Read This First
These Terms are a contract between you and Profile Health, Inc. They cover the whole‑genome sequencing analysis you are about to register for.
Three things matter more than anything else in this document, and we want them stated plainly before the legal language begins:
- This analysis is for research and educational purposes. It is not a diagnostic test. Nothing we report is a diagnosis, and nothing we report should be acted on without your clinician's independent judgment and, where appropriate, confirmatory clinical testing.
- What you learn cannot be unlearned. Genetic information is permanent, it can be distressing, and it says things about your biological relatives that they did not agree to have said. Please read Section 10 before you register your kit.
- How we may use your data is governed by a separate document. Accepting these Terms does not give us permission to use your genetic data for research, product improvement, or artificial‑intelligence model training. That permission is requested separately, in the Research & Data Use Consent, which you may decline without losing access to your results.
01Who We Are, and What This Agreement Covers
1.1 "Profile Health," "we," "us," and "our" mean Profile Health, Inc., a Delaware corporation with its principal place of business at 434 Sausalito Blvd, Sausalito, CA 94965.
1.2 These Terms of Service ("Terms") govern your access to and use of the Profile Health genomic analysis service, including the collection kit, the analysis we perform, the reports we generate, any Profile Health account we make available to you, and any related website, application, or communication (together, the "Service").
1.3 Documents that form part of this agreement. These Terms incorporate by reference:
- the Profile Health Privacy Policy;
- the Notice of Privacy Practices, where we act as a business associate of your clinician under HIPAA; and
- any product‑specific terms presented to you at the time you register a particular kit.
The Research & Data Use Consent is a separate agreement. It is not incorporated into these Terms, it is not a condition of receiving the Service, and declining it has no effect on your rights under these Terms.
1.4 How you accept. You accept these Terms by checking the acceptance box during kit registration. If you do not accept, do not register the kit; contact your clinician or us at support@profilehealth.com to arrange return and refund in accordance with Section 16.
02Definitions
"Analysis" means the bioinformatic processing and interpretation Profile Health performs on Sequence Data, and the Reports produced from it.
"Clinician" means the licensed healthcare provider, practice, clinic, or other business that ordered the Service for you and through whom you obtained the Kit.
"Genetic Data" means data that results from the analysis of your biological sample, including raw sequence data, aligned reads, variant calls, and any information derived from them.
"Kit" means the sample collection kit supplied to you, including the collection device bearing a unique identifier (the "Tube ID"), instructions, and return materials.
"Laboratory" means the independent, CLIA‑certified clinical laboratory that receives your biological sample and performs sequencing. Profile Health is not a laboratory and does not perform sequencing.
"Parent" means a parent or legal guardian with legal authority to consent to healthcare services and to enter into agreements on behalf of a Patient who is a minor.
"Patient," "you," and "your" mean the individual whose biological sample is analyzed. Where the Patient is a minor, "you" also means the Parent accepting these Terms on the Patient's behalf, and both are bound.
"Reports" means the interpretive outputs Profile Health generates, currently comprising polygenic risk scores, Mendelian variant findings, and pharmacogenomic findings, in each case within the scope described in Section 8.
"Self‑Reported Information" means information you provide to us or authorize a third party to provide, including health history, family history, traits, medications, and survey responses.
"Sequence Data" means the raw output of sequencing performed by the Laboratory, including FASTQ files, and the aligned and processed derivatives of that output.
03Eligibility and Who May Accept These Terms
3.1 Adults. If you are 18 or older (19 in Alabama and Nebraska; 21 in Mississippi), you may accept these Terms for yourself.
3.2 Minors. The Service is available to Patients under the age of majority only where:
(a) a Clinician has ordered the Service for the Patient and has confirmed the order is clinically appropriate for a minor;
(b) a Parent with legal authority accepts these Terms on the Patient's behalf and attests to that authority; and
(c) where the Patient is 13 or older, the Patient has provided assent — an affirmative indication that they understand, in age‑appropriate terms, what will be tested and what they may learn, and that they agree to proceed.
