Regulation of innovative technology in healthcare
“there has to be a better way to treat these things”
About the Project
Internet of Things (IoT) technologies in the provision of healthcare are advancing rapidly, testing the adequacy of regulation and ethical oversight. A team of researchers at the University of Melbourne has considered how these technologies are starting to be used in childhood diabetes management.
The researchers have recently concluded a 2-year investigation into stakeholder perspectives on parents' use of personalised hybrid closed loop systems (‘DIY looping’) to manage their children's type 1 diabetes.
The project team has interviewed parents who have built their own looping systems using open-source software. But looping is not regulated, and its use may have a significant impact on other key stakeholders too – healthcare professionals, software developers, medical indemnity insurers and lawyers. These groups contributed their views to the project.
You can read a summary of the project findings here.
Key Research Findings: Parents Using Unregulated Technology to Manage Type 1 Diabetes in Children
Virtual Panel Presentation
Wednesday 4 November 2020, 19.30 – 20.30 AEDT
The project team held an online meeting to present the key findings of the project. An expert panel explored the impacts of this research on indemnity insurance and regulation.
View recording of the webinar:
About the Panellists
David Burren M.Photog
David has been living with Type 1 Diabetes since 1982, and is an active member of the development communities involved in DIY closed-loop pump systems. David has published a survey of users of Do-It-Yourself closed-loop systems (Tien-Ming Hng and David Burren, Appearance of Do-It-Yourself closed-loop systems to manage type 1 diabetes( Internal Medicine Journal 48 (2018) 1400–1404). His diabetes website is https://bionicwookiee.com/
Dr Lee Walsh CPEng
Dr Walsh trained as an electrical and computer systems engineer and a physiologist. He spent the first part of his career doing human research and has over a decade of experience designing software and equipment for measuring human performance and supporting clinical practice.
More recently Lee worked for the Therapeutic Goods Administration (TGA), where he had several roles including Technical Lead for Digital Health in the Emerging Technology and Reform Team. In this role he led legislative reform for software and digital health and worked with the CSIRO to produce the TGA’s Medical Device Cybersecurity Guidance. Lee currently divides his time between supporting small and medium medical device companies and startups with their regulatory obligations, and producing physiological instruments to win motor races.
Emma Monger, BA, LB
Emma has a background in Health Law, having practised at the Medical Council of NSW and the Department of Health and Human Services in Victoria. She has also worked at the Child Protection Legal Office and Mental Health Tribunal in Victoria. Currently Emma is a litigation officer at the Medical Indemnity Protection Society (MIPS) where she manages claims and regulatory matters. Emma lives with Type 1 Diabetes.
About the Project Team
If you’d like to get in touch with the project team, please contact Dr Carolyn Johnston at Carolyn.Johnston@unimelb.edu.au
University of Melbourne Research Team:
Dr Carolyn Johnston, Melbourne Law School
Professor Lynn Gillam, Melbourne School of Population and Global Health
A/Prof Ann Borda, Health and Biomedical Informatics Centre
Dr Jo-Anne Manski-Nankervis, Department of General Practice
Dr Bjorn Nansen, School of Culture and Communication
Mr Suneel Jethani, School of Culture and Communication
Research Partners:
Professor Fergus Cameron, Royal Children’s Hospital, University of Melbourne Honorary
Ms Renza Scibilia, Diabetes Australia
Research Assistants:
Jeremy Latcham, Chriselle Hickerton, Bori Ahn, Alexander Meredith
The Melbourne School of Population and Global Health Ethics Advisory Group approved the project, ‘Personalised Closed Loop Systems for Childhood Diabetes’ (ID 1953678.1)