Secure Method for Software Upgrades for Implantable Medical Devices

A non-invasive software upgrade method for permanent implantable medical devices was developed to alleviate patients＇ suffering due to malfunctions because of software faults,which may cause serious adverse health consequences or require enhancements with new software.The programs distributed to the...

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Published inTsinghua science and technology Vol. 15; no. 5; pp. 517 - 525
Main Author 曹洋 胡春华 马伯志 郝红伟 李路明 王伟明
Format Journal Article
LanguageEnglish
Published Elsevier Ltd 01.10.2010
Subjects
implantable medical device
Macaca mulatta
non-invasive
secure upgrade
software upgrade
医疗器械
安全升级
无线数据传输
植入式
神经刺激器
脉冲发生器
软件升级
软件故障
implantable medical device
non-invasive
secure upgrade
software upgrade
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Abstract A non-invasive software upgrade method for permanent implantable medical devices was developed to alleviate patients＇ suffering due to malfunctions because of software faults,which may cause serious adverse health consequences or require enhancements with new software.The programs distributed to the internal implantable pulse generator（IPG） from the external programmer have been developed so that the upgrade service program in the IPG is simplified with most complex functions executed by the external programmer.A bidirectional protocol including frame definition and transmission mode was designed to insure secure upgrades.A neuro-stimulator was used to verify the upgrade solution with no additional elements,to maintain the hardware reliability.This study emphasizes how to insure a secure and stable upgrade process and reduce power consumption for special wireless and life safety-critical applications.Tests on rhesus monkeys to evaluate the feasibility of the approach for an IPG used for brain stimulation evaluation show that the software upgrade can be implemented stably with good tolerance to the wireless data transmissions.
AbstractList A non-invasive software upgrade method for permanent implantable medical devices was developed to alleviate patients' suffering due to malfunctions because of software faults, which may cause serious adverse health consequences or require enhancements with new software. The programs distributed to the internal implantable pulse generator (IPG) from the external programmer have been developed so that the upgrade service program in the IPG is simplified with most complex functions executed by the external programmer. A bidirectional protocol including frame definition and transmission mode was designed to insure secure upgrades. A neuro-stimulator was used to verify the upgrade solution with no additional elements, to maintain the hardware reliability. This study emphasizes how to insure a secure and stable upgrade process and reduce power consumption for special wireless and life safety-critical applications. Tests on rhesus monkeys to evaluate the feasibility of the approach for an IPG used for brain stimulation evaluation show that the software upgrade can be implemented stably with good tolerance to the wireless data transmissions.
A non-invasive software upgrade method for permanent implantable medical devices was developed to alleviate patients＇ suffering due to malfunctions because of software faults,which may cause serious adverse health consequences or require enhancements with new software.The programs distributed to the internal implantable pulse generator（IPG） from the external programmer have been developed so that the upgrade service program in the IPG is simplified with most complex functions executed by the external programmer.A bidirectional protocol including frame definition and transmission mode was designed to insure secure upgrades.A neuro-stimulator was used to verify the upgrade solution with no additional elements,to maintain the hardware reliability.This study emphasizes how to insure a secure and stable upgrade process and reduce power consumption for special wireless and life safety-critical applications.Tests on rhesus monkeys to evaluate the feasibility of the approach for an IPG used for brain stimulation evaluation show that the software upgrade can be implemented stably with good tolerance to the wireless data transmissions.
Author 曹洋 胡春华 马伯志 郝红伟 李路明 王伟明
AuthorAffiliation School of Aerospace, Tsinghua University, Beijing 100084, China
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software upgrade
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References Maisel, Sweeney, Stevenson (bib20) 2001; 286
Evers X, Johannes S, Malcolm J S. Pacemaker system with enhanced programmable modification capacity. U. S. Patent: 5 843 138. Dec. 1, 1998.
Pallikarakis (bib60)
bib70
Coppess, Miller, Zipes (bib90) 1999; 10
Wittkampt, Candelon, Arrago (bib80) 1984; 7
Shelton B M. Method and apparatus for upgrade implantable medical device operating software. U. S. Patent Application Publication: US 2006/0080654 A1. Apr. 13, 2006.
Hao, Li, Ma (bib140) 2008; 21
Courtois N, Pieprzyk J. Cryptanalysis of block ciphers with over defined systems of equations. In: ASIACRYPT. Queenstown, New Zealand, 2002: 267–287.
Wang, Ma, Hao (bib170) 2009; 28
Maisel, Moynahan, Zuckerman (bib30) 2006; 295
Bellissimo A, Burgess J, Fu K. Secure software updates: Disappointments and new challenges. In: USENIX Hot Topics in Security Workshop. Vancouver, Canada, 2006: 7–7.