3.3 Assent and dissent. A Patient aged 13 or older who declines to assent will not be tested, and we will not process a sample for that Patient, notwithstanding Parental consent. A Patient's dissent is final. This reflects the joint position of the American Academy of Pediatrics and the American College of Medical Genetics and Genomics on genetic testing of adolescents.
3.4 Shared custody. Where legal custody of a minor Patient is shared, the accepting Parent represents that they are authorized to consent alone, or that all Parents whose consent is required have consented. We may require documentation. Where we are notified of a dispute between Parents, we will suspend processing and will not release Reports until the dispute is resolved.
3.5 What we do not report for minors. Section 8.5 describes findings we withhold for Patients under 18 and release when the Patient reaches the age of majority and consents for themselves.
3.6 One person per Kit. Each Kit is for one Patient. You may not submit a sample that is not yours (or, for a Parent, not your minor child's), and you may not submit a sample on behalf of a person who has not authorized it.
3.7 Prohibited purchasers. You represent that you are not an insurer, an employer, or an agent of either, seeking genetic information about an insured person, applicant, or employee.
3.8 Geography. The Service is offered only to Patients located in the United States. We do not offer the Service in any other jurisdiction, and we do not accept samples originating outside the United States.
04Your Clinician's Role and Ours
This section describes a distinction that matters legally and practically. Please read it.
4.1 Your Clinician orders; we analyze. Profile Health does not practice medicine, does not diagnose, and does not treat. Your Clinician made the decision to order this analysis for you, is responsible for determining whether it is appropriate for you, and is responsible for interpreting the Reports in the context of your care.
4.2 We are not your healthcare provider. No physician–patient, provider–patient, or genetic counselor–patient relationship is created between you and Profile Health by your use of the Service. We do not supervise, direct, or control your Clinician, and your Clinician is not our employee or agent.
4.3 We are not responsible for your Clinician's conduct. Your Clinician's decision to offer, order, or act on the Service, and the advice they give you, are theirs alone. Any dispute about the care your Clinician provided is between you and your Clinician.
4.4 Your Clinician is not our agent for consent. Your Clinician cannot consent on your behalf to our use of your data. Every permission we rely on comes from you (or your Parent) directly.
4.5 Two legal capacities. Depending on your Clinician's arrangement with us, we may hold information about you:
(a) as a business associate of your Clinician under HIPAA, in which case our handling of that information is governed by HIPAA, our agreement with your Clinician, and our Notice of Privacy Practices; and/or
(b) under our direct agreement with you, in which case our handling is governed by these Terms, our Privacy Policy, and any consent you give.
We maintain records of which capacity applies to which information. Our Privacy Policy explains what this means for your rights and how to exercise them in each case.
05What the Service Is — and What It Is Not
5.1 Research and educational purpose. The Service is provided for research, informational, and educational purposes. It is intended to help you and your Clinician understand aspects of your genome in light of current scientific literature.
5.2 Not a diagnostic test. The Reports are not intended to diagnose, cure, mitigate, treat, or prevent any disease or condition, and are not intended to be used as the sole basis for any medical decision. Findings that appear significant should be confirmed by validated clinical testing ordered by your Clinician.
5.3 What "not a diagnostic test" does and does not mean. We want to be precise, because this phrase is often misunderstood:
- It means our Reports have not been reviewed or authorized by the U.S. Food and Drug Administration, and that the analytical and clinical validity of our interpretations has not been established to the standard required of a diagnostic device.
- It means a finding in a Report is a signal to investigate, not an answer.
- It does not mean the information is unimportant, or that it cannot affect you. It can. Section 10 explains how.
5.4 The Laboratory is separate. Sequencing is performed by an independent CLIA‑certified Laboratory under its own quality systems. Profile Health does not perform sequencing, does not hold a CLIA certificate for sequencing, and does not control the Laboratory's processes. Our Analysis is performed on the Sequence Data the Laboratory produces.
5.5 The science changes. Genetic interpretation rests on scientific literature that is revised continuously. An interpretation we provide today may be revised, downgraded, or withdrawn in light of later evidence. We may reissue or amend Reports, and we may notify you or your Clinician when a material reclassification affects a finding previously reported to you. We do not guarantee that we will identify every such reclassification.
