Agenda

09:30 – 10:15

Coffee and Registration

10:15 – 10:20

Welcome and Introduction from the Moderator

Moderator: Paul Adamson , Senior European Policy Advisor, Covington & Burling LLP

10:20 – 10:30

Video Presentation: Unlocking the potential of mHealth in Europe

Robert Madelin , Director General, DG CONNECT, European Commission **

10:30 – 12:00

Session 1: Delivering a safe and secure mHealth ecosystem in Europe

In order to ensure the development and safe adoption of mHealth apps, there is a need for a clear legal framework. Currently the deployment of mHealth technologies in Europe falls under a number of existing policy initiatives (for example the Medical Device and the Data Protection Frameworks), and this session will look at the extent to which this existing policy framework is suitable, and what changes may be necessary in order to ensure the safety of citizens using mHealth apps, and the security of their data.

- Is existing legislation (the data protection directive; the medical device directive for instance) appropriate for the successful roll-out of mHealth in all its guises in Europe?
- What should be considered a ‘lifestyle and wellbeing app’, and what should be considered an ‘mHealth device’, and to what extent should these be subjected to different rules in order to ensure their quality and safety?
- What good practices currently exist to better inform end-users and healthcare professionals?
- What needs to be done to secure the personal data of patients using mHealth apps, and given the sensitive nature of health data, to what extent is there a need for additional security and data protection measures outside the scope of existing legislation and systems?
- What additional legal and ethical requirements come into play when considering the mining and storage of health data for research purposes?
- Should data protection and safety issues be handled on a national or European level?

Moderator: Paul Adamson , Senior European Policy Advisor, Covington & Burling LLP

Paul Timmers , Director, Sustainable and Secure Society, DG CONNECT, European Commission
Robert Johnstone , Board Member, European Patients Forum
Joan Antokol , Managing Partner, Park Legal LLC
DS Park , Chief Representative of EU Affairs, Samsung
Emma Woodford , Interim Secretary General, EPHA

12:00 – 13:00

Lunch

13:00 – 14:30

Session 2: Developing standards for coordinated, interoperable and universal mHealth solutions

Interoperability is a critical step in enabling scalable mHealth solutions, and would allow for faster and less costly integration of devices, as well as encouraging innovation. However, despite the EU taking the first steps towards the set up of an interoperability framework via its eHealth network, the adoption of standards and guidelines in this area has still been relatively inconsistent, and further work is required. This session will look at what needs to be done to deliver an interoperable mHealth environment in Europe and beyond, and taking things a step further, at how it can be ensured that patients and consumers everywhere have equal access and accessibility to mHealth solutions.

- What are the major challenges associated with the development of universal standards for mHealth in Europe and Globally?
- Does the eHealth Action Plan go far enough in setting standards and enhancing interoperability of mHealth solutions in Europe, or is there a need for additional action?
- How can it be ensured that standards that are developed are flexible enough to cope with emerging new trends in technological innovation?
- What could the adoption of international standards mean for the implementation of mHealth solutions in low- and middle-income countries?
- What can be done to improve access to mHealth solutions for citizens throughout the EU and beyond?
- What work is being done in mHealth in regions outside Europe, and what level of international co-operation is being seen?
- Are there examples of best practice being seen in other regions that could be used in Europe?

Moderator: Martin Andreasson , Councillor, Västra Götaland; Rapporteur for the Green Paper on mobile health, Committee of the Regions

Richard Bergström , Director General, EFPIA
Nicole Denjoy , Secretary General, COCIR
Suno Wood , Chairman, ETSI EP EHEALTH
Jonathan Zuck , President, ACT | The App Association
Ray Pinto , Senior Government Affairs Manager, Microsoft Europe, Middle East and Africa

14:30 – 14:50

Coffee Break

14:50 – 16:20

Session 3: From niche market to mainstream – integrating mHealth into everyday healthcare systems

For the European ambition of becoming a front runner in mHealth to be achieved, it is crucial to obtain the support of three key groups – patients, healthcare professionals and app developers. This session will look at some of the current obstacles to this, and at what needs to be done at EU and national level to enable this to be realized.

- How close are we to widespread mHealth adoption, and what needs to be done to achieve buy in both from app developers and consumers?
- What reimbursement models are currently available for mHealth services, and is there a need to explore innovative new approaches and models in order to engage consumers and incentivise healthcare professionals?
- What challenges are faced by app developers and web entrepreneurs who want to access the mHealth market, and what can be done to overcome these?
- How can it be ensured that the ‘human’ element of healthcare is not forgotten and that mHealth solutions are designed and used in a way that they complement existing healthcare solutions?
- What assistance can be given to mHealth manufacturers and healthcare professionals to enable them to mitigate the liability risks posed by the use and prescription of mHealth solutions?

Moderator: Ilaria Passarani , Head of the Food and Health Department, BEUC

Andrzej Ryś , Director, Health Systems and Products, DG Health and Consumers, European Commission
Dee O'Sullivan , Director, myhealthapps.net / PatientView
Fiona Adshead , Director of Wellbeing and Public Health, Bupa
Emma Garde , Director, Customer Solutions and Innovation, Sanofi
Sameer Pujari , Technical Officer, WHO
Neil Mortimer , Head of Digital Programmes, West Midlands Academic Health Science Network

16:20 – 16:25

Conference Close