NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Conditions of accreditation

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1 NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Conditions of accreditation Version number: 1.5 Final version Review date: December 2015 Accreditation: Terms and conditions 1 of 9

2 Background 1. The National Institute for Health and Care Excellence (NICE) is an executive nondepartmental public body established under the Health and Social Care Act NICE provides guidance and advice to support health and social care commissioners, providers and others so care and preventative services are of the best possible quality and offer the best value for money. NICE has a statutory role that encompasses the development of quality standards, advice, information and recommendations about NHS, public health and social care services. NICE provides independent, evidence-based guidance on the most effective ways to prevent, diagnose and treat disease and ill health and reduce health inequalities and variations. NICE guidance on public health topics makes recommendations for populations and individuals on activities, policies and strategies that can help prevent disease or improve health. 2. NICE Evidence provides a single searchable evidence base for healthcare and social care professionals who make decisions about treatments or the use of resources, and for patients who want to know more about their care. The evidence is made available in both its original form and through guidelines, pathways, tools and other resources. NICE Evidence also informs patient care, commissioning and service management. 3. NICE has developed an accreditation programme through which it assesses the processes guidance producers use to produce guidance and advice that is accessible via the NICE Evidence portal, where relevant. As the best processes to be followed will depend upon what guidance and advice is being produced, the interpretation of the criteria varies according to the type of guidance, care setting and evidence base used. 4. The accreditation programme also applies to the processes used by clinical decision support providers to develop guidance content, although this content may not be accessible on NICE Evidence. Accreditation excludes recommendations displayed by decision support systems in specific clinical settings as these are dependent on technical algorithms which are outside of the scope of accreditation. Accreditation can be used to inform compliance with ISB 0129 Clinical Safety Risk Management System - Manufacture of Health Software (DSCN 14/2009) and ISB 0160 Clinical Safety Risk Management System - Deployment and Use of Health Software (DSCN18/2009) where appropriate. 5. Guidance producers whose processes meet the accreditation criteria for a category of evidence are able to display the Accreditation Mark in compliance with the brand guidelines. This mark allows health and social professionals to recognise high quality guidance producers. The intent of the accreditation programme is that this will drive up the standard of information available in the longer term. Accreditation: Terms and conditions 2 of 9

3 Length of accreditation 6. Provided the following conditions are complied with, accreditation will last for 5 years from when the decision to award accreditation was approved. 7. Accreditation is conditional upon successful completion of the application process and the acceptance of these conditions of accreditation. 8. If an accredited guidance producer does not comply with these conditions then NICE may withdraw accreditation (including, for the avoidance of doubt, permission to use the Accreditation Mark). 9. NICE may review its award of accreditation at any time during this period, for whatever reason, and accredited guidance producers shall co-operate with any such review. 10. If accreditation is withdrawn the guidance producer shall remove all references to that accreditation (including any instances of the Accreditation Mark) regardless of any possible challenge of the decision to withdraw the accreditation. 11. If the accreditation period expires the guidance producer shall remove all references to that accreditation (including any instances of the Accreditation Mark), save that the guidance producer may continue to display the Accreditation Mark in respect of evidence produced under the accredited processes before the accreditation expired, in accordance with the brand guidelines. The guidance producer shall remove all references to being currently accredited in relation to the accreditation that has expired. Guidance producers shall comply with this paragraph regardless of any possible challenge to the decision not to renew the accreditation. Continuing compliance 12. Accredited guidance producers must take reasonable steps to ensure that the processes approved are followed when generating the type of guidance and advice for which they are accredited. Accredited guidance producers should have quality assurance mechanisms in place to ensure compliance with accredited procedures. 13. Between 36 and 48 months after accreditation is achieved an interim visit will take place. The guidance producer will be asked to complete an interim visit form stating any changes that have been made (if any) to the accredited process. The changes will be reviewed by the technical team to ensure that the process continues to comply with accreditation terms and conditions. 14. Accredited guidance producers shall also ensure that if they produce guidance and advice in collaboration with another organisation, those collaborating organisations adhere to the processes accredited. l. 15. If an accredited guidance producer becomes aware that the procedures accredited are not routinely being followed, it must inform the Accreditation Team of this fact promptly. Accreditation: Terms and conditions 3 of 9