5.6 Population bias. Most genetic association studies — and nearly all polygenic risk score derivations — have been conducted predominantly in populations of European ancestry. Predictive accuracy is materially lower for people of other ancestries. If your ancestry is not well represented in the underlying research, your Reports are correspondingly less reliable, and in some cases may be misleading. We disclose the ancestral composition of the reference data underlying each polygenic score in the Report itself.
5.7 Changes to the Service. We may add, modify, suspend, or discontinue features of the Service. Where a change materially reduces what you receive, we will give you advance notice and, where you have paid for a Service you can no longer receive, a pro‑rata refund.
06Kit Registration and Sample Collection
6.1 Registration. Before your sample can be processed, you must register your Kit by entering the Tube ID, confirming your identity and date of birth, and accepting these Terms. An unregistered sample cannot be linked to a person and, if received, will be destroyed by the Laboratory.
6.2 Accuracy. You must provide accurate registration information. Date of birth in particular determines eligibility, the reporting rules in Section 8.5, and which privacy protections apply to you.
6.3 Collection. Follow the Kit instructions exactly. Improper collection is the most common cause of failed sequencing. If your sample fails quality control, we will arrange one replacement Kit at no charge. Repeated failures may result in cancellation and refund under Section 16.
6.4 Return shipping. Return your sample promptly using the prepaid materials provided. Samples degrade. We may send you reminders about an unreturned Kit; you can turn these off in your account settings.
6.5 Timeline. Typical turnaround from the Laboratory's receipt of a viable sample to Report delivery is 3 to 5 weeks. This is an estimate, not a commitment.
07Your Biological Sample
7.1 Destruction after sequencing. The Laboratory destroys your biological sample after sequencing is complete and quality control has passed. Profile Health does not receive, hold, store, or bank your biological sample at any time.
7.2 No sample storage consent is sought. Because no sample is retained, we do not ask you to consent to sample storage, and no such consent is given by these Terms.
7.3 Your right to require destruction. If you wish to confirm destruction or to require destruction of a sample before sequencing, contact us at support@profilehealth.com and we will direct the Laboratory accordingly and confirm to you. Where state law requires destruction within a defined period following a request, we will meet that deadline.
08What We Analyze and What We Report
8.1 Scope. Our Analysis currently covers three categories:
(a) Polygenic risk scores (PRS) — statistical estimates of population‑level risk for selected common conditions; (b) Mendelian variants — variants in selected genes classified as pathogenic or likely pathogenic under professional guidelines; and (c) Pharmacogenomics (PGx) — variants affecting the metabolism of, or response to, selected medications.
The current gene, condition, and drug lists are published at https://www.profilehealth.com/legal/scope and may change.
8.2 We report within scope only. We do not report findings outside the defined scope of the Analysis, even where our pipeline may have generated data that could support such a finding. Whole‑genome sequencing produces information about the entire genome; we analyze and report only the defined subset.
8.3 No incidental or secondary findings. We do not conduct an open‑ended search for, and will not return, incidental or secondary findings outside the published scope. You should not treat a Profile Health analysis as a screen for anything not on our published lists, and you should not treat the absence of a finding as evidence that you do not carry a variant we did not look for.
8.4 What we cannot detect. Our Analysis has technical limits. Structural variants, repeat expansions, variants in low‑complexity or homopolymeric regions, mosaic variants, mitochondrial variants, and variants in regions of poor coverage may not be detected. A negative result is not proof of absence.
8.5 Findings withheld for Patients under 18.
This section reflects the position of the American Academy of Pediatrics, the American College of Medical Genetics and Genomics, the American Society of Human Genetics, and the American Medical Association that predictive genetic testing for adult‑onset conditions should generally be deferred until an individual can decide for themselves.
For Patients under 18, we:
(a) report pharmacogenomic findings, and Mendelian findings for conditions that are medically actionable during childhood;
(b) do not report Mendelian findings for adult‑onset conditions with no childhood intervention, and do not report polygenic risk scores for adult‑onset conditions;
(c) retain withheld findings in a sealed portion of the record, not visible to the Patient, the Parent, or the Clinician; and
(d) offer release of withheld findings when the Patient reaches the age of majority, at the Patient's own election and after the Patient has been offered genetic counseling. Nothing is released automatically.
