The value of a European approach to mHealth in cancer Unleashing the mHealth potential for cancer patients Pēteris Zilgalvis Head of Unit Health and Wellbeing DG Communications Networks, Content and Technology Peteris Zilgalvis, Head of the Health & Wellbeing Unit, European Commission, DG ----- This was presented at the ​"Unleashing the mHealth potential for cancer patients" event held on Wednesday 25th May 2016 (16​:30-18:30pm) in the European Parliament. #mHealthCancer ​"​mHealth and eHealth are becoming realities in Europe: this is demonstrated by the growing size of mHealth apps’ market, by the raising investments in eHealth infrastructures and by the fast adoption, at various degrees, of mHealth applications by patients. The burden of cancer is also raising: more than 10 million EU citizens are affected by cancer, incidence and prevalence are growing, and the socio-economic impact of cancer heavily burdens both healthcare systems and cancer patients. The recent political agreement on the text the General Data Protection Regulation and the production of the Privacy Code of Conduct mHealth apps further stir the debate regarding the use of new mHealth technologies within cancer care pathways. Are cancer patients enjoying the benefits of mHealth? In which field can cancer patients profit the most from mHealth apps? Is the regulatory framework supporting the development of useful and safe mHealth apps for cancer patients? Are there other structural obstacles to the full integration of mHealth apps in the cancer patients’ journey?​"​ The event will be hosted by MEP Cristian-Silviu Busoi (EPP, Romania), one of ECPC closest champions within the European Parliament and a knowledgeable supporter of the development of eHealth/mHealth in Europe. The event w​as followed by a cocktail reception. Join the discussion on Twitter using​ ​#mHealthCancer​ The event is part of the initiatives for the 2016 European Week Against Cancer #EWAC2016​ Mor​e information can be found on the European Cancer Patient Coalition's website: http://www.ecpc.org/pressroom/events/icalrepeat.detail/2016/04/26/61/-/-

1. The value of a European
approach to mHealth in cancer
Pēteris Zilgalvis
Head of Unit Health and Wellbeing
DG Communications Networks,
Content and Technology
Unleashing the mHealth
potential for cancer patients Brussels, 25 May 2016

2. mHealth can:
• Help to improve treatment
Early symptoms
Faster response
Better outcome
• Support patients
• Access to data
• Decision support systems
• (Digital)health literacy
• Social platforms
• Mobility

3. • Access to health data
• Cross-border healthcare – patient mobility
• Data Protection Directive – Data Protection Regulation
• Big Data
• Personalised medicine
• Interoperability and standardisation
• Patient
empowerment/engagement/partnership/responsibility
• Reimbursement of eHealth services
• Integrated care
• Mobile apps for health and wellbeing
• Digital health literacy
• Digital skills for health workforce
• Cybersecurity
• eIdentification
3
Current Hot Issues
related to mHealth

4. Current legislation on Data Protection
DIRECTIVE 95/46/EC on the protection of individuals with
regard to the processing of personal data and on the free
movement of such data
Objectives:
• protect the right to personal data protection
• guarantee the free flow of personal data between Member
States
DP Regulation maintains the same objectives!
Data Protection

5. New challenges for the
protection of personal data
Globalisation
Internet
Online social networking
E-commerce
Online databases
Electronic Health
Records
Cloud computing
Big Data
Face recognition
Role of DPAs
Governance
Geo-location
Video surveillance
Profiling
Behavioural advertising
Biometric data
Genetic data
mHealth apps
Security breaches
Identity theft
The challenge of technology, globalisation and societal change
Data Protection

6. No control over personal data Lack of
trust
Insufficient awareness, loss of control and trust,
particularly in the online environment:
75% of respondents in recent Eurobarometer say they have only
partial or no control of their data online. 2 in 3 citizens say they
are concerned about this.
Difficulties in exercising data protection rights:
•to exercise legal right of access to one’s personal data;
•to have one’s data deleted;
•to access effective remedies;
•to withdraw and transfer personal data from an application or
service (“data portability”)
Data Protection

