title: [Medical-legal issues in remote monitoring of implantable cardioverter-defibrillators].
abstract: Patients with implanted automatic defibrillators should undergo careful monitoring during follow-up and may require access to the emergency department or hospitalization for device-related problems. Nowadays, the progressive development of information technology allows remote monitoring of patients with cardiac defibrillators using dedicated systems which make it possible to transfer clinical and technical data derived from device interrogation to the Cardiology Center through telephonic line. In patients with an implantable defibrillator, remote monitoring is effective in identifying device malfunctioning and clinical problems, such as heart failure, to an extent similar to traditional ambulatory monitoring, while allowing significant advantages for the patient quality of life and savings in resource management. This different way of organizing care has created new problems in terms of responsibility for manufacturers, responsible for the technical aspect, for the healthcare system, responsible for service supply and management, and for the physician, who should supervise the whole process and ensure the safety of the information provided. Telemedicine is configured as a highly complex activity and therefore any treatment provided through it will, in terms of responsibility, be assessed bearing in mind that "if performance involves the solution of technical problems of special difficulty, lenders are not liable for damages, except in cases of intent or gross negligence". Also important are minor legal issues, such as permissions, problems of inaccessibility to the service, the assessment of medical liability compared to the activity of the team, and all issues related to informed consent and privacy protection.
authors.affiliation: Azienda Ospedaliera Universitaria Federico II, Napoli. riganti@unina.it
authors.forename: Carla
authors.initials: C
authors.lastname: Riganti
authors.forename: Maurizio
authors.initials: M
authors.lastname: Santomauro
authors.forename: Andrea
authors.initials: A
authors.lastname: D'Alessio
authors.forename: Danilo
authors.initials: D
authors.lastname: Ruggiero
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Langella
authors.forename: Luigi
authors.initials: L
authors.lastname: Matarazzo
authors.forename: Serena
authors.initials: S
authors.lastname: Politano
authors.forename: Carlo
authors.initials: C
authors.lastname: Vosa
mesh_terms: D017147:Defibrillators, Implantable; D006801:Humans; D018670:Monitoring, Ambulatory; D017216:Telemedicine / Q000331:legislation & jurisprudence*