Last updated: October 2025
This Agreement is made between ORCHA Health Limited (“ORCHA”, “we”, “our”, “us”) and the Supplier (“Supplier”, “you”, “your”) for participation in the ORCHA Assured Scheme (the “Scheme”). By subscribing to the Scheme, you agree to the following terms and conditions.
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 In this Agreement:
- Assurance Threshold means the minimum overall compliance score (currently 65%) required under the OBR for Bronze status or equivalent under DTAC/OBR+ for Silver.
- Product means any digital health product submitted by the Supplier under this Agreement.
- Subscription Term means the 12-month period during which the Product holds ORCHA Assured status.
2.1 Under this Agreement, the Supplier subscribes to the ORCHA Assured Scheme for the purpose of obtaining and maintaining ORCHA Assured status for its Product(s).
2.2 The Subscription includes:
(a) an initial ORCHA Baseline Review (OBR) or equivalent assessment of each Product submitted under this Agreement;
(b) eligibility for ORCHA Assured Bronze or Silver status, subject to the Product meeting the applicable Assurance Threshold;
(c) inclusion of the Product within ORCHA’s Verify and Compare platforms, with preferential display and ranking consistent with its Assured status;
(d) a single Compare subscription licence for the Supplier, governed by the Compare Terms of Use; and
(e) access to the Product’s OBR Compliance Report, governed by the Verify Compliance Report Terms of Sale and Use.
2.3 The Scheme subscription also entitles the Supplier to use the ORCHA Assured mark in accordance with ORCHA’s brand and usage guidelines.
2.4 Where any inconsistency arises between this Agreement and the Compare Terms of Use or Verify Compliance Report Terms, this Agreement shall take precedence in respect of the ORCHA Assured Scheme.
3.1 The Scheme provides recognition of digital health Products that have achieved the relevant Assurance Threshold through an independent ORCHA assessment.
3.2 ORCHA will carry out assessments using the ORCHA Baseline Review (OBR) or enhanced frameworks (e.g., OBR+ or DTAC) as applicable to the selected tier.
3.3 ORCHA shall maintain the integrity of the Scheme, ensure consistent application of standards, and notify Suppliers of any material changes to the applicable frameworks or scoring methodologies.
4.1 ORCHA will perform an OBR assessment of each Product submitted under this Agreement in accordance with the relevant ORCHA Assurance Framework current at the time of assessment.
4.2 A Product achieving an overall compliance score of 65% or above under the OBR shall be eligible for ORCHA Assured Bronze status. Products meeting an enhanced assurance standard such as DTAC or OBR+ may be designated ORCHA Assured Silver.
4.3 Where a Product scores below 65%, ORCHA will provide the OBR Compliance Report identifying areas for improvement. The Supplier may address those areas and request reassessment once updates have been made.
4.4 The Supplier may resubmit evidence or updated versions of the Product for reassessment at any time during the Subscription Term. No additional fee will apply for any reassessment or resubmission undertaken during an active Subscription Term.
4.5 The Supplier must notify ORCHA promptly of any substantive change to a Product that could affect its compliance, including but not limited to changes to functionality, data flows, privacy policy, ownership, regulatory classification, or clinical claims.
4.6 ORCHA may initiate a reassessment whenever it reasonably believes a substantive change has occurred, or as part of its standard monitoring processes.
4.7 If the reassessment indicates that the Product no longer meets the relevant Assurance Threshold, ORCHA may:
(a) provide the Supplier with notice and a remediation period to resubmit evidence; or
(b) suspend or withdraw the Product’s ORCHA Assured status until compliance is restored.
4.8 Where ORCHA cannot complete an assessment or reassessment due to lack of cooperation or information from the Supplier, ORCHA may suspend the assessment and any applicable visibility or assurance status until requirements are met.