4 16. The procedures in place at an accredited guidance producer may change over time. Accredited guidance producers shall inform the Accreditation Team of any change to a process or to ownership and governance which may impact on the fulfilment of the relevant accreditation criteria. This must be done within 30 days of that change occurring. Furthermore, NICE may update the accreditation criteria against which it assesses guidance producers. NICE will inform accredited guidance producers of any such changes within 30 days. In the event of either type of change, accredited guidance producers are required to assess whether they may no longer fulfil the accreditation criteria. If an accredited guidance producer concludes that there is a reasonable possibility that any of the relevant accreditation criteria are no longer met it will notify the Accreditation Team of that fact promptly. The guidance producer will explain the changes and how fulfilment of the accreditation criteria may be affected. Accessing evidence via the NICE Evidence portal 17. NICE Evidence is a web portal that directs its users to third party websites on which the evidence they are looking for can be found. Where required guidance producers will need to supply a web address when submitting evidence so that relevant accredited guidance is available on the web portal. This does not apply to accredited clinical decision support providers whose guidance content is not intended to be accessible through NICE Evidence. 18. It is the responsibility of the guidance producers to maintain this link and to update it should the relevant web content move. It is also the guidance producer s responsibility to ensure that the evidence it submits to NICE Evidence is displayed in the appropriate format when accessed via NICE Evidence by supplying appropriate metadata, where relevant. 19. For the avoidance of doubt, guidance producers may continue to apply their own terms of use to all content on their own websites. 20. If a guidance producer s website contains a password secure section that NICE Evidence will need access to in order to maintain the NICE Evidence database, the guidance producer must ensure that NICE Evidence will have access to this section by providing NICE Evidence with the necessary access information (typically a user name and password) and ensuring that this information remains valid for the length of time these conditions apply. 21. Where guidance and advice is available on NICE Evidence, guidance producers agree to take all reasonable steps to ensure that the content of their websites is upto-date and appropriate and that any information that can be attributed to NICE Evidence users visiting their website is used appropriately and in particular (but without limitation) the requirements of the Data Protection Act 1998 are complied with. Accreditation: Terms and conditions 4 of 9

5 22. NICE Evidence reserves the right, at its sole and absolute discretion, not to accept or to remove references to evidence from the web portal. Announcements and publicity 23. All final decisions on accreditation, supported by reports, are published by NICE, following the Institute s policy on providing commercially sensitive information, where necessary. 24. Accredited guidance producers must take reasonable steps to ensure that any public statement they make that relates to NICE or NICE Evidence is accurate and appropriate in the circumstances. Such statements should include the following reference to NICE as a source of further information: "NICE has accredited the process used by [insert organisation name] to produce its [insert title of guidance product] guidance. Accreditation is valid for 5 years from [insert date]. More information on accreditation can be viewed at Clinical decision support providers should use: "NICE has accredited the process used by [insert organisation name] to develop content (a) used in [insert product] OR (b) used in the database from which [insert product] is derived [delete (a) or (b) as appropriate]. Accreditation is valid for 5 years from [insert date]. More information on accreditation can be found at Accreditation evaluates only the processes used to develop content and excludes recommendations displayed by decision support systems in specific clinical settings as these are dependent on technical algorithms which are outside of the scope of accreditation. Accreditation can be used to inform compliance with 0129 Clinical Safety Risk Management System Manufacture of Health Software (DSCN 14/2009) and ISB 0160 Clinical Safety Risk Management System Deployment and Use of Health Software (DSCN 18/2009), but cannot be used in isolation to release any product for clinical use. 26. If an accredited guidance producer is in any doubt about whether a proposed statement is accurate and appropriate, it should contact the Accreditation Team for guidance. Use of the Accreditation Mark 27. The Accreditation Mark is a trademark of NICE. Accredited guidance producers are granted a royalty-free, worldwide licence to use the Accreditation Mark in accordance with the Terms of Use which appear as appendix A of these conditions for the duration of their accreditation for a process to produce guidance and advice. Accreditation: Terms and conditions 5 of 9

6 General 28. Accredited guidance producers agree to co-operate with NICE to promote the aims of accreditation and in particular with NICE s assessment and monitoring of a guidance producer s compliance with the accreditation criteria. 29. Accredited guidance producers agree to do nothing that would be likely to bring NICE or accreditation into disrepute. 30. NICE may from time to time supplement or amend these conditions of accreditation at its discretion. Such changes will take effect from the time notified by NICE. Accredited guidance producers will be informed of any such changes via the most appropriate communications channels. 31. The use of accreditation in general and these conditions in particular are subject to English law and the exclusive jurisdiction of the courts of England and Wales. Signed by: On behalf of: [insert name of accredited guidance producer] Signature Name (please print) Job Title (please print) Date Accreditation: Terms and conditions 6 of 9

