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ClinicOnline®: PDF clinical reports with legal value thanks to the certified digital signature |
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ClinicOnline®, Sinaptica IT's digital clinical case history, offers the possibility of signing all events within the clinical case history by means of a digital certificate, guaranteeing their validity, truthfulness and authorship with full legal value.
We are in the age of communication. In this context, Internet becomes an open communications network where anybody can use the net and anybody can exploit its vulnerabilities for fraudulent purposes. The certified digital signature is a fundamental tool to meet an appropriate data security as it provides legal value to electronic documents, as for example PDF files.
On the ClinicOnline® platform, the certified digital signature aims at guaranteeing the validity, truthfulness and authorship of an electronic file and it is the result of an information technology procedure based on a cryptography coding system that is devoted to:
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Confidentiality: only an authorized user by means of user's credential can download a clinical case history event as a PDF file with a certified digital signature;
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Integrity: the information within the certified digital signature file cannot be accidentally or deliberately tampered without explicit evidence;
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Non-repudiation: the certifying server cannot deny generating the file, and at the same time, ClinicOnline® trails all operations.
ClinicOnline®, the web based clinical case history platform, stores information in the form of "events" created by authorized health operators and named clinical case history events. Each event is made of a series of clinical data; examples of events may typically be medical visits, laboratory tests results (even in the form of images), surgery operations or ongoing therapies.
By means of the PDF clinical case history tool, ClinicOnline® allows the implementation of a certified digital signature to clinical case history events. To do so, the operator or the patient will simply need to select the certified signature option when downloading the PDF file. Once these electronic files have been downloaded, they can be archived and used, for any purposes, as certified documents of which the validity has been ascertained by the system thanks to an advanced cryptographic procedure. In this respect, the platform guarantees to the file provable security while it is under the user's responsibility to maintain its secrecy.
Thanks to this new feature, patients are no longer obliged to keep paper documents and they can have as many copies of the reports as needed, always with legal validity, to be forwarded, for example, to other health operators involved in their treatment. On his side, the health operator has the advantage of not needing to print on paper patient’s reports in order to sign them manually.
Taking into consideration the fundamental importance and potentiality of this new feature within the field of clinical research, SinapticaMED has decided to implement it on ClinicalTrials, the web platform for clinical trials data capture. In this case, the certified digital signature will be implemented on data export in the form of an XML (eXtended Markup Language) file. The data export file guarantees the validity, truthfulness and authorship of the file itself in addition to the already active measures in the field of information technology security (among which, the HTTPS data transfer protocol, the 128 Secure Socket Layer cipher coding and the VeriSign Secured EV). Furthermore, this feature will be used for PDF case report forms, including those related to serious adverse events (SAEs), in view of the implementation of an electronic management procedure by competent authorities.
Once more, SinapticaMED is able to supply cutting edge clinical data management technology, providing clients with two different platforms, ClinicOnline® and ClinicalTrials, able to guarantee really high data protection and security standards and offering operators the possibility of making use of digitally signed documents with legal value.
All this translates into an outstanding dynamism benefit for the health operator that is no more tied to paper printing to have a health report with legal value and it gives patients the possibility of having a legally valid copy of their own clinical case histories at hand any moment. |
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Sinaptica IT for Abruzzo |
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The digital clinical case history ClinicOnline® has allowed to keep on providing oncological medical assistance to the earthquake-displaced patients. The web-based Sinaptica IT service has been successfully implemented on Apple iPhones supplied to the operators of the no-profit organization “L'Aquila per la Vita” (“L'Aquila for Life”).
Sinaptica IT and the no-profit organization “L'Aquila per la Vita” have tuned and been using, since may 2009, an innovative telemedicine service that enhances home healthcare assistance to cancer patients from L'Aquila and surrounding areas. This collaboration was born already before the earthquake hit the area, with the goal of improving cancer patients’ quality of life and home healthcare assistance, but after the natural disaster hit the Abruzzo, it has become the organization's volunteer physicians most valuable resource to guarantee a mobile medical assistance to displaced people that had to leave their houses, through an internet connection via GSM-UMTS network.
Sinaptica IT has put its own IT systems at the organization's disposal for this particular project and, more precisely, the digital clinical case history ClinicOnline®, while the organization “L'Aquila per la Vita” has been responsible of final service supply, dealing with all logistical details and supplying dedicated health personnel.
Thanks to the digital clinical case history ClinicOnline®, physicians have been able to remotely check patients’ clinical data through internet by means of iPhones and portable PCs with an internet connection, even being far away from hospital.
With ClinicOnline®, the Sinaptica IT web-based clinical case history, operators can, in real time, register any therapy or patients' conditions changes, share clinical case histories with other specialists in a secure way and even send a therapy reminder to patients or to their care givers via e-mail or SMS. Thus, with ClinicOnline®, health services or control examinations can still be supplied at the temporary patients' address, enhancing the coordination of different health structures still active in the area and field professionals displaced throughout the national territory.