5.1 The Supplier shall:
(a) provide ORCHA with accurate, complete, and current information for each Product;
(b) maintain access credentials or demo versions required for reassessment;
(c) promptly notify ORCHA of any material changes as described in Clause 4.5; and
(d) ensure all submitted materials comply with applicable data protection, clinical safety, and regulatory requirements.
5.2 The Supplier warrants that it holds all necessary rights to provide ORCHA with the materials, documentation, and Product access required to conduct assessments.
5.3 The Supplier shall indemnify ORCHA against any loss, liability, or claim arising from inaccurate, misleading, or incomplete information provided to ORCHA.
6.1 ORCHA will conduct assessments and reassessments with reasonable skill and care, in accordance with its published methodologies.
6.2 ORCHA will maintain up-to-date frameworks and publish significant changes to scoring or criteria that may impact Suppliers.
6.3 ORCHA will notify the Supplier of any adverse findings, suspension, or withdrawal of Assured status, providing reasons and an opportunity to remedy where feasible.
7.1 The Subscription fee covers all assessments, reassessments, resubmissions, and ongoing monitoring conducted during the Subscription Term.
7.2 No separate charge will be made for reassessments required as a result of updates, substantive changes, or routine reviews under Clause 4.
7.3 ORCHA reserves the right to decline or defer excessive or incomplete resubmissions that would materially disrupt the Scheme’s operation or assessment queue.
7.4 Fees are payable in advance and are non-refundable except as required by law.
8.1 The Subscription Term shall run for 12 months from the date of award of ORCHA Assured status.
8.2 ORCHA will invite renewal prior to expiry. Renewal requires continued adherence to these Terms and payment of the then-current subscription fee.
8.3 Upon renewal, ORCHA may perform a light-touch review or full reassessment, depending on the Product’s assurance tier and change history.
8.4 If the Supplier does not renew, the Product’s ORCHA Assured status and right to use the ORCHA Assured mark will lapse automatically.
9.1 ORCHA Assured Products are displayed and ranked with preferential visibility in Verify and Compare.
9.2 The Supplier may use the ORCHA Assured mark and badge in accordance with the ORCHA Assured Brand and Usage Guidelines provided by ORCHA.
9.3 The ORCHA Assured badge may only be displayed in relation to the specific Product that currently holds an active Subscription and continues to meet the applicable OBR minimum standards for its Assured tier.
9.4 The Supplier shall not modify, distort, or combine the badge with any other logo or mark, and shall not use it in a manner that may mislead or imply assurance of any unassessed products.
9.5 The licence to use the badge and mark is non-exclusive, non-transferable, and revocable at ORCHA’s discretion.
9.6 Upon expiry, suspension, or withdrawal of Assured status, or lapse of the Subscription, the Supplier must immediately cease use of the badge and mark and remove any reference to ORCHA Assured status.
9.7 Misuse of the ORCHA Assured badge shall constitute a material breach of this Agreement.
10.1 ORCHA warrants that it will perform its obligations under this Agreement with reasonable skill and care.
10.2 The Supplier warrants that all information provided to ORCHA is accurate, complete, and not misleading.
10.3 The Supplier shall indemnify ORCHA against any third-party claim arising from the content, operation, or performance of the Product or from any breach of Supplier warranties.
10.4 ORCHA’s total aggregate liability under this Agreement shall not exceed the total fees paid by the Supplier in the preceding 12 months.
10.5 ORCHA shall not be liable for indirect, consequential, or reputational losses.
11.1 ORCHA retains ownership of all intellectual property rights in its frameworks, assessment methodologies, and reports.
11.2 The Supplier retains ownership of all intellectual property rights in its Product.
11.3 The Supplier grants ORCHA a non-exclusive licence to use Product information, branding, and related materials for assessment, publication, and assurance purposes, including display within Verify and Compare.
12.1 Each party shall comply with applicable data protection legislation.
12.2 ORCHA may share Product data and assessment results with Verify, Compare, and other ORCHA systems as part of the Scheme’s operation.
