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Terms of Use

This document outlines the terms of use for the ORCHA website

ORCHA terms and conditions – for developers

  1. All text, graphics, user interfaces, visual interfaces, photographs, trademarks, logos, sounds, music, artwork and computer code (collectively, “Content”), including but not limited to the design, structure, selection, coordination, expression, “look and feel” and arrangement of such Content, contained on the Site is owned, controlled or licensed by or to ORCHA Health Ltd, a company registered in England, and is protected by trade dress, copyright, patent and trademark laws, and various other intellectual property rights and unfair competition laws.
  2. Except as expressly provided in these Terms of Use, no part of the Site and no Content may be copied, reproduced, republished, uploaded, posted, publicly displayed, encoded, translated, transmitted or distributed in any way (including “mirroring”) to any other computer, server, Web site or other medium for publication or distribution or for any commercial enterprise, without ORCHA’s express prior written consent.
  3. Any extracts from the website that are reproduced for non-commercial purposes should be supported by a full acknowledgement and reference to ORCHA.
  4. The publishing of hyperlinks to external websites is for information and reference purposes. It does not imply any approval of their contents or commercial affiliation. ORCHA is not responsible for the accuracy, timeliness or relevance of such linked websites.
  5. ORCHA provides an objective and independent assessment of health and medical apps. This is an advisory not regulatory service, but we do advise where regulatory issues may be important and should be considered further. It is however ultimately the responsibility of the developers and/or publishers of an app to ascertain its compliance with all relevant regulatory standards.
  6. Our rating process is undertaken using a rigorous process that has been tested thoroughly by ORCHA reviewers with feedback from independent end users and developers. It is underpinned by evidence that has been academically or clinically verified by, standards, legislation and guidelines. A list of standards used by ORCHA is shown below.
  7. Each app is Scrutinised by a Reviewer, who tests all the features and reads associated information in sections such as Terms & Conditions, About, Read Me. More detail on the review process can be found here.
  8. ORCHA reviews are based on the information provided by app developers within the app itself and available in the public domain and we are not responsible for inaccuracies or errors in the information provided. Even where the information provided is accurate, our review cannot guarantee that an app will perform as promised in any specific circumstances or that the app is free now or in the future from any bugs or issues that might affect its performance.
  9. If we have reviewed an app that you have developed, we will contact you via the email given either on the app or on the app website with the review scores 10 working days in advance of publication. If for any reason, you believe the information on which our review is based is incorrect or has been interpreted incorrectly, please let us know at feedback@orcha.co.uk. If there is a mistake, we will rectify it as soon as possible. ORCHA will not normally enter into a dialogue with you unless we believe there is an inaccuracy.
  10. Review scores are published on the ORCHA App Platform. Developers can access a detailed report by registering via the link provided in the notification email. The report shows reviewer comments and includes suggestions for how information to users can be enhanced to improve your ORCHA rating.
  11. If you later become aware of any bugs or issues affecting an app’s performance please let us know as soon as possible at feedback@orcha.co.uk.
  12. The data we hold on our individual subscribers includes user name, email address, gender, year of birth and postcode. We correlate anonymised data with your download and website interaction patterns to improve our understanding of how the website is used, which apps are most valued and by which groups. We retain your name and email address in case we wish to contact you. All data is held securely, according to the terms of the Data Protection Act 1998. We will not give or sell your data to any third party, but we will share aggregated reports based on anonymised user data with NHS policy makers, commissioners and providers, as well as business clients to assist them to improve their products or services. You may request a copy of the individual data we hold on you at any time.
  13. A developer account will also hold details of all of your apps and related scores. All reviews (included archived earlier versions) are held on file and can be accessed only by the ORCHA review team.
  14. You may request that your account is terminated at any time, by contacting us at feedback@orcha.co.uk. We will continue to hold information held on you prior to that date, but will not collect any more. Terminating an account will however not remove any reviews on your apps that we have published or prevent us reviewing and publishing reviews on any of your apps in the future.
  15. The ORCHA website uses cookies our to help enhance user experience and help make visits to our site more effective. Cookies are small data files which are sent from a web server to a web browser, and, depending on the type of cookie being used, either expire at the end of a browsing session or are stored until a set date. Cookies are used for a variety of purposes, namely to help us monitor how users use our site and how we can best modify it to accommodate their needs. You will have options to restrict the use of cookies, but please note that if you do this it may impact on the functionality of our website. By using our website and agreeing to the terms of this policy, you consent to our use of cookies in accordance with the terms of this policy.
  16. You may not use this website for unlawful purposes, in any way that breaches applicable law or regulation. You may not use our content fraudulently or for the purposes of generating unsolicited (spam) emails or computer viruses.
  17. These Terms and Conditions are governed by English law. We reserve the right to change our Terms and Conditions at any time, as they are updated to meet changing needs and any new legislation.

