthy lifestyle behaviour and disease prevention. Finally, the analysis 
of  digital  health  data  and  patient-reported  data  can  lead  to  improved  procedures,  reduce 
inefficiencies,  support  outcome-oriented  healthcare,  promote  the  evidence-based  assessment 
of innovative health technologies, as well as improve emergency preparedness and response 
to epidemics.  

EU policies have consistently emphasised the importance of digital solutions such as eHealth. 
The afore-mentioned Communication on effective, accessible and resilient health systems and 
the  Annual  Growth  Survey  20169  stress  how  digital  innovations  can  improve  integration  of 
care  through  up  to  date  information  channels  and  deliver  more  targeted,  personalised, 
effective and efficient healthcare, reducing errors and length of hospitalisation. Furthermore, 
the Directive on patients’ rights in cross-border care10 identifies specific areas where Member 
State  co-operation  in  eHealth  can  bring  significant  added  value  to  national  health  systems, 
such as in the cross-border exchange of patient summaries and use of ePrescriptions, and for 
clinical professionals through the European Reference Networks. Finally, making full use of 
the possibilities of digitalisation is one of the policy options identified in the Joint Report on 
Health Care and Long-Term Care Systems and Fiscal Sustainability. 

While the 2015 Digital Single Market Strategy for Europe (DSM)11 did not focus specifically 
on  digital  health  and  care,  there  were  several  references  to  eHealth.  These  references 
mentioned  the  digital  health  sector  as  an  example  (amongst  other  sectors)  where  digital 
services  could  bring  benefits  to  citizens  and  businesses.  The  Communication  highlighted  in 
particular  the  need  to  make  progress  on  standardisation  and  interoperability  of  digital 

8 Health and care has been identified by most of the digital Public-Private Partnerships in Horizon 2020 as a core 
business area where digital technologies can play a major role. The Digitising European Industry (DEI) high 
level group recently established a working group on health. The profound transformation of the job market sees 
an  increasing  number  of  routine  tasks  being  replaced  by  automated  processes,  but  at  same  time  it  leads  to 
opportunities  multiplying  in  the  digital  healthcare  sector  (Deloitte  2016  Transformers:  How  machines  are 
changing every sector of the economy) 

9 Annual Growth Survey 2016. Strengthening the recovery and fostering convergence COM(2015) 690 final 
10 2011/24/EU 
11 COM(2015) 192 final 

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solutions  in  the  health  sector  supporting  health  systems'  reforms.  In  response  to  the  Digital 
Single  Market  Strategy,  work  focused  on  the  major  identified  areas,  including  those  in  the 
digitising industry and public services initiative of April 2016 (specifically in the ICT priority 
standardisation plan12 and the eGovernment action plan13). 

1.2. State of Play  

In May 2017 the Commission Communication on the mid-term review of the Digital Single 
Market14 suggested to increase coordination efforts on the digital transformation of health and 
care  in  Europe,  focusing  on  three  priorities:  (i)  Citizens´  secure  access  to  electronic  health 
records  and  the  possibility  to  share  it  across  borders  and  the  use  of  ePrescriptions,  (ii) 
Supporting  data  infrastructure,  to  advance  research,  disease  prevention  and  personalised 
health and care in key areas including rare, infectious and complex diseases (iii) Facilitating 
feedback and interaction between patients and healthcare providers, to support prevention and 
citizen  empowerment  as  well  as  quality  and  patient-centred  care,  focussing  on  chronic 
diseases and on a better understanding of the outcomes of healthcare systems. 

Other areas of law or policy initiatives are directly relevant for the development of a Digital 
Single  Market  for  health  and  care.  They  include  the  protection  of  personal  data, 
interoperability and research and innovation funding. 

The protection of personal data 

The General Data Protection Regulation (GDPR)15 applicable from 25 May 2018 will provide 
a uniform set of rules for data protection across the EU. The GDPR has direct relevance for 
the  digitalisation  of  health,  and  Article  9  (processing  of  special  categories  of  personal  data) 
defines particular provisions that apply to health data.  

The  General  Data  Protection  Regulation  allows  Member  States  to  maintain  or  introduce 
further  conditions,  including  limitations,  with  regard  to  the  processing  of  genetic  data, 
biometric data or data concerning health (Article 9.4). It is to be noted that Recital 53 of the 
General  Data  Protection  Regulation  states  that  this  should  not  hamper  the  free  flow  of 
personal  data  within  the  Union  when  those  conditions  apply  to  cross-border  processing  of 
such data. After the adoption of the General Data Protection Regulation the Commission has 
established  an  expert  group16  with  the  mission  to  clarify  how  Member  States'  existing  and 
future legislation will ensure effective and uniform application of the General Data Protection 
Regulation.  

12 ICT Standardisation Priorities for the Digital Single Market COM(2016) 176 final 
13 EU eGovernment Action Plan 2016-2020: Accelerating the digital transformation of government, COM(2016) 

179 final  

14 COM(2017) 228 final 
15 Regulation (EU) 2016/679 
16 http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=3461 

4 

 
 
 
                                                            
Under  the  General  Data  Protection  Regulation  the  drawing  up  of  codes  of  conduct  is  to  be 
encouraged  to  contribute  to  the  proper  application  of  the  Regulation,  taking  account  of  the 
specific  features  of  the  various  processing  sectors.  The  Biobanking  and  BioMolecular 
resources  Research  Infrastructure  -  European  Research  Infrastructure  Consortium  (BBMRI-
ERIC)17,  the  Commission-supported  pan-European  distributed  research  infrastructure,  has 
launched  a  roadmap  process  for  the  preparation  of  a  code  of  conduct  for  life  sciences  and 
health  research18. This  builds on the Code of  Practice drafted by the projects  funded  by the 
Innovative Medicines Initiative (IMI).  

Interoperability  

Cross-border  interoperability  and  access  to  health  data  among  Member  States  and  between 
national  healthcare  systems  are  supported  by  different  EU  instruments  that  are  currently 
implemented, such as the Directive 2011/24/EU on the application of patients’ rights in cross-
border healthcare among Member States.  

The 2008 Commission Recommendation on cross-border interoperability of electronic health 
record systems19 has been adopted as a follow-up to the eHealth Action Plan20 which, in 2004, 
defined interoperability of electronic health records as one of the priorities for Member States. 
The  Recommendation  was  intended  to  support  the  premise  that  connecting  people,  systems 
and services is vital for the provision of good healthcare in Europe insofar as it is necessary to 
enable the free flow of patients as well as digital health products and services, and hence may 
contribute significantly to the establishment and functioning of the internal market. 

A refined eHealth European Interoperability Framework (ReEIF) was adopted by the eHealth 
Network  in  November  2015.  The  ReEIF  provides  a  common  framework  of  terms  and 
methodologies  that  aims  to  address  eHealth  interoperability  issues  and  serve  as  a  key 
instrument for the improvement of projects and solutions in the particular domain. Moreover, 
a  new  European  Interoperability  Framework  (EIF)21  was  adopted  on  23  March  2017  in  the 
context  of  the  implementation  of  the  Interoperability  Solutions  for  European  Public 
Administrations  (ISA²)  programme  (2016-2020).  The  new  EIF  is  meant  to  be  a  generic 
interoperability framework that could be used for the alignment of existing, or the creation of 
new,  domain-specific  interoperability  frameworks  (DIFs)  such  as  those  that  could  be 
developed  in  the  field  of  electronic  health  records  and  other  digital  health  applications. 
However, the framework alone does not provide technical specifications.  

Other relevant policy areas 

17 http://www.bbmri-eric.eu/ 
18 "We must urgently clarify data-sharing rules" (Nature 541, 437 (26 January 2017) 
(https://www.nature.com/news/we-must-urgently-clarify-data-sharing-rules-1.21350). 
19 COM(2008)3282 final 
20 Commission Communication on "eHealth - making healthcare better for European citizens: An action plan for 

a European eHealth Area" COM(2004) 356 final. 
http://ec.europa.eu/information_society/activities/health/policy/index_en.htm  

21 COM(2017)134 

5 

 
 
                                                            
The EU provides targeted research and innovation funding under Horizon 202022 supporting 
the use of digital technologies in health and long-term care services and the implementation of 
the  Digital  Single  Market  strategy,  including  a  roadmap  for  standardisation,  harmonisation 
and  interoperability  supporting  sustainable  market  development  for  the  use  of  digital 
technologies  in  health  and  care  services.  Other  actions  relevant  for  future  initiatives  on  the 
digital  transformation  of  health  and  social  care  include  the  work  pursued  by  the  eHealth 
Network23  and  investment  commitments  in  digital  health  and  social  care  from  national  and 
regional  authorities24  working  under  the  European  Innovation  Partnership  on  Active  and 
Healthy Ageing (EIP on AHA).   

Member States' existing and future legislation regarding the processing of data that concerns 
health25  may  affect  access  to  data  across  borders  and  the  advancement  of  research  and 
personalised medicine. 

The 2008 Commission Recommendation on cross-border interoperability of electronic health 
record  systems  and  subsequent  work  carried  out  in  the  development  of  the  European 
Interoperability Framework for eHealth (ReEIF) have so far been insufficient to deliver cross-
border  access  to  electronic  health  records  by  healthcare  professionals26,27  or  to  ensure  that 
citizens have the technical means to access and manage their personal health data28.   

Despite the significant investments made in this area by the EU, Member States and regional 
authorities,  the  uptake  of  digital  innovation  for  health  and  care  remains  slow  and  varies 
greatly amongst Member States and regions. 

22  Regulation  (EU)  No  1291/2013  of  the  European  Parliament  and  of  the  Council  of  11  December  2013 
establishing  Horizon  2020OJ  L347,  20.12.2013,  p.1  In  total,  H2020  Societal  Challenge  1  includes 
approximately  EUR  1  billion  funding  to  support  research  and  innovation  in  digital  health  and  care.  This 
includes  for  example,  the  Active  and  Assisted  Living  Joint  Programme  that  has  leveraged  funding  from  28 
European countries to support more than 300 SMEs in going to the market with digitally based products and 
services in support of active and healthy ageing. The European Innovation Partnership on Active and Healthy 
Ageing  activities,  supported  by  several  large-scale  pilots  funded  under  FP7  and  H2020,  aims  to  implement 
integrated care programmes across European regions. 

23  The  eHealth  Network  has  adopted  guidelines  on  the  minimum  patient  summary  datasets  for  electronic 
exchange  and  on  ePrescriptions.  The  telecommunications  sector  of  the  Connecting  Europe  Facility  is 
financing  an  EU  digital  infrastructure  for  eHealth  with  16  Member  States  to  build  up  concrete  capacity  to 
exchange health data. The Commission, with the endorsement of the eHealth Network, proposed the Refined 
Health Interoperability Framework based on the results of studies, pilots and research projects. On 28 July 
2015  the  Commission  has  adopted  the  Decision  on  the  identification  of  ‘Integrating  the  Healthcare 
Enterprise’ profiles for referencing in public procurement.  

24 In December 2016 the European Commission recognised 74 EU  regions with Reference Site status for their 
commitment to invest over €4 billion in innovative digital services for health and social care to bring benefits 
to over 4 million people in their populations: https://ec.europa.eu/digital-single-market/en/news/74-european-
regions-awarded-investing-digital-health-and-care-elderly  

25 Regulation (EU) 2016/679, Art. 9(4) 
26  European  Hospital  Survey  –  Benchmarking  Deployment  of  eHealth  Services  2012-2013  (PwC) 

https://ec.europa.eu/digital-single-market/en/news/european-hospital-survey-benchmarking-deployment-
ehealth-services-2012-2013. 

27 Patient access to Electronic Health Records – Report of the eHealth Network (June 2013) 
28  Special  Eurobarometer  460  [results  from  March  2017.]  Attitudes  towards  the  impact  of  digitisation  and 

automation on daily life 

6 

 
 
                                                            
1.3. New developments and challenges 

Notwithstanding the considerable potential of digital technology to contribute to better health 
and care outcomes, and the cross-border dimension29 of digital health products and services, 
the  European  Union  is  not  a  fully  functioning  single  market  for  digital  health  and  care 
solutions.  

Most citizens are unable to access their health data both within their own country as well as 
across  borders,  national  initiatives  to  gather  data  to  support  personalised  medicine  remain 
fragmented  (and  small-scale)  across  Europe  and  digital  solutions  are  successfully 
implemented in pilot settings but consistently fail to scale up.  

Below are some of the issues that effectively or potentially affect the realisation of a digital 
single market for health and care. 

1.3.1. Citizens' access to personal data concerning health  

Digital technologies (e.g. smartphones, tablets, wireless sensors, etc.) that can be employed in 
mobile health (mHealth) surveillance, prevention, and intervention efforts have become more 
affordable  and  easy  to  use.  These  solutions  can  help  citizens  and  professionals  address 
preventable  risk  factors  associated  with  chronic  diseases  (e.g.  unhealthy  diet  and  physical 
inactivity). They can also support active and healthy ageing, and facilitate early detection of 
symptoms and timely treatment, thus reducing the need for more burdensome treatments later 
on. Digital solutions that empower citizens with access to their personal health data are central 
to support a shift in health and care provision. They allow the citizen to be actively engaged in 
prevention  of  chronic  conditions30  (active  and  healthy  ageing),  adherence  to  treatments  and 
providing feedback on the quality of health and care.  

However, the citizens' ability to access their personal health data remains differentiated across 
and within Member States. It ranges from non-existent in some, partial in others, to full access 
in certain Member States. Often the personal data concerning the health of a given citizen is 
scattered  across  different  local  and  national  data  repositories  (e.g.  hospital,  primary  care, 
others)31. 

29  For  example  mobile  health  technology,  wellness  wearables  and  applications,  remote  monitoring,  connected 

care at home, telemonitoring, telehealth and telecare solutions that can be delivered cross-border. 

30 Globally, Europe has the highest burden of non-communicable diseases which are responsible for 86 % of all 
deaths. The World Health Organisation considers the rise in non-communicable diseases an epidemic and 
estimates that this will claim the lives of 52 million people in the European Region by 2030. Non-
communicable diseases affect more than 80% of people over 65 in Europe. Amongst the different non-
communicable diseases, mental health is a real public health challenge; an estimated 18.7 million EU citizens 
are expected to suffer from dementia by 2050. 

31 SWD(2017) 155 final 

7 

 
 
 
                                                            
A recent report adopted by the eHealth Network32 provides a snapshot of the current state of 
play of patient access to their electronic health records in the EU:  

  Nine  countries33  have  implemented  systems  at  a  national  level  that  provide  patients 
with online access to their eHealth data for some time now. What patients can access 
can  be  quite  narrow  e.g.  health  information  only  (Hungary),  patient  summary  only 
(Finland).  

  Seven  countries  stated  that  they  had  national  level  electronic  health  record  projects 
that included patient access to electronic health record information in development.  
  Ten countries stated that they provide access to patients to their eHealth data through 
multiple regional, local or speciality systems. Of this group, nine countries described 
current projects to develop a national system with patient access functionality, and the 
Netherlands  are  preparing  guidelines  for  the  development  of  regional  systems  that 
provide patients access to electronic health record data. 

The  three  countries  that  selected  ‘No  electronic  health  record  systems’  (Cyprus,  Czech 
Republic,  Ireland)  are  planning  to  provide  patient  access  to  eHealth  data  ‘within  2  years’, 
‘within 4 years’, and ‘in 5 years or more’ respectively. Malta has an online portal for doctors 
and  their  patients  that  fulfils  much  of  the  functions  of  a  national  electronic  health record  in 
terms of patient access to electronic health record information, but is also planning a national 
project to begin within 2-4 years. 

Health  system  reforms  aim  at  a  shift  from  a  hospital-centred  system  to  more  home  and 
community-based,  person-centred  and  integrated  care  structures.  Portals34  that  provide 
citizens  with  access  to  their  personal  health  data,  are an  important  enabler  of  this  shift.  But 
these portals are far from being the norm across the EU.  

Whilst  several  Member  States  have  launched  initiatives  to  create  national  patient  portals35 
these  initiatives  are  not  currently  coordinated  at  EU  level  in  a  way  that  would  encourage 
cross-border  interoperability  and  secure  cross-border  access  to  electronic  health  records  by 
authorised healthcare professionals. 

1.3.2. Cross-border access to data for research and personalised medicine  

Over  the  last  years  there  has  been  an  extraordinary  increase  in  the  amount  and  quality  of 
health  data generated  by  new  devices  and technologies.  At  the same  time,  improvements  in 
computing  capacity  and  performance  and  the  emergence  of  other  digital  technologies  that 

32 Joint Action to Support the eHealth Network - Final Report on EU state of play on patient access on eHealth 
data adopted by the eHealth Network November 2017 
33 Austria, Bulgaria, Estonia, Finland, France, Latvia, Lithuania, Malta, Spain 
34 ICT-enabled platforms that provide guidance and advice on lifestyle behaviours (physical activity, nutrition 
etc.), allow citizens to access and maintain a repository of data concerning their health (medical exams, 
consultation records etc.), and in some cases enable the user to produce feedback on health and care services. 
35 JAseHN Final Report on EU state of play on patient access on eHealth data adopted by the eHealth Network 
November 2017 

8 

 
 
                                                            
allow large data storage and advanced data analytics make it possible to accelerate research 
and development of new treatments, as well as prevention and early diagnosis of diseases.  

It  is  widely  shared  among  the  stakeholders  that  access  to  varied  data-sets  located  across 
different  Member  States  remains  difficult  or  inexistent,  the  data  is  subject  to  different 
taxonomies  and  standards  and  therefore  scientific  research  invariably  builds  on  relatively 
limited  population  cohorts36.  Larger  scale  cannot  be  achieved  without  cross  border  secure 
access  to  data  sets,  a  shared  computing  and  storage  capacity  and  an  appropriate  regulatory 
framework  that  allows  for  secure  access  to  data-sets  across  borders.  Without  these,  it  is 
increasingly  difficult  for  healthcare  organisations  to  optimise  the  quality  and  efficiency  of 
their services and for EU researchers to achieve the critical scientific breakthroughs needed to 
support  early  diagnosis  of  diseases,  enable  coordinated  response  to  epidemics  or  accelerate 
therapy development cycles across Europe37.   

An  element  highlighted  by  stakeholders  as  being  important  to  enable  the  pooling  of  health 
data for research at EU level will be to proactively ensure that the national laws adopted by 
Member  States  to  further  specify  the  General  Data  Protection  Regulation  with  respect  to 
research and processing of health data38 will not result in further fragmentation of the single 
market. Lack of coordination among Member States in that respect could potentially result in 
major barriers for achieving the required critical mass of data that is necessary to succeed in 
providing personalised medicine solutions for European health systems and citizens.39  

In  this  context,  effective  coordination  among  Member  States  regarding  the  potential  use  of 
new  emerging  solutions  can  play  an  important  role,  if  implemented  systematically  across 
Europe  as  part  of  the  national  and  EU-level  data  and  computation  infrastructures  for 
personalised  medicine.  These  solutions  must  comply  with  the  General  Data  Protection 
Regulation and could build on trusted distributed data ledgers (such as blockchain) for giving 
access  to  personal  health  data.  Conversely,  the  absence  of  coordinated  actions,  and 
fragmented  approaches  to  cybersecurity  solutions,  could  potentially  make  it  increasingly 
difficult for health data to be pooled at EU level to support medical research and personalised 
medicine. 