Halperin, Heydt-Benjamin, Fu (bib10) 2008; 7
Wallace, Kuhn (bib50) 2001; 8
Nechvatal, Baker, Bassham (bib160)
Tsai W T, Mojdehbakhsh R, Rayadurgam S. Experience in capturing requirements for safety-critical medical devices in an industrial environment. In: High-Assurance System Engineering Workshop. Washington, DC, USA, 1997: 32–36.
Wang W M, Ma B Z, Hao H W, et al. System of magnetic coupled PPM transcutaneous wireless communication. In: 7th Asian-Pacific Conference on Medical and Biological Engineering, APCMBE 2008. Beijing, China, 2008: 392–395.
Cao Y, Hao H H, Xue L, et al. A software upgrade method for micro-electronics medical implants. In: Proceedings of the 28th IEEE EMBS Annual International Conference. New York City, USA, 2006: 5009–5012.
References_xml – volume: 10
  start-page: 871
  year: 1999
  end-page: 873
  ident: bib90
  article-title: Software error resulting in malfunction of an implantable cardioverter defibrillator
  publication-title: Journal of Cardiovascular Electrophysiology
– reference: Courtois N, Pieprzyk J. Cryptanalysis of block ciphers with over defined systems of equations. In: ASIACRYPT. Queenstown, New Zealand, 2002: 267–287.
– volume: 7
  start-page: 30
  year: 2008
  end-page: 39
  ident: bib10
  article-title: Security and privacy for implantable medical devices
  publication-title: IEEE Pervasive Computing
– volume: 21
  start-page: 147
  year: 2008
  end-page: 151
  ident: bib140
  article-title: A programmable and implantable neuro-stimulator
  publication-title: Space Medicine & Medical Engineering
– volume: 286
  start-page: 793
  year: 2001
  end-page: 799
  ident: bib20
  article-title: Recall and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators
  publication-title: JAMA
– volume: 7
  start-page: 1207
  year: 1984
  end-page: 1212
  ident: bib80
  article-title: The importance of software programmable pacemakers: In vivo programming of a prototype device
  publication-title: PACE
– reference: Wang W M, Ma B Z, Hao H W, et al. System of magnetic coupled PPM transcutaneous wireless communication. In: 7th Asian-Pacific Conference on Medical and Biological Engineering, APCMBE 2008. Beijing, China, 2008: 392–395.
– reference: Cao Y, Hao H H, Xue L, et al. A software upgrade method for micro-electronics medical implants. In: Proceedings of the 28th IEEE EMBS Annual International Conference. New York City, USA, 2006: 5009–5012.
– volume: 8
  start-page: 301
  year: 2001
  end-page: 311
  ident: bib50
  article-title: Failure modes in medical device software: An analysis of 15 years of recall data
  publication-title: International Journal of Reliability, Quality and Safety Engineering
– ident: bib70
  article-title: FDA's Device Approvals and Clearances (May, 2003)
– ident: bib160
  article-title: Report on the development of the advanced encryption standard (AES). Computer Security Division Information Technology Laboratory, National Institute of Standards and Technology, Technology Administration, U.S. Department of Connerce
– ident: bib60
  article-title: e-Health and patient safety
– reference: Evers X, Johannes S, Malcolm J S. Pacemaker system with enhanced programmable modification capacity. U. S. Patent: 5 843 138. Dec. 1, 1998.
– volume: 28
  start-page: 408
  year: 2009
  end-page: 414
  ident: bib170
  article-title: Study of a transcutaneous wireless communication system
  publication-title: Chinese Journal of Biomedical Engineering
– reference: Tsai W T, Mojdehbakhsh R, Rayadurgam S. Experience in capturing requirements for safety-critical medical devices in an industrial environment. In: High-Assurance System Engineering Workshop. Washington, DC, USA, 1997: 32–36.
– volume: 295
  start-page: 1901
  year: 2006
  end-page: 1906
  ident: bib30
  article-title: Pacemaker and ICD generator malfunctions: Analysis of food and drug administration annual reports
  publication-title: JAMA
– reference: Shelton B M. Method and apparatus for upgrade implantable medical device operating software. U. S. Patent Application Publication: US 2006/0080654 A1. Apr. 13, 2006.
– reference: Bellissimo A, Burgess J, Fu K. Secure software updates: Disappointments and new challenges. In: USENIX Hot Topics in Security Workshop. Vancouver, Canada, 2006: 7–7.
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Snippet A non-invasive software upgrade method for permanent implantable medical devices was developed to alleviate patients＇ suffering due to malfunctions because of...
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SubjectTerms implantable medical device
Macaca mulatta
non-invasive
secure upgrade
software upgrade
医疗器械
安全升级
无线数据传输
植入式
神经刺激器
脉冲发生器
软件升级
软件故障
Title Secure Method for Software Upgrades for Implantable Medical Devices
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