This year, at the 15th HISI conference NSAI's HISC is pleased to host a workshop on Medical Devices and Information Technology on November 17th 2010, at 9.30 to 12.30 a.m. The title of the workshop is: Potential regulation for software in medical devices and healthcare, a lifecycle approach, from design to patient use.
NSAI’s Health Informatics Standards Consultative Committee news
The HISI conference and Scientific Symposium is Ireland’s premier healthcare informatics event and will take place 17th - 18th November 2010 in the Stillorgan Park Hotel, Stillorgan Road, Co. Dublin. This conference is recognised for providing a significant contribution to the development and understanding of information and its associated technologies in the delivery of healthcare. It is the focal point for those interested in Healthcare Informatics in Ireland to network with their peers and learn about the latest developments in Healthcare ICT.
The workshop will be chaired by Mr. Bill Grimson, DIT, and Chairman of HISC. It will seek to examine, not only the impact of this revised legislation on software manufacturers, but also explore the control and regulation that may be necessary to assure the use of software after it is place into use
The speakers and topics for the workshop are as follows:
Title: Medical Devices Directives (MDD): What are medical devices and how are they regulated.
Speaker: Paul Scannell, Irish Medicines Board.
Paul will outline the current practices and process that are carried out under the MDD. This discussion will focus on existing implementation measures generally applied to non-software medical devices.
Presentation 2Title: Potential implications of proposed Guidelines for the qualification and classification of software used in the healthcare environment within the regulatory framework of medical devices:
Speaker: Mats Ohlson, Medicinteknik, Medical Products Agency, Sweden
Mats will outline the historic reasons for the development of the present Swedish approach to regulating software, including the steps to be taken before placing a product on the market in Sweden.Mats will outline the historic reasons for the development of the present Swedish approach to regulating software, including the steps to be taken before placing a product on the market in Sweden.
Presentation 3Title: Concerns of Industry on regulation under the MDD
Speaker: TBA, IMSTA
Speaker will discuss the concerns and readiness of the software manufacturing community in meeting their responsibilities under the revised MDD.
Presentation 4Title: Current developments in Software Processes and Standards for verification and validation of software in medical devices:
Speaker: Dr. Fergal McCaffery, DkIT
Fergal is an expert in Software verification and validation, a fundamental requirement of the MDD, and he will discuss the application of software verification and validation standards to software in medical devices.
Presentation 5Title: Risk based approach to management of IT and Medical Devices in Ireland: IEC 80001 and proposed new work
Speaker: Professor Wil van der Putten, Prof. in Medical Physics, NUIG
Wil will deliver a presentation on network management within the hospital, focusing on the need for, and nature of possible standards and regulation in this post market position.
After the presentations, a panel discussion will be opened during which a number of questions will be posed. The workshop will last for 3 hours approx.
Further details of the conference are available in the Conference Programme