Several  stakeholders  in  the  research  community  have  raised  concerns  with  the  potential 
effects of lack of coordination amongst  Member States in the development of their national 
laws  in  the  area  of  health40  and  research  that  could  result  in  the  establishment  of  widely 
varying  safeguards,  conditions  and  applicable  derogations  and  could  negatively  impact  the 

36 Blueprint on Digital Transformation of Health and Care in the Ageing Society (Dec. 2016) 
37 Overview of National Laws on Electronic Health Records in the EU Member States and their interaction with 
the provision of cross-border eHealth services, July 2014 (Milieu Ltd). 
38 Article 89 of the GDPR allows Member States to further specify in national law safeguards and derogations 
relating to processing for archiving purposes in the public interest, scientific or historical research purposes or 
statistical purposes. 
39 "Stakeholder workshop on GDPR implementation and health data" organised by the European Commission on 
23 October 2017 
40 Based on Article 9(4) of the General Data Protection Regulation (GDPR) 

9 

 
 
                                                            
establishment  of  the  European  Research  Area41.  Such  developments  could  also  undermine 
investments in initiatives such as the European Open Science Cloud, which will rely on secure 
cross-border  flows  of  data.  Stakeholders  representing  the  research  community  and  patients' 
organisations have called for effective cooperation mechanisms between Member States and a 
minimum set of security requirements to ensure an equivalent level of protection of personal 
data shared by patients for healthcare and research purposes across the European Union, and 
to facilitate cross-border healthcare and research42. Furthermore, experts in the scientific and 
medical  research  community  particularly  involved  in  cancer  research  have  consistently 
underlined that the individual right to data protection should not harm the population's right to 
health  and  urged  the  Member  States  to  ensure  that  the  possibility  to  maintain  or  introduce 
further  conditions  regarding  health  data  conferred  upon  them  by  the  new  Regulation  would 
not only make cancer research possible, but also as effective as possible43. 

1.3.3. Security of communication infrastructure and networks 

Secure  information  and  communication  technology  (ICT)  infrastructures  and  data  networks 
are  critical  to  support  the  free  flow  of  health  data  across  borders  in  a  secure  and  trusted 
environment. Healthcare organisations, like other regulated industries, have increased efforts 
to  maximise  security  measures  to  protect  their  own  infrastructure  and  data  networks. 
According to recent research, healthcare data security incidents ranked second for the services 
industry in 201644.  

In addition to the General Data Protection Regulation, which introduces security requirements 
applicable  also  to  healthcare  organisations45,  the  European  Commission  is  also  working  to 
assist  Member  States  and  healthcare  organisations  meet  the  requirements  set  out  in  the 
Directive  on  Security  of  Network  and  Information  Systems46.  Furthermore,  the  European 
Union  Agency  for  Network  and  Information  Security  (ENISA)  has  acknowledged  the 
significance  of  digital  health  networks  as  critical  information  infrastructures  and  has 
developed actions focusing on the security challenges and risks faced by the health sector in 
the Member States. Given that healthcare services have been recognised as a critical societal 
function, the Agency for Network and Information Security has analysed the degree to which 
various  digital  systems  and  infrastructures  are critical  for  the  secure  provision  of  healthcare 
services  and  launched  the  eHealth  Security  experts  group.  In  November  2016,  the  group 

41 Position Statements on "National Implementation of GDPR" by the European Research Federation 
(EFAMRO) and the World Association for Data Research and Insights (ESOMAR), April 2017 

42 European Patients' Forum – Data Protection Regulation November 2012. 
43 Data Saves Lives: The Impact of the Data Protection Regulation on Personal Data Use in Cancer Research. 

Study for the European Parliament ENVI Committee (European Parliament Directorate General for Internal 
Policies, Economic and Scientific Policy)  2016 

44 Symantec’s 2017 Internet Security Threat Report (ISTR) found that reported breach incidents increased by 22 

percent last year, rising to 328 from 269 in 2015 

45 General Data Protection Regulation Article 32 on security requirements; Articles 33 and 34 on data breach and 
notification requirements 
46 Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures 

for a high common level of security of network and information systems across the Union 

10 

 
 
 
                                                            
provided  an  overview  of  recommendations  to  hospitals  and  healthcare  organisations, 
comprising  a  combination  of  organisational  and  technical  security  measures  to  mitigate  the 
risks resulting from cyber threats and corresponding vulnerabilities.  

Efforts to ensure coordination, monitoring and technical support provided to Member States 
in  the  implementation  of  technical  and  organisational  security  measures,  are  expected  to 
continue as the Directive is transposed into national law. 

11 

 
 
 
2.  CITIZENS'  SECURE  ACCESS  TO  ELECTRONIC  HEALTH  RECORDS 
AND THE POSSIBILITY TO SHARE HEALTH DATA ACROSS BORDERS 

2.1. Electronic Health Record47 and digital access to personal health data 

Citizens requiring medical care when traveling or moving  residence to another EU Member 
State are often confronted with the lack of access to their own medical records or medication. 
Access is particularly crucial when citizens seek emergency treatment while travelling outside 
their Member State of origin or residence or when they might be obliged to repeat procedures 
because  they  cannot  access  or  re-use  information  from  procedures  completed  recently  in 
another healthcare institution.  

The  current  lack  of  electronic  health  record  exchange  formats  that  can  be  readable  across 
borders  limits  the  access  of  citizens  and  healthcare  professionals  to  critical  medical 
information about an individual receiving care in another country. This has an impact on the 
quality  of  care  provided  to  European  citizens.  In  some  cases,  the  limited  access to  personal 
health  data across  borders,  could  adversely  affect the  safety  of  patients  because  of  errors in 
medication  lists  and  adverse  drug  reactions  that  otherwise  could  have  been  identified  and 
avoided in time48.   

The 2008 Commission Recommendation on cross-border interoperability of electronic health 
record  systems  and  subsequent  work  carried  out  in  the  development  of  the  European 
Interoperability Framework for eHealth (ReEIF) have so far not delivered cross-border access 
to  electronic  health  records  by  healthcare  professionals49  or  ensured  that  citizens  have  the 
technical means to access and manage their personal health data50.  

Beyond the lack of an established technical specification to support electronic health records 
that  are  readable  across  the  EU,  another  major  obstacle  to  implementation  of  interoperable 
cross-border  access  to  electronic  health  records  remains  the  extensive  use  of  proprietary 
solutions  and  vendor  lock-in  models  that  increase  both  the  cost  and  complexity  of  health 

47 An Electronic Health Record is deﬁned as “an evolving concept deﬁned as a systematic collection of 

electronic health information about individual patients or populations. It is a record in digital format that is 
capable of being shared across different healthcare settings, by being embedded in network-connected 
enterprise-wide information systems. Such records may include a whole range of data in comprehensive or 
summary form, including demographics, medical history, medication and allergies, immunization status, 
laboratory test results, radiology images, vital signs, personal stats like age and weight, and billing 
information." Gunter, T.D. and Terry, N.P., (2005) Electronic Health Record: Wiring Europe’s Healthcare 
48 de Lusignan S, Mold F, Sheikh A, Majeed A, Wyatt JC, Quinn T, et al. (2014). Patients' online access to their 
electronic health records and linked online services: a systematic interpretative review. BMJ Open, 4(9). 
http://dx.doi.org/10.1136/bmjopen-2014-006021. 

49 European Hospital Survey – Benchmarking Deployment of eHealth Services 2012-2013 (PwC) 

https://ec.europa.eu/digital-single-market/en/news/european-hospital-survey-benchmarking-deployment-
ehealth-services-2012-2013. 

50 JAseHN Final Report on EU state of play on patient access on eHealth data 2017 

12 

 
 
 
                                                            
information exchange efforts across the EU51. Vendor lock-in undermines interoperability of 
electronic  health  record  systems  amongst  healthcare  providers  in  the  EU  and  prevents  the 
electronic  health  records  from  being  readable  across  borders  by  healthcare  institutions  and 
professionals52.  

It  is  not  only  citizens  that  feel  the  adverse  effects  resulting  from  the  current  lack  of 
interoperability of electronic health record systems across-borders. The absence of a common, 
shared open format at EU level to support interoperability of electronic health record systems 
increases  barriers  to  open  innovation,  undermining  business  opportunities  for  innovative 
SMEs  and  negatively  impacting  the  process  and  costs  of  digitising  health  information. 
Additionally,  the  existing  lack  of  interoperability  of  electronic  health  record  systems  across 
the  EU  does  not  appear  to  bring  benefits  to  EU  economic  actors  in  general.  Despite  the 
positive  growth  forecasts  for  the  global  market  of  electronic  health  record  systems,  EU 
companies  maintain  a  persistently  modest  market  share53  compared  with  their  US 
counterparts,  which  have  benefited  from  a  domestic  regulatory  environment54  based  on 
standardised and certified electronic health record systems55.  

Furthermore,  in  the  opinion  of  certain  stakeholders,  the  current  lack  of  interoperability  of 
electronic health record systems across the EU significantly hinders the ability of the research 
community  to  access  larger  data-sets  and  make  secondary  use  of  health  data,  creating 
additional headwinds that limit progress in the fields of data-driven healthcare research, new 
health prevention strategies and personalised medicine.  

2.2. State of Play 

2.2.1. Lack of Electronic Health Records interoperability 

Currently,  several  Member  States  are  progressing  in  implementing  interoperable  electronic 
health record systems within a national or regional level (figure 1). However, there is no co-
ordinated  solution  or  approach  in  place  for  a  full-scale  interoperability  of  electronic  health 
records  in  a  European  context  (figure  2).  The  landscape  regarding  the  main  levels  of 

51 Evaluate openEHR Standards for Managing Clinical Content Across the Care Continuum, April 2017, Gartner 

Inc. 

52 See Communication from the Commission “Against lock-in: building open ICT systems by making better use 

of standards in public Procurement” adopted on 25.6.2013 COM(2013) 455 final 

53 Gartner survey of EHR suppliers and systems in the Norwegian market, September 2014, Gartner Inc. 
54 The Health Information Technology for Economic and Clinical Health Act (HITECH Act) legislation was 

created in 2009 to stimulate the adoption of electronic health records and supporting technology in the United 
States. The US Executive Order 13335 from 2004 on Incentives for the Use of Health Information 
Technology and Establishing the Position of the National Health Information Technology. 

55 Vindell Washington et al.: The HITECH Era and the Path Forward, September 2017, N Engl J Med 2017; 

377:904-906 

13 

 
 
 
                                                            
interoperability  (legal,  organisational,  semantic  and  technical)  remains  fragmented  and  is 
widely considered to hinder effective cross-border flow of healthcare data56, 57.  

The lack of interoperability among the electronic health record systems implemented within 
the  Member  States  and  the  adoption  of  various,  different  standards  constitute  a  major 
challenge  leading  to  market  fragmentation  and  to  a  lower  quality  level  of  cross-border 
healthcare  provision58.  Market  analysis  of  the  European  electronic  health  record  market, 
performed  by  Frost  &  Sullivan  in  201559,  concluded  that  "the  absence  of  a  pan-European 
EHR  strategy  has  worsened  market  fragmentation  and  continues  to  act  as  a  barrier  to 
electronic health record adoption". In this context, the absence of a pan-European electronic 
health record strategy was described as a major market restraint. 

Single national v. multiple EHR Systems 
currently in place (N=29) 

3 

10 

16 

One national EHR
system

Multiple EHR systems

No EHR systems

Figure 1: EHR systems in place (national / regional / sectoral) (Based on Source: JAseHN Final 
Report on EU state of play on patient access on eHealth data 2017) 

56 World Health Organization. From innovation to implementation: ehealth in the WHO European Region.  

WHO Regional Office for Europe, 2016 http://www.euro.who.int/en/publications/abstracts/from-innovation-
to-implementation-ehealth-in-the-who-european-region-2016 

57 Fragidis, L. L. and Chatzoglou, D. P. (2017). Development of Nationwide Electronic Health Record (ΝEHR): 

An international survey. Health Policy and Technology, Vol 6, pp. 124–133. 

58 Kierkegaard, Patrick. (2011). Electronic Health Record: Wiring Europe’s Healthcare. Computer Law & 

Security Report. 27. (https://www.sciencedirect.com/science/article/pii/S0267364911001257) 

59 Frost & Sullivan Market Analysis "European Electronic Health Records Market" 2015 

(https://ww2.frost.com/news/press-releases/interoperable-electronic-health-records-can-revolutionize-
healthcare-delivery-europe/)  

14 

 
 
 
 
 
                                                            
Names of the standards 

Figure  2:  Standards  used  to  support  national  EHR  systems  in  the  WHO  European 
Region (Based on the World Health Organization. From innovation to implementation: ehealth in the WHO 
European Region report. WHO Regional Office for Europe, 2016) 

World  Health  Organisation  data  indicates  (see  figure  2)  that  the  current  variety  of  national 
approaches regarding the use of standards for electronic health record implementation poses 
significant  challenges  to  the  development  and  implementation  of  effective  electronic  health 
record  cross-border  exchange.  In  the  same  study,  funding,  capacity,  resources  and 
infrastructure  were  also  identified  as  very  important  barriers  that  hamper  electronic  health 
record implementation. 

15 

 
 
 
 
 
 
 
Figure  3:  Countries  of  the  WHO  European  region  with  a  national  EHR  system  and 
legislation on it, by sub-region. France, Germany and Slovakia are not included in the 
EU-28  group  (World  Health  Organization.  From  innovation  to  implementation:  ehealth  in  the  WHO 
European Region report. WHO Regional Office for Europe, 201660). 

There are also major disparities between EU Member States in the deployment of electronic 
health  records  as  part  of  an  interoperable  infrastructure  that  allows  different  healthcare 
providers  to  access  and  update  health  data  in  order  to  ensure  the  continuity  of  care  of  the 
patient. The same can be said about the approach taken to regulate electronic health records – 
some EU Member States have set specific rules for electronic health records, others rely on 
general  health  records  and  data  protection  legislation.  While  some  EU  Member  States  have 
set detailed requirements as to the content of electronic health records, others do not specify 
what this content should be. The level of details of the legislation on electronic health record 

60 The Commonwealth of Independent States (CIS) includes Armenia, Azerbaijan, Belarus, Kazakhstan, 
Kyrgyzstan, the Republic of Moldova, the Russian Federation, Tajikistan and Uzbekistan; Turkmenistan and 
Ukraine are included as Associate States. * Belarus is not included in this analysis. The Central Asian Republics 
Health Information Network (CARINFONET) consists of Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan 
and Uzbekistan. South-eastern Europe Health Network (SEEHN) consists of Albania, Bosnia and Herzegovina, 
Bulgaria, Croatia, Israel, Montenegro, the Republic of Moldova, Romania, Serbia and the former Yugoslav 
Republic of Macedonia. * The former Yugoslav Republic of Macedonia is not included in this analysis. Small 
countries consist of Andorra, Cyprus, Luxembourg, Iceland, Malta, Monaco, Montenegro and San Marino. 
* Andorra and Monaco are not included in this analysis. The Nordic countries are Denmark, Finland, Iceland, 
Norway and Sweden. 

16 

 
 
 
 
                                                            
 
content  varies  greatly  from  a  simple  reference  to  health  data  in  general  to  exhaustive  and 
detailed list of categories or data items61. 

Regarding  legal  interoperability  for  cross-border  electronic  health  record  exchange  in 
particular,  few  EU  Member  States  have  already  established  a  relevant  framework  of  legal 
provisions (figure 4). A reason behind the specific issue, according to the relevant study62, is 
that the competent authorities perceive cross-border transfer of electronic health records as a 
challenge "that should be dealt with at the EU level and did not want to develop cross-border 
systems  (e.g.  through  regional  and  bilateral  agreements)  that  could  potentially  be  in 
contradiction with the future action of the EU". 

Figure 4: Countries regulating cross-border interoperability. Source: "Overview of the national 
laws  on  electronic  health  records  in  the  EU  Member  States  and  their  interaction  with  the  provision  of  cross-
border eHealth services report, July 2014". 

2.2.2. Citizens' access to electronic health records and cross-border exchange of health data 
amongst professionals 

European  citizens  have  the  right  to  access  their  health  data.  This  right  is  enshrined  in  the 
General  Data  Protection  Regulation,  which  gives  also  European  citizens  the  right  to  share 
their  health  data  with  parties  they  designate  for  a  given  purpose  (for  instance,  for  medical 
treatment or research). In a recent Eurobarometer study, approximately 52 % of respondents 
confirmed  they  wish  to  have  online  access  to  their  health  records  (including  health  data, 
prescriptions and medical records)63. However, only a limited number of citizens are currently 
enjoying this privilege. Only 9% of hospitals in Europe allow citizens to access online their 
own medical records, and most of those only give partial access64.  

In 2008, Estonia became the first country in the world to implement a nationwide “birth-to-
death” electronic health record system for nearly every citizen. However, since then only an 
additional  13  EU  Member  States  have  granted  their  citizens  with  some  access  to  electronic 

61 Overview of the national laws on electronic health records in the EU Member States and their interaction with 

the provision of cross-border eHealth services, July 2014 (Milieu Ltd). 

62 Overview of National Laws on Electronic Health Records in the EU Member States and their interaction with 

the provision of cross-border eHealth services, July 2014 (Milieu Ltd). 

63 Special Eurobarometer 460 [results from March 2017.] Attitudes towards the impact of digitisation and 

automation on daily life 

64  European  Hospital  Survey  –  Benchmarking  Deployment  of  eHealth  Services  2012-2013  (PwC) 
https://ec.europa.eu/digital-single-market/en/news/european-hospital-survey-benchmarking-deployment-
ehealth-services-2012-2013 

17 

 
 
 
 
                                                            
health  records65,  with  the  Member  States  deployment  of  electronic  health  records  being 
greatly varied (see Figure 1). The use of ePrescriptions across Europe is equally diverse, with 
only a minority of Member States having it widely available to their citizens66. 

The  eHealth  Action  Plan,  and  more  specifically  the  EU  Cross  Border  Health  Directive 
(2011/24/EU, Articles 11 and 14), include certain elements - namely electronic health records, 
electronic prescriptions (ePrescriptions) and telemedicine - that constitute crucial components 
to  enable the emergence of innovative digital health and care solutions67. The eGovernment 
Action Plan also aims to support Member States in the development of cross-border eHealth 
services. 

The  digitisation  and  exchange  of  electronic  health  records  and  ePrescriptions  can  enable 
better  provision  of  health  and  care  of  services  to  citizens,  including  when  travelling  across 
different Member States. Additionally, available studies show that the adoption of electronic 
health  records  and  ePrescriptions68  across  the  EU  could  also  generate  efficiencies69,  and 
therefore  contribute  to  the  attainment  of  fiscal  sustainability  goals  for  health  and  long-term 
care systems.  

The percentage of hospitals exchanging electronically clinical care information about patients 
remains  low:  up  to  just  39%  of  hospitals  exchange  care  information  with  other  healthcare 
providers in the same country; whereas only 4% of hospitals do this with healthcare providers 
in another EU country70. The percentage of general practitioners using electronic networks to 
exchange medical patient data with other healthcare providers and professionals varies greatly 
between  Member  States:  from  91.8%  of  general  practitioners  in  Denmark  and  76.2%  in  the 
Netherlands  to  only  5.4%  of  general  practitioners  in  Slovenia.  Even  in  countries  with  high 
levels of domestic exchange of patient data, the exchange with healthcare providers in other 
EU  Member  States  remains  low71.  This  is  particularly  relevant  as  the  number  of  patients 
receiving treatment in another EU Member State continues to increase72. 

65 Overview of National Laws on Electronic Health Records in the EU Member States and their interaction with 

the provision of cross-border eHealth services, July 2014 (Milieu Ltd). 
66 Euro Health Consumer Index 2016 Report - Professor Arne Björnberg, Ph.D 

(http://www.healthpowerhouse.com/files/EHCI_2016/EHCI_2016_report.pdf) 

67  Directive  2011/24/EU  on  the  application  of  patients’  rights  clarified  the  legal  framework  for  patients  to  be 
reimbursed  for  cross-border  healthcare.  Firstly,  it  established  the  principle  that  a  telemedicine  service  is 
considered  to  be  provided  in  the  Member  State  where  the  service  provider  is  established.  Secondly,  the  e-
Health  Network  established  cooperation  between  Member  State  health  systems.  The  Network  has  adopted 
guidelines  on  patient  summaries  and  e-prescriptions,  and  is  working  on  the  use  of  health  data  for  public 
health and research. The IT system supporting the exchange of patient summaries and e-prescriptions is being 
built with funding from the Connecting Europe Facility. 

68  Tora  Hammar,  Sofie  Nyström,  Göran  Petersson,  Tony  Rydberg,  and  Bengt  Åstrand,  “Swedish  Pharmacists 
Value E-Prescribing: a Survey of a Nationwide Implementation,” Journal of Pharmaceutical Health Services 
Research, Vol. 1, No. 1 (March 2010). 

