@DanaMLewis | #OpenAPS | #WeAreNotWaiting |  · Cruise control makes it easier to drive your target...

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Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Closing the loop:#WeAreNotWaiting to change the future of healthcare

@DanaMLewis | #OpenAPS | #WeAreNotWaiting |

www.OpenAPS.org

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Getting diagnosed with a chronic disease is like being struck by

lightning.

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Food, hormones, sickness, stress

Insulin, exercise, sickness, stress

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Cruise control makes it easier to drive your target speed.

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

An artificial pancreas is the closest thing to “cruise control” for diabetes.

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

…But an artificial pancreas is not yet commercially available.

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

The current tools are not perfect….

Insulin Pump

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Insulin is the “gas” pedal.

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

….and there are other tools but they are not interoperable.

Continuous Glucose Monitor (CGM) Insulin Pump

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

This all leaves people frustrated and at risk, every day and every night.

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Data access is also a struggle.

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

If we can’t change existing devices…

what if we could add *new* tools?

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Tackling the problem of less-audible alarms:

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Tackling the problem of less-audible alarms:

1. Get data from device with open source code2. Display data & generate louder alarms3. Share data with loved ones4. Add “snooze” buttons5. Enter specific actions/more buttons6. Create forecast (algorithm) with data sources7. Add additional “smart” alarms with action

recommendations

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

From reactive to predictive: an “open loop”

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

What happens if we “close the loop”?

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

We already have in our pockets the tools

needed for an “artificial pancreas”.

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Components of an open source artificial pancreas

(Illustration by Clint Ford for Popular Science)

1. Continuous glucose monitor

2. Insulin pump

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Components of an open source artificial pancreas

(Illustration by Clint Ford for Popular Science)

1. Continuous glucose monitor 2. Raspberry Pi (“controller”)3. Battery4. CareLink USB stick (“translator”)5. Insulin pump

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Life with a DIY Closed Loop

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

(It’s not “rocket science”)

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

What about regulations?

• Most users “test” their traditional medical devices, too.

• Individual experiments with “off label” use of medical devices are not a regulated activity in the U.S. – and so while we can’t (per the U.S. FDA) “distribute” devices, people can self-experiment with their own.

• The self-QA approach is even stronger when utilizing open source tools made with/by/for the community.

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Taking the DIY, artificial pancreas from (n=1) to (n=1)*many by:

• Focusing on safety

• Limiting dosing ability in hardware and software

• Using same dosing calculations a person would use

• Responding (or not) to unexpected data

• Tolerating communication failures

• Failing back safely to standard device operation

#OpenAPS:

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Documentation

Code

Reference Design

OpenAPS.org Github.com/openaps

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

#OpenAPS is now (n=1)*112+

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

The challenges of traditional regulation:

• Individuals are inadvertently being pressured to not share their innovations (!) for fear of retribution and regulations.

• There need to be more opportunities for individuals, academic research, and commercial innovation efforts to intersect.

• Companies should not be held liable by 3rd

parties (including patients themselves!) innovating or adapting technology – and need to be explicitly encouraged to allow access to data. @DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Traditional innovation

User-driven innovation

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Traditional innovation

User-driven innovation

@DanaMLewis

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

#WeAreNotWaitingto change the future of healthcare.

Are you?

#OpenAPS | @DanaMLewis | OpenAPS.org