Risk management for IT-networks incorporating medical devices – new BS Standard

Issue 29 – July 2011

Recognising that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), a new Standard defines the roles, responsibilities, and activities necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness, and data and system security. BS EN 80001-1:2011 Application of risk management for IT-networks incorporating medical devices. Roles, responsibilities and activities applies after a medical device has been acquired by a responsible organisation and is a candidate for incorporation into an IT-network.

Innovative medical devices will be required as population ages

Issue 29 – July 2011

Greater innovation will have to be seen in the development of medical devices and healthcare systems as the ageing population and other societal changes in Europe demand it, politicians have stated. A meeting of the Employment, Social Policy, Health and Consumer Affairs Council has debated a range of health issues and published its conclusions.

STANDARD IN DEVELOPMENT

Home and Community Support Services Standard

Committee: P8158
Project manager: Robyn Fitzgerald
Estimated Publication Date: March 2012
Comments: The second P8158 Committee meeting was held on 6 April 2011. Working groups reviewed sections of the Standard, removed duplication, and aligned sections with NZS 8134:2008. It was agreed by the Committee not to develop a separate work book, but to include guidance material in the Standard. A further draft is being prepared for a July teleconference and this will then will be edited and prepared for public comment in August.