ORCHA terms and conditions – for end users

  1. All text, graphics, user interfaces, visual interfaces, photographs, trademarks, logos, sounds, music, artwork and computer code (collectively, “Content”), including but not limited to the design, structure, selection, coordination, expression, “look and feel” and arrangement of such Content, contained on the Site is owned, controlled or licensed by or to ORCHA Healthcare Ltd, a company registered in England, and is protected by trade dress, copyright, patent and trademark laws, and various other intellectual property rights and unfair competition laws.
  2. Except as expressly provided in these Terms of Use, no part of the Site and no Content may be copied, reproduced, republished, uploaded, posted, publicly displayed, encoded, translated, transmitted or distributed in any way (including “mirroring”) to any other computer, server, Web site or other medium for publication or distribution or for any commercial enterprise, without ORCHA express prior written consent.
  3. Any extracts from the website that are reproduced for non-commercial purposes should be supported by a full acknowledgement and reference to ORCHA.
  4. The publishing of hyperlinks to external websites is for information and reference purposes. It does not imply any approval of their contents or commercial affiliation. ORCHA is not responsible for the accuracy, timeliness or relevance of such linked websites.
  5. ORCHA provides an objective and independent assessment of health and medical apps. This is an advisory not regulatory service, but we do advise where regulatory issues may be important and should be considered further. It is however ultimately the responsibility of the developers and/or publishers of an app to ascertain its compliance with all relevant regulatory standards.
  6. Our rating process is undertaken using a rigorous process that has been tested thoroughly by ORCHA reviewers with feedback from independent end users and developers. It is underpinned by evidence that has been academically or clinically verified, standards, legislation and guidelines. A list of standards used by ORCHA is here.
  7. Each app is scrutinised by a Reviewer, who tests all the features and reads associated information in sections such as Terms & Conditions, About, Read Me. More detail on the review process can be found here.
  8. ORCHA reviews are based on the information provided by app developers within the app itself and available in the public domain and we are not responsible for inaccuracies or errors in the information provided. Even where the information provided is accurate, our review cannot guarantee that an app will perform as promised in any specific circumstances or that the app is free now or in the future from any bugs or issues that might affect its performance.
  9. The data we hold on our subscribers includes user name, email address, gender and year of birth and postcode. We correlate anonymised data with your download and website interaction patterns to improve our understanding of how the website is used, which apps are most valued and by which groups. We retain your name and email address in case we wish to contact you. All data is held securely, according to the terms of the Data Protection Act 1998. We will not give or sell your data to any third party, but we will share aggregated reports based on anonymised user data with NHS policy makers, commissioners and providers, as well as business clients to assist them to improve their products or services.
  10. ORCHA only share data related to usage and Utilisation patterns of apps and our website. We do not have any means to link the personal data we hold with any patient records, or other records that may be held by public of private bodies. You may request a copy of the data we hold on you at any time.
  11. You may request that your account is terminated at any time, by contacting us at feedback@orcha.co.uk. We will continue to hold information held on you prior to that date, but will not collect any more.
  12. The ORCHA website uses cookies our to help enhance user experience and help make visits to our site more effective. Cookies are small data files which are sent from a web server to a web browser, and, depending on the type of cookie being used, either expire at the end of a browsing session or are stored until a set date. Cookies are used for a variety of purposes, namely to help us monitor how users use our site and how we can best modify it to accommodate their needs. You will have options to restrict the use of cookies, but please note that if you do this it may impact on the functionality of our website. By using our website and agreeing to the terms of this policy, you consent to our use of cookies in accordance with the terms of this policy.
  13. The content on our website is not intended to be a substitute for professional medical care by a qualified doctor or other healthcare professional. You should always check with your doctor if you have any concerns about your health, your condition or any treatment you may be taking or planning to take. If you are a healthcare professional, this website is intended to support and enhance, but not to replace your own judgment and knowledge.
  14. You may not use this website for unlawful purposes, in any way that breaches applicable law or regulation. You may not use our content fraudulently or for the purposes of generating unsolicited (spam) emails or computer viruses.
  15. These Terms and Conditions are governed by English law. We reserve the right to change our Terms and Conditions at any time, as they are updated to meet changing needs and any new legislation.

