Comparison of data security of the electronic patient diary smart medication ™ with manual documentation in a paper diary
A. Roesch1, R. Fischer2, W. Mondorf3, D. Schmoldt1 (1Dreieich, Germany, 2Giessen, Germany, 3Frankfurt am Main, Germany)
Bleeding disorders, coagulation and fibrinolytic factors
Date: 17.02.2017,
Time: 17:15 - 18:15
Objective: Comparison of data security of the electronic patient diary smart medication ™ with manual documentation in a paper diary
Methods: The risk assessment method was used to compare risks associated with the electronic documentation platform smart medication ™ with the traditional methods of paper documentation. Conceivable scenarios, such as loss of data, incorrect data transmission and possible misuse of data have been analyzed and evaluated using a risk-based approach.
Results: The risk assessment revealed clear advantages for the electronic patient diary in particular in the following areas: • no irreversible data loss possible • error minimization through plausibility checks during the patient's entry and later by the physician or the haemophlia nurses • seamless traceability of all data inputs and amendments • highly reduced risk of data misuse due to pseudonymization and access rights control to the electronic diary • sustainable long-term storage reliability
Conclusion: The results show that the electronic patient diary is clearly superior to paper documentation in terms of the confidentiality, security and integrity of the data. However, the selection and implementation of appropriate measures for minimizing risks is decisive. In doing so, product manufacturers must take into account not only the relevant standards, directives and laws, but also technical frameworks such as the recommendations of the Federal Office for Information Security (Bundesamt für Sicherheit in der Informationstechnik, BSI) or standard ISO 27000 ff. on information security.