Dr Silvana Togneri Mac Mahon is an Assistant Professor in DCU having previously worked as a postdoctoral researcher in the Regulated Software Research Centre and Lero in Dundalk Institute of Technology. Silvana’s research to date has involved the development of a framework to allow HDOs to self-assess against the requirements of IEC 80001-1, a standard aimed at the risk management of Health Information Technology Systems. While the IEC 80001-1 standard outlines the roles, responsibilities and activities related to medical IT networks, Healthcare Delivery Organisations (HDOs) often struggle to understand and implement the requirements of the standard. As a result of her research, an assessment framework, MedITNet, was developed which allows HDOs to assess the capability of their risk management processes related to IT networks which incorporate medical devices against the requirements of IEC 80001-1.
The framework provides a flexible approach to the assessment of IT network related risk management processes regardless of the scale of the HDO or the regulatory environment in which the HDO provides care. This work was published as a technical report, ISO TR 80001-2-7, on which Silvana acted as international project leader, author and editor. As project leader, in addition to authoring the technical report, Silvana has presented her research at a number of ISO/IEC Joint Working Group 7 (JWG7) international standard meetings and led the comment resolution and editing of the technical report. As a result, her research has been extensively reviewed by the members of JWG7 and also by members of the Software Process Improvement and Capability Determination (SPICE) community. In addition, Silvana has worked closely with HDOs in the development and validation of the framework. Her doctoral research has resulted in a number of publications in addition to the technical report.
Based on this research Silvana was asked to propose an approach to the revision of the IEC 80001-1 standards. The proposed approach to the revision aligns the revised standard with ISO 31000 and follows the Annex SL structure as outlined in the ISO Directives. Recipient of DKiT President’s award for early career researcher, the NSAI 1997 award and member of ISO TC215 JWG7 leadership team, she is leading the process aspects of the revision of the IEC 80001-1 standard.
She is currently supervising a number of students on a Lero project which focuses on the development of a Medical Device Software Development Framework. This research is being performed in collaboration with companies and Silvana is working closely with these industry partners in performing this research.