Research

Accessible software, and the rule on care algorithms

One rule requires a covered health program's websites and apps to be accessible. A newer one requires it to go looking for decision tools that use race, sex, age or disability as an input.

By Nora Castellan, Standards Editor

Where these duties apply

These requirements sit in the health nondiscrimination rules, and they follow federal financial assistance rather than the act of selling a medicine.

A covered entity is one receiving such assistance for its health programs, along with issuers seeking marketplace certification and states running a marketplace.

A cash-pay telehealth business with no federal health funding is outside this part. Whether a particular business is covered turns on its funding, and nothing here settles that for anyone.

The reason to read it anyway is that these sections describe what a considered accessibility standard looks like when someone has to meet one. That is a useful yardstick even for a business no one is forcing.

Effective communication, and what free of charge means

The communication duty is written as a comparison rather than a checklist.

A covered entity takes appropriate steps to ensure communications with individuals with disabilities, including companions with disabilities, "are as effective as communications with non-disabled individuals" in its health programs.

It provides appropriate auxiliary aids and services where necessary to give an equal opportunity to participate in and enjoy the benefits of the program.

The conditions attached to those aids are the part worth memorizing, because four separate requirements sit in one sentence.

The sentence reads: "Such auxiliary aids and services must be provided free of charge, in accessible formats, in a timely manner". It ends "and in such a way to protect the privacy and the independence of the individual with a disability."

Free of charge is the one people expect. Timely, in an accessible format, and in a way that protects privacy and independence are the ones that get missed.

Buildings, and the flexibility written into the standard

The facilities rule states the harm first. No qualified individual with a disability may be denied benefits, excluded, or otherwise discriminated against "because a covered entity's facilities are inaccessible to or unusable by individuals with disabilities".

The technical requirements then turn on construction and alteration dates, with several dated thresholds and a set of deeming provisions for facilities built to earlier standards.

Those standards are separate published documents incorporated by reference, and their text is not reproduced here.

One sentence in this section generalizes well beyond buildings. "Departures from particular technical and scoping requirements by the use of other methods are permitted where substantially equivalent or greater access to and usability of the facility is provided."

That is the shape of a good accessibility rule: a target that can be met another way, judged by the access actually delivered rather than by conformity to a method.

The website and mobile app requirement

The information technology section is the one that reaches a website, an intake form and a patient portal.

A covered entity "must ensure that its health programs and activities provided through information and communication technology are accessible to individuals with disabilities".

There is a limit, and it is the familiar two-part one: "unless doing so would result in undue financial and administrative burdens or a fundamental alteration in the nature of the health programs or activities."

But invoking that limit does not end the obligation. A fallback applies where compliance would cause such a burden or alteration. Then "a covered entity shall take any other action that would not result in such an alteration or such burdens". The sentence continues "but would nevertheless ensure that, to the maximum extent possible, individuals with disabilities receive the benefits or services".

So the fallback duty is to do the most that can be done, not to stop.

A second paragraph is more specific about the channel. A recipient or state marketplace "shall ensure that its health programs and activities provided through websites and mobile applications comply with the requirements of section 504 of the Rehabilitation Act". Those requirements are interpreted consistently with the disability statute's public-entity title.

Reasonable modification, and who has to prove what

A covered entity must make reasonable modifications to policies, practices or procedures where necessary to avoid discrimination on the basis of disability.

The exception is narrow and, importantly, the burden sits with the entity: "unless the covered entity can demonstrate that making the modifications would fundamentally alter the nature of the health program or activity."

Demonstrate is doing the work in that sentence. The entity has to show the alteration would be fundamental, rather than assert inconvenience.

The term itself is imported from the general disability regulations and is to be read consistently with them, so this is not a bespoke health-sector standard.

Elsewhere in the same part, the written procedure implementing this has to include a process for determining whether a modification would fundamentally alter the program, and for identifying an alternative that would not.

The rule on patient care decision support tools

The newest idea in this part is short enough to read in a minute and broad enough to reach a great deal of clinical software.

The general prohibition first. A covered entity "must not discriminate on the basis of race, color, national origin, sex, age, or disability in its health programs or activities through the use of patient care decision support tools."

That covers the tool as a route to discrimination, however the tool is built.

The second paragraph is the unusual one, because it creates an affirmative search duty rather than a prohibition.

A covered entity "has an ongoing duty to make reasonable efforts to identify uses of patient care decision support tools" in its programs. The tools it has to look for are those "that employ input variables or factors that measure race, color, national origin, sex, age, or disability."

Ongoing is stated in the rule. This is not a one-time inventory.

Identify, then mitigate

The third paragraph completes the structure. For each tool identified, the entity "must make reasonable efforts to mitigate the risk of discrimination resulting from the tool's use" in its programs.