7. General Data Protection Regulation
Replaces Data Protection Directive 95/46/EC new
centrepiece of EU legislation on personal data protection
Objectives:
• reinforce individuals' rights and put them in control of their
personal data
• ensure data protection rules fit for the digital single market
• ensure stronger enforcement of the rules
• streamline international transfers of personal data and set
global data protection standards
(strike the right balance between data protection rights and the
need to support public health and medical research objectives)
Data Protection

8. Conditions for processing sensitive data
• As a rule processing of sensitive data, including
health, is prohibited
• However the prohibition will not apply in certain
cases such as:
- Explicit consent of data subjects
- Data which are manifestly made public by the data subject
- Reasons of public interest on the basis of Union or Member
States law
- Health related purposes (e.g. preventive or
occupational medicine, medical diagnosis)
- Exercise or defence of legal claims
- Historical, statistical and scientific research
purposes.
Data Protection

9. Other EU actions
• Code of Conduct on mHealth apps privacy
• Guidelines on the reliability and validity of mHealth
apps' data
• European standard on quality criteria for the
development of health and wellness apps
• eHealth Network mHealth subgroup
• Intermediate evaluation of the eHealth Action Plan
2012 – 2020
• Horizon 2020
• eHealth Week 2016

10. covering data protection and security principles
voluntary instrument
to be signed by mHealth app developers and possibly to be
approved by the Article 29 Working Party
Legal basis: Article 27 of the Data Protection Directive
Objectives: Increased trust; Raising awareness and facilitating compliance with
data protection rules at EU level; Competitive advantage
Process: Industry code of conduct working group with the EC as facilitator
Next steps: Finalising draft (governance) to be presented to Art 29WP
More information: http://bit.ly/1PoVxRo
10
Privacy Code of Conduct for mobile
health apps
Other EU actions on
mHealth

11. A working group of stakeholder organisations
Civil society, academia, industry, public authorities
Stakeholders – public call for expression of interest
Public authorities – are invited to join the group
Mandate
Draft the guidelines by the end of 2016
Consider and integrate input from all the stakeholders
Process open to all stakeholders via online consultations and
open stakeholder meetings
More information http://bit.ly/1iAPs7p
11
Guidelines for assessing validity and
reliability of mHealth app data
Other EU actions on
mHealth

12. European standard on quality criteria
for the development of health and
wellness apps
PAS 277:2015 on Health and wellness apps – Quality criteria
across the life cycle (BSI)
Aims to encourage innovation in healthcare and development of
safe and effective apps that are of a high quality, and that are
fit for purpose
Does not cover requirements for apps that are classified as
medical devices
2016 Rolling Plan for ICT standardisation
12
Other EU actions on
mHealth

13. mHealth subgroup
Aim
Discuss common challenges
Exchange information on national strategies
Identify areas for future collaboration
Possible topics
regulatory approaches, quality and assessment frameworks,
education and awareness raising, reimbursement strategies,
linking data to EHRs etc
Procedure
Chair and Rapporteur
2-3 meetings in 2016
A report to the 10th meeting of the eHN (autumn 2016) 13
Other EU actions on
mHealth

14. eHealth Action Plan 2012 – 2020
Intermediate evaluation
• Judge the accomplishments of the eHealth Action Plan
2012 -2020 after three years of operation
• Identify and analyse any weaknesses that may prevent
implementing the Action Plan fully by 2020
• Identify areas in which more in-depth actions should be
taken
• Point out new topics that have emerged since the
publication of the Action Plan in December 2012
Next steps:
• Public consultation in autumn 2016
• Staff Working Document – Q1 2017
Other EU actions on
mHealth

15. Horizon 2020
Funding of research and innovation in the fields of
Developing apps for patients and healthcare professionals
Big Data
Digital security for healthcare
Digital health literacy
Facilitating uptake
Together with WHO-ITU establish the EU innovation hub
on mHealth to address in particular non-communicable
diseases
15
Other EU actions on
mHealth

16. 16
Other EU actions on
mHealth

17. More information and contacts
• ec.europa.eu/ehealth
@EU_ehealth
EU.ehealth
peteris.zilgalvis@ec.europa.eu