F

Terms of Service

These Terms of Service govern your use of the website located at https://focalmd.ai and any related products, software, features, APIs, and services provided by Human Unsupervised Pty Ltd trading as Focal ("Focal", "we", "us", or "our").

By accessing https://focalmd.ai, you agree to abide by these Terms of Service and to comply with all applicable laws, regulations, professional obligations, and institutional policies. If you do not agree with these Terms of Service, you must not use this website or any related services provided by Focal.

We may review and amend these Terms of Service at our sole discretion. Upon doing so, we will update this page. Any changes to these Terms of Service will take effect immediately from the date of publication unless stated otherwise.

These Terms of Service were last updated in March 2026.

Limitations of Use

By using this website or any related services, you warrant on behalf of yourself, your users, and any parties you represent that you will not:

  • modify, copy, prepare derivative works of, decompile, or reverse engineer any materials and software contained on this website except as permitted by applicable law;
  • remove any copyright or other proprietary notations from any materials and software on this website;
  • transfer the materials to another person or mirror the materials on any other server;
  • knowingly or negligently use this website or any of its associated services in a way that abuses, disrupts, or creates risk for our systems, users, vendors, or networks;
  • use this website or its associated services to transmit or publish any harassing, indecent, obscene, fraudulent, deceptive, unsafe, or unlawful material;
  • use this website or its associated services in violation of any applicable laws, regulations, professional standards, or institutional rules;
  • use this website in conjunction with sending unauthorized advertising or spam;
  • harvest, collect, or gather user data without the user's consent;
  • upload, submit, store, process, or otherwise disclose personally identifiable information, patient-identifiable information, protected health information, or other regulated health data unless we have expressly agreed in writing to support that use; or
  • use this website or its associated services in any way that may infringe the privacy, confidentiality, intellectual property rights, or other rights of third parties.

Clinical Use and Professional Responsibility

Focal is intended to support qualified healthcare professionals with research, evidence synthesis, drafting, and clinical workflow support. Focal is not a diagnostic tool, not a medical practitioner, not a substitute for professional medical judgment, and not a substitute for a clinician's review of the underlying evidence, patient context, and applicable standards of care.

You acknowledge and agree that:

  • outputs may be incomplete, inaccurate, outdated, inconsistent, or not tailored to a specific patient;
  • Focal does not independently verify every statement, citation, dosage, contraindication, or recommendation returned by the service;
  • you must independently assess all outputs, review source material, confirm patient-specific factors, and exercise your own professional judgment before relying on or acting on any output; and
  • all diagnosis, prescribing, treatment, triage, discharge, escalation, referral, recordkeeping, and other patient-care decisions remain solely the responsibility of the treating clinician or healthcare organization.

Focal must not be used as the sole or primary basis for emergency response, diagnosis, treatment selection, prescribing, or any high-risk clinical decision where human review is required or where an error, delay, or outage could reasonably result in death, personal injury, or material harm.

Regulatory Status and Regional Use

The regulatory treatment of software used in clinical settings varies by jurisdiction, intended use, deployment context, users, claims, and level of human oversight. Depending on how you use the service, requirements administered by regulators and frameworks such as Australia's TGA requirements, New Zealand's Medsafe and health-information privacy rules, Health Canada and applicable federal or provincial health-information rules, the European Union's Medical Device Regulation, In Vitro Diagnostic Regulation, and AI Act, the United Kingdom's MHRA framework, the U.S. Food and Drug Administration, privacy regulators, and professional licensing bodies may apply.

Unless we expressly state otherwise in writing, Focal does not represent or warrant that the service is cleared, approved, certified, registered, or otherwise authorized as a medical device, diagnostic device, software as a medical device, or regulated clinical decision support product in any jurisdiction. You are solely responsible for determining whether and how the service may lawfully be used in your jurisdiction, institution, specialty, and workflow.

You must not use the service in a manner that would cause Focal to become subject to regulatory, security, healthcare, reimbursement, or recordkeeping obligations that we have not expressly accepted in writing.

Sensitive Data and Privacy

Unless we expressly agree otherwise in writing, the service is not designed or intended to receive, store, process, or otherwise use personally identifiable information, patient-identifiable information, protected health information, or other sensitive regulated health data. Focal does not represent that it is compliant with HIPAA or any equivalent healthcare-specific data-handling regime, and no business associate or similar healthcare-specific regulated relationship is created unless separately documented in a written agreement signed by Focal.