Read together, the three paragraphs describe a cycle rather than a rule against a specific practice. Do not discriminate through a tool. Keep looking for tools that use these variables. Where you find one, reduce the risk it creates.

What the section notably does not do is ban the use of these variables. A tool that measures one of them is something to identify and mitigate, not something automatically prohibited.

That distinction matters, because some clinical instruments use such variables deliberately and defensibly, and others carry them as an artifact of the data they were built from.

The rule's answer to that difficulty is procedural: find them, and manage the risk each one creates.

How to use this as a reader

The first use is a standard to hold a health website to, whether or not the law reaches it. Accessible technology, with a fallback duty to do the most possible where full compliance is genuinely burdensome.

The second is a question worth asking any service that scores, triages or sorts patients: does the tool use any of these variables as an input, and what was done about it.

That question is now a written regulatory duty for covered entities, which makes it a reasonable thing to ask of anyone operating similar software.

The third is the free-of-charge point. Where these rules apply, communication aids are free, timely, in an accessible format, and delivered so as to protect privacy and independence.

One limit on this article. Only these five sections of part 92 were read in full. The definitions and application sections, the language access provisions, and the enforcement procedures were not read for this piece.

The technical accessibility standards incorporated by the facilities section are separate published documents. They were not read, and nothing from them is quoted here.

Key takeaways

Frequently asked questions

Does my telehealth provider have to make its website accessible?

Only if it is a covered entity under these rules, which follow federal financial assistance for health programs rather than the sale of medicine. Where the rules do apply, the entity must ensure health programs and activities provided through information and communication technology are accessible to individuals with disabilities. A recipient or state marketplace must also ensure that programs provided through websites and mobile applications comply with the disability access requirements the section names.

Can cost be a reason not to comply?

Only within a defined limit, and it does not end the duty. The technology requirement applies unless compliance would result in undue financial and administrative burdens or a fundamental alteration in the nature of the health programs or activities. Where that is so, the entity must still take any other action that would not cause such burdens or alteration. That action has to ensure, to the maximum extent possible, that individuals with disabilities receive the benefits or services.

Are interpretation and other communication aids charged for?

No, where these rules apply. Appropriate auxiliary aids and services must be provided where necessary to afford an equal opportunity to participate in and enjoy the benefits of the program. The regulation states they must be provided free of charge, in accessible formats, and in a timely manner. They must also be provided in a way that protects the privacy and the independence of the individual with a disability.

Who has to prove that a requested change is unreasonable?

The covered entity. Reasonable modifications to policies, practices or procedures must be made where necessary to avoid discrimination on the basis of disability. The exception applies only where the covered entity can demonstrate that making the modifications would fundamentally alter the nature of the health program or activity. The term is to be read consistently with the general disability regulations rather than as a health-specific standard.

Does the rule ban clinical software that uses race or sex as an input?

No. It prohibits discriminating through the use of patient care decision support tools. It imposes an ongoing duty to make reasonable efforts to identify uses of tools that employ input variables or factors measuring race, color, national origin, sex, age or disability. And it requires reasonable efforts to mitigate the risk of discrimination resulting from each identified tool's use. Identification and mitigation, not prohibition, are what the section requires.

Is the identification duty a one-time exercise?

No. The regulation describes it as an ongoing duty to make reasonable efforts to identify such uses. That wording means the inventory has to keep pace with the tools actually in use, and each newly identified tool brings the mitigation duty with it.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

  1. Title 45 Code of Federal Regulations section 92.202, Effective communication for individuals with disabilities, read in full for the equal effectiveness standard and the four conditions on auxiliary aidsElectronic Code of Federal Regulations, Office of the Federal Register, May 2024
  2. Title 45 Code of Federal Regulations section 92.203, Accessibility for buildings and facilities, read in full for the prohibition, the dated construction thresholds and the equivalent-access departure provisionElectronic Code of Federal Regulations, Office of the Federal Register, May 2024
  3. Title 45 Code of Federal Regulations section 92.204, Accessibility of information and communication technology for individuals with disabilities, read in full for the general duty, the burden and fundamental alteration limit, the fallback duty and the websites and mobile applications provisionElectronic Code of Federal Regulations, Office of the Federal Register, May 2024
  4. Title 45 Code of Federal Regulations section 92.205, Requirement to make reasonable modifications, read in full for the duty, the demonstration burden and the cross-reference for the defined termElectronic Code of Federal Regulations, Office of the Federal Register, May 2024
  5. Title 45 Code of Federal Regulations section 92.210, Nondiscrimination in the use of patient care decision support tools, read in full for the general prohibition, the ongoing identification duty and the mitigation dutyElectronic Code of Federal Regulations, Office of the Federal Register, May 2024