{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T12:56:19Z","timestamp":1771851379119,"version":"3.50.1"},"reference-count":35,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2022,2,17]],"date-time":"2022-02-17T00:00:00Z","timestamp":1645056000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springer.com\/tdm"},{"start":{"date-parts":[[2022,2,17]],"date-time":"2022-02-17T00:00:00Z","timestamp":1645056000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springer.com\/tdm"}],"funder":[{"name":"National Cyber Security Research Center (CSRC), Ben-Gurion University of the Negev","award":["875-376-11"],"award-info":[{"award-number":["875-376-11"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Digit Imaging"],"published-print":{"date-parts":[[2022,6]]},"DOI":"10.1007\/s10278-021-00562-y","type":"journal-article","created":{"date-parts":[[2022,2,17]],"date-time":"2022-02-17T20:06:39Z","timestamp":1645128399000},"page":"666-677","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["A Cyber-Security Risk Assessment Methodology for Medical Imaging Devices: the Radiologists\u2019 Perspective"],"prefix":"10.1007","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3496-4097","authenticated-orcid":false,"given":"Tom","family":"Mahler","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3471-3143","authenticated-orcid":false,"given":"Erez","family":"Shalom","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arnon","family":"Makori","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9641-128X","authenticated-orcid":false,"given":"Yuval","family":"Elovici","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0328-2333","authenticated-orcid":false,"given":"Yuval","family":"Shahar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,2,17]]},"reference":[{"key":"562_CR1","unstructured":"S. Larson, \u201cMassive Cyberattack Targeting 99 Countries Causes Sweeping Havoc,\u201d CNN, 2017. Available: https:\/\/money.cnn.com\/2017\/05\/12\/technology\/ransomware-attack-nsa-microsoft\/."},{"key":"562_CR2","doi-asserted-by":"publisher","unstructured":"C. Czeschik, \u201cBlack Market Value of Patient Data,\u201d in Digital Marketplaces Unleashed, Berlin, Heidelberg: Springer Berlin Heidelberg, Sep. 2018, pp. 883\u2013893, ISBN: 9783662492758. https:\/\/doi.org\/10.1007\/978-3-662-49275-8_78. [Online]. Available: https:\/\/link.springer.com\/chapter\/10.1007\/978-3-662-49275-8_78.","DOI":"10.1007\/978-3-662-49275-8_78"},{"key":"562_CR3","unstructured":"Food and Drug Administration, \u201cPostmarket management of cybersecurity in medical devices,\u201d 2016. Available: https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/postmarket-management-cybersecurity-medical-devices."},{"key":"562_CR4","doi-asserted-by":"publisher","unstructured":"S. Fenz, J. Heurix, T. Neubauer, and F. Pechstein, \u201cCurrent challenges in information security risk management,\u201d Information Management & Computer Security, vol. 22, no. 5, pp. 410\u2013430, Nov. 2014, ISSN: 0968\u20135227. https:\/\/doi.org\/10.1108\/IMCS-07-2013-0053. Available: https:\/\/www.emerald.com\/insight\/content\/10.1108\/IMCS-07-2013-0053\/full\/html.","DOI":"10.1108\/IMCS-07-2013-0053"},{"key":"562_CR5","doi-asserted-by":"publisher","unstructured":"National Institute of Standards and Technology (NIST), \u201cGuide for conducting risk assessments,\u201d National Institute of Standards and Technology, Gaithersburg, MD, Tech. Rep., 2012. https:\/\/doi.org\/10.6028\/NIST.SP.800-30r1. Available: https:\/\/nvlpubs.nist.gov\/nistpubs\/Legacy\/SP\/nistspecialpublication800-30r1.pdf.","DOI":"10.6028\/NIST.SP.800-30r1"},{"key":"562_CR6","unstructured":"BS ISO\/IEC, \u201cISO\/IEC 27005:2008, Information Technology \u2013 Security techniques \u2013 Information Security Risk Management,\u201d vol. 3, 2008. Available: https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso-iec:27005:ed-2:v1:en."