[Diabetes-talk] Pump question

Tue Jun 25 17:56:55 UTC 2013

On Jun 25, 2013, at 11:58 CDT, Bridgit Pollpeter <bpollpeter at hotmail.com> wrote:

> ...medical items would require FDA
> approval, but is this one possibility?
> 

Actually if a medical device that was approved by the FDA used Bluetooth LE, then software developers that wrote software for your smart phone, tablet, or other computing device could write software to display this information and even interact with it to retrieve data without FDA approval. 

Devices like a pump might be an exception, in that if software had the ability to control the pump, then that software would require most definitely FDA approval. If a maker of a meter developed the software than ran on your smartphone or other computing device it would in all likely hood be approved by the FDA initially; however, subsequent version of the software would not go through FDA approval a second time. 

Over time I hope the industry standards will evolve to allow the information (data) on a meter, pump, blood pressure cuff, pulse oximeter, or other medical devoices to be read by any software package. Ideally this would allow you to have one software package collect and track data from all of your medical devices. This concept is probably five to ten years away from being a reality, but I clearly am seeing these standards evolving today.

I have been away from medical technology development for I might mention that my passion for computer science and  electronics started in 1968. I started my first of several companies I own today in 1974. I have consulted on many biomedical design projects. I was directly involved in the design, testing, and certification of somatosensory, audio, and visual evoked potential medical devices.