If you submit any personal data, health data, or sensitive information to the service, you represent and warrant that you have a valid legal basis and all necessary rights, notices, and consents to do so, that the information is limited to what is necessary, and that it has been de-identified or minimized where reasonably possible. If you submit personally identifiable information, patient-identifiable information, protected health information, or other regulated data without our express written approval, you do so entirely at your own risk. You remain solely responsible for compliance with all applicable privacy, confidentiality, health-data, security, retention, and recordkeeping laws and obligations, and we may remove or restrict access to that information at any time.

Intellectual Property

The intellectual property in the materials contained on this website is owned by or licensed to Focal and is protected by applicable copyright, trademark, and other intellectual property laws. We grant users a limited, revocable, non-exclusive, non-transferable license to access and use the website and materials for their internal, lawful use in accordance with these Terms of Service.

This license does not transfer title and automatically terminates if you violate these Terms of Service. We may terminate this license at any time.

User-Generated Content

You retain your ownership rights in content you submit to us. We do not claim ownership of your content. However, you grant us a non-exclusive, royalty-free, transferable, sub-licensable, worldwide license to host, store, reproduce, modify, process, transmit, and otherwise use your content solely as reasonably necessary to operate, secure, improve, support, and provide the service, in a manner consistent with your privacy settings and our Privacy Policy.

You represent and warrant that you have all rights necessary to submit such content and to grant the license above, and that your content does not violate any law, duty of confidentiality, privacy obligation, or third-party right.

Liability

Our website and services are provided on an "as is" and "as available" basis. To the fullest extent permitted by law, Focal disclaims all warranties, express or implied, including without limitation warranties of merchantability, fitness for a particular purpose, title, non-infringement, uninterrupted availability, security, accuracy, and results.

To the fullest extent permitted by law, Focal and its suppliers will not be liable for any indirect, incidental, special, exemplary, punitive, or consequential loss or damage suffered by you or any third party arising from or related to the use of, inability to use, or reliance on this website or the services, including any patient harm, clinical error, misdiagnosis, treatment delay, prescribing error, malpractice claim, regulatory action, reimbursement denial, business interruption, loss of revenue, loss of profit, loss of goodwill, loss of opportunity, or loss or corruption of data.

To the fullest extent permitted by law, Focal's aggregate liability arising out of or relating to the website or services will not exceed the greater of the fees you paid us for the relevant service during the 12 months preceding the event giving rise to the claim or USD $100 (or the equivalent amount in local currency where required by applicable law).

Nothing in these Terms of Service excludes, restricts, or modifies any guarantee, right, or remedy that cannot lawfully be excluded or limited.

Indemnity

You agree to indemnify, defend, and hold harmless Focal, its officers, directors, employees, contractors, affiliates, and suppliers from and against any claims, liabilities, damages, losses, costs, and expenses, including reasonable legal fees, arising out of or relating to:

  • your use of the website or services;
  • your content or data;
  • your breach of these Terms of Service;
  • your violation of any law, regulation, professional obligation, or third-party right; or
  • any diagnosis, treatment, prescribing, triage, documentation, billing, or other clinical or operational decision made in reliance on the services or your use of them.

Accuracy of Materials

The materials appearing on our website or in our services are not comprehensive and are provided for general information purposes only. They may include model-generated content, summaries, or references that are incomplete or inaccurate. Focal does not warrant or make any representation concerning the accuracy, likely results, or reliability of the use of the materials on this website or otherwise relating to such materials or any linked resources.

Links

Focal has not reviewed all of the sites linked to its website and is not responsible for the contents of any linked site. The inclusion of any link does not imply endorsement, approval, or control by Focal. Use of any linked site is at your own risk and we strongly recommend that you make your own investigations regarding the suitability, reliability, and legal status of those sites.

Prices

All prices listed on our website and application are in the currency identified at checkout, in the relevant order form, or otherwise explicitly stated. Where no other currency is identified, prices are in U.S. dollars.

Right to Terminate

We may suspend, restrict, or terminate your right to use our website or services immediately if we reasonably believe you have breached these Terms of Service, created legal or safety risk, or used the service in a manner that could expose us or others to harm.

Severance

Any term of these Terms of Service which is wholly or partially void or unenforceable is severed to the extent it is void or unenforceable. The validity and enforceability of the remainder of these Terms of Service is not affected.

Governing Law

These Terms of Service are governed by and construed in accordance with the laws of Australia. You irrevocably submit to the exclusive jurisdiction of the courts of Australia and any courts competent to hear appeals from those courts.