[NHLakesChapter] 2024 Medical Device Nonvisual Accessibility Act Fact Sheet

Wed Jan 3 21:57:07 UTC 2024

Medical Device Nonvisual Accessibility 
Act (H.R. 1328)

Issue-Inaccessible digital interfaces prevent blind individuals from
independently and safely operating medical devices that are essential to
blind people's daily healthcare needs.

Medical devices with a digital interface are becoming more prevalent and
less accessible for blind Americans.

The rapid proliferation of advanced technology is undeniable. Most new
models of medical devices, such as glucose, oxygen, and blood pressure
monitors, along with the emergence of in-home devices that offer medical
care options, such as chemotherapy treatments and dialysis, require
consumers to interact with digital displays or other interfaces. This new
technology is constantly being developed and deployed without nonvisual
accessibility as an integral part of the design phase, which creates an
accessibility barrier. The inaccessibility of these medical devices is not a
mere inconvenience; when accessibility for blind consumers is omitted from
the medical technology landscape, the health, safety, and independence of
blind Americans are in imminent danger.

According to the Center for Connected Medicine, telehealth currently makes
up 20 percent of all medical visits, and more healthcare providers are
looking to expand telemedicine services.[1] 

 According to the Pew Research Center, Rural Americans live an average of
10.5 miles from the nearest hospital.[2] According to the Journal of the
American Pharmacists Association, across the United States, 8.3 percent of
counties had at least 50 percent of residents with a distance greater than
ten miles from the closest pharmacy,[3] requiring many Americans to rely on
telehealth services. Unfortunately, these visits assume that a person has
easy access to accessible medical devices to take their own vital signs. As
a result of inaccessibility, blind and low-vision Americans are at a
distinct disadvantage when it comes to receiving the same virtual healthcare
as our sighted counterparts. 

Nonvisual access is achievable, as demonstrated by several mainstream
products. 

 Apple has incorporated VoiceOver (a screen reading function) into all of
its 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 tactile feature can make a product accessible at
little to no additional cost for manufacturers.

Current disability laws have not been able to keep up with advancements due
to the rapid evolution of medical technology and its incorporation into
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 a blind consumer's right to
access medical devices. The National Council on Disability concluded that
accessibility standards lag behind the rapid pace of technology, which can
interfere with technology access.[4] 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 regulations for Class II and Class III medical devices with
digital interfaces. 

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 twenty-four months after the
date of enactment of the act, the FDA will publish the final rule including
the nonvisual accessibility requirements.

Requires manufacturers of Class II and Class III medical devices with
digital interfaces to make their products nonvisually accessible. 

Manufacturers will have twelve months following the publication of the final
rule to ensure that all the Class II and Class III medical devices they
produce with digital interfaces are nonvisually accessible.

Authorizes the FDA to enforce the nonvisual access requirements for Class II
and Class III medical devices with digital interfaces. 

Any manufactured device found to be out of compliance, as a result of a
public complaint to the FDA or by an independent FDA investigation, will be
considered an adulterated product under the Federal Food, Drug, and Cosmetic
Act. Manufacturers may file for an exemption for one of two reasons: clear
and convincing evidence that making the medical device nonvisually
accessible would fundamentally alter the product; or evidence that modifying
the medical device would create an undue hardship for the company.

GOAL-END UNEQUAL ACCESS TO MEDICAL DEVICES FOR BLIND AMERICANS.

Cosponsor the Medical Device Nonvisual Accessibility Act (H.R. 1328).

To cosponsor H.R. 1328 contact:

Michelle Paucar, Health Policy Counsel, Rep. Jan Schakowsky (D-IL-09), 

Phone: 202-225-2111, Email:  <mailto:%20Michelle.Paucar at mail.house.gov>
Michelle.Paucar at mail.house.gov

For more information, contact:

Justin Young, Government Affairs Specialist, National Federation of the
Blind

Phone: 410-659-9314, extension 2210, Email: jyoung at nfb.org
<mailto:jyoung at nfb.org>  or visit www.nfb.org <http://www.nfb.org> 

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[1] See Center for Connected Medicine, Telehealth utilization settles in at
20% or less of medical appointments, available at
https://connectedmed.com/resources/post-pandemic-telehealth-utilization-sett
les-in-at-20-or-less-of-medical-appointments/

[2] See Pew Research Center, How far Americans live from the closest
hospital differs by community type, available at
<https://www.pewresearch.org/short-reads/2018/12/12/how-far-americans-live-f
rom-the-closest-hospital-differs-by-community-type/>
https://www.pewresearch.org/short-reads/2018/12/12/how-far-americans-live-fr
om-the-closest-hospital-differs-by-community-type/

[3] See Journal of the American Pharmacists Association, Access to community
pharmacies: A nationwide geographic information systems cross-sectional
analysis available at
<https://www.japha.org/article/S1544-3191(22)00233-3/fulltext>
https://www.japha.org/article/S1544-3191(22)00233-3/fulltext

[4] See NATIONAL COUNCIL ON DISABILITIES, National Disability Policy
Progress Report: Technology that enables access to the full opportunities of
citizenship under the Constitution is a right at 19 (October 7, 2016),
available at
<https://ncd.gov/progressreport/2016/progress-report-october-2016>
https://ncd.gov/progressreport/2016/progress-report-october-2016

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