69  Health  Information  and  Quality  Authority  (HIQA),  “E-Prescribing  and  Electronic  Transfer  of  Prescriptions: 

An International Review,” Report, December 2012.  

70 European Commission Digital Scoreboard 2013 https://ec.europa.eu/digital-single-market/en/create-graphs  
71 Cross-border health care in Europe by Katharine Footman, Cécile Knai, Rita Baeten, Ketevan Glonti, Martin 
McKee (World Health Organization 2014). For example, Techniker Krankenkasse surveying 45,000 German 
insurants  who  had  received  services  abroad  in  2010.  The  company  found  that  37%  of  insurants  required 

18 

 
 
                                                            
 
Regarding  patient  and  healthcare  professionals'  identification,  as  well  as  access  rights  to 
electronic  health  records,  there  is  also  a  significant  variety  of  available  systems  and 
approaches across the EU Member States. 13 Member States make use of a health insurance 
number for patient identification in  their national  eHealth systems, while 14 Member States 
use an ID card number approach, and two Member States are using other solutions. As for the 
identification and authentication of health professionals (e-Signature/ smart card), 15 Member 
States have an identification and authentication method and 16 Member States currently have 
access  rights  differentiated  per  type  of  health  professionals.  It  is  worth  highlighting  that 
eleven Member States have both elements in place in relation to health professionals73. 

Figure  5:  The  percentage  of  GPs  that  exchange  medical  patient  data  with  other 
healthcare providers and professionals (Digital Scoreboard 2013) 

On  the  legislation  part,  several  Member  States  have  already  adopted  a  legal  framework  for 
sharing  digital  data  through  electronic  health  records  between  health  professionals  at  the 
national  level.  However  there  is  limited  evidence  to  suggest  that  the  adoption  of  a  legal 
framework  has  contributed  to  cross-border  sharing  of  electronic  health  records  data  as 
depicted in the next figure: 

follow-up treatment after receiving care abroad, which was mostly provided by a German physician at home 
(92%).  But  communication  between  the  physician  abroad  and  the  patient’s  physician  at  home  was  rare 
(15%). 

72  European  Commission  -  European  Core  Health  Indicators  (ECHI)  based  on  the  Percentage  of  non-resident 

people among all people being discharged from hospital. 

73 The use of CEF eID in the CEF eHealth DSI’ Draft Report V2.0, study prepared for the European 

Commission, Deloitte, 2016 

19 

 
 
 
 
                                                                                                                                                                                          
Figure  6:  National  legislation  on  the  sharing  of  data,  by  sub-region  (WHO  European 
region).  (World  Health  Organization.  From  innovation  to  implementation:  ehealth  in  the  WHO  European 
Region report. WHO Regional Office for Europe, 2016)74. 

Cross-border  exchange  of  health  data  is  starting  to  take  place,  based  on  voluntary  co-
operation  between  the  Member  States.  Under  the  telecommunications  sector  of  the 
Connecting Europe Facility75 eHealth call on Digital Service Infrastructure76 for cross-border 
exchange of Patient data and ePrescription instigated active co-operation of Member States in 
these areas. Sixteen Member States obtained EUR 10.6 million of EU funding to be part of a 
the  exchange  of  Patient  Summaries  and/or 
secure  peer-to-peer  network  allowing 
ePrescriptions, as a first step towards seamless cross-border care and secure access to patient 
health information between European healthcare systems.  

The  eHealth  Digital  Service  Infrastructure  aims  to  enable  medical  personnel  to  obtain  life-
saving  information  in  unplanned  care  situations  and  reduce  the  repetition  of  diagnostic 
procedures. When a citizen makes an unplanned visit to a healthcare provider abroad, within 
the European Union, the eHealth Digital Infrastructure will allow the healthcare professional 
to have access to their Patient Summary. Furthermore, the ePrescription services will enable 
the  patient  to  receive  abroad  the  equivalent  medication  treatment  that  they  would  have 
received in their home country.  

74 The Commonwealth of Independent States (CIS) includes Armenia, Azerbaijan, Belarus, Kazakhstan, 
Kyrgyzstan, the Republic of Moldova, the Russian Federation, Tajikistan and Uzbekistan; Turkmenistan and 
Ukraine are included as Associate States. * Belarus is not included in this analysis. The Central Asian Republics 
Health Information Network (CARINFONET) consists of Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan 
and Uzbekistan. South-eastern Europe Health Network (SEEHN) consists of Albania, Bosnia and Herzegovina, 
Bulgaria, Croatia, Israel, Montenegro, the Republic of Moldova, Romania, Serbia and the former Yugoslav 
Republic of Macedonia. * The former Yugoslav Republic of Macedonia is not included in this analysis. Small 
countries consist of Andorra, Cyprus, Luxembourg, Iceland, Malta, Monaco, Montenegro and San Marino. 
* Andorra and Monaco are not included in this analysis. The Nordic countries are Denmark, Finland, Iceland, 
Norway and Sweden. 

75 The Connecting Europe Facility (CEF) supports trans-European networks and infrastructures in the sectors of 
transport, telecommunications and energy. (https://ec.europa.eu/cefdigital/wiki/display/CEFDIGITAL)  
76 The eHealth Digital Service Infrastructure, or eHDSI, facilitates continuity of care and patient safety of 
citizens seeking cross-border healthcare, allowing health data to be exchanged across national borders 
(https://ec.europa.eu/cefdigital/wiki/display/CEFDIGITAL/2017/05/30/eHealth)  

20 

 
 
 
 
                                                            
A second call in 2017 allowed 6 more Member States to join this cross-border exchange of 
health  data.  In  2018,  for  the  first  time  several  Member  States  will  start  exchanging  Patient 
Summaries and ePrescriptions across borders.  

The solutions used in the eHealth Digital Service Infrastructure build upon the achievements 
of  pilot  projects  that  successfully  tested  the  exchange  of  personal  health  data  between 
Member  States  and  developed  related  open  specifications  and  software,  in  particular  the 
epSOS77 project and the EXPAND78 project; as well as the guidelines on Patient Summaries 
and  ePrescriptions  developed  by  the  eHealth  Network79.  The  European  Interoperability 
Framework was a point of reference for these projects.  

2.3. Remaining challenges at the EU-level 

Cross-border access to and portability of personal health data:  

Despite  over  a  decade  of  Commission  recommendations  and  voluntary  cooperation  in  the 
definition of electronic health record standards, the market has so far not delivered electronic 
health record solutions that are interoperable across borders, mainly due to the prevalence of 
electronic health record systems based on closed proprietary solutions. It clearly undermines 
the  full  realisation  of  a  digital  single  market  for  digital  health  and  care  solutions  and 
disadvantages  European  companies,  notably  SMEs  that  are  unable  to  compete  with  the 
established commercial vendors of closed proprietary electronic health record systems.  

Even with the eHealth Digital Service Infrastructure in place, the potential expansion of cross-
border exchange of health data beyond ePrescriptions and Patient Summaries to full electronic 
health records encounters challenges:  

  Firstly, there are barriers to overcome at national level, such as the need to ensure 
interoperable  connectivity  among  systems  within  the  national  level  (e.g.  among 
hospitals,  general  practitioners,  primary  care  centres  and  pharmacies  within  each 
Member State).  

  Furthermore,  the  cross-border  exchange  of  health  data  sets  wider  than  Patient 
Summaries and ePrescriptions asks for further interoperability issues to be resolved. 
This would in turn require taking intermediate steps (such as aiming for cross-border 
exchange of e.g. discharge letters and data related to chronic conditions) on the way to 
full  electronic  health  record  exchange,  while,  in  parallel,  configuring  an  exchange 
format for full electronic health records.  

  Finally,  mechanisms  to  sustain  the  voluntary  co-operation  between  Member  States 
would  be  required,  which  in  turn  calls  for  configuring  sustainable  governance  and 
financing arrangements. The question of  the long-term sustainability of the Digital 

77 www.epsos.eu 
78 www.expandproject.eu 
79 https://ec.europa.eu/health/ehealth/policy/network_en  

21 

 
 
 
                                                            
Service  Infrastructures  beyond  the  Connection  Europe  Facility  programme  was 
assessed  in  the  study  "Long-Term  Sustainability  of  Digital  Service  Infrastructures". 
The  VALUeHEALTH  project  proposes  an  evidence-based  business  plan  for 
sustainable  interoperability,  with  sustainable  revenue  streams  for  developing  and 
operating priority pan-European eHealth Services beyond 202080.   

Ultimately though, the number of citizens who will have electronic access to and benefit from 
portability  of  their  personal  health  data  will  depend  on  the  level  of  deployment  of 
interoperable  eHealth  solutions  in  national  and  regional  health  systems  in  Member  States. 
Besides  the  well-recognised  need  to  overcome  interoperability  issues,  achieving  wide 
deployment  of  electronic  health  records  and  ePrescriptions  at  national  scale  requires 
significant  investments.  More  targeted  use  of  EU  funds  by  health  authorities  –  such  as  the 
European Structural and Investment Funds and the European Fund for Strategic Investments81 
-  can  be  instrumental  in  mobilising  further  investments  from  the  public  sector  and  private 
investors alike. 

The  use  of  open  standards  and  interfaces,  such  as  OpenEHR82  currently  in  use  in  some 
Member States, fosters semantic scalability, provides a vendor-neutral approach and supports 
flexible interoperability among the various electronic health record solutions implemented in 
the Member States. The building of open ICT systems based on the exploitation of standards 
has  already  been  identified  as  a  good  practice  that  will  increase  competition,  promote 
efficiency and support the development of innovative services that can be used by citizens or 
public  authorities83.  Some  Member  States  have  started  to  address  the  unsustainable  costs  of 
maintaining proprietary closed systems that cannot integrate with other data ecosystems84.  

The  creation  of  an  agreed  exchange  format  (technical  specification)  at  EU  level  -  to  ensure 
that data from electronic health records can be accessed cross-border and patients can provide 
access to their data concerning health to a doctor in another EU Member State (for example 
when  consulting  a  specialist,  receiving  emergency  treatment  or  providing  access  for 
secondary  use  in  research)  -  could  be  achieved  through  EU-level  cooperation  in  the 
development of technical specifications.  

Cross-border interoperability of electronic health record systems can allow citizens to receive 
care  when  travelling  or  living  in  another  EU  Member  State,  by  providing  access  to  their 
health  data.  According  to  stakeholders,  interoperability  of  electronic  health  record  systems 
will  also  positively  impact  EU  SMEs  and  innovative  companies85  competing  in  the  global 
digital health market, and provide new opportunities for the EU research community to access 

80 http://www.valuehealth.eu/  
81 https://ec.europa.eu/commission/priorities/jobs-growth-and-investment/investment-plan_en  
82 OpenEHR http://www.openehr.org/  
83 European Commission COM(2013) 455 final: Against lock-in: building open ICT systems by making better 

use of standards in public procurement 

84 NHS over-reliance on closed EHR systems (Gartner: https://www.digitalhealth.net/2017/09/gartner-says-nhs-

reliant-closed-systems/)  

85 European Commission COM(2013) 455 final: Against lock-in: building open ICT systems by making better 

use of standards in public procurement 

22 

 
 
                                                            
large scale data sets from electronic health records, often required for the development of new 
personalised  treatments  and  medicines86.  However,  there  are  no  inherent  incentives  for 
proprietary  electronic  health  record  systems  developed  and  implemented  at  national  or 
regional level to become interoperable.   

Experiences from other world regions suggest that strong regulatory incentives are necessary 
in order to create market demand for cross-border interoperability solutions and to avoid the 
need  to  retrofit  electronic  health  record  interoperability  only  at  the  EU  level  in  order  to 
remedy existing market fragmentation and piecemeal adoption of relevant solutions.87     

With  the  introduction  and  widespread  adoption  of  a  European  Electronic  Health  Record 
(EEHR)  exchange  format,  based  on  open  technical  specifications,  citizens  could  be 
empowered  to  use  their  personal  data  concerning  health  across  borders,  share  it  with 
authorised  healthcare  professionals  and  make  informed  decisions  about  their  health88.  The 
EEHR exchange format will support the shift to a patient-centred or patient-driven healthcare 
provision model where the patient is empowered by data.  

Access  to  their  personal  data  by  patients  could  overcome  the  difficulties  and  obstacles 
deriving from the lack of cross-border electronic health record interoperability and according 
to Auffray et al. (2016) "provide a wide range of new health service business opportunities 
with major economic potential and unleash new ways to stimulate a competitive health-driven 
economy"89. Health and care practitioners would have quick access to a more comprehensive 
view of the patient’s medical background and history, regardless of their location in the EU, 
enabling  them  to  reach  a  reliable  and  accurate  diagnosis  quicker  than  before,  to  reduce 
medical errors and to provide safer treatment outside the patient's country of residence, while 
simultaneously ensuring the protection of personal data and conﬁdentiality90. 

86 Making sense of big data in health research: Towards an EU action plan, Genome Medicine 2016, 
(https://doi.org/10.1186/s13073-016-0323-y) 
87 Adler-Milstein, J. (2017). Moving past the interoperability blame game. NEJM Catalyst. Retrieved from:  

https://catalyst.nejm.org/ehr-interoperability-blame-game/  

88 Patient access to Electronic Health Records, Report of the eHealth Stakeholder Group, June 2013 
89 Auffray, C.  et al. (2016). Making sense of big data in health research: Towards an EU action plan. Genome 

Medicine 8:71. 

90  Kierkegaard,  Patrick.  (2011).  Electronic  Health  Record:  Wiring  Europe’s  Healthcare.  Computer  Law  & 

Security Report. 27. 503-515. 10.1016/j.clsr.2011.07.013. 

23 

 
 
                                                            
3. BETTER DATA TO ADVANCE RESEARCH, DISEASE PREVENTION 
AND PERSONALISED MEDICINE  

3.1. Fragmented data and computing capacity 

At EU level, there has been a wide recognition that the use of health data to advance research 
and develop personalised medicine91 has the potential to offer significant benefits for patients 
and  healthcare  systems92.  Over  the  past  years,  personalised  medicine  has  gradually  gained 
recognition  as  a  useful  tool  for  healthcare  organisations  across  different  disease  areas. 
Physicians are increasingly welcoming therapies supported by data analytics which have the 
potential to replace trial-and-error with precision diagnosis and treatment, benefiting both the 
provider and recipient of health and care services. 

Figure  7:  Personalised  medicine  programme  primary 
organisations 2016-2018 (Statista) 

focuses  of  healthcare 

An estimated 70 % of citizens in the Union would be ready to share their personal health and 
wellbeing  data  (medical  and  care  data,  lifestyle,  physical  activity,  nutrition,  etc.)  to  support 

91 Personalised medicine has been referred to as a medical model using characterisation of individuals' 

phenotypes and genotypes (e.g. molecular profiling, diagnostic imaging, lifestyle data) for tailoring the right 
therapeutic strategy for the right person at the right time, and/or to determine the predisposition to disease 
and/or to deliver timely and targeted prevention. Personalised medicine relates to the broader concept of 
patient-centred care, which takes into account that, in general, healthcare systems need to better respond to 
patient needs. 

92 RAND Europe study: “Understanding value in health data ecosystems.” (2017) 

24 

 
 
 
                                                            
scientific  research  or  improve  treatment  and  early  diagnosis  of  disease93.  However,  for  the 
time  being  there  is  no  secure,  commonly  accepted  infrastructure  at  EU  level  to  enable 
federated access to health data that can support personalised medicine across the EU.  

The  absence  of  an  agreed  set  of  ontologies  creates  a  high  level  of  uncertainty  around  the 
quality  of  capturing  and  processing  of  health  data.  Lack  of  interoperability  between  data 
sources and limitations in data storage and computing capacity, as well as the different legal 
regimes set forth at national level to further specify the GDPR for the access and processing 
of  health  and  health-related  data  across  the  EU,  remain  the  major  obstacles  to  effectively 
pooling data and resources at EU level and translating health data into better health and care 
outcomes.   

Over the past decade the volume of data generated from medical research and healthcare has 
grown exceptionally fast. The annual data generation is estimated to a 4300% annual growth 
between  the  period  2012  and  202094.  Big  data  in  health  encompasses  high-volumes,  high-
diversity  biological,  clinical,  environmental,  and  lifestyle  information  collected  from  single 
individuals to large cohorts, in relation  to  their health and wellness status, at one or  several 
time points. The amount of data produced by sequencing, mapping, and analysing genomes is 
considerable.  Each  human  genome  has  6  billion  ‘letters’  and  when  sequenced  generates 
approximately 100 gigabytes of data.  

Therefore,  analysing  and  storing  genomes  at  scale  rapidly  runs  into  petabytes  or  even 
exabytes  of  data  storage  and  performance  requirements.  When  combining  this  with  other 
applications (such as transcriptomics and metabolomics), technologies (such as imaging and 
patient  monitoring)  and  with  clinical,  personal  and  environmental  data,  the  requirements 
become  considerable  and  require  both  advanced  computing  performance  and  significant 
storage capacity.  

Figure  8:  Comparison  of  storage  and  computing  needs  demonstrating  the  acquisition, 
storage, distribution, and analysis demands of genomics that is equal or greater than the 
most demanding of the Big Data domains (Stephens et al. 2015) 

93 'Special Eurobarometer 460 [results from March 2017.] Attitudes towards the impact of digitisation and 

automation on daily life 

94 www.csc.com/insights/flxwd/78031-big_data_just_beginning_to_explode 

25 

 
 
 
                                                            
A major challenge faced by healthcare authorities, practitioners and scientists is being able to 
bring  this  wealth  of  data  together  and  interpret  a  genomic  finding  in  the  context  of  the 
individual patient. There is a need to share data, deriving the knowledge gained from data at a 
population level to sort through the ‘noise’ of variation in a person’s genome to identify the 
‘signal’, an individual change or pattern that may be unique to an individual.  

The quality of conclusions on the aetiology of diseases follows a law of large numbers. Cross-
sectional cohort studies of 30,000 to 50,000 or more cases are required to separate the signal 
from  noise  and  to  detect  genomic  regions  associated  with  a  given  trait  in  which  disease-
related genes or susceptibility factors are located95 96. 

Even  some  of  the  largest  national  programmes  to  aggregate  -omics97  data,  such  as  the  UK 
Government-funded 100,000 genomes project, or France’s Médecine Génomique 2025 which 
will  establish  capabilities  for  sequencing  over  200,000  genomes  a  year,  will  have  a  limited 
number  of  individuals  that  share  the  same  genetic  mutation  and  indeed  often  relatively  few 
patients with a specific condition, particularly for rare disorders98.  

Another  challenge  lies  in  the  pooling  of  different  data-sets  from  a  wide  range  of  sources, 
including  human  (e.g.  community,  hospital  or  laboratory  health  services)  and  animal  health 
surveillance,  health  registries,  microbial  and  viral  genomic  data,  pathogen  resistance  data, 
mapping of vectors, climate and environmental data, as well societal data that are correlates of 
disease.  Linking  these  datasets  for  extended  data  mining  purposes  can  open  up  possibilities 
for  improved  early  warning  and  detection  of  infectious  disease  health  threats,  bolster  the 
tracking  and  control  of  infectious  diseases  outbreaks,  and  enable  rapid  and  personalised 
treatment of infected patients. 

3.2. State of Play 

3.2.1. Digital infrastructure to support research and personalised medicine 

The  scientific  and  research  community is  increasingly  engaged  in  a  debate about the  merits 
and advantages  of creating a sustainable and effective ecosystem that  brings  together  cross-
border  access  to  data-sets,  computing  capacity  to  analyse  and  process  that  data,  knowledge 
and scientific expertise needed to accelerate the translation of big data into real outcomes for 

95 2. Wood AR, Esko T, Yang J, Vedantam S, Pers TH, Gustafsson S, et al. Defining the role of common 

variation in the genomic and biological architecture of adult human height. Nat Genet. 2014;46:1173–86. 
96 1. Ideker T, Dutkowski J, Hood L. Boosting signal-to-noise in complex biology: prior knowledge is power. 

Cell. 2011;144:860–3. 

