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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. |
