News about the General Data Protection Regulation

June 15, 2015


Today, Ministers in the Justice Council have sealed a general approach on the Commission proposal on the Data Protection Regulation. Modern, harmonised data protection rules will contribute to making Europe fit for the digital age and are a step forward to the EU Digital Single Market. Trilogue negotiations with the Parliament and the Council will start in June; the shared ambition is to reach a final agreement by the end of 2015.



Opinion of the CNB on mHealth

The CNB (Comitato Nazionale per la Bioetica) has recently released the first Italian opinion on mHealth (Mobile-Health e applicazioni per la salute: aspetti bioetici).


The CNB emphasizes the benefits of mhealth apps both for public health and personalized medicine, but at the same time underlines some controversial ethical issues:


- health protection and security. It is not still clear which mHealth apps shall be considered as a medical devices;

- the protection of privacy and the problems related to the use of health data from third parties (not involved in the medical treatment);

- the management of the informed consent;

- the dependency and the technological vulnerability;

- the medical self-determination;

- the digital divide.



The CNB thus provides 10 ethical recommendations to guide such a technological development. Read the Opinion (Italian only)


mHealth in Europe: next steps

May 28, 2015



After the publication of the Green Paper and the results of the consultation, the European Commission is taking further steps in order to develop policy actions in the field of mHealth. In particular, the Commission aims at the creation of an industry-led Code of Conduct for mobile health apps.


In the last stakeholders' meeting, held in Riga during the eHealth Week, such an initiative was presented and the following three topics were discussed:


- privacy and security;

- safety and transparency;

- web entrepreneurs' access to the market.



See the summing up of the meeting here

Opinion 1/2015 on mHealth issued by the EDPS

May 22, 2015


The European Data Protection Supervisor (EDPS) issued the Opinion 1/2015 on "Mobile Health. Reconciling the technological innovation with data protection".


The Opinion aims at pointing out the most relevant issues of data protection in mHealth, suggesting possible solutions for the compliance of medical apps with the privacy by design principle (in a de iure condito perspective), and proposing possible legislative actions (in a de iure condendo perspective).


In particular, the Opinion draws attention to:

- the types of data processed in the mHealth context;

- the user's empowerment;

- the impact of Big Data;

- the design of mHealth apps.

Specifiche tecniche per l'interoperabilità tra i sistemi regionali di FSE

May 7, 2015


The Working Group coordinated by AgID has released the "Technical specifications for interoperability between the regional systems of Electronic Health Record" ["Specifiche tecniche per l'interoperabilità tra i sistemi regionali di FSE - framework e dataset per i servizi di base", in Italian only].

Specifiche tecniche per l’interoperabilità tra i sistemi regionali del Fascicolo Sanitario Elettronico (PDF), - See more at:
Specifiche tecniche per l’interoperabilità tra i sistemi regionali del Fascicolo Sanitario Elettronico (PDF), - See more at:


The work is the result of tests carried out by the Region of Emilia-Romagna, Lombardy and Veneto which offered to validate, with the support of the CNR, the detailed specifications for the interoperability of the regional systems of FSE, and, in particular the services of search, retrieval and indexing of FSE's documents.


See more at:

EU Commission launches the "Ex-Smokers are Unstoppable" campaign

April 13, 2015


The EU Commission launches a new version of "iCoach", a digital health coaching platform that helps people quit smoking. 


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