Last updated: October 2025
These Terms (“Terms”) apply when a Supplier or Developer (“you”, “your”) requests ORCHA Health Limited (“ORCHA”, “we”, “our”, “us”) to undertake an assessment of your digital health product under the ORCHA Baseline Review (OBR). By submitting a request or commissioning an OBR assessment, you agree to these Terms.
1.1 Capitalised terms have the meanings given in the ORCHA Standard Definitions Schedule (as updated from time to time and available at https://orchahealth.com/legal/definitions).
1.2 These Terms govern the process by which ORCHA carries out an OBR assessment and provides an OBR Compliance Report for your product.
2.1 ORCHA will undertake an independent assessment of your product using the ORCHA Baseline Review (OBR) Framework.
2.2 The assessment will result in an OBR Compliance Report summarising the findings of that assessment.
2.3 The OBR Compliance Report provides transparency and factual information only and does not constitute medical, clinical, legal, or regulatory advice.
3.1 Each OBR assessment is conducted using the ORCHA Baseline Review (OBR) Framework.
3.2 Assessments are based on:
- publicly available information at the time of review; and
- documentation provided directly by you (the Supplier or Developer).
3.3 ORCHA distinguishes between:
- ORCHA Validated Evidence – information independently verified by ORCHA; and
- Developer Trusted Evidence – information supplied by you that could not be independently verified but was accepted in good faith.
3.4 The resulting OBR Compliance Report presents factual outcomes from the assessment. It does not constitute a certification, endorsement, or guarantee that the product meets regulatory, clinical, or safety requirements.
3.5 Each OBR Compliance Report represents a point-in-time evaluation. Information may change after the Assessment Date.
3.6 Where the report shows “No”, “Impaired”, or “Area for Improvement”, this indicates only that no supporting evidence was found within the sources reviewed. It does not mean that the evidence does not exist or that the product fails to meet the criteria.
3.7 The OBR Compliance Report is provided for information purposes only and is intended to support — not replace — your own technical, clinical, or regulatory due diligence.
4.1 You must provide ORCHA with all necessary access, information, and documentation required to complete the OBR assessment, including but not limited to:
- access to the live version of the product (via app, web portal, or test account);
- copies of privacy policies, data-security statements, and clinical or regulatory documentation; and
- a named contact person to respond to queries.
4.2 ORCHA will use reasonable endeavours to complete the assessment in a timely manner once adequate access and information have been provided.
4.3 If you fail to provide sufficient access, documentation, or cooperation, ORCHA may suspend or cancel the assessment. In such circumstances, no refund will be due.
ORCHA processes personal data provided in connection with an OBR assessment request solely to manage, perform, and communicate regarding the assessment and to deliver the resulting Compliance Report. No personal data will be shared beyond this purpose unless required by law.
5.1 The OBR assessment fee will be confirmed at the time of request.
5.2 Payment is due in full at the point of order unless otherwise agreed in writing.
5.3 If ORCHA cannot complete the OBR assessment due to factors outside your control (for example, a technical fault on ORCHA’s systems), a full refund will be provided.
6.1 ORCHA will keep you informed of key stages, including:
- confirmation of receipt and scheduling of the OBR;
- requests for further information; and
- completion and delivery of the OBR Compliance Report.
6.2 You must respond promptly to requests for clarification or documentation to avoid delays.
7.1 Upon completion, ORCHA will provide the OBR Compliance Report.
7.2 The meaning and limitations of the Report are as set out in Clause 3.
7.3 ORCHA retains ownership of all Intellectual Property Rights in the OBR and its outputs. You are granted a non-exclusive right to use the Report for your own internal and marketing purposes, provided that any external reference to the report is factual and not misleading.
8.1 You may cancel the OBR request before work commences and receive a full refund.
8.2 Once work has commenced, refunds will be discretionary, depending on the amount of work completed.
8.3 If ORCHA cancels the assessment due to technical or scheduling reasons, you will receive a full refund.
8.4 No refund will be issued where cancellation results from your failure to provide access, documentation, or responses.
9.1 ORCHA shall not be liable for any delay or failure caused by your failure to provide information or access.
9.2 To the fullest extent permitted by law, ORCHA’s total aggregate liability in connection with any requested OBR assessment shall be limited to the fee paid for that assessment.
9.3 ORCHA shall not be liable for any indirect, consequential, or reputational losses arising from or in connection with the OBR assessment or OBR Compliance Report.
10.1 ORCHA will process any personal data provided in accordance with its Privacy Policy (https://orchahealth.com/privacy-policy ).
10.2 ORCHA may share information from the OBR Compliance Report with relevant ORCHA platforms such as Verify or Compare for transparency purposes.
These Terms and any dispute arising from them shall be governed by and construed in accordance with the laws of England and Wales, and the courts of England and Wales shall have exclusive jurisdiction.