1. Subscription Services
Subject to the provisions in this Contract and the Client Dependencies listed in Section 4, We will provide the services (“Services”) detailed below for the Term:
1.1. Initial Baseline Review
Upon application we will undertake an ORCHA Baseline Review (“Baseline Review”) of Your Product/s. You will provide all relevant access information, credentials and/or such other product information (“Access Information”) as are require to enable the completion of the assessment as part of the application. We will complete the initial Baseline Review within 10 working days of receipt of application or the provision of the Access Information, which ever is later. The detailed assessment specification for the Baseline Review is available on request here
Upon completion of the Baseline Review You will receive an automated notification that provides You with access to Your Account. Your Account provides You with access to a detailed improvement report (“Improvement Report”) that provides You with the full results of the Baseline Review.
You will be able to request a follow on 1 hour Assessor Consultation following the initial Baseline Review to discuss the findings and to explore the potential compliance implications further. We will schedule this Consultation within 10 working days of this request (subject to Your availability). This will also enable the Assessor to provide guidance on any areas that could be improved and they will provide signposting to relevant support in the Academy, Resource centre and if applicable ORCHA Connect partners. The Assessor Consultation will also provide You with a view of other assessment frameworks that could be potentially relevant for Your Product in the short or medium term. The Baseline Review is the gateway or baseline standard for a wide and growing range of national and pan national assessment frameworks. You can see which other frameworks or ‘Schemes’ are underpinned by the Baseline Review here.
1.2. Achieving a score of 65% or more
The minimum Baseline Review score is generally set at 65%. This is the minimum threshold for inclusion in any ORCHA Microsite. An ORCHA Microsite means any patient/citizen facing libraries, professional facing formularies or payer/provider orientated compliance portals. These are the primary outward manifestation of the Baseline Review and other relevant digital health assessment Schemes that ORCHA support.
If Your Product achieves a Baseline Review score of 65% or above, it will automatically be capable of being listed on any relevant ORCHA Microsite. Each Microsite’s product inclusion criteria is ultimately controlled by the relevant Microsite owner that ORCHA supports.
Achieving 65% entitles You to an ORCHA Approved Badge and Certificate which You can access via Your Account. The Badge will automatically appear on any listing of Your Product on an ORCHA Microsite that has enabled this feature. Subject the provisions of this agreement You will have a licence to use the ORCHA Approved Badge for the term of the agreement.
1.3. Re-Assessments
If Your Product does not achieve a score of 65% in the initial Baseline Review You can request a re-assessment. This should be requested after You have taken the key remediation and improvement actions highlighted in the Improvement Report and using the advice and guidance of the Assessors.
We will complete any re-assessment of the Baseline Review within 10 working days of a request via suppliersuccess@orchahealth.com. You will receive the same notifications, Improvement Reports and Assessor support consultations following this and subsequent re-assessments (up to the maximum per annum detailed below).
You will be entitled to up to 2 re-assessments per annum following the initial Baseline Review (3 in total in the first contract year). The re-assessments can be requested by You – for example to try and rectify an under 65% Baseline Review score – or will be triggered automatically if a substantial update or change to Your Product is detected or notified to us. This does not include minor bug fixes but will cover significant feature updates, policy changes, data changes or new evidence becoming available.
We will notify You when we detect a change that we believe requires a re-assessment and You will be able to discuss this ahead of a re-assessment happening. We do however ultimately retain the right to mandate that a re-assessment is undertaken if We believe that the changes we are aware of remain material and capable of impacting the existing Baseline Review score.
If Your Product has undergone 3 Baseline Reviews within the first contract year or 2 in any subsequent contract year, We will not be obliged to – but may at our discretion – undertake a further re-assessment until the start of a new contract year. It is possible to pay for a further re-assessment as an additional service and the fees for this are set out in Section 3.2.