},{"key":"562_CR7","doi-asserted-by":"crossref","unstructured":"C. J. Alberts, A. J. Dorofee, J. F. Stevens, and C. Woody, \u201cIntroduction to the OCTAVE Approach,\u201d Tech. Rep., 2003. Available: https:\/\/resources.sei.cmu.edu\/library\/asset-view.cfm?assetid=51546.","DOI":"10.21236\/ADA634134"},{"key":"562_CR8","doi-asserted-by":"crossref","unstructured":"B. Farquhar, \u201cOne approach to risk assessment,\u201d Computers & Security, vol. 10, no. 1, pp. 21\u201323, Feb. 1991, ISSN: 01674048. 10. 1016\/0167\u20134048(91)90051-E. Available: https:\/\/www.sciencedirect.com\/science\/article\/pii\/016740489190051E?via%3Dihub.","DOI":"10.1016\/0167-4048(91)90051-E"},{"key":"562_CR9","unstructured":"Z. Yazar, A Qualitative Risk Analysis and Management Tool \u2013 CRAMM, 2002. Available: https:\/\/www.sans.org\/reading-room\/whitepapers\/auditing\/qualitativerisk-analysis-management-tool-cramm-83."},{"key":"562_CR10","doi-asserted-by":"publisher","unstructured":"J. Freund and J. Jones, Measuring and managing information risk a FAIR approach. 2015, ISBN: 978\u20130\u201312\u2013420231\u20133. https:\/\/doi.org\/10.1016\/C2013-0-09966-5.","DOI":"10.1016\/C2013-0-09966-5"},{"key":"562_CR11","unstructured":"C. Harpes, A. A. Adelsbach, S. Zatti, and N. Peccia, \u201cQuantitative Risk Assessment With ISAMM on ESA\u2019s Operations Data System,\u201d Proceedings of TTC, pp. 173\u2013176, 2007."},{"key":"562_CR12","doi-asserted-by":"publisher","unstructured":"Stine, M. Rice, S. Dunlap, and J. Pecarina, \u201cA cyber risk scoring system for medical devices,\u201d International Journal of Critical Infrastructure Protection, Apr. 2017, ISSN: 18745482. https:\/\/doi.org\/10.1016\/j.ijcip.2017.04.001. Available: https:\/\/www.sciencedirect.com\/science\/article\/pii\/S187454821730063X.","DOI":"10.1016\/j.ijcip.2017.04.001"},{"key":"562_CR13","doi-asserted-by":"publisher","unstructured":"T. Yaqoob, H. Abbas, and N. Shafqat, \u201cIntegrated Security, Safety, and Privacy Risk Assessment Framework for Medical Devices,\u201d IEEE Journal of Biomedical and Health Informatics, pp. 1\u20131, 2019, ISSN: 2168\u20132194. https:\/\/doi.org\/10.1109\/JBHI.2019.2952906. Available: https:\/\/ieeexplore.ieee.org\/document\/8896075\/.","DOI":"10.1109\/JBHI.2019.2952906"},{"key":"562_CR14","unstructured":"T. Mahler, Y. Elovici, and Y. Shahar, \"A new methodology for information security risk assessment for medical devices and its evaluation,\" arXiv:2002.06938 [cs.CR], Feb. 2020. Available: https:\/\/arxiv.org\/abs\/2002.06938."},{"key":"562_CR15","doi-asserted-by":"publisher","unstructured":"P. FitzGerald, J. Bennett, J. Carr, P. M. Edic, D. Entrikin, H. Gao, M. Iatrou, Y. Jin, B. Liu, G. Wang, J. Wang, Z. Yin, H. Yu, K. Zeng, and B. De Man, \u201cCardiac CT: A system architecture study,\u201d Journal of X-Ray Science and Technology, vol. 24, no. 1, pp. 43\u2013 65, Mar. 2016, ISSN: 08953996. https:\/\/doi.org\/10.3233\/XST-160537. Available:https:\/\/content.iospress.com\/articles\/journalof-x-ray-science-and-technology\/xst537.","DOI":"10.3233\/XST-160537"},{"key":"562_CR16","unstructured":"Gede B. Suparta, Focusing Computed Tomography, 2000. Available: https:\/\/www.ndt.net\/article\/wcndt00\/papers\/idn143\/idn143.htm."},{"key":"562_CR17","unstructured":"D. M. Higgins, ReviseMRI.com: System architecture, 2017. Available: https:\/\/web.archive.org\/web\/20170904143947\/, https:\/\/www.revisemri.com\/tools\/system\/."