[Diabetes-Talk] Medical Device Non-Visual Accessibility Act

Sat Jan 23 21:53:40 UTC 2021

Veronica,
The act is calling on the US access board to create rules that the FDA will then publish so that companies know they have to comply.
One year after that all devices would need to be accessible.
So to answer your question, the access board creates the rules the FDA inforces the rules.

I hope that helps.

Robert Stigile, Second Vice-President
National Federation of the Blind of California
President San Fernando Valley Chapter
818-381-9568

> On Jan 23, 2021, at 1:14 PM, Bridgit Kuenning-Pollpeter via Diabetes-Talk <diabetes-talk at nfbnet.org> wrote:
> 
> Veronica,
> 
> Great question, and thanks for pointing out.
> 
> B
> 
> -----Original Message-----
> From: Diabetes-Talk <diabetes-talk-bounces at nfbnet.org> On Behalf Of Veronica Elsea via Diabetes-Talk
> Sent: Saturday, January 23, 2021 3:11 PM
> To: 'Diabetes Talk for the Blind' <diabetes-talk at nfbnet.org>
> Cc: Veronica Elsea <veronica at laurelcreekmusic.com>
> Subject: Re: [Diabetes-Talk] Medical Device Non-Visual Accessibility Act
> 
> Hi everyone. 
> I was wondering if anyone can clear something up for me. This act says one year after the final rule. Who makes these rules? I don't quite get the early part of the process. Are we asking Congress to tell the FDA what to do, or is there someone in between who isn't mentioned in this language?
> I know that it is Congress who instructs the FDA and actually, three years ago, several members of the FDA told me they were going to set up an accessibility task force. Funny thing, that email never came. Anyway, just a bit confused. Thanks.
> Veronica
> 
> 
> "Guide Dogs, First Hand", Veronica Elsea's classic album is now available on iTunes, along with other music from her and from the Guide Dog Glee Club. 
> To learn more, visit:
> 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 Melanie Torrance via Diabetes-Talk
> Sent: Friday, January 22, 2021 6:37 PM
> To: Diabetes Talk for the Blind
> Cc: Melanie Torrance
> Subject: [Diabetes-Talk] Medical Device Non-Visual Accessibility Act
> 
> Below is a copy of one of four issues to be presented to our legislators during the Washington Seminar at the National NFB in February. It comes from the NFB web site. Although insulin pumps are not specifically named. I think this covers everything pretty well. This seminar will be virtual of course, so contact your state affiliate and plan to attend.
> 
> Fact Sheet: Medical Device Nonvisual Accessibility Act Issue--Advanced digital interfaces create barriers that prevent blind individuals from independently and safely operating home-use medical devices that are essential to their daily healthcare needs.
> 
> Home-use medical devices are becoming more prevalent and less accessible for blind Americans. The rapid proliferation of advanced technology is undeniable. Most newer models of home-use medical devices, such as glucose and blood pressure monitors, along with the emergence of in-home devices that offer medical care options, such as chemotherapy treatments and dialysis, require that consumers interact with a digital display or other interfaces. This new technology has been and continues to be developed and deployed without nonvisual accessibility as an integral part of the design phase, which creates a modern-day barrier. The inaccessibility of home-use medical devices is not a mere inconvenience; if accessibility for blind consumers is omitted from the medical technology landscape, the health, safety, and independence of blind Americans will be in imminent danger.
> Advancements in home-use medical devices have the potential to transform how people live in society but are currently designed for those with no functional limitations.1 This flaw in product design limits options for blind Americans who need nonvisual access to critically important devices that help them to maintain their health and are available to people without disabilities.2 Nonvisual access is achievable, as demonstrated by a number of mainstream products. Apple has incorporated VoiceOver (a text-to-speech function) into all of their products, making iPhones, Macbooks and Mac desktops, and iPads fully accessible to blind people right out of the box. Virtually all ATMs manufactured in the United States are accessible, and every polling place is required to have a nonvisually accessible voting machine. Frequently, a simple audio output or vibrotactile feature can make a product fully accessible at little to no additional cost for manufacturers.
