Who has responsibility for emerging technologies in diabetes management

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2 ROYAL CHILDREN S HOSPITAL ACADEMIC CENTRE Who has responsibility for emerging technologies in diabetes management A/Prof Bernadette Richards, Adelaide Law School, University of Adelaide Prof Fergus Cameron, Department of Endocrinology, RCH Dr Carolyn Johnston, Melbourne Law School, University of Melbourne

3 Broad concepts Innovation is assumed to be good. What happens when parents introduce something into the treatment cycle? Ethical and legal concerns Legal standard of care responsible body of peers Who are the key players and what might the issues be: How to protect the best interests of the child Issue of first do no harm How can responsibility be attributed when there is something independently introduced into the clinical treatment plan Who has responsibility/ who ought to have responsibility?

4 The Case: Amy is 5 years old and has T1D. She is under the care of the RCH paediatric endocrinology team. Her parents are highly knowledgeable about her condition and are managing her diabetes with a continuous glucose monitor and an insulin pump. They want a better bespoke solution. They download open source software from the internet to modify the algorithm settings which automate insulin delivery. Closed loop systems looping The hospital team are concerned about their ethical and legal duties of care.

5 #WeAreNotWaiting Diabetes DIY Movement Hashtag #WeAreNotWaiting Developing platforms, apps and cloudbased solutions to adapt devices.

6 Clinical concerns Knowledge of the therapy Risk to patient Well being of patient Responsibility medico legal issues

7 KNOWLEDGE OF THERAPY

8 Unregulated No clinical trial data Anecdotal evidence only from patient group

9 RISK TO PATIENT

10 Devices malfunction or can be mis-used Retrospective 12 month survey of 235 children ( yrs) on CSII for a mean of 2.6 yrs 104/235 (45%) reported a least 1 pump related adverse event 23% pump replacement 8% hospital admission/er attendance Wheeler et al Diabet Technol Therap :204-7

11 Devices are vulnerable to malicious third parties..researchers also showed off a hack against a Medtronic insulin pump. they demonstrated how to stop a scheduled dose of insulin from being delivered. Conversely, An attacker can.cause an insulin (bolus) delivery.

12 RESPONSIBILITY

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14 Medico-legal concerns Position of clinician if using an unapproved drug delivery system to maintain life and health in a child and an adverse event occurs.

15 Regulation of device Regulation of medical devices - Therapeutic Goods Administration A medical device includes the software necessary for its proper application Open source software outside the regulatory framework The TGA recognises that is has become an issue of real concern

16 Medical indemnity insurance?

17 Responsibility for decision-making Parents parental authority Are they acting in child s best interests? Clinical team What is the scope of their duty of care? To discuss the risks of looping and support current management with CGM and insulin pump To support use of closed loop system

18 Ethical issues Application of traditional ethical principles Autonomy Beneficence Maleficence Justice

19 Amy is 5 years old Her parents are highly knowledgeable about her condition Managing her diabetes with a continuous glucose monitor and an insulin pump Diabetes is well controlled Trevor is 17 years old Using a sensor-augmented insulin pump Irregular attendance at clinics Non adherent to traditional therapies A computer geek

20 Voting Do you think clinician should support looping for Amy Yes No Do you think clinician should support looping for Trevor Yes No

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