},{"key":"562_CR18","doi-asserted-by":"publisher","unstructured":"R. W. Brown, Y. C. N. Cheng, E. M. Haacke, M. R. Thompson, and R. Venkatesan, Magnetic Resonance Imaging: Physical Principles and Sequence Design, Second Edition, 2nd ed. Chichester, UK: John Wiley & Sons Ltd, Apr. 2014, p. 978, ISBN: 9781118633953. https:\/\/doi.org\/10.1002\/9781118633953. Available: https:\/\/onlinelibrary.wiley.com\/doi\/book\/10.1002\/9781118633953.","DOI":"10.1002\/9781118633953"},{"key":"562_CR19","doi-asserted-by":"publisher","unstructured":"D. W. McRobbie, E. A. Moore, and M. J. Graves, MRI from Picture to Proton. Cambridge: Cambridge University Press, 2017, p. 394, ISBN: 9781107706958. https:\/\/doi.org\/10.1017\/9781107706958. Available: https:\/\/www.cambridge.org\/core\/books\/mri-from-picture-to-proton\/83CFA27533607FC2F45EFC48C0FC628B.","DOI":"10.1017\/9781107706958"},{"key":"562_CR20","unstructured":"D. Elster and J. H. Burdette, Questions and Answers in Magnetic Resonance Imaging, 2nd ed. Mosby, Aug. 2001, ISBN: 0323011845."},{"key":"562_CR21","doi-asserted-by":"publisher","unstructured":"M. T. Vlaardingerbroek and J. A. Boer, Magnetic Resonance Imaging, Theory and Practice, 3rd ed. Berlin, Heidelberg: Springer-Verlag Berlin Heidelberg, Jul. 2003, ISBN: 978\u20133\u2013662\u201305252\u20135. https:\/\/doi.org\/10.1007\/978-3-662-05252-5. Available: https:\/\/www.springer.com\/gp\/book\/9783540436812.","DOI":"10.1007\/978-3-662-05252-5"},{"key":"562_CR22","unstructured":"M. Kutz, Biomedical Engineering and Design Handbook, Volume 2. New York, Chicago, San Francisco, Lisbon, London, Madrid, Mexico City, Milan, New Delhi, San Juan, Seoul, Singapore, Sydney, Toronto: McGraw-Hill, 2009, ISBN: 9780071498395. Available: https:\/\/www.accessengineeringlibrary.com\/browse\/biomedical-engineering-anddesign-handbook-volume-2%20www.unhas.ac.id\/tahir\/BAHAN-KULIAH\/BIO-MEDICAL\/NEW\/HANBOOK\/25_Instrumentation_Design_For_Ultrasonic_Imaging.pdf."},{"key":"562_CR23","unstructured":"Texas Instruments, Ultrasound System Design Resources and Block Diagram. Available: https:\/\/www.ti.com\/solution\/ultrasound-scanner."},{"key":"562_CR24","unstructured":"tech3, Block Diagrams-Texas Instruments-Ultrasound System Design Resources and Block Diagram, 2009. Available: https:\/\/www.element14.com\/community\/docs\/DOC-3573\/l\/block-diagrams-texas-instruments-ultrasound-system-designresources-and-block-diagram."},{"key":"562_CR25","unstructured":"T. Mahler, N. Nissim, E. Shalom, I. Goldenberg, G. Hassman, A. Makori, I. Kochav, Y. Elovici, and Y. Shahar, \u201cKnow Your Enemy: Characteristics of Cyber-Attacks on Medical Imaging Devices,\u201d [cs.CR], Jan. 2018. Available: https:\/\/arxiv.org\/abs\/1801.05583."},{"key":"562_CR26","unstructured":"C. Skinner, \u201cLos Angeles hospital paid hackers $17,000 ransom in bitcoins,\u201d Aol., 2016. Available: https:\/\/www.aol.com\/article\/2016\/02\/18\/los-angeles-hospital-paid-hackers-17-000-ransomin-bitcoins\/21314819\/."},{"key":"562_CR27","unstructured":"E. Strickland, \u201c5 Major Hospital Hacks: Horror Stories from the Cybersecurity Frontlines,\u201d IEEE Spectrum, 2016. Available: https:\/\/spectrum.ieee.org\/the-human-os\/biomedical\/devices\/5-majorhospital-hacks-horror-stories-from-the-cyber-security-frontlines."},{"key":"562_CR28","unstructured":"J. Wong, \u201cLos Angeles hospital returns to faxes and paper charts after cyberattack,\u201d The Guardian, 2016. Available: https:\/\/www.theguardian.com\/us-news\/2016\/feb\/16\/los-angeles-hospital-cyberattack-ransomware-data-computers."},{"key":"562_CR29","unstructured":"R. Winton, \u201cHollywood hospital pays $17,000 in bitcoin to hackers; FBI investigating,\u201d The Los Angeles Times, 2016. Available: https:\/\/www.latimes.com\/business\/technology\/la-me-ln-hollywood-hospital-bitcoin-20160217-story.html."