1.4. Baseline Scores below 65%
If Your Product does not achieve a score of 65% or having achieved it in a prior review, then loses it in a re-assessment, Your Product listings on all supported ORCHA Microsites will be updated with an advisory warning notice indicating Your Product is undergoing a re-assessment. You will be provided with a 45-day remediation period from the completion of the re-assessment to address any key issues that are impacting the score. We will undertake a further re-assessment (subject to the annual limit set out above) within 10 working days of Your confirmation that the remediation action has been taken and a request to re-assess being received via suppliersuccess@orchahealth.com. If the score returns to above 65% the advisory notice will be automatically removed from Your Product listings on ORCHA Microsites.
If Your Product’s score remains below 65% beyond the 45 day remediation period (plus 10 days if a re-assessment has been requested within that period), it will be automatically removed from all ORCHA Microsites that operate a score based and automated inclusion criteria. Your licence to display the ORCHA Approved Badge will be suspeneded. Where Your Product has been specifically selected and included on a Microsite through a Microsite Owner selection process, Your Product will not be automatically removed, but the Microsite Owner will be notified of the non-compliance. It will ultimately be for the Microsite Owner to then decide what action to take.
We recognise that there are potentially difficult consequences arising from Your Product not maintaining a Baseline Review of 65% but it is imperative that there is a high degree of trust in the Baseline Review and the wide array of Microsites, Schemes and wider initiatives it supports. You therefore formally consent to the action outlined above and indemnify and hold ORCHA harmless for all and any consequences (including all claims, actions, proceedings, losses, damages, expenses, liabilities and/or costs (including without limitation court costs and reasonable legal fees)) arising from this.
You will be entitled to request a formal review of any assessment/re-assessment by our Assessment Review Panel. Please contact suppliersuccess@orchahealth.com who can provide details of this process.
1.5. Baseline Review Changes
The Baseline Review is a reflection of the key global standards and best practice that applies to digital health technologies. As a result it is regularly updated to reflect changes in these wider standards. The Baseline Review will rarely update more than once a year unless something urgent happens in the wider market that demands an update.
Outside of this scenario You will be notified at least 3 months in advance of any formal Baseline Review changes. You will be consulted on any proposed changes as part of an extensive stakeholder engagement process ahead of any formal Baseline Review changes.
We will – if the Baseline Review changes impact Your Product – undertake a re-assessment of Your Product against the updated Baseline Review version, at least 4 weeks ahead of the formal switch over of the live Baseline Review from the current to the new version. This re-assessment will not be part of the annual re-assessment allowance detailed in section 2.2.
If Your Product does not achieve a score of 65% under the new version of the Baseline Review, we will provide You with the relevant assessment feedback, Improvement Reports and other support. We will undertake one further re-assessment of Your Product under the new version of the Baseline Review. This re-assessment is also not part of the annual re-assessment allowance.
If Your Product does not achieve a score of 65% or above, the provisions of Section 2.2 will apply.
2. Subscription Fees
2.1. Fees
The annual subscription fee is set out in the Contract Details on application. All fees attract applicable VAT and/or Sales taxes.
On each anniversary of the Contract the relevant fee will increase by a sum equivalent to the then applicable Retail Prices Index in the UK.
2.2. Upgrade Options and Additional Services
You will be entitled to upgrade Your current Subscription to a higher Level at any point. Any amount already paid on annual basis will be discounted from the higher Subscription Annual Fee. You will also be entitled to an upgrade discount from month 4 of the Contract onwards of 25% of any higher subscription fee. This is instead of, not additional to, any other promotions that maybe in existence at the time.
Additional re-assessments can be purchased for £100 per re-assessment.
Additional consultation session can be added for £70 per session.
2.3. Subscription Service Alert
Please note that this is a subscription service and all fees are payable for the entirety of the Term. We will provide the Services set out in Section 2 and it is Your responsibility to ensure You make use of those services. Failure to do so does not entitle You to any reduction or refund of the Fees or allow any early termination or unpaid extension of the relevant subscription. It is important to ensure that any Assessment support services are requested before month 9 of the Initial Term to minimise the risk that this element of the Services cannot be provided within that Initial Term.
3. Client Dependencies
You will be responsible for the timely delivery of the dependencies and responsibilities set out in this Section 4 (“Client Dependencies”). Any failure to deliver these Client Dependencies in a timely manner may result in Us not being unable to deliver any of the Assessments Services in the time frames indicated and we will not be liable for any failure so to do.