97 Omics’ technology is a general term for a broad discipline in science and engineering for analysing the 
interactions of biological information objects in various ‘omes’ that include the genome, proteome, 
metabolome, transcriptome etc. Its main focus is on developing technologies and tools for gathering 
information on various classes of biomolecules and their ligands, and understanding relationships among 
them, including the related regulatory mechanisms. (SWD(2013) 436) 

98 QuintilesIMS Real-World Evidence in Oncology conference (https://pharmaphorum.com/views-and-

analysis/nhs-real-world-evidence-cancer/)  

26 

 
 
 
                                                            
citizens and healthcare systems across the EU99. The EU has invested over EUR 2.6 billion in 
personalised  medicine  research  and  innovation  in  Horizon  2020  and  its  predecessor 
Framework Programme 7100. 

High-performance computing  involves thousands of processors working in parallel to analyse 
billions of pieces of data in real time. High-performance computing allows to design and test 
new  medicines,  simulate  their  effects,  and  provide  faster  diagnosis,  better  treatments  and 
personalised  healthcare.  Currently,  EU  industry  provides  approximately  5%  of  high-
performance computing resources worldwide, but consumes one third of them. In April 2016 
in the European Cloud Initiative – part of the EU's strategy to digitise European industry – the 
Commission urged Member States to step up cooperation in high-performance computing to 
boost  Europe's  scientific  capabilities  and  industrial  competitiveness.  It  also  committed  to 
develop a high-performance computing ecosystem based on European technology, including 
low power chips.  

Several  Member  States  agreed  in  March  2017101  to  work  together  with  the  European 
Commission to support the next generation of computing and data infrastructures, within the 
framework  of  a  European  project.  The  plan  is  to  establish  the  European  High-Performance 
Computing Joint Undertaking102 for acquiring and deploying an integrated world-class high-
performance  computing  infrastructure  capable  of  at  least  1018  calculations  per  second  (so-
called exascale computers). This will be available across the EU for scientific communities, 
industry and the public sector, no matter where the users are located. 

The  European  High-Performance  Computing  Joint  Undertaking  initiative  builds  on  existing 
cooperation initiatives among Member  States, industry  and science  stakeholders such as the 
Partnership  for  advanced  computing  in  Europe  (PRACE103),  the  European  technology 
platform for High Performance Computing (ETP4HPC104) and the pan-European data network 
for the research and education community linking national research and education networks 
across Europe (GÉANT105). 

The  European  Commission  proposed  the  new  legal  instrument  European  High-Performance 
Computing Joint Undertaking with a view to have the HPC initiative operational by 2019106. 
Advanced high-performance infrastructure and services will then be available to industry and 
SMEs, as well as the public sector among others. This will also support the  European Open 
Science Cloud107 and allow millions in the research community to share and analyse data in a 
trusted environment across technologies, disciplines and borders. 

99 Making sense of big data in health research: Towards an EU action plan (Genome Medicine 2016) 
100 https://www.futuremedicine.com/doi/full/10.2217/pme-2017-0003 
101 http://europa.eu/rapid/press-release_IP-18-64_en.htm. 
102 http://europa.eu/rapid/press-release_IP-18-64_en.htm 
103 http://www.prace-ri.eu/  
104 http://www.etp4hpc.eu/  
105 https://www.geant.org/  
106 COM(2018) 8 final 
107 SWD(2018)83/F1 

27 

 
 
                                                            
The  European  Open  Science  Cloud108  aims  to  give  Europe  a  global  lead  in  scientific  data 
infrastructures, to ensure that European scientists reap the full benefits of data-driven science. 
Practically,  it  is  expected  to  offer  1.7  million  European  researchers  and  70  million 
professionals  in  science  and  technology  a  virtual  environment  with  free  at  the  point  of  use, 
open  and  seamless  services  for  storage,  management,  analysis  and  re-use  of  research  data, 
across borders and scientific disciplines. The results of the consultation with stakeholders and 
Member States show that its development should be driven by the scientific community, who 
are the most advanced users and the largest producers of science in the world. It also shows 
that  the  European  Open  Science  Cloud  should  be  also  open  for  education  and  training 
purposes  in  higher  education  and,  over  time,  to  government  and  business  users  as  the 
technologies developed will be promoted for wider application. 

As announced in the Commission’s Communication of 19 April 2016109, Horizon 2020 would 
be  used  to  integrate  and  consolidate  e-infrastructure  platforms,  to  federate  existing  research 
infrastructures and scientific clouds and to support the development of  cloud-based services 
for Open Science. This will make access to scientific data easier, cheaper and more efficient. 
It will enable the creation of new market opportunities and new solutions in key areas such as 
health,  environment,  or  transport.  The  European  Open  Science  Cloud  will  provide  a  secure 
environment  where  privacy  and  data  protection  must  be  guaranteed  by  design,  based  on 
recognised standards, and where users can be confident concerning data security and liability 
risks. 

It  is  envisaged  that  the  establishment  of  the  European  High-Performance  Computing  Joint 
Undertaking  Joint  Undertaking  and  the  European  Open  Science  Cloud  will  provide  a  solid 
basis for the enhancement and further development of personalised medicine in Europe. This 
will however rely on access to health data-sets and integration with European scientific and 
knowledge networks in the respective fields of application. 

3.2.1.1 The opportunities from data clouds and exascale computing for personalised medicine 

Genome  sequencing  and  analysis  are  complex  tasks  that  demand  powerful  analytics 
platforms.  The  time  needed  for  sequencing  has  been  reduced  considerably  in  recent  years, 
making it possible to drastically increase the amount of genomic data collected on large study 
populations.  This  opens  the  way  to  new  omics-  based  improvement  of  healthcare  services, 
leveraging  in  depth  and  comprehensive  genomic  analyses  for  a  predictive  and  personalised 
medicine  that  can  achieve  better  and  predictive  diagnosis,  more  efficient  treatments  and 
customised therapies. 

To achieve this, sequence analysis must be available on a large-scale, and complex analytics 
must be supported by adequate computing technology. This requires computational power and 
data  storage  capabilities  on  an  unprecedented  scale.  Cooperation  within  the  Union  can  help 
achieve this scale. For example, by joining medical research, data-sets and high-performance 

108 https://ec.europa.eu/research/openscience/index.cfm?pg=open-science-cloud 
109 COM(2016)178 final 

28 

 
 
                                                            
computing,  there  are  major  new  opportunities  for  personalised  and  optimised  treatment 
options  for  cancer  based  on  analysis  of  genetics  and  other  data  sources.  In  a  typical  cancer 
study  today,  more  than  eight  million  measurements  are  taken  from  the  biopsy  of  a  single 
tumour.  But  as  current  technologies  allow  researchers  to  characterise  the  biological 
components  of  cancer  with  greater  levels  of  accuracy,  the  substantial  amounts  of  data 
generated by these technologies have out-paced the ability to quickly and accurately analyse 
them. 

To  tackle  these  complicated  and  consequential  personalised  medicine  problems,  researchers 
globally  are  looking  towards  the  promise  of  exascale  computing  combined  with  advanced 
data  analytics,  modelling  and  simulation  on  the  basis  of  very  large  data-sets.  This  has  the 
promise  to  detect  risks  much  earlier  and  to  develop  precise  options  for  personalised 
interventions. 

3.2.2. National and international initiatives on personalised medicine 

Omics data are central to advance personalised medicine and progress in genomic sequencing 
has produced a fundamental change in clinical and translational research over the past decade, 
leading to improved success in discovery and development of new treatments and diagnosis of 
disease110.  

Development  of  major  initiatives  in  genomics  and  personalised  medicine  is  a  global  trend 
with significant investments being committed, for example by the governments of the United 
States (1 million genomes and EUR 3.8 billion planned investment) and China (100 million 
genomes and EUR 7.9 billion planned investment).  

In  Europe  the  most  comprehensive  initiatives,  encompassing  clinical  implementation, 
research and enterprise, are being seen in Member States such as the UK (100,000 Genomes 
Project) and France (Médecine Génomique 2025). There has also been significant long-term 
investments  and  strategies  relating  to  genomics,  with  skills  and  infrastructure  developed  in 
countries such as Estonia, Denmark, Iceland, and Finland; and others leading in the clinical 
application of genomics, such as the Netherlands111. Major genomics programmes provide a 
basis  for  a  more  personalised  medicine  leading  to  more  efficient  healthcare  systems  and 
stimulating economic returns112.  

Project 

Origin and funding  

Purpose 

100,000 GENOMES PROJECT (UK) 

UK 

UK government; funding in 
excess of £300 million to 
date 

Sequencing and analysis of 100,000 genomes to inform the 
diagnosis of patients with cancer and rare diseases.  
Its four main aims are to: 

110 Cardon, LR & Harris, T; Precision medicine, genomics and drug discovery; Hum Mol Genet. 2016 Oct 

1;25(R2):R166-R172. Epub 2016    

111 In  April 2018, 14 Member States signed a joint declaration on cooperation "Towards access to at least 1 

million sequenced genomes in the European Union by 2022", https://ec.europa.eu/digital-single-
market/en/news/eu-countries-will-cooperate-linking-genomic-databases-across-borders 

112 The economic impact of the Human Genome Project in the USA has been calculated as $796 billion from a 

USD 3.8 billion investment. 

29 

 
 
 
                                                            
1.  Create an ethical and transparent programme based on 

consent; 

2.  Bring benefit to patients and set up a genomic medicine 

service for the NHS; 

3.  Enable new scientific discovery and medical insights;  
4.  Kick-start the development of a UK genomics industry. 

DANISH GOVERNMENT AND REGIONS 
NATIONAL STRATEGY FOR 
PERSONALISED MEDICINE 2017-2020 

Danish Ministry of Health 
and Regions; initial funding 
of DKK100 million  

Strategic action areas: 
1. 

DK 

2. 

3. 
4. 

Transparent governance structure with nationwide 
involvement 
Clear legal framework addressing ethical principles and 
data privacy and security 
Patients and citizens must be involved 
A technological infrastructure with secure, efficient and 
equal access 

5.  Genomics research must be international and deeply 

6. 
7. 

integrated in the healthcare system 
Tools and competencies to use genetic data 
Attractive development in relation to personalised 
medicine 

The project was proposed as being of huge cultural value and 
leading in this area in global research. It is has collected over 
50,000 samples (5% of adult population) and links this to clinical 
and survey data to form a rich data set. Genotyping analysis has 
been performed on these samples, along with sequencing in a 
proportion, along with additional samples and investigations in 
many. There are ambitions to grow it further to cover a 
significant percentage of the population and embed genomics 
within the health system as part of clinical decision support. It 
has gathered significant awareness and support across a large 
proportion of the population. 

The aim of the strategy is to 
1.  Make Finnish healthcare more effective through better 
and more targeted care, with integration of genomics in 
clinical care, individuals able to make use of their genomic 
data, and a containment of healthcare costs and better 
allocation of resources; 
Researchers will have entirely new opportunities for 
utilizing genomic data; 
Transform Finland into an internationally attractive 
environment for research and business in the field of 
genomics 

3. 

2. 

Targets of the 2025 France Genomic Medicine Plan 
1. 

Position France among the leading big countries in the 
field of genomic medicine within the next ten years, with 
the aim of exporting expertise and developing a strong 
medical and industrial framework; 
To establish a generic care pathway with access to 
genomic 
medicine for all French people affected by cancer, a rare 
disease or a common disease; 
To be capable by 2020 of sequencing 235,000 genomes a 
year for rare diseases and cancer, with growth beyond 
2020 to cover common diseases. 

2. 

3. 

Aims aligned to Five Year Forward View and health 
sustainability: 
1. 
2. 

Improved prevention based on underlying predisposition; 
Earlier diagnosis of disease as a result of identifying 
abnormality earlier; 

3.  More precise diagnosis based on cause; and 
4. 

Targeted interventions through the use of companion 
diagnostics to identify and stratify effective treatments. 

Strategic funding for research in personalised medicine. 
Targeted across R&D from biomarker validation through to 
therapies and service implementation. Main goal is for patients 
to benefit more quickly. Ethical, legal and economic challenges 
and engagement and information platforms are also included 
within this.  

ESTONIAN GENOME PROJECT 

Estonian Government 

FINLAND’S GENOME STRATEGY 

FRANCE MÉDECINE GÉNOMIQUE 2025 

NHS ENGLAND PERSONALISED 
MEDICINE STRATEGY 

EE 

FI 

FR 

UK 

Ministry of Social Affairs 
and Health, Finland; 
funding of  

French Government; 
investment of €670 million 
in public-private 
partnerships 

NHS England lead the 
National Health Service in 
England 

PERSONALISED MEDICINE – ACTION 
PLAN (GERMANY) 

Federal Ministry of 
Education and Research, 
Germany (BMBF); up to 
€360 million funding 

DE 

30 

 
 
PRECISION MEDICNE INITIATIVE 
(CHINA) 

CN 

Chinese Government; 
expected funding of ¥60 
billion (€7.9 billion) by 
2030 

The Chinese government confirmed plans to make precision 
medicine part of its Five Year Plan for 2016-2020 as it works to 
prioritise genomics to drive better healthcare outcomes. 

PRECISION MEDICNE INITITATIVE (ALL 
OF US - USA) 

US Government; initial 
funding of over $200m 

US 

Aim is to enrol one million or more volunteers to enable 
research for a wide range of diseases and increase our 
understanding of healthy states. Scientific opportunities 
presented by All of Us include: the ability to: 
1.  Develop ways to measure disease risk based on 

environmental and genetic factors; 
2. 
Pharmacogenomics; 
3. 
Biomarker identification and validation; 
4.  Use mHealth technologies to correlate activity, 

physiological measures and environmental exposures with 
health outcomes; 

5.  Develop new disease classifications and relationships; 
6. 

Empower study participants with information to improve 
their health;  
Create a platform to enable trials of targeted therapies. 

7. 

Figure  9:  Catalogue  of  genomic  data  initiatives  in  the  Union  and  in  certain  third 
countries113  

The  Commission  has  contributed  to  several  large  scale  international  initiatives  aiming  at 
collecting  harmonised  and  standardised  omics  data  for  research  purposes.  This  includes  the 
International Human Epigenome Consortium (IHEC)114 which coordinates the production of 
reference maps of human epigenomes for key cellular states relevant for health and disease. 
Common  bioinformatics  standards,  data  models  and  analytical  tools  are  used  to  organise, 
integrate  and  display  whole  epigenomic  data  for  use  by  the  research  community.  The  EU 
contributed  EUR  30  million  to  the  BLUEPRINT115  project  which  delivered  more  than  100 
reference  epigenomes  relevant  for  diseases  of  the  haematopoietic  system  to  the  IHEC  Data 
Portal. The  EU  has  also  contributed  to  the  mapping  of  cancers  through  the  International 
Cancer  Genome  Consortium  (ICGC)116.  The  ICGC  Data  portal  include  comprehensive 
description of genomic, transcriptomic and epigenomic changes in 50 different tumour types 
and/or  subtypes  which  are  of  clinical  and  societal  importance  across  the  globe.  These  and 
other  initiatives  are  also  interacting  with  the  Global  Alliance  for  Genomics  and  health 
(GA4GH)117 which aims to contribute to the policy-framing and technical standards-setting to 
enable  responsible  genomic  data  sharing.  Further  efforts  in  the  area  of  mapping  the 
microbiome, and to establish an atlas of all human cells are important next steps towards the 
better understanding of human health and disease.  

Under the leadership of the European Commission several initiatives related to personalised 
medicine  have  come  together  and  in  November  2016  the  International  Consortium  for 

113 Overview provided by the European Personalised Medicine Association, Million European Genomes Alliance 

(2016) 

114 http://ihec-epigenomes.org/  
115 http://www.blueprint-epigenome.eu/  
116 http://cordis.europa.eu/project/rcn/94422_en.html 
117 https://www.ga4gh.org  

31 

 
 
 
                                                            
Personalised  Medicine  (IC  PerMed)  was  launched.  IC  PerMed118  is  a  Member  States  led 
initiative  which  brings  together  research  funders  and  policy-making  organisations  from  28 
countries  to  coordinate  research  and  health  policy  to  advance  the  implementation  of 
personalised medicine. A first action plan has been released in March 2017, in which 8 of 22 
research actions concern research on standardising and sharing of data119. 

3.2.3. Initial areas of application 

Several  areas  of  application  already  gather  the  scientific  expertise  and  the  basic  semantic 
frameworks to support data exchange and data-sets that can allow for significance in findings 
and development of new solutions.  

3.2.3.1. Diagnosis and personalised treatment of rare diseases 

Around 30 million EU citizens are affected by an estimated 5000 to 8000 life-threatening or 
chronically  debilitating  rare  and  complex  diseases.  Patients  with  rare  diseases  often  spend 
years  waiting  for  the  correct  diagnosis120  and  most  rare  diseases  lack  efficient  therapy  and 
cure.  With  small  and  dispersed  patient  populations  in  each  country,  advanced  clinical  and 
scientific  expertise  on  rare  diseases  is  fragmented,  scarce  and  scattered  in  different 
laboratories  and  knowledge  centres  throughout  the  EU.  This  scarcity  of  expertise  translates 
into poor access to specialised care for those suffering from rare diseases, delayed diagnosis, 
and  fewer  products  and  therapies  as  research  and  development  investment  in  medicinal 
products  for  rare  disease  treatments  is  low.  The  EU  invested  over  EUR  1  billion  for  rare 
diseases research in Horizon 2020 and its predecessor Framework Programme 7121. 

Set  up  under  the  Directive  on  Patient  Rights  in  Cross-Border  Healthcare,  the  24  European 
Reference Networks on rare, low prevalence complex diseases are virtual networks from 25 
European  countries  including  Norway  bringing  together  more  than  900  healthcare  units  in 

118 The consortium includes 22 EU Member States, including 9 of the EU13, five countries associated to Horizon 
2020 and Canada as an international partner. It also includes a number of EU regions, which along with the 
involvement of Ministries for Health enforces both the link to the authorities responsible for delivery of 
healthcare and to the common funds for regional development. In the Smart Specialisation strategies for 
research and innovation (RIS3), approximately a third of the regions and countries identify personalised 
medicine as one of their thematic priorities. Of the 146 regions or countries having issued a strategy, at least 
45 have identified personalised medicine a priority. 

119 As one of the vehicles for implementing the recommendations of the Action Plan, the Commission is co-

funding an ERA-Net, called ERA-PerMed, which started in December 2017 and will issued its first call in 
early 2018. This ERA-Net has currently 31 participating funding organisations from around Europe and 
Canada, but is open to further extension. ERA-PerMed has a total investment projected to reach over EUR 30 
million, of which the Commission contributes close to EUR 10 million, Among the areas to be funded by the 
ERA-Net are aspects related to data analysis, management and protection, corresponding to the challenge 
"integrating big data and ICT solutions".   

120 Shire's Rare Disease Impact Report https://globalgenes.org/wp-content/uploads/2013/04/ShireReport-1.pdf   

published in April 2013 estimates diagnosis takes on average 5.6 years 
121 http://ec.europa.eu/research/health/index.cfm?pg=area&areaname=rare 

32 

 
 
 
 
                                                            
over  300  hospitals  across  Europe  to  tackle  rare  or  complex  diseases  and  conditions  that 
require  highly  specialised  healthcare  and  a  concentration  of  knowledge  and  resources. 
Connected through a dedicated IT platform financed by the telecommunications sector of the 
Connecting  Europe  Facility,  the  European  Reference  Network  can  convene  a  "virtual" 
advisory board of medical specialists across different disciplines to review the patient's case 
for diagnosis and treatment. The European Reference Networks will give healthcare providers 
access to a much larger pool of expertise and knowledge, increasing the chances of patients 
suffering  from such  conditions and diseases to receive the best advice to  treat  and diagnose 
their  condition.    The  European  Reference  Networks  will  serve  as  research  and  knowledge 
centres stimulating new innovative treatments and therapies for patients across the EU and the 
development  of  eHealth  tools  to  enhance  access  to  care.  The  development  of  a  data 
infrastructure  would  enhance  the  potential  use  of  the  European  Reference  Network  patient 
data, with patient consent, for research, new therapies and better care outcomes. 

