_________________________________________________________________________________________________________________Proceedings of the Central European Conference on Information and Intelligent Systems 237 An Overview of Cybersecurity Regulations and Standards for Medical Device Software Nadica Hrgarek Lechner MED-EL Elektromedizinische Geräte GmbH Fürstenweg 77, 6020 Innsbruck, Austria
[email protected] Abstract. This paper discusses current cybersecurity 1970, Ware finalized a report about security controls regulations and standards for medical device for computer systems and emphasized that design of a software set by government agencies and agencies secure system must provide protection against the developing industry and international standards such various types of vulnerabilities such as accidental as the FDA (Food and Drug Administration), CFDA disclosure, deliberate penetration, active infiltration, (China Food and Drug Administration), ISO and physical attack (Ware, 1970). Ware (1970) stated (International Organization for Standardization), IEC the following general characteristics as desirable in a (International Electrotechnical Commission), UL secure system: flexible, responsive to changing (Underwriters Laboratories), and others. The operational characteristics, auditable, reliable, concepts described within this paper can be utilized manageable, adaptable, dependable, and assuring by medical device manufacturers in order to establish configuration integrity. a cybersecurity program as part of their quality Burns et al.