Medical Translation Requirements for U.S. Healthcare Organizations

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In the United States, hospitals, clinics, and health plans that receive federal funding must give patients with limited English proficiency (LEP) free, accurate, and timely language assistance under Section 1557 of the Affordable Care Act and its regulations at 45 CFR Part 92. That means qualified interpreters and translators, translated vital documents, notices of free language help in the state’s top 15 languages, and human review of any machine translation used for critical content. Medicaid and Medicare plans, clinical research, and state laws add their own requirements on top.

Who has to comply?

Section 1557 applies to every health program or activity that receives federal financial assistance from the Department of Health and Human Services (HHS), to programs HHS runs itself, and to the ACA health insurance marketplaces. In practice, that includes most hospitals and health systems, physician practices that accept Medicare Part B or Medicaid, community health centers, behavioral health providers, nursing facilities, pharmacies, and health insurers that take federal funds.

Covered entities must also adopt written language access procedures and train relevant staff on them. Those with 15 or more employees must designate a Section 1557 coordinator.

What Section 1557 requires for translation and interpreting

Under 45 CFR 92.201, a covered entity must take reasonable steps to provide meaningful access to each person with LEP it serves or is likely to encounter. Language assistance must be free of charge, accurate, and timely, and must protect the person’s privacy and independent decision-making. The rule spells out what that means:

• Qualified translators. Written translations must be done by a qualified translator: someone with demonstrated proficiency in both languages who translates accurately and impartially and follows translator ethics, including confidentiality.
• Qualified interpreters. Spoken interpreting must be done by a qualified interpreter, in person or remotely.
• Human review of machine translation. If machine translation is used for text that is critical to a person’s rights, benefits, or meaningful access, where accuracy is essential, or where the source contains complex, non-literal, or technical language, a qualified human translator must review it.
• Limits on family and staff interpreters. A provider may not require patients to bring their own interpreter. It may rely on an accompanying adult only in an emergency involving an imminent threat to safety, or when the patient asks for it in private and the adult agrees. A minor child may interpret only in an emergency when no qualified interpreter is immediately available. Bilingual staff may interpret only if they are qualified.
• Video interpreting standards. Video remote interpreting must deliver real-time, full-motion video and audio with a clear image of the interpreter’s face and the patient’s face, and clear audio.

The notice of language assistance

Under 45 CFR 92.11, covered entities must tell patients that free language help is available. The notice must be provided in English and in at least the 15 languages most commonly spoken by people with LEP in the relevant state or states, and in alternate formats for people with disabilities. It must be posted on the website and in physical locations, provided annually and on request, and included with key documents, including:

• The notice of nondiscrimination and the notice of privacy practices
• Application and intake forms, complaint forms, and patient or member handbooks
• Consent forms and instructions for medical procedures, medical powers of attorney, and living wills
• Discharge papers
• Notices about eligibility, benefits, denials, appeals, cost, and payment, and communications that require a response

Which documents should be translated?

Section 1557 asks for meaningful access, not translation of every page. Prioritize vital documents, the ones a patient needs to understand their care, their rights, or their bills, in the languages your patients actually speak. Most health organizations start with:

Stage of care	Documents to translate first
Registration	Intake and registration forms, consent to treat, financial assistance policy and application, notice of privacy practices
Treatment	Informed consent forms, procedure instructions, advance directives
Discharge	Discharge instructions, medication guides, follow-up instructions
Billing and coverage	Statements, notices of denial or termination, appeal and grievance rights
Ongoing	Patient education, portal messages, and public health notices

Health plans, Medicaid, and Medicare

• Medicaid and CHIP managed care (42 CFR 438.10): written materials critical to obtaining services, such as member handbooks, provider directories, and notices of denial, appeal, and grievance rights, must be available in the prevalent non-English languages in the state, with taglines explaining how to get help.
• Medicare Advantage and Part D: plans must translate required materials into any non-English language spoken by at least 5 percent of people in the plan’s service area, and give members a way to request materials in their language going forward.
• State laws: many states, including California, add language assistance requirements for health plans and providers. Check the rules in each state where you operate.

Clinical research and life sciences

Federal research rules (45 CFR 46.116 and 21 CFR 50.20) require informed consent information to be in language the participant understands. For participants who do not read English, that means a translated consent form approved by the IRB, or a short-form consent process with a qualified interpreter. Patient-reported outcome questionnaires are often translated with forward and back translation and cognitive debriefing, so results can be compared across languages.

HIPAA and your translation vendor

A translation or interpreting company that handles protected health information on your behalf is a business associate under HIPAA. Sign a Business Associate Agreement before sending patient records, and confirm the vendor uses secure file transfer, access controls, and confidentiality agreements for every linguist. Do not paste patient information into public machine translation tools.

What a compliant medical translation process looks like

1. Write for the reader first. Plain-language source text, at a reading level patients can follow, translates better and costs less.
2. Translate with a qualified medical translator who knows the subject and the target audience.
3. Revise with a second linguist, as ISO 17100 requires, before anything reaches a patient.
4. Keep approved terminology in a glossary and translation memory, so drug names, procedures, and instructions read the same way in every document.
5. Check the layout, including forms, tables, and signature blocks, in the final format.
6. Keep records of who translated and reviewed each document, and when, so you can show your work in an audit.

Frequently Asked Questions

Is Section 1557 still in effect?

Yes. In June 2026, HHS published notice that a federal court in Tennessee v. Kennedy had vacated certain provisions of the 2024 rule that extended sex discrimination to gender identity. HHS stated that the other provisions of the rule remain in force, including the language access requirements.

Can bilingual staff translate patient documents?

Only if they meet the definition of a qualified translator. Being bilingual is not enough; the person must have demonstrated proficiency in written translation, translate accurately and impartially, and follow translator ethics. Many organizations use bilingual staff for conversation and professional translators for documents.

Can we use machine translation for patient materials?

For critical content, such as consent forms, discharge instructions, and notices of rights or benefits, machine output must be reviewed by a qualified human translator under the Section 1557 rule. Never put protected health information into a public machine translation tool.

What is a vital document in healthcare?

A document a patient needs to understand their care, rights, or obligations, or to get services. Consent forms, discharge instructions, intake forms, financial assistance applications, and notices of denial or appeal rights are typical examples.

Do we need certified translations for medical records?

For patient care, the standard is a qualified translator, not a certificate. For immigration, court, or insurance purposes, the receiving office may require a certified translation with a signed certificate of accuracy.

Which languages do we need to cover?

For the Section 1557 notice, the 15 most common LEP languages in your state. For documents and interpreters, the languages your patients actually speak, based on your own patient data and community data.

This guide is general information, not legal advice. Confirm your obligations with counsel.