AAMI/IEC 80001-1 – Sharing the Burden: Collaborating to Keep Networks Safe, Secure and Effective
ANSI/AAMI/IEC 80001-1:2010 stresses the need for cooperation internally as well as between hospitals, medical device manufacturers and information technology (IT) systems and service vendors. How can diverse stakeholders work together to achieve the benefits promised by the convergence of medical devices and health IT while maintaining patients’ safety, data and systems security and operational effectiveness?
80001-1 recognizes that it is necessary to have a team to manage the risks from these networks that includes expertise from multiple sources within the healthcare delivery organization (HDO), as well as suppliers of the devices and services that make up the network. Therefore, it sets expectations of medical device manufacturers and other IT component suppliers to provide information to the care provider and to assist in the identification and management of hazards that can negatively impact the key properties.
The requirements for collaboration in 80001-1 are at a high level. How should they be implemented? Is it possible to voluntarily get the cooperation that is needed? What will this look like?
The webinar covers:
- When 80001-1 applies and who is involved
- What 80001-1 says about collaboration
- HDO readiness – assessing governance and internal collaboration
- The discovery process – identifying and understanding key external collaborators
- Building relationships and getting participation – steps to a responsibility agreement
- Responsibility agreements – what should they look like and what should they cover
- The need for common information and formats
- What if suppliers won’t help?
- Building on what exists – experience with service-level agreements
| WHO SHOULD PURCHASE |
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| This webinar is designed for everyone that needs to collaborate for a successful project implementing 80001-1: clinical technology managers, clinical and biomedical engineers, BMETs, hospital IT staff, supply chain managers, device product managers, device risk managers, field support personnel, telecommunications implementers and system integrators. | |
| QUESTIONS? | |
For questions about ordering the CD, please contact AAMI publications at 1-877-249-8226 or 240-646-7031. |
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SPEAKERS
The speakers are all principals at 80001Experts, LLC, providing expertise, platform, educational and practical tools to help members of the healthcare delivery industry reduce their risks when utilizing medical devices connected to their information technology networks.
Todd Cooper
- Co-convener of the joint IEC and ISO working group that developed IEC 80001-1
- 20+ years experience in medical device software architecture and informatics
- Convener, ISO TC215 WG7 Health Informatics - Devices
- Co-chair, HL7 Health Care Devices and IEEE 11073 WGs
- Board, Integrating the Healthcare Enterprise (IHE) International
Yadin David
- Directed biomedical engineering department and implemented medical technology assessment and risk mitigation programs at the largest medical center in the country
- Editor/author of several books and chapters on clinical engineering and technology management
- Asst. Professor, University of Texas School of Public Health
- Member of the AAMI/EM Electromagnetic Compatibility Committee
- Member AAMI/ES Electrical Safety Committee
- Member AAMI/IT Committee
- Chairman IFMBE/Clinical Engineering Division (CED)
Sherman Eagles
- Co-convener of the joint IEC and ISO working group that developed IEC 80001-1
- 40+ years software experience including 20 years in medical device software safety and reliability
- Convener of the joint IEC and ISO working group that developed ANSI/AAMI/IEC 62304 Medical Device Software Life Cycle Processes and AAMI/IEC TR 80002-1 Medical Device Software Guidance on the Application of ISO 14971 to Medical Device Software
- Member of GHTF software ad hoc committee
- Co-chair of the AAMI software committee and member of AAMI IT committee
WEBINAR CD - Includes pdf of handout materials and webinar recording on CD.
- $150 for webinar registrants
- $250 for non-registrants
- Please note: domestic and international shipping rates apply
WAYS TO ORDER
- Online - Purchase this webinar online.
- Phone - 1-877-249-8226 or 240-646-7031 to order with a credit card.
- Fax - Select and download the order form and fax to 240-396-5781 .
- Mail - Select and download the order form and mail with payment to:
BCKWCD AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211