Target audience
The Symposium is addressed to decision makers from hospitals and Healthcare Delivery
Organizations (HDO’s) like medical and administrative directors, CIO’s and Quality Assurance
Managers. It is also dedicated to R&D, Compliance- and Product Managers
from Medical Device Manufacturers and providers of IT-Infrastructure and -Services.

Motivation and background
Collaboration betweenMedical DevicesManufacturers and HDO’s is going to face dramatic
changes. Backgrounds are basically four megatrends in the Healthcare Industry.

• increasing reliance on software to provide required functionality of Medical Devices
• integrated, user-assembled,medical electrical system
• evolution of Health Information Technology (HIT) to a patient-centered system using information to improve efficiency, lower costs and deliver better outcomes for patient health
• increasing use of interconnected medical devices in the homecare environment

All aspects require reliable connectivity and functionality within the HIT-System. Besides
providing basic safety and essential performance, medical electrical systems
need to incorporate privacy and security solutions that include reasonable administrative,
technical and physical safeguards to ensure confidentiality, integrity and availability
of patient data while preventing unauthorized or inappropriate access.

In the homecare application the devices need to communicate over public data networks
to the healthcare provider’s IT network. Remote Access to Medical Devices can
exploit further potential to reduce cost of healthcare delivery.
To support the collaboration between HDO’s and Manufacturers, on October 27th2010,
IEC the International Standardization Organisation published the International
Standard IEC 80001-1 “Application of Risk-Management for IT-networks incorporating
Medical Devices; Part 1: Roles, Responsibilities and activities”.

After a preparation time of ~10 years, HDO’s integrating Medical Devices from different
manufacturers into one Medical IT-Network, can now rely on a well defined responsibility
sharing with their suppliers. While proactive hospitals already implemented
IEC 80001-1 requirements by running pilot projects, the wide majority of the responsible
organizations is still in the process to get started now.
To give further guidance and to facilitate the practical implementation of IEC 80001-1,
a set of new Technical Reports has been developed. They will be published in summer
2011 after a finalizing meeting in Best, Netherlands just days before the symposium.
The outcome of this meeting will be introduced during the course of the symposium
as well as the latest developments addressing:

• Step by Step Risk Management of Medical IT-Networks; Practical Applications
  and Examples
• Guidance for the communication ofmedical device security needs, risks and controls
• Guidance for wireless networks
• Health Delivery Organization Implementation Guidance (Draft status only!)

The 3rd International Symposium on “IT Networks incorporating Medical Devices in
Hospitals and Medical Facilities” will be held on March, 17th-18th, 2011 in Brussels,
Belgium at the renowned Husa President Park Hotel. Speakers will be key representatives
from the EU-Commission, COCIR, EU hospitals, Medical Device Manufacturers
and International Standardization Organizations.
All presentations will be held in English.

Host and Organizers
Organizers are the VDE Institute, a notified Body for Medical Devices and Quality
Management Systems, in cooperation with PROSYSTEM AG, an established, international
Consulting company for Medical Devices with focus on Risk Management and
Software Security.