3.1. The Digital Health Products
You will be responsible for clearly defining the Product/s that We are to undertake the relevant Assessments on and to which this Subscription applies at the point of contract signature.
You will be responsible for Us having full access to all relevant parts and platforms (iOS, Android and / or WebApp) of the Digital Health Product(s) prior to requesting a Baseline Review. This will include patient and clinician/health and care professional modules/features.
Where a Product/s is dependent on a specific connected device to demonstrate its full functionality, You will provide ORCHA with a demo version of the relevant device for the period of the Baseline Review and any subsequent re-assessments prior to or at the point of requesting a Baseline Review or re-assessment.
3.2. Baseline Reviews
You will be responsible for ensuring that all information, document items and materials in any form provided to Us in connection with the Products is accurate and complete in all material respects, and that no false or misleading information is provided to Us.
You will be responsible for the accuracy and completeness of the information provided in any of the Baseline Review sources listed and this information will be provided in a timely manner.
3.3. Re-Assessment and Maintenance
You will inform Us of any upcoming planned Changes (beyond routine bug fixes) to any Product at least thirty (30) Working Days before release/implementation of the relevant Change.
You will not hold out any Digital Health Product as being ORCHA Approved if You are aware that the Product has had Changes that have not been notified to ORCHA and re-assessed within 60 days of the Change going live with a resultant score of 65% or more or in relation to which a re-assessment has been undertaken within the 60 days that has established that the Product is below 65%
Failure to comply with this provision will in addition to the remedies detailed above, entitle Us (at our discretion) to terminate the Contract and to update all ORCHA Microsites with a notice alerting users to the fact that the Product is no longer meeting the 65% threshold and is therefore not approved. You will not be entitled to any refund on any Fees paid. There will be no obligation upon Us to support further re-assessments. In addition, We will be entitled to inform all ORCHA clients and other third parties directly that the Product is no longer approved.
Indemnity – You shall indemnify Us in full against all liabilities, costs, expenses, damages and losses (including any direct, indirect or consequential losses, loss of profit, loss of reputation and all interest, penalties and legal costs (calculated on a full indemnity basis) and all other professional costs and expenses) suffered or incurred by Us arising out of or in connection with any claim brought against Us arising out of, or in connection with any breach by You of Your obligations in this Section.
4. Confidentiality
Each party may be given access to Confidential Information from the other party to perform its obligations under the Contract. A party’s Confidential Information will not be deemed to include information that, is or becomes publicly known other than through any act or omission of the receiving party, was in the other party’s lawful possession before the disclosure, is lawfully disclosed to the receiving party by a third party without restriction on disclosure; or is independently developed by the receiving party, which independent development can be shown by written evidence.
Subject to the other provisions of this Section, You and Us will hold the other’s Confidential Information in confidence and not make the other’s Confidential Information available to any third party or use the other’s Confidential Information for any purpose other than the implementation of the Contract.
You and Us will take all reasonable steps to ensure that the other’s Confidential Information to which it has access is not disclosed or distributed by its employees or agents in violation of the terms of the Contract.
You and Us may disclose Confidential Information to the extent such Confidential Information is required to be disclosed by applicable law, provided that, to the extent it is legally permitted to do so, You or Us (as the context requires) gives the other as much notice of such disclosure as possible and, where notice of disclosure is not prohibited and is given in accordance with this Section, takes into account the reasonable requests of the other in relation to the content of such disclosure.
You acknowledge that details of the Services, and the results of any performance of the same, constitute Our Confidential Information.
You will not make, or permit any person to make, any public announcement concerning the Contract without Our prior written consent.
The above provisions of this Condition will survive termination of the Contract, however arising.
5 Liability
5.1. Unlimited liability
Nothing in the Contract will exclude or limit either party’s liability:
- for death or personal injury caused by its (or its agent’s or sub-contractor’s) negligence or for fraud or fraudulent misrepresentation.
