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

  title={A Proposed Approach to the Revision of IEC 80001-1 Following Annex SL},
  author={Silvana Togneri MacMahon and Todd Cooper and Fergal McCaffery},
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… 


Risk management of medical IT networks: an ISO/IEC 15504 compliant approach to assessment against IEC 80001-1
Research to date which has led to the development of a Process Reference Model (PRM) and Process Assessment Model (PAM) which can be used by Healthcare Delivery Organisations to assess themselves against IEC 80001-1 is presented.
Development of a Process Assessment Model for Assessing Medical IT Networks against IEC 80001-1
The TIPA transformation process developed by Public Research Centre Henri Tudor was used to develop a process assessment model (TIPA PAM) for ISO/IEC 20000-1 and how that model can be developed following that transformation process to assess Medical IT networks against IEC 80001-1 is examined.
Towards a Process Assessment Model for Management System Standards
This paper presents how a process assessment model for management system standards has been built based on the High Level Structure proposed by ISO, which defines a set of common requirements for managementSystem standards.
Connecting devices and data on the healthcare network.
This new healthcare “industrial space” is a highly dynamic and complex frontier that will require new working relationships between doctors, nurses, hospital administrators, clinical engineers, medical device manufacturers, third-party service providers, and IT experts.
The role of patient care teams in chronic disease management
  • E. Wagner
  • Medicine, Political Science
    BMJ : British Medical Journal
  • 2000
A Medline search for randomised controlled trials of team care using the MeSH heading “patient care team” considered the implications of these observations for the structure and functioning of patient care teams in primary care.
High-confidence medical device software and systems
Given the shortage of caregivers and the increase in an aging US population, the future of US healthcare quality does not look promising and definitely is unlikely to be cheaper. Advances in health
Auto-provisioning of biomedical devices on a converged IP network.
A large number of hospitals have or are moving toward a converged IP network and are looking at ways to connect IT devices, biomedical devices, and guest services on a converges IP network.
Improving chronic illness care: translating evidence into action.
The CCM is described, its use in intensive quality improvement activities with more than 100 health care organizations, and insights gained in the process are described, to guide quality improvement.
Medical Device Networks Trouble Industry
  • Tim Gee
  • Medicine, Computer Science
  • 2009
The transition of medical device systems into the hospital's enterprise network holds both promise and risk for medical device and network vendors, in addition to healthcare providers.
Interoperable Medical Devices
This paper discussed interoperable biomedical devices. This topics discussed environmental functional architecture, MDIE communication protocol, MDIE operational architecture, attack vectors for IMD