1. Geneva, Switzerland, 25-26 September 2012 m-Cloud for Homecare - Policy & Regulatory Challenges - Francesca Fontana, Associate at ICT Legal Consulting & Fellow of the European Privacy Association francesca.fontana@ictlegalconsulting.com ITU Experts Group Meeting on m-Health: Towards Better Care, Cure and Prevention in Europe Geneva, Switzerland, 25-26 September 2012

2. 2 Introduction The exponential increase of chronic diseases amongst the rapidly aging population, the progressive patient demand of home care, and the need of several EU national governs to strain healthcare budgets are demanding new approaches to healthcare. The mobile approach, largely encouraged by the cloud, could fill the needs of innovative technologies to support the design of distributed healthcare services, in particular provided at the patient’s house, and reduce expenditure. Geneva, Switzerland, 25-26 September 2012

3. 3 Structure of the presentation 1 Case-study 2 Legal issues 3 Conclusions & Recommendations Geneva, Switzerland, 25-26 September 2012

4. 4 Case-study Geneva, Switzerland, 25-26 September 2012 Architecture for remote sensoring of patient physiological parameters. Wireless sensors communicate with a mobile phone and are collected by a web application running in the cloud.

5. 5 Legal issues 1 Lack of harmonization concerning: Healthcare specific legislation Data protection 2 Practical difficulties in applying current data protection rules to cloud computing Geneva, Switzerland, 25-26 September 2012

6. 6 A29WP Opinion 5/2012 Checklist 1 Controller-processor relationship 2 Cloud client’s responsibility as a controller 3 Subcontracting safeguards 4 Compliance with fundamental data protection principles: Transparency Purpose specification and limitation Data retention Geneva, Switzerland, 25-26 September 2012

7. 7 A29WP Opinion 5/2012 Checklist 5 Contractual safeguards: In general Access to data Disclosure of data to third parties Obligations to cooperate Cross-border data transfers Logging and auditing of processing Technical and organizational measures Geneva, Switzerland, 25-26 September 2012

8. 8 Conclusions & recommendations Parties have to work on cloud service agreement Regulators to improve legal certainty for e-Health Geneva, Switzerland, 25-26 September 2012