- for any fraudulent or dishonest act or omission by either party or any member of that party’s Group or its officers, employees, agents, or sub-contractors; or
- that cannot, as a matter of law, be limited or excluded.
5.2. Limitation of liability
Subject to Condition Unlimited Liability, other than in respect of Your obligation to pay Fees, neither of us shall be liable to the other whether in equity (including restitution), contract, tort (including negligence), breach of statutory duty, misrepresentation, or in any other way for:
- any Excluded Losses, in each case whether direct or indirect; or
- any indirect or consequential loss, costs, damages, charges, or expenses however arising under the Contract.
- Our aggregate liability to You and Your aggregate liability to Us, whether in equity (including restitution), contract, tort (including negligence), breach of statutory duty, misrepresentation, or in any other way in respect of all Defaults (in the aggregate and not for each and every Default) that occur in a Year shall be limited to 100% of the Annual Fees paid to Us by You during that Year.
Where a Default first occurs in a Year and continues into any subsequent Year(s) it shall for the purposes of this Condition be deemed to have occurred only in that first Year.
5.3. General liability principles
Except as expressly and specifically provided in the Contract:
- You assume sole responsibility for results obtained from the use of the ORCHA Products, and for conclusions drawn from such use.
- We have no liability for any damage caused by errors or omissions in any information, instructions or scripts provided to Us by You in connection with the Contract or any actions taken by Us at Your direction.
- all warranties, representations, conditions, and all other terms of any kind whatsoever implied by statute or common law are, to the fullest extent permitted by Applicable Law, excluded from the Contract.
The exclusions and limitations of liability set out in Condition Liability shall not apply to the indemnities set out in Conditions Licences, Permissions, Consents & Applicable Laws or to Your obligation to pay the Fees.
6. Force Majeure
We will have no liability to You under the Contract if We are prevented from or delayed in performing Our obligations under the Contract, or from carrying on Our business, by acts, events, omissions or accidents beyond Our reasonable control, including, strikes, lock-outs or other industrial disputes (whether involving the workforce of Us or any other party), failure of a utility service or transport or telecommunications network, act of God, pandemic or epidemic, war, riot, civil commotion, malicious damage, compliance with any law or governmental order, rule, regulation or direction, accident, breakdown of plant or machinery, fire, flood, storm or default of suppliers or sub-contractors.
7. Consequences of Termination
Upon termination of this Contract in accordance with the provisions set out in Section 1 You will cease to be entitled to any of the Services set out in Section 2.
If Your Product is at the point of termination live on any ORCHA Microsites and remains compliant with the 65% Baseline Review score threshold, we may continue to maintain this listing. We will be under no obligation to maintain the listing and will be entitled to remove the Product at our discretion. You will not be entitled to use the ORCHA Approved Badge and this will be automatically removed from all listings. Your Product will be automatically removed from any Microsites that have an automated inclusion policy based on ORCHA Approved status.
If the Product undergoes a Change post termination of this Contract or is in the process of re-assessment but that remains incomplete, we will use our reasonable endeavours at our discretion to undertake a re-assessment in a timely manner. We will be under no obligation to re-assess the product or to re-assess it in priority to any other Product. To the extent the Product remains listed pending a re-assessment, it will carry the advisory warning notice detailed in Section 2.2. We may at our discretion temporarily remove the Product from relevant Listings if the delay in re-assessment becomes too substantial.
If we implement a Baseline Review Change as outlined in Section 2.3, we will be under no obligation to reassess Your Product to the updated Baseline Review version.
We will retain Your Product and Contact data in order to provide You with potential opportunities that can arise from time to time. You can request that we delete all non public data in writing via suppliersuccess@orchahealth.com.
Please note the information set out in Section 3.3. Any failure to fully utilise the Services during the Term does not entitle You to any refund, extension or other remedy at the end or during the Term.
8. Governing Law
The Contract and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) will be governed by and construed in accordance with the law of England and Wales.
9. Jurisdiction
You and Us irrevocably agree that the courts of England and Wales will have exclusive jurisdiction to settle any dispute or claim arising out of or in connection with the Contract or its subject matter or formation (including non-contractual disputes or claims).