Collaboration between IT, Security and Regulators in Wearable Sensor Research
Peer reviewing among IT and regulatory affairs academics in healthcare
In a previous article, I was talking about Peer Reviewals and the importance of collaboration between IT, the security industry and regulators in med tech. The FDA have recently said that security issues in network connected medical devices are an IT problem for the IT industry to solve. It is widely recognized that there is lack of collaboration between the IT industry, who don't understand the regulatory mindset and the regulators, who don't grasp the IT concepts or security concerns. I previously noted that there is very few academic articles which bridge the various world views.
Ironically, after my last post, I was invited to be part of an international collaboration of the IMIA (International Medical Informatics Association) Wearable Sensors in Healthcare Working Group. This is an area related to my M.Sc. Thesis at National University of Ireland which I'm currently completing.
Our topic was "Unintended Consequences of Wearable Sensor Use in Healthcare". The collaboration brought together 7 international academics of various fields from Australia, Ireland and Germany.
My contribution was on security, regulatory affairs (FDA, 21 CFR 820, Design Control, Validation etc.), quality risk, patient safety and psychological factors.
The International Medical Informatics Association (IMIA) is the world body for health and biomedical informatics. Their prestigious Yearly Journal is to be published in early 2016 and will be pubmed indexed. A major feature of the IMIA's Working Groups is the focus on collaboration between different sectors.
Wearable Sensors like fitbits have become increasingly ubiquitous in our lives. The Working Group had contributed on this topic last year, but this year there was much more focus on security, psychological factors and regulatory affairs.
The effort had the backing and participation of distinguished academics such as Dr. Michael Shutak of NUI Galway and OSNA cyber-security research group, who led the contribution on security.
It will be a highly interesting read for those who are interested in collaboration among various industries in healthcare.
Contact me if there are future collaboration opportunities for journal articles related to medtech, security and regulatory affairs.
More about IMIA at www.imia-medinfo.org