Security aspects for medical device vigilance information exchange. 1996

G Pangalos
Informatics Laboratory, Faculty of Technology, Aristotelian University of Thessaloniki, Greece.

The implementation of appropriate security mechanisms for an effective and efficient medical device vigilance information exchange is very important, as the system handles sensitive information. These mechanisms have to be designed in such a way that they maintain confidentiality, integrity and availability of the data of medical devices. In this paper the security aspects of the information exchange on medical device vigilance is examined in detail.

UI MeSH Term Description Entries
D007256 Information Systems Integrated set of files, procedures, and equipment for the storage, manipulation, and retrieval of information. Ancillary Information Systems,Emergency Care Information Systems,Information Retrieval Systems,Perinatal Information System,Ancillary Information System,Information Retrieval System,Information System,Information System, Ancillary,Information System, Perinatal,Perinatal Information Systems,Systems, Information Retrieval
D011358 Product Surveillance, Postmarketing Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale. Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D011795 Surveys and Questionnaires Collections of data obtained from voluntary subjects. The information usually takes the form of answers to questions, or suggestions. Community Survey,Nonrespondent,Questionnaire,Questionnaires,Respondent,Survey,Survey Method,Survey Methods,Surveys,Baseline Survey,Community Surveys,Methodology, Survey,Nonrespondents,Questionnaire Design,Randomized Response Technique,Repeated Rounds of Survey,Respondents,Survey Methodology,Baseline Surveys,Design, Questionnaire,Designs, Questionnaire,Methods, Survey,Questionnaire Designs,Questionnaires and Surveys,Randomized Response Techniques,Response Technique, Randomized,Response Techniques, Randomized,Survey, Baseline,Survey, Community,Surveys, Baseline,Surveys, Community,Techniques, Randomized Response
D003219 Confidentiality The privacy of information and its protection against unauthorized disclosure. Patient Data Privacy,Privacy of Patient Data,Privileged Communication,Confidential Information,Secrecy,Communication, Privileged,Communications, Privileged,Data Privacy, Patient,Information, Confidential,Privacy, Patient Data,Privileged Communications
D003625 Data Collection Systematic gathering of data for a particular purpose from various sources, including questionnaires, interviews, observation, existing records, and electronic devices. The process is usually preliminary to statistical analysis of the data. Data Collection Methods,Dual Data Collection,Collection Method, Data,Collection Methods, Data,Collection, Data,Collection, Dual Data,Data Collection Method,Method, Data Collection,Methods, Data Collection
D004864 Equipment and Supplies Expendable and nonexpendable equipment, supplies, apparatus, and instruments that are used in diagnostic, surgical, therapeutic, scientific, and experimental procedures. Apparatus and Instruments,Devices,Medical Devices,Device, Medical,Devices, Medical,Equipment,Inventories,Medical Device,Supplies,Device,Instruments and Apparatus,Inventory,Supplies and Equipment
D005062 European Union An economic union with the principal objectives of free movement of goods, capital, and labor. The constituent countries are Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden. (https://europa.eu/european-union/about-eu/countries accessed 12/31/2020) Common Market,Euratom,European Atomic Energy Community,European Coal and Steel Community,European Common Market,European Community,European Economic Community,Community, European Economic,EEC,Economic Community, European,Common Market, European,Common Markets,Common Markets, European,Communities, European,Communities, European Economic,Community, European,Economic Communities, European,European Common Markets,European Communities,European Economic Communities,Market, Common,Market, European Common,Union, European
D016494 Computer Security Protective measures against unauthorized access to or interference with computer operating systems, telecommunications, or accompanying data; especially the modification, deletion, destruction, or release of data in computers. It includes methods of forestalling interference by computer viruses or computer hackers aiming to compromise stored data. Computer Viruses,Data Protection,Data Security,Compromising of Data,Computer Hackers,Computer Worms,Cyber Security,Cybersecurity,Data Encryption,Information Protection,Computer Hacker,Computer Virus,Computer Worm,Data Compromising,Data Encryptions,Encryption, Data,Encryptions, Data,Hacker, Computer,Hackers, Computer,Protection, Data,Protection, Information,Security, Computer,Security, Cyber,Security, Data,Virus, Computer,Viruses, Computer,Worm, Computer,Worms, Computer

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