A Parent may not override (b) or obtain early release of withheld findings.
8.6 Reanalysis. As the scientific literature develops and our scope expands, we periodically reanalyze the variant data we hold for you and update your Reports where a finding changes. We will notify you or your Clinician when a material change affects a finding previously reported to you.
This is part of the Service and requires no additional consent from you. It is a practice, not a guarantee: we do not commit to a particular schedule, we cannot promise to identify every reclassification, and reanalysis is limited to the data we retain and the scope described in Section 8.1. Reanalysis beyond that data — for example, against parts of the genome outside our published scope — may require a new sample.
09Delivery of Results
9.1 To your Clinician. Reports are delivered to the ordering Clinician, together with the quality information they need to interpret them.
By accepting these Terms you expressly authorize us, in writing, to disclose your Reports and the Genetic Data underlying them to the Clinician who ordered the Service for you, and to the practice they order through, for the purpose of your care. This authorization is what allows the analysis your Clinician ordered to be returned to them. It covers the ordering Clinician only — disclosure to anyone else is controlled by you under Section 9.5 and Section 12.3.
You may withdraw this authorization by contacting us at support@profilehealth.com. Because a Report that cannot be returned to the Clinician who ordered it serves no purpose, withdrawal before delivery will end the Service and we will refund you under Section 16; withdrawal after delivery cannot retrieve a Report already sent.
9.2 To you. Your Report is yours, and you do not need your Clinician's permission to obtain it from us.
Your Clinician receives your Report first and will normally go through it with you, because results are most useful when someone explains them. If you would also like your own copy directly from us, ask at support@profilehealth.com. We provide it at no charge, electronically or on paper as you prefer, within 10 business days of verifying who you are. You may ask at any time, including before your appointment.
Where we make a Profile Health account available to you, your Reports and explanatory material will also be accessible there.
9.3 Genetic counseling. We make genetic counseling available at no cost in connection with Reports containing Mendelian findings, and we recommend it before you review such a Report. If you request a Report of that kind directly from us, we will offer counseling first — and if you still want the Report, we will send it. We will not use counseling as a reason to withhold your own results from you. To arrange counseling, write to support@profilehealth.com.
9.4 Minors. Where the Patient is a minor:
(a) the Parent receives the Report and may request copies, as the Patient's personal representative; (b) a Patient aged 13 or older may request their own copy, and the Parent may agree to a confidential relationship between the Patient and Profile Health with respect to some or all information, which we will honor to the extent permitted by applicable law; (c) withheld findings under Section 8.5 are not provided to either; and (d) when the Patient reaches the age of majority, the Patient controls their own records and Parental access ends unless the Patient elects to continue it.
9.5 We do not withhold your own information from you. Subject only to Section 8.5, you may access, download, and export your Reports, and you may request your Sequence Data, at any time.
10Limitations, Risks, and Things You Should Consider Before Registering
Please read this section carefully. It is the most important section of this document.
10.1 Genetics is probabilistic, not predictive. Very few traits or conditions are determined by a single gene. Most are shaped by many genes together with environment, behavior, and chance. A polygenic risk score in a high percentile does not mean you will develop the condition; a low percentile does not mean you will not. A polygenic risk score is a statement about populations, not a forecast about you.
10.2 Interpretations change. A variant reported today as "likely pathogenic" may be reclassified as "uncertain" or "benign" as evidence accumulates — and the reverse. Reclassification is common, not exceptional.
10.3 You cannot un‑know what you learn. Genetic information about yourself is irreversible. You may learn something that distresses you, that changes how you see your future, or that you would have preferred not to know. You should not assume that what you learn will be welcome.
10.4 You may learn things about your family. Your genome is shared, in part, with your biological relatives. Results may reveal, or allow others to infer, information about parents, siblings, and children who did not consent to testing — including that a person is at risk for a condition, or that a biological relationship is not what was believed. Misattributed parentage is discovered in a meaningful minority of family genetic testing. We cannot prevent this, and it is not an error when it occurs.
