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HIPAA

Business Associate Agreement

Version 2026-10-05

1. Parties and purpose

This Business Associate Agreement ("Agreement") is entered into between the organization identified at signing ("Covered Entity" or "Organization") and AllerLysis, 4422 N Ravenswood Ave, Chicago, IL 60640 ("Business Associate").

It applies to the extent the Organization is a covered entity or business associate under HIPAA and allergy or dietary information entered into AllerLysis is protected health information ("PHI"). If HIPAA does not apply to your organization, the privacy and security commitments below still apply as contractual terms.

2. Permitted uses and disclosures

AllerLysis will use and disclose PHI only to provide the food allergen screening service: screening items against allergy profiles, storing screening history, sending the compliance alerts the Organization configures, and producing reports for the Organization.

AllerLysis will not sell PHI, use it for marketing, or use it to train machine-learning models.

3. Safeguards

AllerLysis will maintain administrative, physical and technical safeguards appropriate to the information, including encryption in transit and at rest, per-organization access controls and role-based permissions so one organization's records are not visible to another.

Subcontractors that process PHI on AllerLysis's behalf (such as hosting and text-extraction providers) must agree to restrictions at least as protective as this Agreement.

4. Reporting incidents

AllerLysis will report to the Organization any use or disclosure of PHI not permitted by this Agreement, and any security incident or breach of unsecured PHI it discovers, without unreasonable delay and no later than 30 calendar days after discovery.

5. Individual rights

AllerLysis will make PHI available to the Organization so it can respond to requests for access, amendment and an accounting of disclosures, and will support the Organization in meeting those obligations.

6. Organization responsibilities

The Organization is responsible for obtaining any consents or authorizations required before entering allergy information about the individuals it serves, for entering only the minimum information necessary, and for keeping profiles current against official care plans.

The Organization remains responsible for its own compliance decisions. AllerLysis is not a medical service and screening results are not a guarantee of allergen absence.

7. Term and termination

This Agreement remains in effect while the Organization uses AllerLysis. On termination, AllerLysis will return or destroy PHI on request, or, if that is not feasible, extend these protections for as long as it is retained.

Data consent signed with this agreement

  • I am authorized to sign on behalf of this organization.
  • Our organization has obtained, or will obtain before entry, any consent or authorization required from each individual, parent or guardian whose allergy information we enter.
  • We will enter only the allergy and dietary information needed to screen food, and we will keep it consistent with each person's care plan.
  • We understand AllerLysis is an operational screening tool, not a guarantee of allergen absence, and does not replace staff review of the physical package.

How to sign

An organization administrator signs electronically in the workspace under Plan & policy. Allergy profiles can't be added until it is signed. Each signature records the signer's name, title, email, the agreement version and the time.

Sign in your workspace

Need a custom agreement? Email info@allerlysis.com.

AllerLysis

Questions merchants ask before using AllerLysis

Straight answers about compliance, privacy and what the tool does — and does not — do.

Is AllerLysis a guarantee that food is safe?

No. AllerLysis is a screening tool and an operational aid, not a guarantee of allergen absence. Results depend on ingredient information from product databases, label photographs and text recognition, which can be incomplete, out of date or unreadable.

Final decisions about serving food to any person always rest with your trained staff, following each individual's care plan, allergy action plan and physician guidance. AllerLysis never replaces human judgment or your facility's allergy policy — it documents and supports it.

Does AllerLysis replace staff training or human review?

No. The app is an operational tool that helps your team check items consistently and keep a record of each check. It does not replace a trained person reviewing the physical package, asking questions about the food's preparation, or following your facility's procedures.

Every result — red, amber or green — should be treated as one input before a decision, and staff should still verify against the actual label and the person's care plan.

How does AllerLysis handle HIPAA?

AllerLysis is not a medical service and does not provide medical advice, diagnosis or treatment. Whether information entered into AllerLysis is protected health information depends on your organization's role and use.

The service is built to support careful handling of personal and health-related information: data is encrypted in transit and at rest, and records are separated by organization with per-organization access controls so one organization's records are not visible to another.

If your use of AllerLysis is covered by HIPAA, you remain responsible for compliance decisions, including whether a Business Associate Agreement is required for your situation. Every organization's administrator signs our standard BAA and data consent in the workspace before allergy information can be entered; contact us at info@allerlysis.com for a custom agreement.

Read and sign the Business Associate Agreement and data consent →

What about FERPA and school records?

For schools, allergy profiles and screening records may be considered education records or health information under FERPA. AllerLysis keeps each organization's data separated, and access is limited to the administrators and staff of that organization.

School administrators are responsible for FERPA decisions, including parent consent and disclosure choices. We do not sell personal information and we do not share screening records with advertisers or data brokers.

Who can see our screening records and profiles?

Only members of your own organization. Administrators and staff of your organization can see screening records submitted by members and by visitors checking in under your organization's code.

AllerLysis staff do not browse your records; we access data only to operate, troubleshoot or respond to legal requirements. Parents and visitors see only their own submissions and results.

Where is our data stored, and can we get it deleted?

Data is stored in our cloud database with encryption in transit and at rest, using per-organization row security so tenants are isolated from one another. Screening records are retained while your organization subscribes and for a reasonable period afterwards.

You may request access to, correction of, or deletion of your personal information, or deletion of your organization's records when ending your subscription, by contacting info@allerlysis.com.

Do parents and visitors need an account?

No. Parents can pre-check food from their organization's app access, and visitors can check food through a public check-in link or QR code posted at the entrance without creating an account.

We collect only the minimum information needed for a check: a name the submitter chooses to give, the food item and its result.

Does the app use AI to decide whether food is allowed?

No. Every result is produced by a fixed, deterministic rules engine that examines ingredient text, “Contains” statements and precautionary wording. The same product text always produces the same result, and the evidence behind each result is recorded.

AI is used only to extract text from label photographs — it never assigns the outcome. Barcode lookups consult third-party product databases such as Open Food Facts and USDA FoodData Central; we never treat a third-party source as authoritative on its own.

Is AllerLysis a medical device or regulated product?

No. AllerLysis is not a medical device and is not intended to diagnose, treat, cure or prevent any disease or allergic reaction. It does not verify the physical contents of food, detect allergens in the food itself, or replace laboratory testing.

It is a documentation and screening aid for facility operations. You agree to use it only as a screening aid, to always verify against the physical package, and to train your staff accordingly, as described in our Terms of Service.

What does it cost, and is there a trial?

New organizations start with a 30-day free trial — no card required. Paid plans start at $49 per home each month. Enterprise pricing is customized for larger organizations and multi-site needs.

You can cancel at any time; cancellation takes effect at the end of the current billing period. See the plans section above or contact info@allerlysis.com.

Have a question we didn't cover? Email info@allerlysis.com or read our Privacy Policy and Terms of Service.

AllerLysis screens for the nine FDA major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. It is a screening tool, not a guarantee of allergen absence. Always check the physical package and follow each person's care plan.

Contact4422 N Ravenswood Ave
Chicago, IL 60640
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