},{"key":"562_CR30","unstructured":"S. Becker, L. Jendele, O. Skopek, N. Berger, S. Ghafoor, M. Marcon, and E. Konukoglu, \u201cInjecting and removing malignant features in mammography with CycleGAN: Investigation of an automated adversarial attack using neural networks,\u201d arXiv, vol. 1811.07767, Nov. 2018. Available: https:\/\/arxiv.org\/abs\/1811.07767."},{"key":"562_CR31","unstructured":"Y. Mirsky, T. Mahler, I. Shelef, and Y. Elovici, \u201cCT-GAN: Malicious Tampering of 3D Medical Imagery using Deep Learning,\u201d in 28th USENIX Security Symposium (USENIX Security 19), Santa Clara, CA: USENIX Association, 2019, pp. 461\u2013478, ISBN: 978\u20131\u2013939133\u201306\u20139. Available: https:\/\/www.usenix.org\/conference\/usenixsecurity19\/presentation\/mirsky."},{"key":"562_CR32","doi-asserted-by":"publisher","unstructured":"L. Ayala, Cybersecurity for Hospitals and Healthcare Facilities. Berkeley, CA, 2016, pp. 47\u201351, ISBN: 978\u20131\u20134842\u20132154\u20139. https:\/\/doi.org\/10.1007\/978-1-4842-2155-6. Available: https:\/\/link.springer.com\/book\/10.1007%2F978-1-4842-2155-6.","DOI":"10.1007\/978-1-4842-2155-6"},{"key":"562_CR33","unstructured":"Pan, B. Yang, S. LI, W. Kang, and W. Zhengbo, \u201cSonic Gun to Smart Devices: Your Devices Lose Control Under Ultrasound\/ Sound,\u201d in Black Hat USA, 2017. Available: https:\/\/www.blackhat.com\/us-17\/briefings\/schedule\/index.html#sonic-gun-to-smart-devices-your-devices-lose-control-under-ultrasoundsound-6184."},{"key":"562_CR34","doi-asserted-by":"publisher","unstructured":"T. Mahler, E. Shalom, Y. Elovici, Y. Shahar, \u201cA Dual\u2010Layer Architecture for the Protection of Medical Devices from Anomalous Instructions,\u201d In: M. Michalowski, R. Moskovitch (eds) Artificial Intelligence in Medicine. AIME 2020. Lecture Notes in Computer Science, vol 12299, 2020. Springer, Cham.\u00a0https:\/\/doi.org\/10.1007\/978-3-030-59137-3_25.","DOI":"10.1007\/978-3-030-59137-3_25"},{"key":"562_CR35","doi-asserted-by":"publisher","unstructured":"T. Mahler, E. Shalom, Y. Elovici, and Y. Shahar, \u201cA dual\u2010layer context\u2010based architecture for the detection of anomalous instructions sent to medical devices,\u201d Artificial Intelligence in Medicine, Volume 123, 102229, 2022, ISSN: 0933\u20103657.\u00a0https:\/\/doi.org\/10.1016\/j.artmed.2021.102229.","DOI":"10.1016\/j.artmed.2021.102229"}],"container-title":["Journal of Digital Imaging"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10278-021-00562-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10278-021-00562-y\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10278-021-00562-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,31]],"date-time":"2022-05-31T16:41:55Z","timestamp":1654015315000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10278-021-00562-y"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,2,17]]},"references-count":35,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2022,6]]}},"alternative-id":["562"],"URL":"https:\/\/doi.org\/10.1007\/s10278-021-00562-y","relation":{},"ISSN":["0897-1889","1618-727X"],"issn-type":[{"value":"0897-1889","type":"print"},{"value":"1618-727X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,2,17]]},"assertion":[{"value":"2 February 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 November 2021","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 December 2021","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 February 2022","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}},{"value":"The authors declare no competing interests.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing Interests"}}]}}