10.5 Discrimination risk that federal law does not cover. The federal Genetic Information Nondiscrimination Act ("GINA") prohibits health insurers and most employers from using genetic information against you. GINA does not cover life insurance, disability insurance, or long‑term care insurance. It does not cover employers with fewer than 15 employees, and it does not cover the U.S. military. In most states, an insurer offering life, disability, or long‑term care coverage may lawfully ask whether you have had genetic testing and what it showed, and may decline coverage or price it accordingly. Some states — including California — extend protection further. You should consider obtaining any life, disability, or long‑term care coverage you may want before you receive genetic results, and you should understand that failing to disclose results when asked may constitute insurance fraud.
10.6 Genetic information for a child persists for a lifetime. Where the Patient is a minor, information generated now may affect insurance and other decisions decades from now. This is the principal reason we withhold adult‑onset findings under Section 8.5, and the principal reason to consider carefully whether to test a child who has no symptoms.
10.7 Sharing is irreversible. If you share your Reports or Sequence Data with anyone — a family member, an employer, an insurer, a third‑party interpretation service, or a public database — we cannot retrieve it. Information you place in your medical record may become accessible to future providers and, in some circumstances, to insurers.
10.8 Laboratory error. The Laboratory is independent of us. Sequencing errors, sample mix‑ups, and contamination are rare but possible. We have no control over the Laboratory's processes and do not warrant the accuracy of the Sequence Data it produces. Where we have reason to believe a sample was compromised, we will tell you and arrange re‑collection.
10.9 Transplants and transfusions. If you have received a bone marrow or stem cell transplant, your sample may contain donor DNA and results may be unreliable or uninterpretable. Tell your Clinician before collecting.
10.10 Emotional response. It is normal to feel anxious about genetic results. If you are feeling significant anxiety, speak with your Clinician, a genetic counselor, or a mental health professional before you collect your sample.
10.11 The Service is not a substitute for medical care. Do not delay seeking care, and do not start, stop, or change any medication or treatment, based on a Report. Speak to your Clinician first.
11Your Representations
By accepting these Terms you represent, on each occasion you use the Service, that:
(a) the information you provide is true, accurate, and complete; (b) the sample you submit is your own, or that of a minor Patient for whom you have legal authority to consent; (c) you have the legal capacity and authority to enter into these Terms; (d) you are located in the United States; (e) you are not an insurer or employer, or acting for one, seeking information about an insured, applicant, or employee; (f) you understand the Service is for research and educational purposes and is not a diagnostic test; and (g) you have read Section 10 and accept the risks described in it.
Breach of any representation entitles us to suspend or terminate your access and to decline to process or release results.
12Your Account and Security
12.1 You are responsible for maintaining the confidentiality of your credentials and for activity under your account. Notify us immediately at support@profilehealth.com of any unauthorized access.
12.2 We offer multi‑factor authentication and strongly recommend you enable it. Genetic data is a high‑value target.
12.3 You may not share your credentials. If you wish another person to have access to your Reports, tell us in writing at support@profilehealth.com. We record the grant, act on it only as you describe it, and end it as soon as you tell us to. Every grant and every disclosure made under it is logged, and we will show you that log on request.
12.4 We are not liable for loss arising from your failure to safeguard your credentials, except to the extent caused by our own failure to maintain reasonable security.
13Your Data
13.1 Our collection, use, disclosure, retention, and deletion of your information is described in the Privacy Policy, which forms part of these Terms.
13.2 What these Terms permit. Accepting these Terms permits us to use your Genetic Data, Self‑Reported Information, and account information only to:
(a) provide the Service to you — sequencing coordination, Analysis, Report generation, delivery, and support; (b) operate, secure, and troubleshoot the Service; (c) comply with law and enforce these Terms; and (d) perform quality control on our own pipeline, using your data solely to verify that the Analysis you received was performed correctly.