> Current disability laws are not able to keep up with advancements due to the expeditious evolution of medical technology and its incorporation into home-use medical devices. Although the Americans with Disabilities Act and other laws require physical accessibility for people with disabilities (e.g., wheelchair ramps, Braille in public buildings), no laws protect the blind consumer’s right to technology such as home-use medical devices. The National Council on Disability concluded that accessibility standards lag behind the rapid pace of technology, which can interfere with technology access.3 This trend of inaccessibility will continue if accessibility solutions are ignored. Only a fraction of medical device manufacturers have incorporated nonvisual access standards into their product design, while others continue to resist these solutions.
> Solution--Medical Device Nonvisual Accessibility Act:
> Calls on the Food and Drug Administration (FDA) to promulgate nonvisual accessibility standards for home-use medical devices. The FDA will consult with stakeholders with disabilities and manufacturers and issue a notice of proposed rulemaking no later than twelve months after the date of enactment of the act. No later than 24 months after the date of enactment of the act, the FDA will publish the final rule including the nonvisual accessibility standards.
> Requires manufacturers of home-use medical devices to make their products nonvisually accessible. Manufacturers will have twelve months following the publication of the final rule to ensure that all of the home-use medical devices they produce are nonvisually accessible. 
> Authorizes the FDA to enforce the nonvisual access standards for home-use medical devices. Any manufactured device found to be out of compliance, whether by a public complaint to the FDA or by an independent FDA investigation, will incur the same penalties as failing to meet the same safety standards as other home-use medical devices.
> 
> GOAL--END UNEQUAL ACCESS TO HOME-USE MEDICAL DEVICES FOR BLIND AMERICANS. 
> Cosponsor the Medical Device Nonvisual Accessibility Act
> 
> 
> Sent from Melanie's i phone
> 
>> On Jan 22, 2021, at 9:12 PM, Bridgit Kuenning-Pollpeter via Diabetes-Talk <diabetes-talk at nfbnet.org> wrote:
>> 
>> Yes, Apple was sued; most companies are. I was contracted to write a research paper on this topic of the rise of ADA legal suits because companies refuse to make products accessible. In fact, Apple was 100% resistant about making its devices accessible. I will never forget the quote from Apple about iPhones: "It's a fundamentally visually orientated product that is useless if you cannot see.". And we obviously proved this wrong. My point was that Apple did not have to start from the beginning, creating a new product. It coded Voiceover and installed into existing products.
>> 
>> BTW, it's likely going to take legal action for pump companies to follow suit.
>> 
>> Bridgit
>> 
>> -----Original Message-----
>> From: Diabetes-Talk <diabetes-talk-bounces at nfbnet.org> On Behalf Of 
>> Veronica Elsea via Diabetes-Talk
>> Sent: Friday, January 22, 2021 4:56 PM
>> To: 'Diabetes Talk for the Blind' <diabetes-talk at nfbnet.org>
>> Cc: Veronica Elsea <veronica at laurelcreekmusic.com>
>> Subject: Re: [Diabetes-Talk] Medtronic sharing site
>> 
>> Actually, Apple created VoiceOver because it was being sued. They also had a much larger user base. What would we say the number of blind people using their pumps would be. It's about money when all is said and done and if there aren't enough of us, they're not going to invent a new system. And if they have their own operating system, they would pretty much have to invent from the ground up. And then there would be the models already out. And then there's the FDA. Of course if they really wanted to, they could work with these hurdles. But then, they could have done that decades ago while they were spouting all of those empty promises. Part of what we really have to do with all of these companies is to convince them that there's something in it for them. That's one of the problems with for profit medicine. Not saying we shouldn't go after them, but we need to really understand where they are and what we're up against.
