A Way Forward for the MDCG 2019-16 Medical Device Security Guidance

Steve Taylor; Martin Gilje Jaatun; Karin Bernsmed; Christos Androutsos; Dietmar Frey; Simone Favrin; João Rodrigues; DušKo Milojević; Dimitrios Karras; Ioannis Siachos; Gregory Epiphaniou; Nabil Moukafih; Sotiris Messinis; Ioannis Rallis; Nicholas E. Protonotarios; Paul Gedeon; Andres Castillo; Carsten Maple; Nikolaos Matragkas; Rance Delong; Theodoros Arvanitis; Konstantinos Katzis

doi:10.1145/3652037.3663894

A Way Forward for the MDCG 2019-16 Medical Device Security Guidance

Steve Taylor^*
, Martin Gilje Jaatun
, Karin Bernsmed
, Christos Androutsos
, Dietmar Frey
, Simone Favrin
, João Rodrigues
, DušKo Milojević
, Dimitrios Karras
, Ioannis Siachos
, Gregory Epiphaniou
, Nabil Moukafih
, Sotiris Messinis
, Ioannis Rallis
, Nicholas E. Protonotarios
, Paul Gedeon
, Andres Castillo
, Carsten Maple
, Nikolaos Matragkas
, Rance Delong

Theodoros Arvanitis, Konstantinos Katzis

^*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › peer-review

9 Scopus citations

Abstract

MDCG 2019-16 is intended to assist practitioners in compliance with the Medical Device Regulation and the In-Vitro Device Regulation. This paper presents a gap analysis of MDCG 2019-16, identifying key gaps and proposing a robust set of recommendations to enhance the IoMT regulatory framework. This work has been undertaken by a selection of current (2023-2025) projects, all funded under the Horizon Europe call "Enhancing cybersecurity of connected medical devices": HORIZON-HLTH-2022-IND-13-01, and this paper summarises observations and recommendations from across these projects. There is considerable consensus across the projects in many recommendation themes, notably; linking cybersecurity with patient safety and privacy; keeping the guidelines current; and usage recipes for the guidelines. The paper also suggests toolkit solutions to address some of the recommendations.

Original language	English
Title of host publication	Proceedings of the 17th ACM International Conference on PErvasive Technologies Related to Assistive Environments, PETRA 2024
Editors	Enamul Karim, Sama Nikanfar, Hamza Reza Pavel
Publisher	Association for Computing Machinery
Pages	593-599
Number of pages	7
ISBN (Electronic)	9798400717604
DOIs	https://doi.org/10.1145/3652037.3663894
State	Published - 26 Jun 2024
Externally published	Yes
Event	17th ACM International Conference on PErvasive Technologies Related to Assistive Environments, PETRA 2024 - Crete, Greece Duration: 26 Jun 2024 → 28 Jun 2024

Publication series

Name	ACM International Conference Proceeding Series

Conference

Conference	17th ACM International Conference on PErvasive Technologies Related to Assistive Environments, PETRA 2024
Country/Territory	Greece
City	Crete
Period	26/06/24 → 28/06/24

Bibliographical note

Publisher Copyright:
© 2024 Owner/Author.

Keywords

Clinical Benefit
Cybersecurity
Guidelines
MDCG
Medical Devices
Recommendations
Regulation
Risk Management

ASJC Scopus subject areas

Human-Computer Interaction
Computer Networks and Communications
Computer Vision and Pattern Recognition
Software

Access to Document

10.1145/3652037.3663894

Cite this

Taylor, S., Jaatun, M. G., Bernsmed, K., Androutsos, C., Frey, D., Favrin, S., Rodrigues, J., Milojević, D., Karras, D., Siachos, I., Epiphaniou, G., Moukafih, N., Messinis, S., Rallis, I., Protonotarios, N. E., Gedeon, P., Castillo, A., Maple, C., Matragkas, N., ... Katzis, K. (2024). A Way Forward for the MDCG 2019-16 Medical Device Security Guidance. In E. Karim, S. Nikanfar, & H. R. Pavel (Eds.), Proceedings of the 17th ACM International Conference on PErvasive Technologies Related to Assistive Environments, PETRA 2024 (pp. 593-599). (ACM International Conference Proceeding Series). Association for Computing Machinery. https://doi.org/10.1145/3652037.3663894

Taylor, Steve ; Jaatun, Martin Gilje ; Bernsmed, Karin et al. / A Way Forward for the MDCG 2019-16 Medical Device Security Guidance. Proceedings of the 17th ACM International Conference on PErvasive Technologies Related to Assistive Environments, PETRA 2024. editor / Enamul Karim ; Sama Nikanfar ; Hamza Reza Pavel. Association for Computing Machinery, 2024. pp. 593-599 (ACM International Conference Proceeding Series).