Pooling  data  and  computing  capacity  from  different  countries  is  the  only  way  to  achieve  a 
sufficient  sample  size  for  epidemiological  and/or  clinical  research,  to  improve  the 
understanding of the natural history of rare diseases and of the patient phenotypes, necessary 
to make progress in the diagnosis and treatment of rare diseases.   

Cooperation within the Union and between Member States and EU funded actions in the field 
of  rare  diseases  allow  to  pool  resources,  knowledge  and  expertise.  RD-Connect122  has 
developed  an  integrated  platform  connecting  databases,  registries,  biobanks  and  clinical 
bioinformatics for rare disease research in which complete clinical profiles are combined with 
–omics  data.  The  platform  accepts  data  from  other  projects  funded  nationally,  at  EU  or 
international  level.  RD-Connect  collaborates  closely  with  two  other  EU-funded  projects 
EuRenomics123 and Neuromics124 focussing on the molecular characterisation of a large group 
of  rare  diseases  using  “-omics”  technologies.  Their  work  has  helped  understand  disease 
mechanisms and opened avenues for new diagnostic tools and therapies. Standardised formats 
are used for the description of the diseases and their detailed phenotypic characteristics based 
on the Orphanet Rare Disease Ontology (ORDO) and the Human Phenotype Ontology (HPO) 
promoted by the International Rare Diseases Research Consortium (IRDiRC125). The current 
work  programme  of  Horizon  2020  includes  a  topic  for  Rare  Disease  European  Joint 
Programme Cofund which aims to create a research and innovation pipeline "from bench to 
bedside" ensuring rapid translation of research results into clinical applications and uptake in 
healthcare for the benefit of patients126. EU contribution of EUR 50-55 million is reserved for 
the topic. 

There is no established digital infrastructure to support cross border access to relevant health 
data for research. For example, while the recently established European Reference Networks 
(ERNs)  on  rare,  low  prevalence  complex  diseases  are  breaking  new  ground  in  cross-border 

122 http://cordis.europa.eu/project/rcn/105860_en.html  
123 http://cordis.europa.eu/project/rcn/105363_en.html  
124 http://cordis.europa.eu/project/rcn/105392_en.html  
125 http://www.irdirc.org/  
126 Horizon 2020 Work Programme 2018-2020, 8. Health, demographic change, wellbeing: 
http://ec.europa.eu/research/participants/data/ref/h2020/wp/2018-2020/main/h2020-wp1820-health_en.pdf 

33 

 
 
                                                            
healthcare, the lack of a European digital infrastructure leads to a high level of fragmentation 
in terms of rare disease data-bases and patient registries, and the same applies to other fields. 

interoperability  and  comparability  of 

Common  data  structures,  coding  systems,  terminologies  and  standards  are  crucial  for  the 
semantic 
rare  disease  data.  The  Orphanet 
nomenclature127  improves  the  interoperability  of  rare  disease  systems  and,  by  harmonising 
rare disease codification, adds  value to the re-usability of data for research. The EU funded 
Orphanet,  the  largest  global  repository  of  rare  disease  information  and  therapies,  is  key  to 
maintaining 
tools  Orphacode  and  ORDO  ontology.  Its  further 
development is fundamental for rare disease diagnosis, treatment and research.  

interoperability 

the 

To  overcome  the  fragmentation  of  rare  disease  patient  data  contained  in  over  600  patient 
registries  across  Europe,  the  European  Platform  for  Rare  Diseases  registration  (EU  RD 
Platform)  provides  EU  standards  and  recommendations  for  rare  disease  data  collection  and 
sharing. In October 2017, the EU RD Platform defined a "Set of Common Data Elements for 
Rare  Diseases  Registration".  Improving  the  interoperability  of  patient  registries  enables  the 
critical  mass  of  data  necessary  for  epidemiological,  clinical,  translational,  pharmacological 
and  other  studies  and  research  at  European  level,  thus  supporting  knowledge  generation  on 
rare diseases and helping to improve diagnosis, treatment and care for rare disease patients.  

3.2.3.2. Anticipation, rapid EU-wide identification and quick response to epidemics 

Next generation genome sequencing and analysis, as well as mining of pooled Big Data, can 
improve  the  anticipation  of  epidemics  and  accelerate  EU-wide  identification  of  infectious 
threats  (within  days),  thus  allowing  swift  response  to  infectious  outbreaks.  These  tools  are 
made  possible  by  novel  IT  infrastructure  (high-performance  computing,  high-speed  internet 
transfer)  and  advanced  IT  technologies  which  are  needed  to  rapidly  process,  transfer,  store 
and compare the relevant data and meta-data.  

Worldwide,  infectious  diseases  are  responsible  for  around  20%  of  all  deaths128.  Increasing 
global  travel  and  trade  enhance  the  potential  for  infectious  diseases  to  spread.  At  the  same 
time, the evolution of viruses and bacteria means that there is a constant risk that new diseases 
may emerge as well as different more virulent forms of existing diseases may emerge. When 
they  are  not  contained  these  diseases  can  have  devastating  human,  social  and  economic 
impact,  as  was  demonstrated  by  the  2014-2015  Ebola  epidemic  and  the  2009  influenza 
pandemic. 

Countering these threats requires: 

-  comprehensive  modelling  to  more  accurately  predict  the  possibility  and  trajectory  of 
potential  future  outbreaks.  These  risk  prediction  models  are  based  on  the  integration  and 
comparative  analysis  of  diverse  Big  Data  sets  e.g.  climate  and  geo-observation  data, 

127 http://www.orpha.net/consor/cgi-bin/Education_AboutOrphanet.php?lng=EN 
128  Saker,  L;  et  al.;  (2004)  Globalization  and  infectious  diseases,  A  review  of  the  linkages.  UNDP/World 
Bank/WHO Special Programme on Tropical Diseases Research, Geneva 

34 

 
 
                                                            
demographic  and  population  movement  data,  human  and  animal  health  data,  disease  vector 
surveillance etc.; 

- well-functioning surveillance systems able to rapidly identify infecting organisms (based on 
next generation sequencing and analysis); 

-  integration  of  surveillance  data  with  real-time  information  e.g.  vaccination  coverage,  data 
from  health  registries,  hospitals  and  laboratories,  and  societal  data  from  informal/non-
traditional sources  like social  media or  health  apps  in  order to  map  the evolution and guide 
management of the epidemic.  

Science to support better preparedness and response capacities for infectious disease threats is 
a rapidly developing field increasingly based on digital tools. So far under Horizon  2020, at 
least  EUR  456  million  has  been  committed  to  relevant  preparedness  research  for  infectious 
diseases129.  

The  Horizon  2020  project  COMPARE130,  addresses  the  challenges  and  the  opportunities 
linked  to  these  advances,  as  a  large-scale  pilot.  With  a  budget  of  almost  EUR  21  million, 
COMPARE  brings  together  key  national  reference  laboratories  from  10  EU  countries.  The 
project  is  developing  a  globally  linked  data  and  information  sharing  platform  that  uses 
advanced  IT  technologies  to  generate  genomic  data  of  infectious  pathogens  and  integrate 
these  data  with  other  relevant  (clinical,  epidemiological,  demographic,  environmental  etc.) 
data. It aims to facilitate rapid identification of emerging infectious threats in human health, 
animal  health  and  food  safety.  Similar  application  of  high-performance  computing  on 
genomics were also used during the Ebola outbreak, by the EU-funded project EVIDENT131, 
which researched the mutational rate of the Ebola virus during the West African epidemic and 
performed real-time molecular epidemiology based on sequencing in the field.  

Projects like COMPARE and EVIDENT provide insight on how supercomputing capacity and 
artificial intelligence, bringing together large data sets from different sources and disciplines, 
can  improve  the  understanding  of  epidemics,  and  accelerate  EU-wide  identification  of 
infectious  threats.  Advanced  IT  technologies  can  also  support  the  development  of  new  risk 
models to predict the possibility and trajectory of potential future outbreaks, by facilitating the 
integration  and  comparative  analysis  of  inputs  from  various  data  sources,  e.g.  from  human 
and  animal  health  data,  vaccination  coverage,  vector  surveillance,  laboratory  data, 
environmental data, population density, travel, etc. EU research funds have already supported 

129 Work Programmes on health, demographic change and wellbeing: 
http://ec.europa.eu/programmes/horizon2020/en/h2020-section/health-demographic-change-and-wellbeing 
130 COMPARE is a multidisciplinary research network that has the common vision to become the enabling 

analytical framework and globally linked data and information sharing platform  for the rapid identification, 
containment and mitigation of emerging infectious diseases and foodborne outbreaks (http://www.compare-
europe.eu/about)  

131 Correlates protection, determinants of outcome, and clinical management (http://www.evident-project.eu/)  

35 

 
 
 
                                                            
the development of such models for vector-borne diseases in general (cf. EDENext project132) 
as well as disease-specific models e.g. for Dengue (cf. DENGUETOOLS project133) and Zika 
(cf.  the  ongoing  ZikaPLAN134  and  ZIKAlliance135  projects).  From  a  very  different 
perspective,  the  TELL  ME136  project  used  social  simulation  models  to  understand  the 
complex relationships between communication, personal protective behaviour and the spread 
of an (influenza) outbreak.  

The  abovementioned  projects  illustrate  the  potential  of  advanced  IT  technologies  for 
improved  preparedness,  early  detection  and  response  of  infectious  disease  threats.  The 
challenge now is to make sure that these piloted applications are expanded towards a common 
and large-scale use across the EU. Allowing for a swift response to infectious outbreaks, such 
technologies  can  support  the  reduction  of  outbreak-associated  human,  health  system,  and 
socioeconomic impact, and contribute to an increased protection of European citizens.  

3.2.3.3. Real World Data (RWD) in healthcare  

Big  data  in  health  may  come  from  a  variety  of  sources  including  social  media,  physical 
activity trackers, electronic health records, insurance claim databases, patient registries, health 
surveys and observational studies, provided that the requirements of the GDPR are complied 
with.  

Real world data is big data, but the term specifically refers to any type of data not collected in 
a randomised clinical trial. This data can complement randomised clinical trial data to fill the 
knowledge gap between clinical trials and clinical practice, provide new insights into disease 
patterns and help improve the safety and effectiveness of health interventions.  

Patients  selected  for  randomised  clinical  trials  often  have  characteristics,  experiences,  and 
treatment  protocols  that  differ  from  patients  in  daily  practice  and  therefore  it  may  not  be 
possible to generalise the information gained in randomised clinical trials to a broader group 
of  patients.  There  can  also  be  a  large  uncertainty  on  the  health  gain  obtained  with  a  new 
product  based  on  randomised  clinical  trial  findings  due  to  possible  differences  in  the  way 
patients and healthcare providers are going to use the product in real life. Randomised clinical 
trials may also be particularly difficult to conduct for some health interventions when the size 
of the population to be treated is small. This applies in the case of orphan products and may 
apply  to  personalised  medicines.  Moreover,  due  to  the  typically  short  follow-up  of 
randomised  clinical  trials,  long-term  health  outcome  cannot  always  be  captured.  Cost-
effectiveness analyses are thus often based on predicted outcomes relying on intermediate or 
surrogate outcomes.  

132 Biology and control of vector-borne infections in Europe (https://www.edenext.eu/) 
133 Innovative tools and strategies for surveillance and control of dengue 

(https://cordis.europa.eu/project/rcn/100455_en.html)  

134 Fighting Zika Virus and Building Long-term Outbreak Response Capacity in Latin America 

(https://zikaplan.tghn.org/about-zikaplan/) 

135 Global alliance for Zika virus control and prevention (https://zikalliance.tghn.org/) 
136 Transparent communication in Epidemics: Learning Lessons from experience, delivering effective Messages, 

providing Evidence (https://www.tellmeproject.eu/)  

36 

 
 
                                                            
Real  world  data  is  increasingly  used  for  regulatory  purposes  and  Health  Technology 
Assessment. The objective is to provide (early) access to innovative health interventions while 
ensuring safety and efficacy. After authorisation, real world data can contribute in the health 
technology assessment process by better predicting the effectiveness of the new treatment in 
daily  practice or  to  serve as  input in payment model such  as  outcome-based managed  entry 
agreement.  In  such  cases,  price  and  reimbursement  conditions  that  have  been  agreed  on  at 
launch  can  be  reviewed  over  time,  comparing  real  world  data  with  initial  predicted  health 
outcomes.  

Challenges related to the use of real world data 

However, despite technological advances in big data mining and analytics, there are a number 
of  issues  that  prevent  the  wider  use  of  real  world  data.  In  particular,  generating,  collecting, 
storing  and  exploiting  such  real  world  data  poses  methodological  and  legal  challenges 
regarding the further processing of data as there is no widely accepted regulatory guidance.  

In this context, Regulatory Science can enhance the scientific basis of the regulatory process, 
by  integrating  data  from  relevant  sources  outlined  above.  These  include  Electronic  Health 
Record information, Real Word Data and other healthcare parameters. It offers an incentive to 
accelerate understanding of the spectrum of action of potentially new healthcare products in 
ways pertinent to the personalisation of healthcare.  

EU actions to support use of Real World Data 

Increasing the use of real world data is being addressed through a variety of EU initiatives in 
the  fields  of  research,  regulation  of  medical  products,  therapies  and  health  technology 
assessment.  The  Joint  European  Medicines  Agency  and  Head  of  Medicines  Agencies 
(EMA/HMA)  Task  Force  on  Big  Data  is  exploring  how  medicine  regulators  can  use  real 
world  data  to  support  research,  innovation  and  medicines  development  for  the  benefit  of 
human  and  animal  health.  The  Joint  Action  European  Network  for  Health  Technology 
Assessment137  is  producing  evidence  generation,  with  a  focus  on  patient  registries  and, 
looking to the future, the European Commission plans to strengthen EU cooperation on health 
technology assessment post 2020, including issues related to real  world data generation and 
use.  In  the area  of transplant  medicine, the Commission, national competent authorities and 
professionals are exploring how real world data could be integrated into regulatory oversight.  

Additionally,  the  public-private  partnership  Innovative  Medicines  Initiative  is  making  an 
important  contribution  to  realize  the  potential  of  Big  Data,  including  real  world  data  in  the 
context  of  European  healthcare.  However,  more  efforts  are  needed  to  guide  clinicians, 
researchers,  regulatory  and  health  decision-makers  on  the  collection  and  translation  of  real 
world data into meaningful health outcomes. The outcomes and lessons learned from some of 

137 https://www.eunethta.eu/ 

37 

 
 
 
                                                            
the initiatives could catalyse such  efforts and be highly instrumental for the development of 
EU level guidance to engage data holders to optimize real world data collection, sharing and 
use. For example: 

  The  European  Medical  Information  Framework  project  (EMIF-AD  &  EMIF-
Metabolic)  aims  to  federate  heterogeneous  sources  of  real  world  data  to  help 
researchers  understand  how  treatments  work  when  applied  in  clinical  practice 
environments and provide new insights into disease patterns. Methodology and tools 
developed  in  these  projects  can  be used  to  improve  both  medical  product  safety  and 
effectiveness by targeting subgroups of patients who stand to benefit the most.  

 

In  the  area  of  product  development  (in  view  of  regulatory  process),  the  Electronic 
Health Record for Clinical Research (EHR4CR) aims to facilitate clinical trial design 
and  patient  recruitment  which  in  turn  allows  to  shorten  clinical  trial  phase  and 
accelerate access for patients to new treatments, targeting patient population, lowering 
clinical trial costs. 

  To  support  the  Health  Technology  Assessment  (HTA)  process,  the  GET  REAL138 
project aims to provide methods and tools to better assess the effectiveness of the new 
treatment in daily practice (e.g. methods to combine randomised clinical trial data and 
real world data). In addition, two H2020 projects (IMPACT-HTA and COMED) that 
started in January 2018, investigate the same issue. 

  To  support  the  regulatory  process,  the  development,  authorisation  and  vigilance  of 
(novel)  transplant  and  transfusion  therapies,  the  GAPP  Joint  Action  (facilitating  the 
authorisation  and  preparation  process  for  blood,  tissues  and  cells)  is  engaging  27 
regulatory  authorities  and  professional  associations  to  provide  a  stronger  evidence 
basis through the use of clinical real world data by regulatory authorities.  

In addition to these initiatives on real world data, several EU-funded projects working on big-
data (including MIDAS139, BigO140, IASIS141, PULSE142, CrowdHEALTH143, EVOTION144) 
focus  on  how  to  better  acquire,  manage,  share,  model,  process  and  exploit  data  to  develop 
integrated solutions that support  public health authorities in healthcare system  management, 
long-term policy making and increase the ability to provide actionable insights at the point of 
care. Bigmedylitics, a large scale pilot of EUR 17 million (EUR 15 million of EU funding) 
was  launched  in  January  2017  to  deliver  a  big  data  healthcare  analytics  platform  and 

138 New methods for RWE collection and synthesis (http://www.imi-getreal.eu/)  
139 Meaningful integration of data, analytics and services (http://www.midasproject.eu/)  
140 Big data against childhood Obesity (https://bigoprogram.eu/) 
141 Big data for precision medicine (http://project-iasis.eu/)  
142 Platform for European Medical Support During Major Emergencies (http://www.pulse-fp7.com/) 
143 Integration of high volumes health-related heterogeneous data from multiple sources with the aim of 

supporting policy making decisions (http://www.crowdhealth.eu/)  

144 Big data supporting public hearing health policies (http://h2020evotion.eu/)  

38 

 
 
 
                                                            
components, enabling  data integration to  support healthcare  innovation.  It involves  12 large 
scale pilots in different fields of application. 

3.3. Remaining challenges at the EU-level 

It  is  widely  acknowledged  that  not  one  Member  State  alone  will  be  able  to  develop  the 
expertise,  data  capacity  and  infrastructure  needed  to  accelerate  diagnosis,  personalised 
treatment and prevention of diseases, particularly if compared with major emerging initiatives 
on personalised medicine such as those being pursued in the United States and China.  

EU actions to support coordinating national and regional initiatives in personalised medicine 
and  genomics,  and  the  establishment  of  a  digital  infrastructure  with  associated  technical 
agreements  to  allow  sharing  of  expertise  and  distributed  access  to  health  data  sets  stored in 
different  locations  across  the  EU,  could  help  the  EU  Member  States  remain  competitive  in 
providing  the  Union's  population  with  the  most  advanced  medical  and  care  solutions.  This 
could  also  allow  them  to  explore  the  potential  of  innovation  to  support  the  future 
sustainability and resilience of healthcare systems. If the Union can achieve the scale to match 
other investments in the global race for personalised medicine, European companies may be 
better positioned to capture investment and explore personalised medicine solutions, allowing 
EU citizens access to innovative and personalised therapies. 

It is equally important to explore synergies between the EU and Member States research and 
innovation actions, particularly defining together the areas of future pilots that can exploit the 
potential of genomic data at the EU-level. Cooperation with health professionals will also be a 
key element for the success of data driven innovations in healthcare and for taking advantage 
of  the  new  opportunities  arising  from  big  data,  such  as  interpretation  of  information  for 
genetic assessment to improve diagnosis and treatment.  

Faster  scientific  advances  can  be  achieved  through  pooling  resources  at  EU-level.  Pooling 
resources in a decentralised / distributed model that provides cross-border access to expertise, 
data and computing capacity (without centralising these resources) can accelerate research in 
areas such as genetics, cancer treatment or infectious diseases outbreaks and is only possible 
through EU cooperation encompassing a network of multiple public authorities and research 
organisations across the EU. Maximising the use of real world data can fill knowledge gaps 
between clinical trials and clinical practice; however more efforts are necessary to engage and 
guide stakeholders, in particular clinicians, into the sharing of such data.  

Faster diagnosis and more personalised treatment of rare genetic diseases can be achieved if 
scientific  expertise  and  data  are  pooled  across  borders,  significantly  reducing  the  estimated 
5.6 years on average that it takes to diagnose a rare disease in Europe. With high performance 
computing, infectious diseases can be identified earlier, preventing outbreaks across the EU.  