12.3 ORCHA shall process any personal data in accordance with its Privacy Policy (https://orchahealth.com/privacy-policy).
13.1 ORCHA may suspend or withdraw ORCHA Assured status if:
(a) the Product fails to maintain the Assurance Threshold following reassessment;
(b) the Supplier fails to provide required information or access; or
(c) the Supplier breaches any material obligation under this Agreement.
13.2 Upon termination or expiry, the Supplier’s right to use the ORCHA Assured mark ceases immediately.
13.3 Renewal may be offered subject to then-current Scheme criteria and pricing.
This Agreement and any dispute arising from it 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.
15.1 The Supplier shall maintain in full force and effect, with a reputable insurer, appropriate insurance policies for the duration of this Agreement and for a period of not less than six (6) years thereafter, including:
(a) Professional Indemnity Insurance, with a limit of not less than £1,000,000 per claim;
(b) Public and Product Liability Insurance, with a limit of not less than £2,000,000 per occurrence; and
(c) Cyber Liability or Data Protection Insurance, where applicable to the nature of the Product.
15.2 The Supplier shall provide ORCHA with evidence of such insurance upon request.
15.3 Maintenance of insurance does not relieve the Supplier of any of its obligations or liabilities under this Agreement.
16.1 Each party shall keep confidential and not disclose any information obtained in connection with this Agreement that is not publicly available, except:
(a) as required by law or by a competent authority;
(b) to its professional advisers bound by equivalent confidentiality obligations; or
(c) as expressly permitted under this Agreement.
16.2 The Supplier acknowledges that, as part of the ORCHA Assured Scheme, ORCHA collects and processes Supplier Information, including Product documentation, images, and descriptions, and that certain elements of this information are used to create Disclosable Information for display within ORCHA’s Verify and Compare platforms.
16.3 The Supplier grants ORCHA a worldwide, royalty-free, non-exclusive licence to use, reproduce, and publish such Disclosable Information for the purposes of:
(a) maintaining and promoting the Product’s listing within ORCHA platforms;
(b) augmenting public listings with enhanced Supplier or Product data; and
(c) demonstrating ORCHA’s assurance and compliance activities to health systems, regulators, and users.
16.4 ORCHA shall not disclose any Confidential Information marked or identified by the Supplier as “Commercially Sensitive” or otherwise designated within the Product Information Form as not for public release.
16.5 ORCHA shall take reasonable care to segregate and protect any such Confidential Information from unauthorised access, disclosure, or use.
16.6 The obligations in this Clause 16 shall survive termination or expiry of this Agreement for a period of five (5) years.
17.1 Neither party shall be liable for any delay or failure in performance of its obligations under this Agreement caused by events or circumstances beyond its reasonable control, including but not limited to acts of God, flood, fire, pandemic, industrial action, war, governmental restrictions, or interruption of utility services, provided that it promptly notifies the other party and uses reasonable endeavours to mitigate the impact.
17.2 If such circumstances continue for a period of more than sixty (60) days, either party may terminate this Agreement by written notice without further liability.
18.1 Any notice under this Agreement shall be in writing and may be delivered by hand or sent by email to the contact details provided by the parties.
18.2 Notices sent by email shall be deemed received at the time of transmission unless sent outside normal business hours, in which case receipt shall be deemed to occur at 9:00 a.m. on the next business day.
18.3 Each party shall keep its contact information current and notify the other of any changes.
19.1 This Agreement constitutes the entire agreement between the parties and supersedes any prior agreements, representations, or understandings relating to its subject matter.
19.2 If any provision of this Agreement is held invalid or unenforceable, that provision shall be deemed modified to the minimum extent necessary to make it valid and enforceable, and the remaining provisions shall remain in full force and effect.
19.3 Nothing in this Agreement limits or excludes liability for fraud or fraudulent misrepresentation.
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