7 APPENDIX A TERMS OF USE 1. The Accreditation Mark is a registered trademark of the National Institute for Health and Care Excellence (the Institute). 2. Organisations that have been accredited by the Institute (accredited guidance producers) are granted a royalty-free, worldwide licence (the Licence) to use the Accreditation Mark for as long as they remain accredited provided always that these Terms of Use are complied with. Ownership 3. Accredited guidance producers acknowledge the ownership of the Accreditation Mark by the Institute and: 3.1 shall do nothing inconsistent with such ownership; 3.2 acknowledge that the use of the Accreditation Mark by accredited guidance producers and all goodwill and reputation generated in the Accreditation Mark by accredited guidance producers shall inure to and be on behalf of the Institute, and that accredited guidance producers will hold any such goodwill and reputation generated thereby as bare trustee for the Institute; 3.3 shall not dispute or challenge the validity of the Accreditation Mark or any other rights of the Institute to it; and 3.4 shall not use the Accreditation Mark in any way which would be materially detrimental to or inconsistent with the good name, goodwill, reputation, image and prestige of the Institute. 4. Nothing in these Terms of Use shall give accredited guidance producers any right title or interest in the Accreditation Mark other than the right to use it in accordance with these Terms of Use. Use of the Accreditation Mark 5. The Accreditation Mark may be posted against guidance and advice submitted by an accredited guidance producer to NICE for inclusion on NICE Evidence that is in the category of evidence covered by its accreditation. Provided the evidence in question is submitted, the Accreditation Mark may be displayed on or in relation to that guidance and advice elsewhere than the NICE Evidence web portal. 6. NICE may ask an accredited guidance producer to inform the sources team within NICE each time a new guidance document produced through an accredited process is published. This will generally be requested if the guidance producer publishes infrequently and when an automated process for identifying accredited guidance is not possible. This information should be ed to ian.saunders@nice.org.uk. Accreditation: Terms and conditions 7 of 9

8 7. The Accreditation Mark may not be used in relation to any guidance and advice that is not in a category for which the guidance producer is accredited. 8. The Accreditation Mark may be used to indicate that a process used by a guidance producer has been accredited provided it is made clear which categories of guidance and advice the accreditation relates to. 9. Clinical decision support providers may display the Accreditation Mark only on their website, corporate and marketing literature 1 pertaining to those products for which the content development process has been accredited, and not on other extraneous peripheral marketing items. 10. Accredited guidance producers may use the Accreditation Mark in other circumstances provided the Institute has given its prior written consent to that use, such consent to be granted at the Institute's sole and absolute discretion. If an accredited guidance producer seeks to use the Accreditation Mark in such other circumstances it shall contact the Institute in advance with details of the proposed use so that it may consider granting the necessary permission. 11. Wherever an accredited guidance producer uses the Accreditation Mark it shall acknowledge that the Accreditation Mark is a registered trademark belonging to the Institute. 12. If an accredited guidance producer uses the Accreditation Mark outside of NICE Evidence it must display an explanation alongside the Accreditation Mark which explains how accreditation works. "NICE has accredited the process used by [insert organisation name] to produce its [insert title of guidance product] guidance. Accreditation is valid for 5 years from [insert date]. More information on accreditation can be viewed at " Providers of clinical decision support content should use: "NICE has accredited the process used by [insert organisation name] to develop content (a) used in [insert product] OR (b) used in the database from which [insert product] is derived [delete (a) or (b) as appropriate]. More information on accreditation can be found at Accreditation evaluates only the processes used to develop content and excludes recommendations displayed by decision support systems in specific clinical settings as these are dependent on technical algorithms which are outside of the scope of NICE accreditation. Accreditation can be used to inform compliance with ISB 0129 Clinical Safety Risk Management System Manufacture of Health Software (DSCN 14/2009) and ISB 0160 Clinical Safety Risk 1 Marketing literature includes but is not limited to brochures, newsletters, circulars, flyers, and leaflets, and includes print and electronic formats. Accreditation: Terms and conditions 8 of 9

9 Management System Deployment and Use of Health Software (DSCN 18/2009), but cannot be used in isolation to release any product for clinical use." 13. It is an accredited guidance producer s responsibility to ensure that the Accreditation Mark is used in accordance with these terms of use so far as its own evidence and other information produced or published by it is concerned. Consequences of accreditation coming to an end 14. If for any reason an accredited guidance producer s accreditation is withdrawn the Licence to use the Accreditation Mark in relation to that accreditation shall terminate and the guidance producer shall remove all references to that accreditation. 15. If an accredited guidance producer s accreditation expires the licence to use the Accreditation Mark in relation to that accreditation shall terminate with immediate effect, including in relation to information that was produced under accredited processes before the termination save that the guidance producer may continue to display the Accreditation Mark in respect of evidence produced under the accredited processes before the accreditation expired. The guidance producer shall remove all references to being currently accredited in relation to that category of evidence. 16. For the avoidance of doubt, if accreditation is withdrawn or expires but a guidance producer continues to be accredited for another category of guidance and advice the Licence shall continue in relation to the use of the Accreditation Mark for evidence in that accredited category. 17. Any continued use of the Accreditation Mark under paragraph 15 after the expiry of accreditation remains subject to compliance with this Licence. General 18. Accredited guidance producers shall not be entitled to assign or transfer or purport to assign or transfer any of their rights or obligations under this Agreement. Accredited guidance producers shall not be entitled to sub-licence use of the Accreditation Mark. 19. A variation of these Terms of Use is valid only if it is in writing and signed by or on behalf of the Institute. 20. These Terms of Use are governed by, and shall be construed in accordance with, English law and each party agrees to submit to the exclusive jurisdiction of the courts of England & Wales. Accreditation: Terms and conditions 9 of 9