The use of networked medical devices can provide a number of benefits such as improved patient safety, reduced costs of care and a reduction in adverse events. While medical devices are stringently regulated and tested, the incorporation of a medical device into an IT network can introduce additional risks, compromising the safety, effectiveness and the security of the IT network. IEC 80001-1:2010 was developed as a step towards addressing these risks. However, Healthcare Delivery Organisations (HDO) face challenges when implementing the requirements of this standard.
Research on the risk management of medical IT networks and Health Information Technology systems is led by Dr Silvana Togneri Mac Mahon.
Silvana works closely with the standards community in the development and validation of a framework (MedITNet), published as ISO TR 80001-2-7: 2015. She is also the author, editor and international project leader for this technical report and has attended and presented at standard meetings and presented her research at international conferences. The framework focuses on assessing improve the risk management of medical IT network at any HDO. Silvana is a recognised Irish Expert and a member of the ISO TC 215 IEC SC 62A Joint Working Group 7 Leadership team and has devised the approach to the revision of the IEC 80001-1 standard and is currently leading the process aspects of the revision of the standard.