Health operators from the organization “L'Aquila per la Vita” have found the combination of both, the digital clinical case history ClinicOnline® and the Apple iPhone smartphone, really practical. By means of an internet connection, secure and coded patients' data have always been available on a really small multiple feature device, perfect on particularly difficult situations, as the one after an earthquake, guaranteeing, even in critical conditions, a continuous healthcare assistance to patients.
“To our company, it is extremely important – stated Marco Capoferri, Sinaptica IT Research & Development Director- to have checked that our solutions are able to supply a functional platform to healthcare assistance even when physical infrastructures and links cannot guarantee any service. We have indeed confirmed the present value of a solution tuned to work through internet, on any internet connected device, without any installation needed.” |
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ClinicOnline con RomAil per l'assistenza ospedaliera domiciliare |
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There are no translations available.
La cartella clinica digitale ClinicOnline® di Sinaptica IT è utilizzata con successo come piattaforma web per il Progetto ASDOM dell'Ospedale Ematologico Domiciliare RomAil "Giuseppe Papa", consentendo a oltre 100 operatori attivi sul territorio di erogare prestazioni di continuità assistenziale ad alto contenuto tecnico e sanitario.
Nato da un'intuizione del Prof. Mandelli, pioniere dell'umanizzazione delle cure in ematologia, l'ospedale "virtuale" Giuseppe Papa vede la strettissima collaborazione fra i team di ematologia operanti presso l’Ospedale S. Eugenio, coordinato dal Dott. Pasquale Niscola, e presso il Policlinico Umberto I, con la direzione del Dott. Claudio Cartoni. A questi team, si è aggiunto da alcuni mesi quello dell’Ematologia dell’Ospedale San Giovanni coordinato dal Dott. Bartolini. Obiettivo del progetto è quello di deospedalizzare i pazienti affetti da malattie del sangue e di spostare il servizio di assistenza dalle strutture tradizionali alle case dei malati.
Sinaptica IT ha raccolto l'impegnativa sfida di offrire una soluzione integrata software e hardware immediatamente pronta all'uso che consentisse di operare in mobilità. Il sistema realizzato permette al personale sanitario di accedere alla cartella clinica direttamente da casa del paziente utilizzando un notebook, cioè un computer portatile di minimo ingombro, collegato via HSDPA (tecnologia 3G).
Gli elementi tecnologici su cui si basa la soluzione sono la cartella clinica digitale ClinicOnline® di Sinaptica IT e i leggeri notebook forniti in comodato d'uso e dotati di connessione Internet ad alta velocità.
L'infrastruttura che abbiamo messo a punto per il Progetto ASDOM è paradigmatica della nostra filosofia aziendale. Le soluzioni di Sinaptica IT sono sviluppate per offrire la massima compatibilità con l'esistente e consentire così una reale ottimizzazione dei costi. In questo caso il fatto che la nostra cartella clinica digitale ClinicOnline® sia compatibile con qualunque browser ha permesso di dotare gli operatori di comunissimi netbook senza dover ricorrere a costosi quanto inutili hardware dedicati, come troppo spesso vediamo nel settore della telemedicina, e senza dover effettuare nessuna installazione di software specifico, con un evidente risparmio in termini di licenze e assistenza."
L'utilizzo di hardware neutro e senza la necessità di programmi dedicati rende inoltre possibile associare all'attività del Progetto ASDOM qualunque ulteriore postazione di accesso ai dati, sia che si tratti di computer fissi, anche in ambito ospedaliero o di laboratorio di analisi, sia che si tratti di altri apparati mobili come laptop, palmari o cellulari dotati di connesione Internet.
Cuore del sistema sviluppato per ASDOM è la cartella clinica digitale ClinicOnline®, accessibile via web ovunque si trovi l'operatore. Uno strumento che rende disponibili in tempo reale i dati clinici dei pazienti per il medico che opera in mobilità, garantendo nel contempo i più elevati standard di sicurezza, necessari per la gestione dei dati sensibili: tutte le informazioni in transito vengono criptate e sottoposte a una triplice procedura di controllo.
"Il vantaggio di utilizzare una piattaforma web per accedere ai dati clinici è quanto mai evidente nel Progetto ASDOM - spiega l'Ing. Marco Capoferri, responsabile del settore ricerca e sviluppo di Sinaptica IT - Infatti non solo gli operatori possono accedere ovunque ai dati dei pazienti, ma gli stessi dati con la medesima interfaccia operativa sono presenti in tempo reale anche in ospedale o presso eventuali specialisti associati. Ad esempio, se i risultati di un esame si rendono disponibili mentre l'operatore è già impegnato per il suo giro di visite, grazie all'accesso via web in tempo reale potranno essere consultati senza dover tornare in ospedale. Questo è quello che noi consideriamo telemedicina, cioè l'utilizzo degli strumenti tecnologici per offrire un concreto miglioramento dell'efficienza e della efficacia dell'assistenza medica."