>> Veronica
>> 
>> 
>> "Guide Dogs, First Hand", Veronica Elsea's classic album is now available on iTunes, along with other music from her and from the Guide Dog Glee Club. 
>> To learn more, visit:
>> 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 Kuenning-Pollpeter via Diabetes-Talk
>> Sent: Friday, January 22, 2021 2:43 PM
>> To: 'Diabetes Talk for the Blind'
>> Cc: Bridgit Kuenning-Pollpeter
>> Subject: Re: [Diabetes-Talk] Medtronic sharing site
>> 
>> Well, obviously, this is not the same as other digital devices. And not necessarily every program will work for every device. But the concept is the same. Medtronic just has to code a text-to-speech program that works with its platform. It does not have to build up from ground zero.
>> 
>> When Apple first created smart devices, it did not include Voiceover. When it finally realized accessibility was an important feature and discovered it would broaden its market reach, Apple programmers created a text-to-speech feature to work for its smart devices, as we all know. It didn't have to create a new phone; it just added the new feature into its existing platform.
>> 
>> No reason Medtronic can't do the same.
>> 
>> Bridgit
>> 
>> -----Original Message-----
>> From: Diabetes-Talk <diabetes-talk-bounces at nfbnet.org> On Behalf Of 
>> Veronica Elsea via Diabetes-Talk
>> Sent: Friday, January 22, 2021 2:58 PM
>> To: 'Diabetes Talk for the Blind' <diabetes-talk at nfbnet.org>
>> Cc: Veronica Elsea <veronica at laurelcreekmusic.com>
>> Subject: Re: [Diabetes-Talk] Medtronic sharing site
>> 
>> Medtronic can't include a TalkBack feature because they don't use that sort of operating system. They'd have to invent something from scratch and they sure aren't going to do that.
>> Veronica
>> 
>> 
>> "Guide Dogs, First Hand", Veronica Elsea's classic album is now available on iTunes, along with other music from her and from the Guide Dog Glee Club. 
>> To learn more, visit:
>> 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 Patricia Maddix via Diabetes-Talk
>> Sent: Thursday, January 21, 2021 5:03 PM
>> To: Diabetes Talk for the Blind
>> Cc: Patricia Maddix
>> Subject: Re: [Diabetes-Talk] Medtronic sharing site
>> 
>> I just filled out the Medtronic idea request encouraging them to update their software on their pumps to include a talkback feature and two create an app that allows the user to control the pump from the app in an accessible way for the blind.
>> I encourage as many people as possible from this list to do the same and who knows they might actually take notice. I think there is power in numbers.  I am not holding my breath however it can’t hurt.
>> Patricia
>> 
>> Sent from my iPhone
>> 
>>>> On Jan 21, 2021, at 3:40 PM, Jamie Gurganus via Diabetes-Talk <diabetes-talk at nfbnet.org> wrote:
>>> 
>>> Here is the link to the share your ideas page.
>>> 
>>> 
>>> 
>>> https://www.medtronicdiabetes.com/share-your-idea?utm_source=Eloqua
>>> <https://www.medtronicdiabetes.com/share-your-idea?utm_source=Eloqua&
>>> u
>>> tm_med
>>> ium=Email&utm_campaign=NTIJan_01302021&utm_content=ShareNow&elqTrackI
>>> d
>>> =bbd5d
>>> c92b63c4ff7ad19fee1956b9320&elq=5430f22d0e8948b8bcbd8a9448f7a9e7&elqa
>>> i
>>> d=3784
>>> &elqat=1&elqCampaignId=1853>
>>> &utm_medium=Email&utm_campaign=NTIJan_01302021&utm_content=ShareNow&e
>>> l
>>> qTrack
>>> Id=bbd5dc92b63c4ff7ad19fee1956b9320&elq=5430f22d0e8948b8bcbd8a9448f7a
>>> 9
>>> e7&elq
>>> aid=3784&elqat=1&elqCampaignId=1853
>>> 
>>> 
>>> 
>>> Jamie Gurganus, Resource Coach       
>>> 
>>> Phone:  515-291-8451
>>> 
>>> 
>>> 
>>> "be Yourself;  Everyone else is already taken."
>>> 
>>>                                Oscar Wilde
>>> 
>>> 
>>> 
>>> 
>>> 
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>> 
>> 
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>> 
>> 
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>> laurelcreekmusic.com
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>> 
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