13.3 What these Terms do not permit. These Terms do not permit us to use your Genetic Data to:
- develop, train, validate, or improve machine‑learning or artificial‑intelligence models;
- conduct research beyond the quality control described in 13.2(d); or
- build or improve products other than the one you received.
Those uses require your separate, specific, revocable permission under the Research & Data Use Consent, which is presented on a screen of its own after you accept these Terms and which asks for all of them together as one optional election. You may decline it and receive the full Service at the same price. It is not offered at all for Patients under 18, or to Maryland residents.
13.4 What nothing permits. We do not transfer, license, or otherwise disclose your Genetic Data or the data derived from it — in identified or de‑identified form — to any third party for that party's own use. That includes research partners, universities, pharmaceutical and biotechnology companies, and data brokers. This is not a permission we ask for and not one you can grant; we have chosen not to operate a data‑licensing business. The only outside parties who handle your Genetic Data are the Laboratory that produces it and the infrastructure vendors that store it, in each case under contract, solely for us, and with no right to any use of their own.
13.5 Retention. We retain your Genetic Data and Reports for as long as your account remains open, so that you can access your results and so that we can reanalyze on your request. On deletion request, we delete in accordance with the Privacy Policy. We do not retain data indefinitely without a stated basis, and specific retention limits apply to Patients who were minors when tested — see the Privacy Policy.
13.6 Law enforcement. Our policy is to require valid legal process, to resist requests we consider overbroad, and to notify you unless prohibited. The full policy, including our transparency reporting, is in the Privacy Policy.
14Intellectual Property and Rights in Discoveries
14.1 Our property. The Service, our pipelines, models, report formats, interpretive content, and software are owned by Profile Health and protected by intellectual property law. Nothing in these Terms transfers any of it to you.
14.2 Your data remains yours. We claim no ownership of your Genetic Data or Self‑Reported Information. Where a state statute recognizes a property right in your genetic material or data, these Terms do not waive it.
14.3 Limited licence to serve you. You grant us a non‑exclusive, worldwide, royalty‑free licence to process your Genetic Data and Self‑Reported Information solely as necessary to provide the Service under Section 13.2, and, if and only to the extent you give it, as permitted by the Research & Data Use Consent. This licence ends when the underlying permission ends.
14.4 No rights in discoveries. If we develop any product, model, method, or discovery in the course of activities you have permitted, you acquire no ownership interest in it and no right to compensation from it. We state this plainly because it is a real consequence, not a formality: research and product development that your data contributes to may generate commercial value in which you do not share. If you are not comfortable with that, decline the Research & Data Use Consent.
14.5 Feedback. Suggestions you send us may be used without restriction or compensation.
15Acceptable Use
You may not:
(a) submit a sample that is not yours or your minor child's, or submit a sample without the subject's authorization; (b) use the Service to obtain genetic information about another person without their consent; (c) attempt to re‑identify any de‑identified data, or to access data belonging to another person; (d) reverse engineer, scrape, or attempt to extract our models, pipelines, or interpretive content; (e) resell, sublicense, or commercially redistribute the Service or Reports; (f) upload malicious code or attempt to disrupt the Service; (g) misrepresent Reports as diagnostic, clinically validated, or FDA‑authorized; or (h) use the Service for any unlawful purpose, including employment or insurance screening.
16Fees, Payment, and Refunds
16.1 Who pays. Depending on your Clinician's arrangement, the Service may be paid for by your Clinician, by you directly, or by a combination. The applicable price and payer are disclosed to you before registration.
16.2 No insurance billing. We do not bill health insurance for the Service. Because the Service is not a diagnostic test, it is generally not reimbursable, and you should not assume that it is.
16.3 Refunds. Before your sample is received by the Laboratory, you may cancel for a full refund. After sequencing has begun, fees are non‑refundable except:
(a) where sequencing fails for reasons not attributable to your sample collection and we cannot provide a replacement; (b) where we discontinue the Service before delivering your Reports; or (c) where required by law.
16.4 Laboratory error. Where the Laboratory produces invalid or unusable data, we will arrange re‑collection and re‑sequencing at no additional charge, or refund you if that is not possible.