> Bridgit
> 
> -----Original Message-----
> From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf
> Of Gregory D. Rosenberg
> Sent: Tuesday, June 25, 2013 11:53 AM
> To: Diabetes Talk for the Blind
> Subject: Re: [Diabetes-talk] Pump question
> 
> 
> Good morning everyone,
> 
> Let me add my two cents specific to the security issue. Bluetooth
> version 4.x and Bluetooth Low Energy (BT LE) both use a very high level
> of encryption. Bluetooth Low Energy plays a second vital role. It
> reduces the amount of power used by Bluetooth. Which results in longer
> battery life for our devices. 
> 
> I have a keyboard that uses Bluetooth LE V4.0 and quotes a battery life
> of ten years. It is a relatively new keyboard so I can confirm first
> hand if it truly lasts ten years. Don’t expect this kind of life from a
> pump or a Glucometer. 
> 
> === A bit technical ===
> 
> That said, I just got a sample Electrocardiogram (ECG) chip from Texas
> Instruments yesterday. It is no bigger than the nail on your pinky. That
> includes a Bluetooth Low Energy transceiver. This literally means you
> can have a wearable ECG machine that is literally the size of a big
> watch. The size is limited only be the fact that you have to have a
> place to plug in the cables and buttons and a small display or audio
> device for a user interface.
> 
> This technology is all made possible by a concept called a System on a
> Chip (SOC). A SOC combines almost everything that is in your computer
> onto a small wafer of silicon no bigger than a ¼” square. 
> 
> We are not far away from the watches of SiFy, those warn by soys in the
> movies, on TV, in a novel, or in your favorite comic book series.
> 
> === End of Tech ===
> 
> Enjoy the rest of your week :-)
> 
> 
> On Jun 25, 2013, at 11:23 CDT, "Veronica Elsea"
> <veronica at laurelcreekmusic.com> wrote:
> 
>> In this case, I think the guy was trying to make a point of security 
>> of medical devices. I often wondered if there could be interference 
>> say, at a convention where everyone sat together sending information 
>> and requests to insulin pumps. But boy could this be quite the episode
> 
>> of murder for hire on an individual, couldn't it. And I was just 
>> across town at a different conference when this happened. Oh how I 
>> wish I'd been there! But I'd bet the reason someone would want to hack
> 
>> in would be related to the same reason most meters wouldn't let us 
>> delete items from the memory. People wanting to get rid of a crummy BG
> 
>> number or a large bolus taken for a big meal. Says a lot for how the 
>> medical establishment has treated most people though and that's not 
>> good. Just my quarter's worth. <grin> Veronica
>> 
>> Watch the video as The Guide Dog Glee Club sings "Rehab!" Yes! Yes! 
>> Yes! http://youtu.be/JvakJ5lk6Us Then find more music from Veronica 
>> Elsea and The Guide Dog Glee Club at: http://www.laurelcreekmusic.com
>>                Veronica Elsea, Owner
>> Laurel Creek Music Designs
>> Santa Cruz, California
>> Phone: 831-429-6407
>> 
>> 
>> 
>> -----Original Message-----
>> From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On 
>> Behalf Of Bridgit Pollpeter
>> Sent: Tuesday, June 25, 2013 8:54 AM
>> To: 'Diabetes Talk for the Blind'
>> Subject: Re: [Diabetes-talk] Pump question
>> 
>> Those are the people who either aren't diabetic and therefore don't 
>> directly deal with these situations, or they are those diabetics who 
>> don't give a fig. It's like those not understanding the importance of 
>> any consumer group advocating and promoting the causes and educating 
>> about them in order to bring equality, awareness and a better quality 
>> of life for all.
>> 
>> Bridgit
>> 
>> -----Original Message-----
>> From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On 
>> Behalf Of Mike Freeman
>> Sent: Tuesday, June 25, 2013 10:36 AM
>> To: Diabetes Talk for the Blind
>> Subject: Re: [Diabetes-talk] Pump question
>> 
>> 
>> And people ask why we need a NFB or a Diabetes Action Network.
>> 
>> Mike Freeman
>> 
>> 
>> On Jun 25, 2013, at 8:05, Bridgit Pollpeter <bpollpeter at hotmail.com>
>> wrote:
>> 
>>> LOL, I thought of the exact episode when I read that post, smile. He
>>> was actually hacking into a hospital system so that when glucose 
>>> levels were taken, lows would show as highs, and patients were being 
>>> given insulin they obviously didn't need, sending them into
> inevitable
>> 
>>> comas.
>>> 
>>> The hacker turned out to be a high school student who was working 
>>> with
>> 
>>> a couple of friends to get revenge. His father, a diabetic, had been 
>>> a
>> 
>>> patient at said hospital, and due to mismanagement, he lost his
>>> vision. The dad and son blamed the hospital.
>>> 
>>> I saw this episode shortly after I started training at IDB. I was
>>> bothered by the father's comments while on the stand. He broke down, 
>>> stating how terrible his life was now blind. I remember he said that 
>>> he couldn't eat at a restaurant alone anymore because he couldn't 
>>> order from the menu, couldn't have a social life and couldn't even 
>>> dial a phone anymore on his own. I summarily dialed the phone and 
>>> called my now-husband to report on the episode, grin.
>>> 
>>> Bridgit
>>> 
>>> -----Original Message-----
>>> From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On
>>> Behalf Of limestone lady
>>> Sent: Tuesday, June 25, 2013 9:16 AM
>>> To: coe at impactcil.org
>>> Cc: diabetes-talk at nfbnet.org
>>> Subject: Re: [Diabetes-talk] Pump question
>>> 
>>> 
>>> A few years ago, law and order had a story about a young kid who was 
>>> able to hack into a hospital's computer, and tamper with insulin 
>>> guidelines which caused the death of at least one person. Diabetes 
>>> had caused his dad to lose his sight, and he felt like he had lost 
>>> his dad, and was very bitter. Many of those shows were discribed as 
>>> being ripped from today's headlines, so I wonder if it was true.
>>> The main reason I remember it was because the hacker was from
> Toronto,
>> 
>>> which meant of course that it was a cross border crime. Linda.
>>> 
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>>> 40
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>>> 
>>> 
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>>> ix.com
>> 
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>> 
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>> laurel
>> creekmusic.com
>> 
>> 
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>> is.com
> 
> 
> P.S. We have moved.
> 
> P.S. Text the word BLIND to 85944 to donate $10 to the NFB Imagination
> Fund via your phone bill.
> 
> --
> 73' & 75'
> Gregory D. Rosenberg AB9MZ
> gregg at ricis.com
> 
> RICIS, Inc.
> 7849 Bristol Park Drive
> Tinley Park, IL 60477-4594
> http://www.ricis.com
> 
> 708-267-6664 Cell 
> 708-444-2690 Office
> 708-444-1115 Fax (Call First)
> We are tired of SPAM faxes.
> 
> 
> 
> 
> 
> NOTICE: This e-mail message and all attachments transmitted with it are
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> 
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P.S. We have moved.

P.S. Text the word BLIND to 85944 to donate $10 to the NFB Imagination Fund via your phone bill.

--
73' & 75'
Gregory D. Rosenberg AB9MZ
gregg at ricis.com

RICIS, Inc.
7849 Bristol Park Drive
Tinley Park, IL 60477-4594
http://www.ricis.com

708-267-6664 Cell 
708-444-2690 Office
708-444-1115 Fax (Call First)
We are tired of SPAM faxes.

NOTICE: This e-mail message and all attachments transmitted with it are intended solely for the use of the addressee and may contain legally privileged and confidential information. If the reader of this message is not the intended recipient, or an employee or agent responsible for delivering this message to the intended recipient, you are hereby notified that any dissemination, distribution, copying, or other use of this message or its attachments is strictly prohibited. If you have received this message in error, please notify the sender immediately by replying to this message and please delete it from your computer.