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title = "A Way Forward for the MDCG 2019-16 Medical Device Security Guidance",

abstract = "MDCG 2019-16 is intended to assist practitioners in compliance with the Medical Device Regulation and the In-Vitro Device Regulation. This paper presents a gap analysis of MDCG 2019-16, identifying key gaps and proposing a robust set of recommendations to enhance the IoMT regulatory framework. This work has been undertaken by a selection of current (2023-2025) projects, all funded under the Horizon Europe call {"}Enhancing cybersecurity of connected medical devices{"}: HORIZON-HLTH-2022-IND-13-01, and this paper summarises observations and recommendations from across these projects. There is considerable consensus across the projects in many recommendation themes, notably; linking cybersecurity with patient safety and privacy; keeping the guidelines current; and usage recipes for the guidelines. The paper also suggests toolkit solutions to address some of the recommendations.",

keywords = "Clinical Benefit, Cybersecurity, Guidelines, MDCG, Medical Devices, Recommendations, Regulation, Risk Management",

author = "Steve Taylor and Jaatun, \{Martin Gilje\} and Karin Bernsmed and Christos Androutsos and Dietmar Frey and Simone Favrin and Jo{\~a}o Rodrigues and Du{\v s}Ko Milojevi{\'c} and Dimitrios Karras and Ioannis Siachos and Gregory Epiphaniou and Nabil Moukafih and Sotiris Messinis and Ioannis Rallis and Protonotarios, \{Nicholas E.\} and Paul Gedeon and Andres Castillo and Carsten Maple and Nikolaos Matragkas and Rance Delong and Theodoros Arvanitis and Konstantinos Katzis",

note = "Publisher Copyright: {\textcopyright} 2024 Owner/Author.; 17th ACM International Conference on PErvasive Technologies Related to Assistive Environments, PETRA 2024 ; Conference date: 26-06-2024 Through 28-06-2024",

year = "2024",

month = jun,

day = "26",

doi = "10.1145/3652037.3663894",

language = "English",

series = "ACM International Conference Proceeding Series",

publisher = "Association for Computing Machinery",

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Taylor, S, Jaatun, MG, Bernsmed, K, Androutsos, C, Frey, D, Favrin, S, Rodrigues, J, Milojević, D, Karras, D, Siachos, I, Epiphaniou, G, Moukafih, N, Messinis, S, Rallis, I, Protonotarios, NE, Gedeon, P, Castillo, A, Maple, C, Matragkas, N, Delong, R, Arvanitis, T & Katzis, K 2024, A Way Forward for the MDCG 2019-16 Medical Device Security Guidance. in E Karim, S Nikanfar & HR Pavel (eds), Proceedings of the 17th ACM International Conference on PErvasive Technologies Related to Assistive Environments, PETRA 2024. ACM International Conference Proceeding Series, Association for Computing Machinery, pp. 593-599, 17th ACM International Conference on PErvasive Technologies Related to Assistive Environments, PETRA 2024, Crete, Greece, 26/06/24. https://doi.org/10.1145/3652037.3663894

A Way Forward for the MDCG 2019-16 Medical Device Security Guidance. / Taylor, Steve; Jaatun, Martin Gilje; Bernsmed, Karin et al.
Proceedings of the 17th ACM International Conference on PErvasive Technologies Related to Assistive Environments, PETRA 2024. ed. / Enamul Karim; Sama Nikanfar; Hamza Reza Pavel. Association for Computing Machinery, 2024. p. 593-599 (ACM International Conference Proceeding Series).

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › peer-review

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ER -

Taylor S, Jaatun MG, Bernsmed K, Androutsos C, Frey D, Favrin S et al. A Way Forward for the MDCG 2019-16 Medical Device Security Guidance. In Karim E, Nikanfar S, Pavel HR, editors, Proceedings of the 17th ACM International Conference on PErvasive Technologies Related to Assistive Environments, PETRA 2024. Association for Computing Machinery. 2024. p. 593-599. (ACM International Conference Proceeding Series). doi: 10.1145/3652037.3663894

A Way Forward for the MDCG 2019-16 Medical Device Security Guidance

Abstract

Publication series

Conference

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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Cite this