Un ulteriore elemento di novità è inoltre l'utilizzo della piattaforma ClinicOnline® per uno studio contestuale sulla qualità della vita dei pazienti domiciliari, resa possibile grazie al fatto che tra le funzionalità integrate nella cartella clinica digitale di Sinaptica IT c'è la raccolta di dati clinici e l'esportazione delle informazioni in formato XML.
"Il caso dell'ospedale Giuseppe Papa è un esempio di come le soluzioni Sinaptica IT abbiano l'obiettivo di innescare un circolo virtuoso che coniughi qualità della vita dei pazienti e ottimizzazione delle risorse - conclude l'Ing. Capoferri - Se da un lato è evidente il beneficio economico che consegue alla deospedalizzazione del paziente (secondo i dati RomAil il costo giornaliero per un paziente in ospedale è di 350 euro) per noi l'obiettivo centrale di questa collaborazione rimane tuttavia quello di creare un'infrastruttura tecnologica per la rivoluzione copernicana, fortemente sostenuta da RomAil, di un sistema sanitario con al centro il paziente e i suoi bisogni. Che un'adeguata assistenza in un contesto familiare sia possibile grazie all'efficienza, all'efficacia e all'economicità dei nostri sistemi è per noi motivo di orgoglio e perfettamente corrispondente alla nostra filosofia aziendale." |
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SinapticaMED at the AIL Conference on in-home assistance |
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SinapticaMED has taken part at the Italian Association against Leukaemia-Lymphoma and Myeloma (AIL) National Conference, that took place last November 21st and approached “Home assistance in the field of Hematology: the third millennium challenge”. The talk given by the engineer Marco Capoferri, Research and Development Director of Sinaptica IT focused on the interaction between the development of information technologies and the new approaches to in-home assistance in Hematology.
The congress, which was held in an outstanding Roman conference hall (“Spazio Novecento”), aimed at “making the Public Health System more aware of social implications and economic savings resulting from a new home assistance organization, helping citizens in a straightforward way and avoiding useless hospital admissions”.
A challenge that has been met by the eHealth system used by SinapticaMED in the RomaAil ASSDOM project, thanks to which it is possible to assist patients affected by hematological malignancies directly at their home.
A data transmission tool that achieves new subject care patterns focused on patients themselves and on their quality of life, making, in the healthcare environment as well, the paradigm of Efficiency, Efficacy and Economical1 services a truth. An affordable system, thanks to the fact that hospitalization is no longer needed, that, according to what came to light during the Conference can make a significant difference on the highly expensive costs of hematological home healthcare services.
ASSDOM, an Italian acronym which stands for ASSistenza DOMiciliare (in-home assistance), is an initiative that has been promoted by the RomAil Hematological Home Assistance Hospital “Giuseppe Papa” located at the Roman Hospitals “S. Eugenio” and “Policlinico Umberto I”.
The cornerstone of the information technology implemented in the project is ClinicOnline®, a digital case history accessible via web no matter where we are. An innovation solution that puts together pervasiveness and accessibility with maximum sensitive data treatment security.
This system, designed by SinapticaMED, is conceived to get medical and paramedical personnel at patients’ home address, with a really small portable computer, so as to connect themselves via web to the digital case history using any web browser available and avoiding to install any dedicated software. This way, they are able to have access to patients’ data in real time and to update them. Transferred data are encrypted with the same methodology that is actually used in bank transfers, and they undergo through a real time threefold control, the 3A REALTIME2 modality (Authentication, Authorization, Access).
A perfect example of how an innovative healthcare pattern focused on patients’ quality of life can see the light thanks to the interaction of appropriate and secure technological solutions. Also the IT support that is provided to in-home care operators, the Asus Eee PC 701, follows the same global policy in terms of resources innovation and inexpensiveness. An essential computer even if completely suitable to the home assistance activities and light in what weight and cost concerns, as it is leased without charge by the telephone company provider together with a flat Internet connection access.
“We do not need sophisticated technological devices to be able to use a leading edge system” stated the engineer Capoferri during the meeting. “A really edge system today -he added- is a system fine-tuned to be highly compatible with the surrounding world. Let us think about Google. A system which is “simple but not simpler” as Einstein would once state. This is our job and our company vision: to supply systems with maximum functionality at a minimum cost, enhancing what is already available. Solutions that may provide, as in this case, the best working conditions, not only counting on what the system needs to know how to do, but with already available resources at the customers site as well; always hoping that those who will take most profit of it all will be patients themselves.” |
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