IEC 80001:Risk management of networks incorporating medical devices

Medical technology professionals are encouraged to take part in efforts to develop an international standard that would address the challenges associated with the integration of medical devices with IT networks.

IEC 80001, Risk management of networks incorporating medical devices, is under development and is expected to be published in 2010. The standard aims to balance the essential properties of safety, effectiveness, data and system security, and interoperability; apply risk management throughout the life cycle o fIT networks that incorporate medical devices; and define responsibilities for the various parties involved.

“Risk management has traditionally been a concern of device manufacturers as they incorporate risk management into product development,” says Todd Cooper, a board member of the Healthcare Information Technology Standards Panel (HITSP) and a member of the committee charged with developing IEC 80001. “But IEC 80001 focuses on maintaining patient safety and device efficacy throughout the entire life cycle of these systems, starting with technology evaluation and acquisition, to deployment, to system decommissioning.”