Understanding and Benefiting from AAMI/IEC 80001-1
ANSI/AAMI/IEC 80001-1:2010 is now approved and published. It defines the multi-stakeholder framework necessary to manage risk for IT-networks that incorporate one or more medical devices. It stresses the need for cooperation internally as well as between hospitals, medical device manufacturers and technology vendors to achieve patient safety, effectiveness and data security. What does this mean to you if you supply medical devices, IT technology or telecommunications to hospitals? Are there regulatory implications? What will your customers expect? What does your company need to know when your customers ask about your support for IEC 80001?
To assist you in understanding this new standard, AAMI is offering this webinar on CD on Understanding and Benefiting from ANSI/AAMI/IEC 80001-1, Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities.
PROGRAM
| Introduction to 80001-1 | ||
| Background and intent | ||
| When does 80001-1 apply | ||
| The key properties to be maintained | ||
| Relationship to other standards and regulatory requirements | ||
Elements of 8000-1 |
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| Roles and responsibilities of: | ||
Hospitals and their top management |
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| Information to be made available to the hospital | ||
| Additional information and responsibility agreements | ||
| Risk Management policies, planning and activities | ||
| Change-release management and configuration management | ||
| Documentation | ||
| Creating partnerships and building relationships to: | ||
| Meet expectations of customers | ||
| Work cooperatively with other suppliers of technology | ||
| Future related standardization | ||
| General guidance on process and methods | ||
| Technology-specific guidance | ||
| Templates for standard ways to share information | ||
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 & informatics
- Convener, ISO TC215 WG7 Health Informatics - Devices
- Co-chair, HL7 Health Care Devices & 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
1. Phone – 1-877-249-8226 or 240-646-7031 to order with a credit card
2. Fax – Select and download the order form and fax to 240-396-5781 .
3. Mail – Select and download the order form and mail with payment to:
80001 Webinar CD Package
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For questions about ordering the CD, please contact AAMI Publications at 1-877-249-8226 / 240-646-7031. For CD content questions, please contact Emilee Hughes at 703-253-8278.