Ethical and Legal Issues

The Management of Ethical and Legal Aspects in the Hearten Project

The HEARTEN project has the potential to improve the quality of life of hearth failure patients; however, the development of a mHEALTH platform for monitoring adherence and managing HF patients can carry and reveal some risks. Therefore, it is crucial that the desire for improving the HF management should never compromise the patient safety and/or quality of life, be careful in patient’s information as well as respectful of her/his consent and/or dropout willingness, guarantee their confidentiality and anonymity. For these reasons, specific guidance for undertaking the national and European legal and ethical requirements will be taken into consideration throughout the entire HEARTEN project.

The main responsible for guiding and monitoring the ethical and legal implications arising from the project research activities is the Ethical and Privacy Issues Manager, Dr. M. Giovanna Trivella. Her main duties are to ensure that all measures have been taken in order for the project to timely identify, analyse and address potential ethical and privacy issues, arising from accessing patient health information. She will closely co-operate with the Project Coordinator, Prof. Abdelhamid Errachid, and the Technical Manager, Prof. Dimitrios Fotiadis, inform all partners about the necessary measures that have to be taken at all project phases, including analysis of project requirements and architecture design, components implementation, platform integration and system evaluation.

Moreover, in order to provide the HEARTEN consortium with an ethical and legal framework of reference and ensure compliance with EU directives and regulations, an Advisory Board is established. The Board consists of selected members of the consortium with expertise in the field of medical environment, ICT, ethics and law and it is managed by Dr M.Giovanna Trivella. The appointed members of the Advisory Board are:

• Dr. M.Giovanna Trivella, Ethical and Privacy Issues Manager, UNIPI
• Prof. Dimitrios Fotiadis, Technical Manager, FORTH
• Mr. Rafael Ordóñez Benavente, ICT consultant, EVERIS
• Mr. Carlos Luis Parra Calderón, Member of the Spanish Society of Health Informatics, SAS
• Mr.  Kostas D. Sarlis, Attorney at Law before the Supreme Court of Athens, Greece, CARE
• Mr. Jochen Klaus Schubert, D.E.A.A. Physician and chemist, Professor in Anaesthesiology, UMR 
• Mr. Angelo Gemignani MD, PhD, MS, Associate Professor of Psychophysiology, UNIPI
• Mrs. Tiziana Marino, Consultant at Telecom Italia S.p.A, "Prepaid” Business Unit/“IT Governance” department, SESA

Contact: Dr. M.Giovanna Trivella