Access  to  larger  volumes  of  health  data  pooled  securely  across  borders  maximising  the 
potential  of  Exascale  high  performance  computing  could  vastly  improve  and  accelerate 

39 

 
 
 
development  of  new  therapies.  Freedom  of  movement  requires  EU-wide  coordination  is 
necessary  for  an  effective  and  sustainable  response  to  infectious  threats  across  the  Union 
territory. The EU is ideally placed to support the protection of EU citizens and Member States 
from major public health threats, by helping to prevent health threats spreading and providing 
rapid responses when a threat emerges - but also helping to ensure that there is a robust data 
and computing capacity to anticipate epidemics.  

Personalised  treatments  for  complex  diseases  like  cancer  require  the  ability  to  process  very 
large  amounts  of  data,  while  applying  methods  of  interpreting  data  and  extracting  new 
knowledge such as computer modelling, machine learning or artificial intelligence.  

Personalisation  of  health  requires  interconnection  of  data  sources  (patient,  hospital,  bio-
banks),  biological  levels  (molecular,  genetic,  imaging,  behavioural),  and  disciplines 
(medicine,  pharmacology,  social  sciences  and  humanities).  A  convergent  effort  to  build  a 
whole new framework focused more on big data is needed, able to understand the molecular 
interactions and to support diagnostic image processing and running of predictive models, in 
order  to  diagnose  much  earlier  and to  select  the  best  therapeutic  strategies.  This  framework 
needs to be based on advanced computing and clever algorithms. While clinical applications 
may need a combination of multiple computational strategies adapted to the heterogeneity of 
data and careful protection of sensitive data, simulations in research (that can complement the 
testing of biomedical products and other experimental results) process and also generate new 
data likely to require exascale computing.  

Covering gaps for both health and research data infrastructures will significantly improve the 
understanding  of  cancer  and,  consequently,  the  impact  of  cancer  treatments.  European  and 
Member States research is supported today by multiple initiatives that continuously generate 
data. A few platforms/repositories for medical data and computer-models storing/sharing and 
for  clinical  workflows  simulations  exist.  Based  on  the  use  of  high-performance  computing 
and  cloud  infrastructures,  they  show  how  dedicated  health  data  infrastructures  can  advance 
research  and  personalised  medicine  in  medical  applications  like  brain  aneurysm,  leukaemia 
and solid cancers. 

The mapping and connecting of these initiatives using cloud and high-performance computing 
data infrastructures will already mean a first step for progress. EU coordination and support to 
federate  these  e-infrastructures  and  further  connections  with  Euro-HPC  and  EOSC  services 
will contribute to build a common data infrastructure effective in managing the health-related 
big  data  and  preparing  the  ground  for  a  predictive,  preventive,  personalised  and  safe 
medicine.  

The  establishment  of  a  shared  data  and  computation  infrastructure,  as  well  as  pooling  of 
scientific and medical expertise, is critical for Europe to benefit from the power of big data 
and  analytics  to  offer  citizens  early  diagnosis  of  diseases  and  new  personalised  treatments. 
This would lead to faster diagnosis of rare diseases (this will need cross-border data brought 
together),  would  allow  for  faster  identification  of  and  response  to  infectious  diseases  and 
would  also  allow  for  the  development  of  personalised  medicine.  A  European  data  and 

40 

 
 
computation infrastructure could support access to large volumes of health-related data across 
borders based on which prevention, diagnosis and therapy development could be improved. 

Possible national  laws further specifying  the General Data  Protection Regulation in specific 
areas  must  not  undermine  the  objective  of  the  free  flow  of  personal  data  in  the  Union  (see 
recital 53 of the General data Protection Regulation). If that were  to  happen,  major  barriers 
could  be  created  for  achieving  the  required  critical  mass  of  data  to  succeed  in  providing 
personalised medicine solutions for European health systems and citizens. In this context, new 
emerging  cybersecurity  solutions  building  on  trusted  distributed  data  ledgers  for  protecting 
the  access  to  personal  health  data  such  as  blockchain  could  play  an  essential  role  if 
implemented  systematically  across  Europe  as  part  of  the  national  and  EU  level  data  and 
computation infrastructures for personalised medicine.  

41 

 
 
 
4.  DIGITAL  TOOLS  FOR  CITIZEN  EMPOWERMENT  AND  PERSON-
CENTRED CARE  

4.1. Challenges for health systems and the strive for affordable innovative solutions 

4.1.1. Coping with an epidemic of chronic conditions 

The  "Health  at  a  Glance:  Europe  2016"  report145  revealed  that  across  the  EU  deaths  from 
major non-communicable diseases translate into around 3.4 million potentially productive life 
years  lost,  or  EUR  115  billion  in  potential  economic  loss  each  year  for  the  EU  economies. 
Moreover, large health inequalities persist in EU Member States between people with higher 
levels of education and income and the more disadvantaged, largely due to different exposure 
to health risks, but also to disparities in health behaviour and access to high quality care.  

In  addition  to  suffering  and  premature  deaths,  non-communicable  diseases  account  for  the 
vast bulk of the money spent by health and social systems. Up to 7% of GDP  is unnecessarily 
lost due to the impact of non-communicable diseases that are, to a large extent, preventable. 
Many  non-communicable  diseases  share  the  same  behavioural  risk  factors:  tobacco  use, 
alcohol  consumption,  unhealthy  diet,  physical  inactivity.  According  to  recent  estimations, 
more  than  30%  of  the  overall  disease  burden  in  the  EU  can  be  attributed  to  such  risk 
factors146. 

Prevention  of  disease  and  promotion  of  healthy  living  are recognised as  essential  principles 
for reducing the health burden related to both communicable and non-communicable diseases, 
requiring  cooperation  across  borders  and  coordination  within  the  EU147.  Investing  in  health 
promotion  and  disease  prevention  can  be  cost-effective148,  yet  EU  Member  States  allocate 
only around 3% on average of their health budget to public health and prevention, according 
to  "Health  at  a  Glance:  Europe  2016".  Importantly,  prevention  comprises  promotion  of 
healthy lifestyles  (individual lifestyle choices such as  not  smoking, eating healthy, avoiding 
alcohol and exercising more) underpinned by policy choices that help create school, work and 
community environments conducive to leading healthy lifestyles.  

The  need  to  shift  the  focus  from  sickness  and  cure  to  promoting  health  and  disease 
prevention,  including  combating  health  inequalities,  is  well  recognised  at  national  and  EU 

145 OECD/EU (2016), Health at a Glance: Europe 2016  – State of Health in the EU Cycle, OECD Publishing, 

Paris. http://dx.doi.org/10.1787/9789264265592-en  

146 Institute for Health Metrics and Evaluation, http://ghdx.healthdata.org/gbd-results-tool  
147 Art. 168 of the Treaty on the Functioning of the European Union emphasises disease prevention and health 
protection  and  encourages  cooperation  between  Member  States  in  liaison  with  the  Commission,  especially 
regarding guidelines and indicators, the organisation of exchange of best practice, and the preparation of the 
necessary elements for periodic monitoring and evaluation 

148  "Promoting  Health,  Preventing  Disease.  The  economic  case",  WHO  Europe,  OECD  &  the  European 

Observatory on Health Systems and Policies Series, 2015 

42 

 
 
 
                                                            
level149.  It  has  been  highlighted  in  the  Joint  Report  on  Health  Care  and  Long-Term  Care 
Systems  and  Fiscal  Sustainability150,  as  one  of  the  recommended  policy  options  to  enhance 
the fiscal sustainability and cost-effectiveness of health systems.  

To  face  the  challenges  which  non-communicable  diseases  pose  to  health  systems,  Member 
States have committed to reaching the voluntary targets of the United Nations/World Health 
Organisation  on  non-communicable  diseases  by  2025151.  The  European  Commission  is 
committed  to  support  Member  States  in  reaching  these  goals  which  go  hand  in  hand  with 
Sustainable  Development  Goal  3  related  to  healthy  lives  and  well-being  for  all  at  all  ages, 
notably Goal 3.4 concerning non-communicable diseases, including mental health. 

The Member State Steering Group on Health Promotion and Prevention and Management of 
Non-Communicable Diseases provides strategic advice to the Commission and is a forum for 
consultation among Member States on the strategic planning in this area of health including 
the selection of best practices for transfer and scale-up within and across countries. This work 
is complemented by pertinent pan-EU collaborative actions, such as the joint actions on non-
communicable diseases and healthy ageing "CHRODIS" (2013-2017) and "CHRODIS PLUS" 
(2017-2020) co-funded by the 3rd Health Programme. 

4.1.2. People at the heart of reformed health and social care models 

The  ageing  of  the  population  and  rising  prevalence  of  chronic  conditions  are  increasing  the 
demand  for  health  and  social  care.  This,  combined  with  workforce  shortages,  is  putting  the 
standards  of  care  and  the  sustainability  of  health  and  social  care  systems  at  risk.  Member 
States  and  regional  authorities  are  looking  for  innovative  approaches  to  address  these 
challenges and have been embarking on reforms of their health and long-term care systems, 
with the goal of achieving sustainable, effective and accessible care for all. These reforms aim 
at  shifting  care  from  hospital  to  primary,  community  and  home  settings,  adopting  person-
centred approaches that integrate care152,153 across the continuum of health and social care154. 
In  such  reformed  care  models,  the  citizens,  their  families  and  informal  caregivers  have  a 
significant role in the provision of healthcare together with care authorities.  

Firstly, an important element in person-centred care is that citizens become more involved in 
their care and engage in self-management of their well-being and health conditions. This is by 
participating  actively  in  prescribed  measures  for  health  promotion,  disease  prevention, 

149 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52009DC0567&from=EN 
150  Prepared  by 

the  European  Commission  and 

the  Economic  Policy  Committee,  October  2016. 

https://ec.europa.eu/info/publications/economy-finance/joint-report-health-care-and-long-term-care-systems-
fiscal-sustainability-0_en     

151 http://www.who.int/nmh/ncd-tools/definition-targets/en/  
152 "WHO global strategy on people-centred and integrated health services", World Health Organisation, 2015. 
153  Council  Conclusions:  Towards  modern,  responsive  and  sustainable  health  systems,  OJ  C  202,  8.7.2011,  p. 

10–12  

154  Examples  can  be  found  in  the  Reference  Sites  and  the  regions  participating  in  the  Action  Groups  of  the 

European Innovation Partnership on Active and Healthy Ageing. 

43 

 
 
                                                            
adherence  to  treatment  and  management  of  chronic  conditions.  In  other  words,  citizens  are 
empowered to support from their side the sustainability of health and social care systems.  

Secondly,  citizens  empowered  in  the  way  described  above,  can  become  a  valuable  "human 
resource"  to  health  and  social  care  systems.  This  is  crucial  considering  the  various  issues 
regarding  the  workforce  in  health  and  social  care,  which  have  been  identified  for  many 
years155  such  as:  challenges  related  to  recruitment  and  retention  of  health  and  social  care 
professionals, adverse demographic trends in workforce, difficult working conditions, lack of 
career  perspectives  for  low-skilled  health  and  social  care  staff,  as  well  as  the  need  for  new 
skills in digital technologies and new roles in reformed care models.  

Finally, citizens can also help improve the quality of care, by having the possibility to provide 
healthcare  professionals  with  feedback  and  health  data  related  to  their  treatment  or  health 
condition.  Such  data,  typically  referred  to  as  patient-reported  experiences  (PREMs)  and 
patient-reported  outcomes  (PROMs)  are  of  great  relevance  to  patient-centred  care  and  can 
present  decision-makers  with  evidence  to  help  them  improve  health  outcomes  and  allocate 
resources more efficiently. An example can be found at the Martini Klinik in Germany, which 
specialises  in  prostatectomy  and  focuses  on  outcomes  that  matter  to  patients,  not  only  to 
mortality  reduction.  The  achieved  results  present  a  large  improvement  in  patient-reported 
outcomes  when compared to  other hospitals in Germany; namely in  cases of severe erectile 
dysfunction  and  incontinence156.  The  EU  Expert  Group  on  Health  Systems  Performance 
Assessment  has  recommended  that  greater  attention  should  be  given  to  the  assessment  of 
patient experiences such as PREMs and PROMs157.  

The  Active  and  Assisted  Living  Joint  Programme158  also  provides  important  indicators  to 
demonstrate the general benefit of involving users to meet real end-user needs and priorities 
in the innovation design processes, from idea creation to product testing and business model 
development159. The projects in this programme adopt a multidisciplinary approach, including 
the  close involvement  of  end-users at  all stages  of  new  solutions  and  product  design.  Users 
account  for  an  average  of  18%  of  project  participants.  This  active  user  involvement 
determines  actual  user  needs  instead  of  merely  guessing  or  generalising  what  makes  the 
difference between a real innovation for users or a simply interesting technical development. 
It also lowers the barriers for large-scale deployment of ICT-based solutions. 

As  indicated  above,  the  digital  transformation  and  new  care  models  require  health  and  care 
professionals  to  develop  new  skills  and  competences  in  a  range  of  aspects:  using  digital 
technologies, devices and data; new roles, knowledge and techniques to support patients with 

155 "Adequate social protection for long-term care needs in an ageing society", Report jointly prepared by the 
     Social Protection Committee and the European Commission, 2014. 
http://ec.europa.eu/social/BlobServlet?docId=12808&langId=en 

156 https://www.martini-klinik.de/en/results/  
157 "So what? Strategies across Europe to assess quality of care". Report by the Expert Group on Health Systems 

Performance Assessment, 2016 

158 http://www.aal-europe.eu/  
159 http://www.aal-europe.eu/wp-content/uploads/2015/02/AALA_Guideline_YOUSE_online.pdf  

44 

 
 
                                                            
multiple  chronic  conditions  and  to  allow  better  health  promotion  and  disease  prevention; 
working in multi- and inter-disciplinary teams; and new ways of working to provide care at a 
distance. Without these, health system transformations, such as the one to digitally-supported 
person-centred  care,  are  at  risk  due  to  resulting  skills  mismatches  of  health  and  care 
professionals. Equally important is the need for citizens and patients to improve their health 
and  digital  literacy  in  order  to  assume  greater  responsibility  for  their  health  and  engage  in 
self-care. 

4.1.3 The role of digital solutions 

There  is  a  growing  body  of  evidence  to  support  arguments  that  digital  solutions  can  bring 
better  health  and  care  outcomes  for  citizens  and  contribute  to  improving  the  effectiveness, 
accessibility and resilience of health and care systems160, when designed purposefully with the 
involvement of users and implemented on the basis of cost-effective criteria.  

This can be illustrated by the following examples:  

  Health information portals, smartphones and mHealth apps empower citizens to take a 
more  active  role in  looking  after their  health,  change  their  health  behaviours  (within 
supportive environments) and engage in primary disease prevention.  

  Digitally  connected  portable  devices,  sensors  and  apps  can  support  patients  in  their 
adherence  to  treatments,  managing  their  chronic  conditions  at  their  own  home,  and 
providing  health  data  to  their  healthcare  professionals  as  well  as  feedback  on  the 
quality of the health and care they receive.  

  Electronic  health  records  and  telemedicine  can  facilitate  the  working  conditions  and 
the collaboration among health and social care professionals in delivery of integrated 
care services,  also  outside  hospital settings,  and  can  improve  patient  management  as 
well as access of citizens to healthcare by overcoming geographical distances. 

Patient  and  user-generated  health  and  care  data  are  expected  to  further  proliferate  in  the 
coming  decade,  creating  continuously  evolving  and  learning  health  systems161.  This  could 
potentially disrupt the established status quo of health and social care delivery, opening up the 
ability  to  deliver  more  targeted  health  and  social  care  services  to  citizens,  and  unlocking 
opportunities for new, data-driven economic models in public and consumer markets162. 

160  "The  Impact  of  eHealth  on 

the  Quality  &  Safety  of  Healthcare",  Imperial  College  London,  
http://www.ehealthnews.eu/images/stories/Impact_of_eHealth.pdf    &    "Monitoring  and  Evaluating  Digital 
Health Interventions: A practical guide to conducting research and assessment", World Health Organisation, 
2016 

161 In terms of data production, the landscape is changing dramatically – from the amount of data produced, who 
produces it, to the way it is stored and used. According to the eHealth Task Force Report "Redesigning health 
in Europe for 2020", “experts point to a 4300% increase in annual data generation between 2012 and 2020” 
https://joinup.ec.europa.eu/sites/default/files/document/2014-12/eHealth%20Task%20Force%20Report%20-
%20Redesigning%20health%20in%20Europe%20for%202020%20-%20Part%20I_0.pdf  

162 The healthcare analytics market is expected to reach USD 24.55 Billion by 2021 from USD 7.39 Billion in 
2016 at a compound annual growth (CAGR) of 27.1% from 2016 to 2021. Moreover, the use of analytics in 
precision and personalised medicine, an increasing focus on value-based medicine and cloud-based analytics, 

45 

 
 
                                                            
 
Patient-reported  outcomes  have  proven163  most  effective  if  collected  and  processed  through 
digital means. Advantages include simple and reliable data storage, enhanced mechanisms to 
improve completion by patients (as compared to non-digital PROMs) and better accessibility 
through customised interfaces. However, more effort is needed164 to reach the necessary scale 
at  which  one  can  make  full  use  of  the  valuable  information  generated  by  patient-reported 
outcomes:  this  includes  infrastructure,  training  of  staff,  demonstration  of  benefits  and 
engagement of citizens. 

4.2. State of Play 

4.2.1 Relevant initiatives and evidence 

To  realise  the  potential  of  digital  solutions  to  facilitate  access  to  healthcare  in  a  fair  and 
inclusive  way,  the  eHealth  Stakeholder  Group  has  made  a  number  of  recommendations 
regarding  "Health  inequalities  and  eHealth"165  including:  improving  access  to  eHealth  and 
involving  all  stakeholders;  accommodating  diverse  needs;  improving  digital  health  literacy; 
integrating eHealth into the overall health and social care system policy; evaluating the impact 
of  eHealth  solutions  and  building  up  an  evidence  base;  giving  specific  consideration  to 
empowering patients with disabilities or specific diseases; and considering financial subsidies 
for the purchase of eHealth equipment / ICT access. 

The  literature  on  the  impact  of  telehealth  solutions  for  chronic  conditions  suggests  that 
telehealth  can  reduce  hospital  admissions  and  mortality  for  chronic  heart  failure  patients, 
improve blood pressure control in patients with hypertension, reduce hospital admissions for 
chronic obstructive pulmonary disease and improve glycaemic control in diabetes166, 167, 168,169. 

Concerning cost-effectiveness, the evidence base is less clear, with most of the studies being 
of insufficient  quality. The lack of robust evidence is partly due to the absence  of available 

an increasing number of patient registries, and the emergence of social media and its impact on the healthcare 
industry provide significant growth opportunities in the market. North America is expected to dominate the 
global  market  in  2016,  with  the  USA  accounting  for  a  major  share  of  this  regional  market.  Source: 
http://www.marketsandmarkets.com/Market-Reports/healthcare-data-analytics-market-905.html  

163 Shah KN et al. Patient-Reported Outcome Measures: How Do Digital Tablets Stack Up to Paper Forms? A 

Randomized, Controlled Study,  American Journal of Orthopedics 01 Nov 2016, 45(7):E451-E457, 
http://europepmc.org/abstract/med/28005113. 
164 https://www.ncbi.nlm.nih.gov/books/NBK361255/  
165 http://ec.europa.eu/information_society/newsroom/cf/dae/document.cfm?doc_id=5170  
166 Brettle AJ et al. Telehealth: The effects on clinical outcomes, cost effectiveness and the patient experience: a 

systematic overview of the literature, University of Salford, accessible at 
http://usir.salford.ac.uk/29392/1/Telehealth_v8_.pdf 

167 Inglis SC et al. Structured telephone support or non-invasive telemonitoring for patients with heart failure. 

Cochrane Database of Systematic Reviews 2015, Issue 10. Art. No.: CD007228. DOI: 
10.1002/14651858.CD007228.pub3.   

168 Flodgren G et al. Interactive telemedicine: effects on professional practice and health care outcomes. 

Cochrane Database of Systematic Reviews 2015, Issue 9. Art. No.: CD002098. 
DOI:10.1002/14651858.CD002098.pub2. 

169 "TECS evidence base review. Findings and recommendations", NHS England, April 2017. 

