Open Research Data in the Life Sciences

March 6, 2015


See the presentation at the Conference "Open Science for a Better Research", held in Rome, "Sapienza" University



New Paper on the legal issues of Personal Health Records

New publication on the legal issues of PHR and the Italian e-health legislation


Guarda P., Ducato R., Profili giuridici dei Personal Health Records: l’autogestione dei dati sanitari da parte del paziente tra privacy e tutela della salute [Legal issues of Personal Health Records: the patient self-management of health data between privacy and the right to health], in Rivista Critica di Diritto Privato, n. 3, 2014, pp. 389-419





In 2012 the Italian Legislator has begun a process of mandatory adoption of the national Electronic Health Records (EHR) system, in which the patient plays a pivotal role: with the implementation of the Fascicolo sanitario elettronico (FSE), patients will have access to their EHRs through the online platform, and decide which data to share and with whom. In this perspective, one of the most interesting innovations is the socalled 'taccuino', a digital space of patients' FSE in which they can autonomously record data and information relating to their health. Patients' ability to access their own health data and EHR at any time and to enter information by themselves in a personal area is a unique form of power at a European level, but their legal consequences are still vague. The aim of this contribution is to offer a first review of the Italian ehealth reform, showing the most critical aspects.

Overview of the national laws on electronic health records in the EU Member States

The EU Commission has recently published a legal study on EHR


The analysis focuses in a comparative fashion on the national laws on electronic health records within the EU Member States and it further assesses the interaction of such norms with the provision of cross-border eHealth services mentioned in Directive on patients’ rights in cross-border healthcare (2011/24/EU).


Here you can find the final report and reccommendations; while, here all the country reports



Il pianeta connesso. La nuova dimensione della privacy

January 28, 2015


As a part od the 2015 European Data Privacy Day, the Italian data protection Authority has organized a conferende dedicated to the current challenges of data protection in an interconnected world.


See the program

Green Paper on mHealth: now online the consultation results

January 12, 2015


The Commission has finally published the results of the public consultation on mHealth launched through the Green Paper in April 2014.


According to the Summary Report, 211 responses were received.


In brief:

- "97 respondents believe that strong privacy and security tools (such as data encryption and authentication mechanisms) are needed to build users' trust. Half of the respondents called for a strengthened enforcement of data protection and the rules applicable to mHealth devices.


- Nearly half of the respondents ask for more patient safety and transparency of information, by means of certification schemes or quality labelling of lifestyle and wellbeing apps. Nevertheless, some warn against the risks of over-regulation.


- Web entrepreneurs consider it difficult to access the market due to the lack of a clear regulatory framework, interoperability and common quality criteria.


- 71 respondents think performance and safety requirements and liability rules applicable to lifestyle and wellbeing apps should be clarified, through legislation, self-regulation or guidance.


- A fifth of respondents believe more evidence is needed on the cost-effectiveness of mHealth. 21 respondents referred to specific studies and projects which have demonstrated efficiency gains. For example, according to one study, trials in the Nordic countries have shown that mHealth could generate a 50-60% reduction in hospital nights and re-hospitalization for patients with Chronic Obstructive Pulmonary Disease. The same study estimates that mHealth could reduce overall elderly care expenditure by 25%.



Respondents also suggested that:


- EU and national actions should ensure interoperability of mHealth solutions with Electronic Health Records (EHRs) for continuity of care and for research purposes.


- Greater emphasis should be put on actions to promote open standards and the use of the common open architecture or open Application Programming Interfaces.


- Health professionals, care-givers and users should be actively involved in co-designing mHealth solutions".


In the course of 2015, the Commission will discuss with the stakeholders the proposed suggestions in order to adopt further actions in this sector.


You can download each contribution here

Guidelines on ePrescriptions

18th November 2014


The eHealth Network has recently released the Guidelines on eprescriptions for the purpose of interoperability between Member States.


The aim is to facilitate implementation of the recognition and delivery of prescriptions issued in another Member state in support of the implementation of Article 11 of Directive 2011/24/EU on the application of patient's rights in cross-border healthcare.


The Guidelines define the minimum dataset to share prescriptions across borders, set the technical measures for assuring the interoperability, and provide the patient gives his or her consent to use the ePrescription service.


The full text of the guidelines here