Recently introduced bipartisan legislation seeks to improve access to home medical devices for blind and visually impaired users.
Let’s start with some background info first.
Historically, digital home devices and accessibility standards have not gone hand-in-hand. In fact, there is currently no federal agency that requires device manufacturers to include accessibility features for blind or visually impaired patients.
With telehealth services making up 20% of all medical visits—plus the promise for expansion of such services in the near future—utilization of home medical devices is becoming more commonplace but less accessible for visually impaired and blind individuals.
So what’s the argument?
As the National Federation of the Blind (NFB) has advocated, the need for nonvisual access is a necessity. “Accessibility is not a matter of mere convenience, but a moral imperative that, with respect to healthcare, can make the difference between good and poor health outcomes and even between life and death,” stated Mark Riccobono, president of the NFB. “Blind Americans must have nonvisual access to medical technology that is crucial to our well-being.”
Now this bill.
With companion legislation H.R. 1328 introduced in the House of Representatives by U.S. Rep. Jan Schakowsky (D-Ill) in 2023, this 2024 bipartisan bill (S.3621) was most recently introduced by Senators Maggie Hassan (D-NH) and Mike Braun (R-Ind).
The legislation seeks to amend the Federal Food, Drug, and Cosmetic Act to establish “nonvisual accessibility standards for certain devices with digital interfaces”—dubbed the Medical Device Nonvisual Accessibility Act of 2024.
And its stance?
Among key findings summarizing the current landscape of non-visually-accessible medical digital technology, S.3621 argues that medical devices could be designed to incorporate nonvisual access technology for those who are blind or visually impaired at little to no extra cost—providing “such compatibility is taken into consideration at the beginning of the design process.”
The intention of such devices: “Consumers who are blind or have low-vision must be able to operate medical devices in an equally effective and equally integrated manner and with equivalent ease of use as consumers without disabilities,” the bill stated.
So what is it proposing?
Essentially, for lawmakers to develop specific standards for medical devices that would require manufacturers to build accessible products that meet the needs of visually impaired and blind individuals, such as through audio prompts or tactile buttons.
There’s also a stipulation: Such accessibility features would only be added providing they don’t “change the fundamental nature of the device,” according to a release from Sen. Hassan.
Which medical devices would these include?
Per the legislation, a device covered under these terms would apply to Class I and II medical devicesand those that contain a user interface—a screen or mobile application through which a human user interacts or communicates with the device by either inputting or receiving information.
These devices also include those that are:
- 510(k)-cleared devices under Section 513(f)(2) (De Novo classification)
- Not intended solely for use by a healthcare provider (HCP) or in a setting outside the home
Give me specific examples.
These devices include insulin pumps and glucose monitors for diabetes, as well as continuous positive airway pressure (CPAP) machines and heart monitors.
And would these new requirements be regulated?
Per the bill, manufacturers would be trained and educated on the necessary interface needed to be added to such medical devices based on the new standards (as listed above), as well as how to comply with them.
What do these senators have to say?
According to Sen. Hassan: “Almost all smartphones and computers include accessibility features that make it easier for visually impaired people to use them, but home medical devices—which people often need to live—rarely include this basic functionality.”
Similarly, Sen. Braun stated that, “Ensuring accessibility of certain medical devices for people who are visually impaired is a no-brainer and has the potential to greatly improve the user’s quality of life.”
And has the NFB weighed in?
Indeed they have. NFB released a statement on January 24, 2024, following the introduction of S.3621 that fully supported the legislation.
And in a statement to Glance, the organization reaffirmed its belief in the bill’s potentially groundbreaking impact: “We believe it is critical to the health, safety, and independence of blind and low-vision Americans.”
So what’s next for the bill?
Per Congress records, the legislation has been read twice and referred to the Senate Committee on Health, Education, Labor, and Pensions on January 18, 2024.
While reports have noted that the bill isn’t a current priority for lawmakers, Sen. Hassan is said to be in the process of educating her colleagues on the issues.
Meanwhile Rep. Schakowsky (with just four Republicans as cosponsors of H.R. 1328) in the House of Representatives, is working to make strides as well.
“There are people who have sight problems who are Republicans, Democrats, Independents. If we can do something about this, we should,” she told StatNews. “I’m looking forward to getting their help in getting more Republican cosponsors.”
*Disclaimer: The information provided in this article does not and is not intended to constitute legal advice; instead, all information, content, materials available herein are for general information purposes only.