Abstract
Software-based medical devices need to be maintained throughout their entire life cycle. The efficiency of after-sales maintenance can be improved by managing medical systems remotely. This paper presents how to design the remote access function extensions in order to prevent risks imposed by uncontrolled remote access. A thorough analysis of standards and legislation requirements regarding safe operation and risk management of medical devices is presented. Based on the formal requirements, a multi-layer machine design solution is proposed that eliminates remote connectivity risks by strict separation of regular device functionalities from remote management service, deploys encrypted communication links and uses digital signatures to prevent mishandling of software images. The proposed system may also be used as an efficient version update of the existing medical device designs.
Acknowledgment
This work was supported in part by research programme P2-0246 by the Slovenian Research Agency.
Conflict of interest: The authors indicate no potential conflicts of interest in this work.
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Articles in the same Issue
- Frontmatter
- Review
- Wheeze sound analysis using computer-based techniques: a systematic review
- Research articles
- Effect of a combination of flip and zooming stimuli on the performance of a visual brain-computer interface for spelling
- A cost-sensitive Bayesian combiner for reducing false positives in mammographic mass detection
- Influence of acquisition frame-rate and video compression techniques on pulse-rate variability estimation from vPPG signal
- Design of a secure remote management module for a software-operated medical device
- Long-term recording of electromyographic activity from multiple muscles to monitor physical activity of participants with or without a neurological disorder
- Biomechanical investigation of different surgical strategies for the treatment of rib fractures using a three-dimensional human respiratory model
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- Designs and performance of three new microprocessor-controlled knee joints