46 

 
 
 
                                                                                                                                                                                          
data collected over long periods of time. Experts argue that it can take several years to see a 
clear impact in terms of cost-effectiveness at health system level. There are, however, some 
examples which have demonstrated cost-effectiveness and even cost-savings: 

  The home telehealth services of the Veterans Health Administration in the USA have 
achieved lower patient mortality, 59% reduction of bed days of care, 35% reduction in 
hospital admissions and savings of USD 1,999 per patient per year170. 

 

  The  Telecare  Development  Programme  in  Scotland  brought  efficiency  gains  of 
approximately  GBP  78.6  million  over  a  five  year  period  (2006-2011)  thanks  to 
expedited  hospital  discharges,  avoided  hospital  and  care  home  admissions  and  bed 
days, and reduced home check visits171. 
In the German region of Kinzigtal, an integrated care programme making use of ICT 
solutions has led to lower mortality and increased life expectancy of enrolled patients, 
morbidity-adjusted efficiency gain of 16% of the total costs, and reduction of 16.9% in 
per-capita  expenditure  of  enrolled  policy  holders  versus  those  in  the  control  group 
over the period 2005-2010. Data from eight years of activity (2006-2014) has shown 
close  to  3%  net  annual  saving  for  the  health  insurance  funds,  considering  all  policy 
holders in Kinzigtal, whether enrolled in the integrated care programme or not172. 

A common element in these examples is that the evidence of cost-effectiveness became clear 
after  the  accumulation  of  data  from  thousands  of  patients  over  years  of  operations.  This 
reinforces the argument that the return on investment will not appear immediately and that a 
systematic approach to evaluation is required, which relies on evidence from a large number 
of patients receiving actual services rather than on short-duration project trials.  

Another  observation  is  that  it  matters  greatly  how  a  new  care  model  using  digital  tools  is 
designed  and  implemented  to  fit  the  local  context  and  user  needs.  In  other  words,  "how"  a 
care  model  with  a  digital  solution  is  implemented  determines  its  success  or  failure.  This 
emphasises  the  importance  of  spreading  knowledge  and  building  stakeholder's  capacity  on 
"how" to implement successfully.  

Several initiatives across Europe have promoted collaboration of a wide range of stakeholders 
in developing, testing and replicating innovative approaches to health and care services, in the 
field  of  disease  prevention,  integrated  care  and  new  ways  for  managing  non-communicable 

170 Darkins et al. Reduced cost and mortality using home telehealth to promote self-management of complex 

chronic conditions: a retrospective matched cohort study of 4,999 veteran patients. Telemed J E Health. 2015 
Jan;21(1):70-6. doi: 10.1089/tmj.2014.0067. &  

     Telehealth Services in the Department of Veterans Affairs (VA) accessible at http://www.e-

healthpolicy.org/docs/2014_Sessions/Darkins.pdf  

171 Joint Improvement Team for the Scottish Government, An Assessment of the Development of Telecare in 

Scotland 2006-2010, 2010  &  

     European Commission, European Innovation Partnership on Active and Healthy Ageing Reference Sites: 

Excellent innovation for ageing - A European Guide, 2013   

172 Gesundes Kinzigtal Case Study Report, Strategic Intelligence Monitor on Personal Health Systems Phase 3 

(SIMPHS3), European Commission Joint Research Centre, 2014, 
http://publications.jrc.ec.europa.eu/repository/bitstream/JRC93763/jrc93763.pdf 

47 

 
 
                                                            
diseases  and  co-morbidities,  often  with  the  use  of  digital  solutions  such  as  telehealth  and 
mHealth.  The  European  Innovation  Partnership  on  Active  and  Healthy  Ageing  (EIP  on 
AHA)173, the Active and Assisted Living Joint Programme (AAL)174, the EIT Health175, and 
the  Joint  Action  CHRODIS176  are  such  examples  of  transnational,  inter-regional  and  inter-
sectoral collaborations. These have been brought to light good practices, produced tools and 
guidance  and  have  been  supporting  mutual  learning  and  knowledge  exchange  with  the 
purpose of facilitating the deployment of innovative solutions for health and care177.   

4.2.2. Low uptake of digital health from pilot to large-scale deployment 

There is a growing observation of low scalability of digital health and care approaches from 
pilots  to  large-scale  deployment  and  widespread  uptake.  Despite the recognised  potential  of 
integrated,  person-centred  care  models  and  the  digital  transformation  of  health  and  care 
provision,  benefits  have  not  come  to  fruition  in  many  cases  as  initiatives  remain  at  project 
stage and do not permeate health and care provision at scale. Implementing such innovations 
at large scale, to offer services to all citizens who can benefit from them, is a major challenge.  

Most stakeholders acknowledge that technology itself is no longer the problem in this regard. 
Instead, organisational and financing issues (such as commitment from authorities, the need to 
re-configure services, new patient pathway designs, new roles and skills for health and social 
care  professionals,  interoperability,  privacy  and  data  protection,  sustained  investments  and 
new  governance,  contracting  and  payment  schemes)  as  well  as  the  diversity  of  European 
health  and  care  systems  and  the  associated  market  fragmentation  for  technology  providers 
constitute important obstacles and prevent statistically sound evaluation178. 

173 https://ec.europa.eu/eip/ageing/home_en  
174 www.aal-europe.eu  
175 https://www.eithealth.eu/  
176 http://chrodis.eu/  
177 - Repository of Good Practices of the European Innovation Partnership on Active and Healthy Ageing: 

https://ec.europa.eu/eip/ageing/repository_en     

- The "How To" Guide of the Reference Sites of the European Innovation Partnership on Active and Healthy 

Ageing: http://ec.europa.eu/research/innovation-union/pdf/active-healthy-ageing/how_to.pdf 

- Repository of Good Practices on chronic diseases from the Joint Action CHRODIS: http://platform.chrodis.eu/  
- The Multimorbidity care model from the Joint Action CHRODIS: http://chrodis.eu/wp-
content/uploads/2017/02/deliverable-7-02-of-joint-action-chrodis_final.pdf       

- The Maturity Model, developed by the Action Group on Integrated Care of the EIP on AHA, for assessment of 

readiness to adopt integrated care: http://www.scirocco-project.eu/maturitymodel/   

178 Synthesis report on the public consultation on the European Innovation Partnership on Active and Healthy 

Ageing (http://ec.europa.eu/health//sites/health/files/ageing/docs/consult_report_en.pdf)  

48 

 
 
                                                            
Example: Pilots and the "Valley of Death" 

The  EU  project  FICHe  (2013-2016)  challenged  European  SMEs  to  develop  applications  using 
Future  Internet  technology  (FIWARE)  for  the  Health  market.  The  project  followed  a  funnel 
approach: from 308 entries, 80 were selected to propose a Business Plan. Out of them, 40 were 
asked to prepare a Concept. Finally, only 20 received support to test a Pilot in collaboration with 
customers in one of the three regional field labs located in Spain, Finland and the Netherlands. 

Seven companies tested their solutions in the same number of hospital departments belonging to 
the Regional Healthcare Provider of Murcia (Spain). Out of the pilots, five turned out to deliver 
quite positive results for both the companies and the healthcare organisation. 

However, once the funding was over, this Healthcare organisation has been struggling to scale 
the successful pilots into wide adoption. There is currently no culture, governance or incentives 
to internally scale the solutions, which likely result in the non-adoption of the innovations in the 
near future. For this reason, EU added-value is expected to be high for potential candidates for 
scaling-up  or  knowledge  sharing,  since  few  regions  have  so  far  built  up  such  a  framework. 
Experience  sharing  could  be  particularly  valuable  for  less  advanced  regions,  not  as  a  specific 
benefit on a specific topic, but rather as a more general strategic approach. 

(Original case study: https://www.ticbiomed.org/english/beyond-pilots-scaling-up-innovation/) 

In the UK, the "Whole System Demonstrator" programme provided positive evidence of the 
use of telehealth and telecare, for instance a significant reduction in mortality rates for chronic 
conditions179. In  addition, the  Department of Health estimated potential  savings of GBP 1.2 
billion  through  telecare  and  telehealth  over  five  years.  The  Department  launched  the  "3 
Million Lives" campaign which aimed to encourage industry to develop new business models, 
to  emphasise  patient  education  and  to  support  health  and  social  care  professionals  in 
implementing  telehealth  and  telecare.  However,  the  campaign  failed  to  reach  the  desired 
impact on deployment. According to a paper180 prepared for the National Assembly of Wales 
Health and Care Committee, among the reasons was the approach taken, as it was perceived 
too  top-down  and  industry-led,  and  that  improvements  were  not  entirely  attributable  to 
technology.  Practitioners  and  users/patients  were  not  sufficiently  involved.  A  longitudinal 
qualitative  analysis  of  a  GBP  37  million  national  health  programme  ("Delivering  Assisted 
Living  Lifestyles  at  Scale",  DALLAS) 
the 
implementation of digital health at scale (see recommendations181). 

identified  barriers  and  facilitators  for 

The 2016 innovation twinning exercise of the European Innovation Partnership on Active and 
Healthy  Ageing  is  an  integral  part  of  the  Partnership's  scaling-up  strategy.  Twenty  pairs  of 
"originators"  and  "adopters"  of  good  practices  were  selected  by  the  European  Commission 

179 Steventon A. et al. for the Whole System Demonstrator Evaluation Team," Effect of telehealth on use of 

secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial", BMJ 
2012;344:e3874 doi: 10.1136/bmj.e3874   

180 http://www.senedd.assembly.wales/documents/s43139/MT%20AI8%20ADSS%20Cymru.pdf  
181 Lennon MR et al. Readiness for Delivering Digital Health at Scale: Lessons From A Longitudinal Qualitative 
Evaluation of a National Digital Health Innovation Program in the United Kingdom, J Med Internet Res. 
2017 Feb 16;19(2):e42. doi: 10.2196/jmir.6900, https://www.ncbi.nlm.nih.gov/pubmed/28209558  

49 

 
 
 
                                                            
and representatives of an accompanying study project, ScaleAHA182. Key lessons from these 
twinning exercises regarding both the conceptual and implementation dimensions concern: 

o  Key barriers to innovation scaling-up initiatives: (1) financial dimensions and access 
to  EU  funding  opportunities;  (2)  institutional  capacities  related  to  the  knowledge 
exchange itself; (3) human factors proving to be determinant in the level of acceptance 
and implementation of shared practices. 

o  Key  success  factors:  (1)  clear  vision,  strong  political  commitment  and  clear 
identification of the benefit for each party involved; (2) identifying and analysing the 
current  state  of  research  and  a  clear  awareness  of  research  outcomes  for  actual 
capacity  for  fruitful  knowledge  exchange;  (3)  ensuring  user  acceptance  (of  patients 
and health and social care professionals) mainly based on actual skills and capacity to 
use  the IT concepts and tools  – the capacity of making the best use of innovation at 
individual level will then support long-term ownership and acceptance by users. 

Similarly,  the  report  of  the  Expert  Group  on  Health  Systems  Performance  Assessment183 
highlighted  a  number  of  principles  and  factors  which  are  important  for  the  successful 
implementation of integrated care: (1) political support and commitment; (2) governance; (3) 
stakeholder engagement; (4) organisational change; (5) leadership; (6) collaboration and trust; 
(7)  workforce  education  and  training;  (8)  patient  focus/empowerment;  (9)  financing  and 
incentives; (10) ICT infrastructure and solutions; and (11) monitoring/evaluation system. 

Example of overarching strategy, supported by collaboration at EU level  

EU-supported projects implemented in the Basque Country in Spain proved to be successful in 
redesigning delivery patterns and improving both patient experience and cost-efficiency.  

A prerequisite to be highlighted for this is the long-term political commitment of the authorities, 
embedded in a synergised and comprehensive policy agenda. The Basque authorities, made the 
best use of the EU projects to cover strategic steps of healthcare pathways in a synergetic way: 
population  stratification  (ASSEHS  project),  telehealth  technologies  for  patients  with  chronic 
conditions  (United4Health  project),  management  of  patients  with  complex  health  and  social 
needs (Care Well project) or with mental disorders (Master Mind project).  

The  supportive  role  of  this  overarching  strategy  in  a  context  of  innovative  practices  and 
knowledge sharing has been clearly identified as a key success factor of all EU projects. 

With  regard  to  successful  implementation  of  good  practices  for  reducing  the  burden  of 
investment, 
chronic  conditions, 

thoughtful  design  and  good  governance,  adequate 

182 http://www.scale-aha.eu/home.html  
183 "BLOCKS: Tools and methodologies to assess integrated care in Europe". Report by the Expert Group on 

Health Systems Performance Assessment, 2017  

50 

 
 
 
                                                            
empowering the target population, and educating and training care professionals are among 
the 12 main elements identified by the Joint Action CHRODIS184. 

On  the  specific  points  mentioned  above,  the  EU  added  value  is  very  important, considering 
the capacity developed at EU level in the field of experience sharing and benchmarking.  

4.2.3  Market  fragmentation  and  challenges  to  European  enterprises  integrating innovations 
into the health and care systems  

Expanding a business beyond the realm of its home market is usually taking a plunge into the 
near-unknown. There are still many barriers that need to be overcome when breaking into and 
expanding  sales  in  different  European  markets.  These  barriers  include  cultural  diversity, 
language, market size and geographic location. There is no single European healthcare system 
or market like in the United States where there is a much more homogenous market.  

In  the  health  domain,  an  additional  hurdle  is  the  fact  that  healthcare  systems  represent 
complex  value  networks  involving  governments,  care  providers,  insurance  payers,  patients 
and citizens and also tend to differ from one country to another. Introduction of new solutions 
is difficult and small and medium-sized enterprises (SMEs), in particular, struggle to access 
new  markets  and  new  ecosystems.  This  is  mainly  because  of  a  lack  of  knowledge  and 
experience related to these new markets, and because of a (perceived or real) lack of budget 
and time to overcome the costs associated with entering into new partnerships and markets. 

Examples of EU level supported SME cross-border market access  

The  project  APOLLON  (http://cordis.europa.eu/project/rcn/191724_en.html),  funded  under  the 
Competitiveness  and  Innovation  Framework  Programme,  demonstrated  that  for  SMEs  cross-
border  pilots  forced  them  to  re-think  the  initial  business  case  into  a  European  context.  This 
increased  the  development  process  for  building  the  right  proposition  and  a  better  product  fit, 
which  had  a  huge  impact  -  in  a  positive  way  -  on  how  they  are  developing  and  deploying  the 
product/service.  Cross-border  exchanges  gave  SMEs  the  opportunity  to  discuss  the  healthcare 
ecosystem in other countries. This enabled them not only to identify different needs and possible 
enhancements  to  their  products  but  also  to  explore  new  (business)  opportunities  and  gave 
insights  into  the  requirements  and  operational  issues  related  to  transferring  products  to  other 
markets outside the base market. 

The Active and Assisted Living Joint Programme has been operational since 2008 and provided 
support to more than 300 SMEs in bringing new products and services to the market by lowering 
the barriers for access to EU level cooperation through the joint efforts from the Member States 
and  the  EU.  In  addition  it  has  allowed  Member  States  to  add  value  to  their  related  national 
activities by providing an easy framework for EU level cooperation. 

The  argument  in  favour  of  consumer-friendly  apps  and  other  eHealth  services  is  also 
challenged by the fact that there is still little robust proof of the value of such solutions. More 

184 "12 steps towards implementing practices to reduce the burden of chronic diseases", Joint Action CHRODIS, 
available at http://chrodis.eu/wp-content/uploads/2015/06/ja-chrodis_12steps_final.pdf  

51 

 
 
 
                                                            
research  and  new  evaluation  approaches  are  needed,  in  line  with  the  messages  in  section 
4.2.1, to qualify and quantify the benefits of digital health technologies when it comes to cost-
effectiveness, value calculations and user experience. For a more systematic recommendation 
and  use  of  digital  tools  in  healthcare  practice,  healthcare  professionals  need  greater 
confidence  in  them  as  well  as  stronger  clinical  evidence  of  their  value.  On  the  whole, 
physicians are wary of formally recommending apps or electronic devices to patients without 
robust  evidence  of  their  benefit,  guidelines  for  their  use  or  assurance  that  the  patient’s 
personal information will remain secure. Insurers and employer health programmes also want 
clear  evidence  of  benefit  before  considering  reimbursement  or  promoting  the  use  of  digital 
tools. Health authorities have started to respond to this need185.  

The  validity  and  reliability  of  data  from  digital  health  solutions  is  a  major  concern  as 
confirmed  by  the  Open  Public  Consultation  held  in  preparation  of  the  Commission 
Communication  on  Transformation  of  Health  and  Care  in  the  Digital  Single  Market.  It 
remains an important topic in European Commission policy.  

Digital health solutions which are intended to be used for a specific medical purpose may be 
regulated  as  medical  devices  and  therefore  subject  to  the  stringent  safety  and  performance 
requirements  of  the  EU  medical  device  legal  framework.  The  new  Regulation  on  medical 
devices, which will become applicable as from May 2020, reinforces requirements on clinical 
data for devices and, in the case of software and apps, foresees new dedicated classification 
rules which, in many cases, will determine an upgrade of their risk class and a more stringent 
conformity  assessment  prior  to  certification.  In  addition  to  that,  more  specific  safety  and 
performance requirements for medical software and apps are therein laid down.  

Digital  solutions  which  are  not  medical  devices  are  not  covered  by  any  specific  legislation 
and  rules  for  their  certification  might  well  vary  across  different  EU  Member  States.  With 
respect  to  this  latter  category,  in  2016  the  European  Commission  established  a  Working 
Group  on  mHealth  assessment  guidelines.  The  mandate  of  the  group  was  "to  develop 
guidelines  for  assessing  the  validity  and  reliability  of  the  data  that  health  apps  collect  and 
process".  The  Working  Group  reported  in  June  2017186  that  a  considerable  amount  of  work 
was put into this objective of issuing guidelines but it appeared that building these guidelines 
was a much more complex exercise than expected at the beginning of the process, and that the 
work to be done goes beyond the original mandate of the Working Group. The experience of 
different stakeholders collected and documented by the Working Group is a useful basis for 
the  future  actions,  notably  by  the  eHealth  Network  and  the  mHealth  Hub,  a  very  recently 
launched project funded by the Horizon 2020 programme.  

The Commission has also verified that, in light of the fact that most healthcare professionals 
and  healthcare  institutions  make  use  of  apps  which  are  certified  as  medical  devices,  any 

185 Papadopoulos, H., Sheth, V.B., & Wurst, M. (2013). “Comparison of US and EU regulatory approaches to 

mobile health apps: Use cases of myVisionTrack and USEFIL.” European Journal of ePractice, 21. 
186 https://ec.europa.eu/digital-single-market/en/news/report-working-group-mhealth-assessment-guidelines  

52 

 
 
                                                            
further  initiative  from  the  Commission  to  tackle  market  fragmentation  in  this  specific  field 
should  address  the  full  range  of  mHealth  apps,  while  remaining  fully  compatible  with  the 
medical device legal framework.  

From  a  commercial  point  of  view,  another  key  challenge  recognised  is  the  difficulty  of 
operators  to  identify  the  legal  framework  which  is  applicable  to  their  product,  as  the 
borderline  area  between  digital  health  solutions  which  are medical  devices  and those  which 
are not is a complex one, involving in many cases very technical analysis and considerations. 
This  is  an  area  where  certain  stakeholders  expressed  calls upon  the  Commission  to  develop 
concrete instruments to provide economic operators with the necessary guidance.   

A series of workshops in 2016 resulted187 in a common commitment to building a European 
Reference Framework as a basis for informed investment decisions in retrofitting and building 
housing suitable and adaptable to technology-supported age-friendly independent living. This 
nascent framework188, in the same way as the guidelines on mHealth solutions, is expected to 
provide common visions and decision support in order to inform investment decisions (both 
public and private) and policy on housing stock suitable for the demands of an ageing society. 

4.2.4 From start-up to scale-up 

The  global  entrepreneurship  organisation  Mind  the  Bridge  estimates  that  there  are 
approximately  4,200  fast  growing,  high-tech  companies  in  Europe  called  "scale-ups".  The 
term  scale-up  distinguishes  companies  from  early-stage  start-ups,  which  are  still  struggling 
with  initial  challenges  to  build  their  business  models  and  find  investment.  Scale-ups  have 
overcome  this  phase,  are  executing  their  business  models,  have  found  investment,  are 
producing  revenues,  and  are  growing  in  terms  of  market  access,  number  of  employees  and 
revenue through relationships with established companies and investors189.  

