Skip to main content
Fachgebiete
Automobil + Motoren Bauwesen + Immobilien Business IT + Informatik Elektrotechnik + Elektronik Energie + Nachhaltigkeit Finance + Banking Management + Führung Marketing + Vertrieb Maschinenbau + Werkstoffe Versicherung + Risiko
DE
EN
Bücher
Zeitschriften
Themenseiten
Organisationspsychologie Projektmanagement Marketing Smart Manufacturing
Weitere Formate
Podcasts Webinare Technik Webinare Wirtschaft Kongresse Veranstaltungskalender Awards
Jetzt Einzelzugang starten
Zugang für Unternehmen
Referenzkunden
SLX-Digitalkonferenz: Zukunftswerkstatt 2024

Mehr Umsatz mit Top-Kontakten

Am 7. Mai erfahren Sie, wie Vertriebsteams Leadgenerierung, Leadnurturing und Leadstrategien effizient steuern können.
Erweiterte Suche
Anmelden
nach oben
Erschienen in:
NDT-Agile: An Agile, CMMI-Compatible Framework for Web Engineering Kapitel lesen Erstes Kapitel lesen

2017 | Supplement | Buchkapitel

A Proposed Approach to the Revision of IEC 80001-1 Following Annex SL

verfasst von : Silvana Togneri MacMahon, Todd Cooper, Fergal McCaffery

Erschienen in: Software Process Improvement and Capability Determination

Verlag: Springer International Publishing

Einloggen

Aktivieren Sie unsere intelligente Suche, um passende Fachinhalte oder Patente zu finden.

search-config
loading …

Abstract

IEC 80001-1 was published in 2010 and is now undergoing revision. Feedback gathered on the adoption of the standard has revealed a number of barriers that have impacted its adoption. The standard provides requirements related to the roles, responsibilities and activities that need to be performed for the risk management of medical IT networks. One reported barrier is a lack of drivers to motivate Top Management to implement the standard. In addition, there is a lack of alignment between IT and biomedical engineering departments within hopitals. Finally, the IEC 80001-1 standard was considered to be too complicated and complex to implement. This paper presents the barriers identified in the feedback and presents an approach to the revision of the standard as a process based management system standard in accordance with ISO/IEC Directives Annex SL as a means to overcome these barriers.

Sie haben noch keine Lizenz? Dann Informieren Sie sich jetzt über unsere Produkte:

Springer Professional "Wirtschaft+Technik"

Online-Abonnement

Mit Springer Professional "Wirtschaft+Technik" erhalten Sie Zugriff auf:

  • über 102.000 Bücher
  • über 537 Zeitschriften

aus folgenden Fachgebieten:

  • Automobil + Motoren
  • Bauwesen + Immobilien
  • Business IT + Informatik
  • Elektrotechnik + Elektronik
  • Energie + Nachhaltigkeit
  • Finance + Banking
  • Management + Führung
  • Marketing + Vertrieb
  • Maschinenbau + Werkstoffe
  • Versicherung + Risiko

Jetzt Wissensvorsprung sichern!

Jetzt informieren

Springer Professional "Technik"

Online-Abonnement

Mit Springer Professional "Technik" erhalten Sie Zugriff auf:

  • über 67.000 Bücher
  • über 390 Zeitschriften

aus folgenden Fachgebieten:

  • Automobil + Motoren
  • Bauwesen + Immobilien
  • Business IT + Informatik
  • Elektrotechnik + Elektronik
  • Energie + Nachhaltigkeit
  • Maschinenbau + Werkstoffe




 

Jetzt Wissensvorsprung sichern!

Jetzt informieren

Springer Professional "Wirtschaft"

Online-Abonnement

Mit Springer Professional "Wirtschaft" erhalten Sie Zugriff auf:

  • über 67.000 Bücher
  • über 340 Zeitschriften

aus folgenden Fachgebieten:

  • Bauwesen + Immobilien
  • Business IT + Informatik
  • Finance + Banking
  • Management + Führung
  • Marketing + Vertrieb
  • Versicherung + Risiko




Jetzt Wissensvorsprung sichern!

