etsi george macginnis 13 june 2016 · 2016-06-13 · our deep industry knowledge together with...
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FIRST DO NO HARM: REALISING THE POTENTIAL OF IoT IN HEALTHCARE
ETSI
George MacGinnis
13 June 2016
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Which one is a medical device?
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Global trends in
health
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How can IoThelp?
Is healtha special
case?
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Healthcare – overwhelmed by change
Acute care provided in more specialised
hospitals
Where possible, care moves closer
to the patient
Improved self care and prevention tostem rising demand
Improved research to speed time
to market
Source: . “Digital Health in the UK”, The UK Office for Life Sciences, 2015
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IoT will impact health across a spectrum of scenarios
Our understanding of your request…
Self Care
Managingcondition
Professional Supported Care
Pre-disease
Fitness and activity tracking
Food monitoring
Tracks glucose levels
Continuous patient
monitoring
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Global trends in
health
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How can IoThelp?
Is healtha special
case?
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Digital health introduces a new dynamic in fielding solutions
Market CentricMaximize consumer valueFoster competition‘Just enough’
Patient CentricSafety FirstDemonstrate efficacy‘at least, do no harm’
‘Contrasting environments are reflected in two very different regulatory regimes which now have to work together
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Back to the question: Which one is a medical device?
It all depends on ‘the intended use’
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This regulatory environment holds back use of IoT
Multiple regulatory touch points lead to uncertainty about what applies:
Medical device regulation does liability sit with the ‘manufacturer’ or service provider
Over-classification of devices due to a poor understanding of risk
Privacy regulations limit the scope of patient-clinician interactions
Regional differences hinder growth and scale
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Global trends in
health
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How can IoThelp?
Is healtha special
case?
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IoT means almost anything can be used to improve health
What differentiates a proprietary solution from the internet of things?
Other clinician
Healthservice
provider
Health information
service operatorClinician
Patient
loTdevices
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M2M Making News
Would YOU be microchipped? Kaspersky implants chip in man's hand that could
one day be used to pay for goods and even unlock his home … One expert believes there is even potential to link with the nervous system
Daily Mail, London 3 September 2015
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Safety – freedom from malicious interference
Certainty - Trust, truth and provenance: “Is this what I think it is?”
Privacy – clarity on the aggregation, use, and reuse of data: “What am I signing up to?”
What does health need from IoT security
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IoT opens up significant opportunities in health
Trust and privacy - Health needs are not very different
Early growth markets are likely to be end-user driven
Value comes from solutions, rather than products
Regulatory hurdles gobeyond technical issues
Closing thoughts
Does IoT need health as much as health needs IoT?
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