According  to  a  recent  report  "On  the  Rise:  An  Analysis  of  1000+  European  Scale-ups"  of 
Tech.eu190 the first half of 2017 has been especially strong for scale-ups in Europe, with EUR 
9 billion already raised in 409 deals, compared to just EUR 12.2 billion raised in the whole of 
2016. Fintech (the use of technology in the financial services sector) is the strongest vertical 
sector for scale-ups, followed by the medical/healthcare sector and transportation.  

The recent European Health Tech Report 2016191 states that HealthTech192 is at the forefront 
of start-ups and scale-ups, in the United States as well as in Europe. This report highlights that 

187 https://ec.europa.eu/digital-single-market/en/news/together-smart-age-friendly-homes-and-neighbourhoods-

shaping-european-reference-framework  

188 https://ec.europa.eu/digital-single-market/en/news/final-report-recommendations-european-reference-

framework-age-friendly-housing  

189 Tech.eu defines scale-ups as companies that have had an investment of at least EUR 5-20 million or a series 

B funding round, exist for 3 years or more and have not yet exited through an IPO (Initial Public Offering) or 
acquisition.  

190 http://tech.eu/product/on-the-rise-an-analysis-of-1000-european-scale-ups/  
191 https://fr.slideshare.net/omohout/europe-health-tech-report-2016  

53 

 
 
                                                            
in 2016 HealthTech is the second most funded industry in number of deals and that 64% of 
European  HealthTech  scale-ups  are  business-to-business  (B2B)  oriented.  In  average,  13 
HealthTech  deals  of  at  least  EUR  750  000  are  closed  in  Europe  every  month  and  the 
European HealthTech scale-ups together raised EUR 1.094 billion in 2016 or on average EUR 
90  million  per  month.  However,  compared  to  the  USD  4.2  billion  in  the  USA193,  Europe  is 
still lagging behind to un-tapping the huge market potential of the digital health market. The 
report  also  shows  that  it  takes  in  average  five  years  for  HealthTech  companies  to  raise 
substantial  external  financing.  In  most  EU  countries  digital  health  incubators  stimulate  the 
local start-up ecosystem and investments quite well, but support for taking the start-ups to the 
scale-up  phase  is  less  elaborated.  These  time  cycles  need  to  be  shortened  and  investment 
instruments streamlined if leveraging the potential of European companies active in the digital 
health field is to be fully realised. Too often, European start-ups use the fact that they benefit 
from  European  SME-support  as  a  label  for  getting  access  to  second  round  financing  in  the 
USA and deploy their go-to-market phase in the USA instead of Europe. Start-up companies 
like the Belgian based Cubigo194 realised a real break-through and recognition on the European 
market  after  being  selected  by  Google  BlackBox  connected  boot  camp195  in  January  2015; 
and  in  April  2017  they  announced  EUR  4  million  investment  for  international  expansion. 
Also the Portuguese based start-up Sword Health196 went to the USA for the market roll-out of 
its solution.  

The  recently  established  Thematic  Smart  Specialisation  Platforms  (TSSP)197  offer  a  new 
approach  to  help  coordinate  regional  stakeholders  and  open  the  path  to  a  stronger 
collaboration  for  both  private  and  public  investors.  This  can  unlock,  among  others,  the 
potential  of  synergies  between  European  Structural  and  Investment  Funds  (ESIF)  and  the 
European  Fund  for  Strategic  Investments  (EFSI)  for  the  healthcare  sector198.  In  this  regard, 
the  TSSP  partnership  on  Medical  Technology,  led  by  the  French  region  Auvergne-Rhône-
Alpes  and  composed  by  stakeholders  of  15  EU  regions,  addresses  the  key  challenge  of 
digitalising the economy of the healthcare sector while limiting its costs for both citizens and 
service providers (e.g. public hospitals).  

4.2.5. Lack of strategic approaches to investments  

192 Health Technology is defined by the World Health Organization as "the application of organized knowledge 
and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health 
problem and improve quality of lives. According to the report, four categories can be distinguished:  
•         MedTech : typical being used by medical professionals and often requires connected hardware 
•         CareTech: typical support the healthcare process such as booking platforms  
•         HealthTech: typically being used by the patient directly and 
•         Lifescience: digital solution used by or for the life science industry 

193 https://rockhealth.com/reports/2016-year-end-funding-report-a-reality-check-for-digital-health/  
194 http://www.cubigo.com/en 
195 http://www.xpats.com/google-names-belgian-app-one-worlds-most-promising-start-ups   &  

https://startups.be/blog/post/limburg-scale-cubigo-gets-4m-international-expansion  

196 https://www.swordhealth.com/ 
197 http://s3platform.jrc.ec.europa.eu/s3-thematic-platforms 
198 http://s3platform.jrc.ec.europa.eu/medical-technology 

54 

 
 
                                                                                                                                                                                          
According to a recent WHO report, the lack of funding is one of the most significant barriers 
to the deployment of digital solutions in health199. The same holds true for the implementation 
of new care models in the context of health system reforms. Up-front investment is typically 
required  to  cover  the  set-up  costs  and  the  costs  of  transition  to  a  new  care  model  such  as 
integrated  care:  costs  for  buildings,  facilities  and  ICT;  costs  for  human  resources, 
training/development  and  continuous  technical  support;  costs  of  implementing  innovations 
and  organisational  changes  etc.  Furthermore,  the  investment  needs  to  be  sustained  during  a 
transitional  period  until  the  new  care  model  achieves  beneficial  outcomes  and  realises 
efficiencies.  The  return  on  investment  may  thus  only  come  in  medium-long  term  and, 
consequently, investments in new care models, which may also employ digital solutions, are 
considered to be of high risk.  

From the above, it is also clear that investing into a new care model entails investments in a 
range  of  areas  and  elements.  Several  potential  sources  of  finance  may  be  considered  and 
deemed  available,  for  instance:  national  and  regional  innovation  funds,  European  funds, 
private  Venture  Capital  and  Business  Angels  funds,  insurance  and  pension  funds,  loan 
facilities from banks, charitable and philanthropy bonds, crowd funding etc. However, due to 
specialisation  of  most  funds,  few  financing  schemes  -  if  any  at  all  -  are  investing  in  all  the 
elements needed to implement a new care model at scale. 

In  February  2017,  the  European  Commission,  in  cooperation  with  the  European  Investment 
Bank,  organised  a  seminar  to  discuss  these  challenges  around  investments  for  innovative 
forms of healthcare200. One of the main messages from the seminar is that long-term thinking 
together  with  a  reform  plan  and  an  investment  strategy  are  required  to  deliver  transformed 
health  services.  An  integrated  investment  approach  should  be  pursued,  which  considers  the 
overall needs for (i) infrastructure, (ii) technologies and (iii) service models together, and also 
aims  at  accessing  and  blending  financing  from  different  sources  in  a  strategic  way.  In  this 
context, it is important for health authorities to raise their capacities to manage new financial 
instruments. A broad range of public and  private partners and investors need  to  engage  and 
work together. Investment strategies need to be underpinned by new contracting and payment 
schemes, which encourage all partners to jointly design, finance and deliver new care models 
for transformed health services.  

Partnerships among purchasers and providers of care services form a fundamental element in 
this regard. Various partnership schemes are possible (e.g., lead contractor, alliance contracts, 
integrated  providers,  accountable  care  organisations,  etc.)  with  differing  approaches  to 
contractual and governance aspects and the degree of sharing risks, assets and rewards among 
partners. Similarly, various payment models may be considered such as pay-for-performance, 
bundled  payments,  shared  savings  schemes  and  population-based  payments  (in  the  form  of 

199  "From  Innovation  to  Implementation.  eHealth  in  the WHO  European Region", World  Health Organisation, 

2016. 

200  Seminar  "Strategic  investments  for  the  future  of  healthcare",  27  February  2017.  Report,  presentations  and 

main messages available at https://ec.europa.eu/health/investment_plan/events/ev_20170227_en  

55 

 
 
                                                            
capitation  or  global  budgets)201,202.  There  is  no  "one  size  fits  all";  instead  it  is  crucial  to 
consider  the  local  context  where  services  will  be  delivered.  Long-term  approaches  are 
particularly helpful in providing certainty until the anticipated benefits from new care models 
and the return-on-investment materialise. 

4.3. Remaining challenges at the EU-level 

While  there  are  numerous  examples  of  proven  digital  innovations  across  Europe,  most  of 
them remain on a small scale and fail to scale-up, despite the recognised benefits they could 
bring  to  citizens  and  society.  The  preceding  sections  indicated  a  number  of  reasons,  which 
have been manifesting as critical aspects and gaps in implementation capacity for a number of 
years:  market  fragmentation,  lack  of  investments,  re-organising  the  models  of  care  and 
generating robust evidence. These highlight the fact that digital tools are only a component of 
a care model and that the potential benefits from using digital tools will not materialise before 
care authorities succeed in developing further their capabilities to implement person-centred 
care models  at scale. The  WHO report "From  Innovation to Implementation. eHealth in  the 
WHO  European  Region"  emphasises  the  need  for  Member  States  to  build  capacity  for 
implementing and managing eHealth solutions.  

The above challenges are common to all Member States, despite the diversity in their health 
and  care  systems,  and  point  to  areas  where  action  and  collaboration  at  EU  level  will  bring 
added value, more specifically along the routes of:  

a)  Support  to  the  supply  side  of  digital  health  in  Europe  using  existing  knowledge  in 

Member States and regions. 

b)  Providing assistance to national and regional care authorities to build their know-how 
and  capacity  to  implement  successfully  digitally-supported,  integrated,  person-
centred care at scale, as part of their health system reforms. 

c)  Mobilising investments for large scale implementation.  

Further action at EU level might help address the issue of critical mass both from the demand 
and  supply  points  of  view.  Building  on  existing  EU-level  cooperation,  such  as  in  the 
European Innovation Partnership on Active and Healthy Ageing, Active and Assisted Living 
Joint  Programme,  EIT  Health  and  Joint  Actions  of  the  Health  Programme,  further 
collaboration  at  EU  level  could  strengthen  mutual  learning,  knowledge  sharing  and  transfer 
among care authorities and help those who wish to ease their path to large scale adoption of 
digital health innovations.  

201 Financial Models for Care Integration, report from the project INTEGRATE, available at 

http://projectintegrate.eu.com/integrated-care/resource/articles/financial-models-for-care-integration    
202 OECD (2016), Better Ways to Pay for Health Care, OECD Health Policy Studies, OECD Publishing, Paris. 

http://dx.doi.org/10.1787/9789264258211-en  

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Joint action can also boost the possibilities for economies of scale for technology and service 
suppliers  and  reduce  the  risk  of  fragmentation  in  care  delivery  for  citizens.  Collaboration, 
exchange  of  expertise  and  the  creation  of  scalable  markets  at  EU  level  can  facilitate  the 
formation  of  stakeholder  ecosystems  for  building  strong  investment  propositions  and  for 
creating better conditions to implement reforms in health and care. 

The shift to new models of care can be supported by increased awareness amongst healthcare 
stakeholders  of  financing  opportunities  at  European,  national  and  regional  level,  stronger 
collaboration  of  public  and  private  investors,  as  well  as  financial  brokerage/technical 
assistance services. Making a more complementary use of European funds - for example the 
the  European  Fund  for  Strategic 
European  Structural  and  Investment  Funds  and 
Investments203 - to trigger further investment in the integration of health and care can be one 
path towards the realisation of these opportunities. The examples of Primary Care Centres in 
Ireland204  and  Estonia  (see  box  below),  demonstrate  how  the  infrastructural  needs  for  the 
transition to new care models can be met with a combination of European financing, national 
funding and private co-financing.   

European financing in support of health system reforms: New models for Primary Care 

In  Estonia,  investments  from  the  European  Structural  and  Investment  Funds  (EUR  85 
million, plus co-financing  from the government)  are  directed at building a network of primary 
care  health  centres  that  will  employ  multi-professional  teams  (General  Practitioners,  nurses, 
midwives and  physiotherapists), with coordinated access to hospital specialist care. In a future 
phase,  social  care  services  and  mental  health  services  for  children  are  considered  too.  The 
investment  plan  was  approved  in  August  2016  and  foresees  development  of  59  primary  care 
health centres between 2018 and 2023. 

The  Investment  Plan  for  Europe,  through  its  European  Fund  for  Strategic  Investments 
(EFSI), is backing Ireland's health reform strategy. In May 2016, the European Investment Bank 
granted a 25-year loan of EUR 70 million EFSI financing for the construction of 14 new primary 
healthcare  centres across Ireland over a two-year period. This is part of a larger investment  of 
EUR 135 million, with the additional financing coming from a Public-Private Partnership (PPP) 
consortium. The construction of these primary care centres is part of a national strategy to shift 
care to community level, bringing together General Practitioners, nurses, occupational therapists, 
social  workers  and  other  specialists  to  provide  a  range  of  integrated  care  services  in  the 
community.  

A  number  of  studies  point  out  that  enabling  the  digital  single  market  for  health  and  care 
solutions  would  create  pan-European  business  opportunities,  including  for  innovative  start-
ups and SMEs205. The global market for mobile health is growing fast and is expected to be 

203 https://ec.europa.eu/commission/priorities/jobs-growth-and-investment/investment-plan_en  
204 https://ec.europa.eu/health/sites/health/files/investment_plan/docs/2016_funds_healthsector_en.pdf  &  

http://www.eib.org/infocentre/press/releases/all/2016/2016-123-eibs-first-backing-for-primary-health-care-
investment-in-europe-supports-14-schemes-across-ireland  

205 Quotes from market forecasts studies:  

57 

 
 
 
                                                            
 
 
  
 
worth USD 23 billion in 2017206. In Europe, the scaling up of mobile health technology able 
to  support  self-management  of  health  and  wellbeing  could  potentially  generate  important 
savings by boosting prevention. The estimated annual savings amount  to EUR 69 billion207. 
Although there is a recognition that mHealth can support better health and care provision to 
citizens, the emergence and widespread use of mHealth applications also raises new questions 
concerning the regulatory frameworks that apply to the validity and use of data generated by 
mHealth applications and the security of EU citizens making use of those apps.  

Addressing  the  non-communicable  diseases  epidemic,  EU  level  action  should  be  ambitious 
and  include  a  clear  focus  on  social  and  technological  innovation208.  The  transfer  of  good 
practices  across  EU  Member  States  and  regional  health  and  care  authorities  could  be  more 
actively supported, in order to jointly address barriers to the uptake of such practices, reach 
implementation at large scale and facilitate cross-border actions on digital health programmes 
to  tackle  non-communicable  diseases  -  including  the  development  of  quality  control 
instruments based on feedback systems between users and healthcare providers. 

Disparities in absorption capacity for digital health and care innovation across selected 
European countries 

There  are  currently  large  variations  across  Europe  in  the  capacity  of  countries  to  absorb 
digital  health  and  care  innovations.  The  following  graph  shows  the  differences  between 
selected European countries in markets for digital health and care209. 

-  BCC  Research,  Global  Markets  for  Telemedicine  Technologies,  2014  –  the  global  telemedicine  tools 
market  will  likely  reach  USD  43.4  billion  within  five  years;  the  market  segment  for  telehome  (telehealth) 
technologies is predicted to grow from USD 6.5 billion in 2013 to USD 24 billion by 2019;  
-  PwC,  Touching  lives  through  mobile  health:  Assessment  of  the  global  market  opportunity,  2012  –  this 
report  forecasts  that  the  global  mobile  health  market  will  reach  a  value  of  EUR  17.5  billion  in  2017,  with 
Europe being the largest market segment (EUR 5.2 billion);  
-  Manyika,  J.  et  al.,  Disruptive  technologies:  Advances  that  will  transform  life,  business,  and  the  global 
economy,  McKinsey  Global  Institute,  2013  –  estimates  the  potential  economic  impact  of  the  Internet  of 
Things across healthcare applications to be USD 1.1 trillion to USD 2.5 trillion per year by 2025. 

206  Emerging  eHealth:  Paths  for  growth  (PwC  and  Economist  Intelligence  Unit  2014).  Mobile  health  services 
include  solutions  for  the  patient  (wellness,  prevention,  diagnosis,  treatment  and  monitoring  services)  or 
healthcare system solutions (e.g. healthcare practitioner support, administration). Remote monitoring services 
and applications are expected to account for nearly 65%, corresponding to $15 billion by 2017. It is projected 
that  the  EU  and  Asia-Pacific  will  have  the  biggest  market  share  of  about  30%  each,  offering  significant 
economic growth opportunities. 

207 Socio-economic impact of eHealth. An assessment report for the European Union (PwC 2013) 
208 Council conclusions “Innovative approaches for chronic diseases in public health and healthcare systems”, OJ 

C 74, 8.3.2011, p. 4–5 

209 Source Statista study on eHealth markets, http://www.statista.com  

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6

5

4

3

2

1

0

2017

2020

Figure 10: Differences between selected European countries in markets for digital health 
and care  - normalised by 1,000,000 inhabitants  for comparability (in millions of  Euro) 
for 2017 and estimated for 2020 (Source: Statista study on eHealth markets) 

In the context of the Digital Single Market, it is critical to work towards the capacity of all 
Member  States  and  regions  to  create  value  through  novel  approaches  to  health  and  care 
delivery.  

This  can  also  be  an  opportunity  to  tackle  differences  in  the  effectiveness  of  the  market  for 
digital health and care provision. Expenditure and spending patterns as indicators vary greatly 
across  Europe.  For  example,  Eurostat  data  shows  large  differences  in  long-term  care 
expenditure  in  Member  States,  between  4.0%  of  GDP  in  Finland  and  0.01%  in  Bulgaria210. 
While  there  is  no  linear  relationship  between  healthcare  expenditure  and  achieved  health 
outcomes,  and  digital  transformation  does  not  intend  to  close  gaps  in  healthcare  spending, 
digital  solutions  can  help  health  and  social  care  systems  achieve  more  with  the  resources 
available.  

Numerous  stakeholders  point  out  that  insufficient  EU-level  coordination  could  mean  that 
efficiencies, which can be generated by innovative digital solutions and care models, would 
remain  slow,  small-scale  and  limited  to  a  particular  region  or  Member  State,  further 
accentuating  health  market  inequalities  between  Member  States.  In  this  context,  it  is  often 
underlined that swift deployment at large-scale of digital solutions and new care models can 
best  be  achieved  by  working  together  at  EU  level,  sharing  experiences  in  deploying, 

210 Eurostat Healthcare expenditure statistics, http://ec.europa.eu/eurostat/statistics-
explained/index.php/Healthcare_expenditure_statistics#Long-term_care_expenditure  

59 

 
 
 
                                                            
measuring  impact  and  transferring  innovation  across  several  EU  Member  States  and 
regions211.  

Hence, it is widely recognised that coordinated innovation support should aim to ensure that 
the benefits of innovation can be exploited across Europe and that the single market creates 
the conditions for wider absorption of innovation capacity. Such coordinated efforts in 
deploying value-oriented innovation in health and care are demonstrated, for instance, in the 
joint procurement of innovation by the RITMOCORE212 consortium. The EU co-funded 
cooperation between partners from Spain, the United Kingdom, the Netherlands and Italy will 
procure remote support centres for monitoring and data flow (from pacemakers and other 
devices), using apps and multi-channel communication for patient activation. The project puts 
emphasis on cost-effectiveness, patients' wellbeing and growth and innovation effects. To 
evaluate these, it applies a common approach using the Monitoring and Assessment 
Framework for the EIP on Active and Healthy Ageing 213. An important outcome with 
European added value is the evaluation of the new procurement approach itself with its 
ambition to scale beyond individual cases. 

211 The European Scaling Up Strategy in Active and Healthy Ageing (2015), 

https://ec.europa.eu/eip/ageing/library/european-scaling-strategy-active-and-healthy-ageing_en  

212 http://cordis.europa.eu/project/rcn/206004_en.html  
213http://mafeip.eu/ 

60