Jetzt informieren
Vorheriges Kapitel Deep Learning in Automotive: Challenges and Opportunities
Nächstes Kapitel Enterprise SPICE Extension for Smart Specialization Based Regional Innovation Strategy
Literatur
1.
West Health Institute: The Value of Medical Device Interoperability - Improving patient care with more than $30 billion in annual health care savings (2013)
2.
Hamilton, A., Nau, R., Burke, R., Weinstein, S., Dlatt, C.K.B., Fiore, S., Conyers, J.L.: Summary of the August 2011 Symposium on the Role and Future of Health Information Technology in an Era of Health Care Transformation. The George Washington University (2011)
3.
Lee, I., Pappas, G.J., Cleaveland, R., Hatcliff, J., Krogh, B.H., Lee, P., Rubin, H., Sha, L.: High-confidence medical device software and systems. Comput. (Long. Beach. Calif.) 39, 33–38 (2006)
4.
5.
6.
7.
8.
Wagner, E.H.: The role of patient care teams in chronic disease management. BMJ Br. Med. J. 320, 569 (2000)CrossRef
9.
Wagner, E.H., Austin, B.T., Davis, C., Hindmarsh, M., Schaefer, J., Bonomi, A.: Improving chronic illness care: translating evidence into action. Health Aff. 20, 64–78 (2001)CrossRef
10.
Hoffman, C., Rice, D.: Chronic Care in America: A 21st Century Challenge. Robert Wood Johnson Found, Princeton (1996)
11.
12.
13.
Castañeda, M.: Connecting devices and data on the healthcare network. Biomed. Instrum. Technol. 44, 18–25 (2010)CrossRef
14.
Whitehead, S.F., Goldman, J.M.: Getting connected for patient safety how medical device “Plug-and-Play” interoperability can make a difference. Patient Saf. Qual. Healthc. 1–5 (2008)
15.
Venkatasubramanian, K.K., Gupta, S.K.S., Jetley, R.P., Jones, P.L.: Interoperable Medical Devices - Communication Security Issues. IEEE Pulse, 2 September/October 2010
16.
17.
Rakitin, S.R.: Networked Medical Devices: Essential Collaboration for Improved Safety. AAMI.org. (2009)
18.
Loughlin, S., Williams, J.S.: The top 10 medical device challenges. Biomed. Instrum. Technol. 45, 98–104 (2011)CrossRef
19.
Mehta, T., Mah, C.: Auto-provisioning of biomedical devices on a converged IP network. Biomed. Instrum. Technol. 43, 463–467 (2009)CrossRef
20.
21.
Eagles, S.: An Introduction to IEC 80001: Aiming for Patient Safety in the Networked Healthcare Environment. In: IT Horizons, vol. 2008 (2008)
22.
National Cybersecurity and Communications Integration Center: Attack Surface: Healthcare and Public Health Sector (2012)
23.
24.
25.
Shuren, J.: Health Information Technology (HIT) Policy Committee Adoption/Certification Workgroup - Testimony of Jeffrey Shuren, Director of FDA’s Centre for Devices and Radiological Health (2010). http://​www.​cchfreedom.​org/​pr/​Health, IT Deaths - FDA jeffrey Shuren.pdf
26.
Eagles, S.: IEC 80001: An Introduction. 80001-1 Experts (2012)
27.
Cooper, T., David, Y., Eagles, S.: Getting Started with IEC 80001: Essential Information for Healthcare Providers Managing Medical IT-Networks. AAMI (2011)
28.
IEC: IEC 80001-1 - Application of Risk Management for IT-Networks incorporating Medical Devices - Part 1: Roles, responsibilities and activities (2010)
29.
Association for the Advancement of Medical Instrumentation: Health IT risk management, Arlington, Virginia (2017)
30.
ISO: ISO 14971:2007 - Medical Devices - Application of Risk to Medical Devices (2007)
31.
ISO: ISO 31000:2009 Risk management – Principles and guidelines (2009)
32.
ISO: ISO/TR 80001-2-7: 2015 - Application of risk management for IT-networks incorporating medical devices – Application guidance – Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1 (2015)
33.
34.
IEC: IEC 82304-1:2016 Health software – Part 1: General requirements for product safety (2016)
35.
British Standards Institute: BS EN 15224:2016 Quality management systems. EN ISO 9001:2015 for healthcare (2016)
36.
ISO/IEC: ISO/IEC Directives, Part 1 Consolidated ISO Supplement — Procedures specific to ISO - Annex SL (2015)
37.
ISO/IEC: ISO/IEC 15504-2:2003 - Software engineering — Process assessment — Part 2: Performing an assessment (2003)
38.
MacMahon, S.T., McCaffery, F., Keenan, F.: Transforming Requirements of IEC 80001-1 into an ISO/IEC 15504-2 Compliant Process Reference Model and Process Assessment Model (2013)
39.
Barafort, B., Betry, V., Cortina, S., Picard, M., St Jean, M., Renault, A., Valdés, O., Tudor, P.R.C.H.: ITSM Process Assessment Supporting ITIL: Using TIPA to Assess and Improve your Processes with ISO 15504 and Prepare for ISO 20000 Certification. Van Haren, Zaltbommel (2009)
40.
Barafort, B., Renault, A., Picard, M., Cortina, S.: A transformation process for building PRMs and PAMs based on a collection of requirements – Example with ISO/IEC 20000 (2008)
41.
MacMahon, S.T., McCaffery, F., Eagles, S., Keenan, F., Lepmets, M., Renault, A.: Development of a Process Assessment Model for assessing Medical IT Networks against IEC 80001-1 (2012)
42.
ISO/IEC: ISO/IEC TR 24774:2010 - Systems and software engineering — Life cycle management — Guidelines for process description (2010)
43.
Cortina, S., Mayer, N., Renault, A., Barafort, B.: Towards a process assessment model for management system standards. Commun. Comput. Inf. Sci. 477, 36–47 (2014)
44.
ISO/IEC: ISO/IEC 33004:2015 Information technology – Process assessment – Requirements for process reference, process assessment and maturity models (2015)
45.
ISO: ISO 9001: 2015 Quality management systems – Requirements (2015)
46.
47.
Hegarty, F.J., MacMahon, S.T., Byrne, P., McCaffery, F.: Assessing a hospital’s medical IT network risk management practice with 80001-1. Biomed. Instrum. Technol. 48, 64–71 (2014)CrossRef
Metadaten
Titel
A Proposed Approach to the Revision of IEC 80001-1 Following Annex SL
verfasst von
Silvana Togneri MacMahon
Todd Cooper
Fergal McCaffery
Copyright-Jahr
2017
Buch
Software Process Improvement and Capability Determination

Print ISBN: 978-3-319-67382-0

Electronic ISBN: 978-3-319-67383-7

Copyright-Jahr: 2017

DOI
https://doi.org/10.1007/978-3-319-67383-7_22