17Term, Suspension, Termination, and Deletion
17.1 These Terms apply from acceptance until your account is closed.
17.2 Your right to close. You may close your account and request deletion at any time by writing to support@profilehealth.com. Deletion is handled under the Privacy Policy. Closing your account also revokes any Research & Data Use Consent going forward.
17.3 Our right to suspend or terminate. We may suspend or terminate your access where you materially breach these Terms, where we are required to by law, or where we reasonably believe continued access presents a security or safety risk. Except where immediate action is necessary, we will give you notice and an opportunity to cure.
17.4 Before we discontinue. If we discontinue the Service entirely, we will give you at least 90 days' notice and a means to export your Reports and Sequence Data before access ends.
17.5 Survival. Sections 10, 11, 13, 14, 18, 19, 20, 21, and 23 survive termination.
18Disclaimer of Warranties
18.1 To the fullest extent permitted by law, the Service is provided "as is" and "as available." We disclaim all warranties, express or implied, including merchantability, fitness for a particular purpose, and non‑infringement.
18.2 Without limiting the foregoing, we do not warrant that the Service will be uninterrupted or error‑free; that Reports will be accurate, complete, or current; that interpretations will not be revised; that the Analysis will detect any particular variant; or that the Service will meet your expectations.
18.3 We are not responsible for the acts or omissions of the Laboratory or of your Clinician.
18.4 Some states do not allow the exclusion of implied warranties. Where that is so, the exclusions above apply to the maximum extent permitted, and you may have additional rights.
19Limitation of Liability
19.1 To the fullest extent permitted by law, neither Profile Health nor its officers, directors, employees, or suppliers will be liable for indirect, incidental, special, consequential, exemplary, or punitive damages, or for lost profits, lost data, or loss of goodwill, arising out of or relating to the Service, whether based in contract, tort, strict liability, or otherwise, even if advised of the possibility.
19.2 To the fullest extent permitted by law, our aggregate liability arising out of or relating to the Service will not exceed the greater of (a) the amounts paid by or for you for the Service in the twelve months preceding the claim, or (b) US$500.
19.3 What this does not limit. Nothing in this Section limits liability that cannot be limited under applicable law, including liability for fraud, for willful misconduct, or for gross negligence, or any statutory remedy provided by a genetic privacy or consumer protection statute that expressly cannot be waived.
19.4 Some jurisdictions do not allow certain limitations. Where that is so, the limitations apply to the maximum extent permitted.
20Indemnification
You will indemnify and hold harmless Profile Health and its officers, directors, employees, and agents from claims, damages, losses, and reasonable costs (including attorneys' fees) arising out of:
(a) your breach of these Terms; (b) your submission of a sample that is not yours or a minor Patient's for whom you have authority; (c) your sharing of Reports or Genetic Data with any third party; or (d) your violation of any law or of the rights of any third party.
This does not apply to the extent the claim arises from our own negligence or willful misconduct. We will notify you of any claim and you may control the defense with counsel reasonably acceptable to us; no settlement that imposes obligations on us may be made without our consent.
21Dispute Resolution — Please Read, It Affects Your Legal Rights
21.1 Informal resolution first. Before starting a formal proceeding, you and we agree to try to resolve the dispute informally. Send a written notice describing the dispute and the relief sought to Legal Notices, Profile Health, Inc., 434 Sausalito Blvd, Sausalito, CA 94965; we will do the same to your account address. Either party may request a telephone conference. If the dispute is not resolved within 60 days, either party may proceed. This step is a condition precedent, and the limitations period is tolled during it.
21.2 Binding arbitration. Except as provided in 21.4 and 21.6, any dispute arising out of or relating to these Terms or the Service will be resolved by binding individual arbitration administered by the American Arbitration Association (AAA) under its consumer arbitration rules, before a single arbitrator, in the county where you reside or by videoconference at your election. The Federal Arbitration Act governs. You and we are giving up the right to a trial by jury.
21.3 Class action waiver. Arbitration will be conducted on an individual basis only. You and we waive the right to bring or participate in a class, collective, consolidated, or representative action. If this waiver is found unenforceable as to a particular claim, that claim must proceed in court and is severed from arbitration; the remainder of this Section continues to apply.
21.4 Your right to opt out. You may opt out of Sections 21.2 and 21.3 by sending written notice within 30 days of first accepting these Terms to support@profilehealth.com, stating your name, the email on your account, and that you opt out of arbitration. Opting out costs you nothing and has no effect on any other part of these Terms or on your access to the Service. If you opt out, disputes proceed in court under Section 21.7.
21.5 Costs. We will pay all arbitration filing and administrative fees exceeding what you would have paid to file in court. Each party bears its own attorneys' fees unless the arbitrator awards them under applicable law.
21.6 Exceptions. Either party may bring an individual action in small claims court, and either party may seek injunctive or equitable relief in court to protect intellectual property or to prevent unauthorized access to data. Nothing here prevents you from reporting a matter to a government agency or from participating in a government enforcement action.
21.7 Court proceedings. Where a dispute proceeds in court, the state and federal courts located in Marin County, California will have exclusive jurisdiction, and you and we consent to personal jurisdiction there — except that you may bring a claim in the courts of your own state of residence where required by that state's law.
21.8 Mass arbitration. Where 25 or more substantially similar demands are filed by or with the assistance of the same counsel within a 90‑day period, they will be batched in groups of no more than 50, a single arbitrator will decide each batch, and the parties will confer in good faith to select bellwether cases. The limitations period is tolled for all demands in the queue.
21.9 Time to file. Any claim must be brought within one year after it accrues, or within the period the applicable statute of limitations provides if that period cannot lawfully be shortened.
22Changes to These Terms
22.1 Notice. We may update these Terms. We will post the updated version with a new effective date and, for material changes, notify you by email at least 30 days before they take effect.
22.2 Your choice. Continued use after the effective date constitutes acceptance. If you do not accept, you may close your account and request deletion, and we will refund any prepaid amounts for Services not yet delivered.
22.3 We will not expand data use retroactively. This is a commitment, not boilerplate. We will not apply broadened data‑use, research, retention, sharing, licensing, or model‑training terms to data collected under narrower prior terms. If we want to do something with your data that your existing permissions do not cover, we will ask you for a new, specific permission. If you do not give it, your data continues to be governed by the terms in force when you gave it.
22.4 Version history. We maintain and publish a dated archive of prior versions of these Terms, the Privacy Policy, and the Research & Data Use Consent at https://www.profilehealth.com/legal/archive, so you can always see the terms that applied to you when you enrolled.
23General
23.1 Entire agreement. These Terms, the Privacy Policy, and the Notice of Privacy Practices are the entire agreement between you and us about the Service, and supersede prior understandings. The Research & Data Use Consent is a separate agreement.
23.2 Severability. If a provision is unenforceable, it is modified to the minimum extent necessary or severed, and the rest remains in effect.
23.3 No waiver. Our failure to enforce a provision is not a waiver.
23.4 Assignment. You may not assign these Terms. We may assign them in connection with a merger, acquisition, reorganization, or sale of assets — subject to the commitments in the Privacy Policy governing what happens to your Genetic Data in such a transaction, which are binding on us and on any successor.
23.5 Force majeure. Neither party is liable for delay or failure caused by events beyond its reasonable control.
23.6 Governing law. California law governs, without regard to conflict‑of‑laws principles, except where the law of your state of residence provides rights that cannot be waived.
23.7 Notices. We will send notices to the email on your account; you are responsible for keeping it current. Send notices to us at Legal Notices, Profile Health, Inc., 434 Sausalito Blvd, Sausalito, CA 94965.
23.8 Relationship. Nothing creates a partnership, joint venture, employment, or agency relationship.
23.9 Third‑party beneficiaries. There are none, except that the Laboratory and your Clinician are intended beneficiaries of Sections 18, 19, and 20 to the extent those sections limit their exposure through us.
23.10 Contact. Profile Health, Inc. 434 Sausalito Blvd, Sausalito, CA 94965 General: support@profilehealth.com Privacy: support@profilehealth.com Legal: support@profilehealth.com