STANDARDS USED FOR ORCHA APP REVIEWS

ORCHA value and risk assessment is derived from a number of standards and guidelines, which were used to develop the review tool. These are discussed below

App Data

We cover the following areas:

  1. Data collection - what the app collects and how
  2. Data management - how the app protects that data
  3. Data Utilisation - how the app uses that data

There are a number of important standards and legislation relating to information security, data protection, data and information sharing. These inform some of the questions in the Quality and Safety theme.

Freedom of Information Act 2000 http://www.legislation.gov.uk/ukpga/2000/36/contents

Data Protection Act 1998 - Principle s 3, 4, 5, 6, 7 & 8. See ICO Summary of Data Protection Principles https://ico.org.uk/for-organisations/guide-to-data-protection/data-protection-principles/

ISO/IEC 27001 - Information security management Data protection Act

DD ISO TS 25237, Health informatics – Pseudonymization

GREAT BRITAIN. The Data Protection Act 1998. London: The Stationery Office.

GREAT BRITAIN. The Consumer Protection Act 1987. London: The Stationery Office.

SNOMED Clinical terms. Available from: http://ihtsdo.org/snomed-ct/

HEALTH & SOCIAL CARE INFORMATION CENTRE. UK Terminology Centre (UKTC). Available from:
http://systems.hscic.gov.uk/data/uktc .

HEALTH & SOCIAL CARE INFORMATION CENTRE. HSCIC interoperability toolkit (ITK). Available from:
http://systems.hscic.gov.uk/interop/background/itk/faqs

National Information Board Interoperability guidance
http://www.isb.nhs.uk/about/publications/interoperability.pdf

See also standards for risk - BS EN ISO 14971, Medical devices – Application of risk management to medical devices. This standard was used in the design of the ORCHA risk methodology.

PAS 277:2015: Health and wellness apps – Quality criteria across the life cycle – Code of practice and the Medical Devices Directive (CE mark for medical devices): Council Directive 93/42/EEC relevant to all sections.

Efficacy and Assurance

We cover the following areas:

  1. Clinical Or User Trials
  2. Professional Knowledge
  3. Validation and Accreditation

Clinical validation is an essential concept within the CE Mark Directive. Again, the Quality System standards are relevant.

ISO13485 – Medical Devices: Quality Management Systems: Requirements for Regulatory Purposes. This is a version of ISO9000 applied specifically to medical devices.

BS ISO/IEC 90003, Software engineering – Guidelines for the application of ISO 9001:2000 to computer software.

BS EN ISO 14971, Medical devices – Application of risk management to medical devices. This standard was used in the design of the ORCHA risk methodology.

PAS 277:2015: Health and wellness apps – Quality criteria across the life cycle – Code of practice and the Medical Devices Directive (CE mark for medical devices): Council Directive 93/42/EEC relevant to all sections.

Design & Testing

We cover the following areas:

  1. Compliance with design standards
  2. UX
  3. Benefit

Design and testing is enshrined in the Quality Systems standards for medical devices and for medical software.

ISO13485 – Medical Devices: Quality Management Systems: Requirements for Regulatory Purposes. This is a version of ISO9000 applied specifically to medical devices.

BS ISO/IEC 90003, Software engineering – Guidelines for the application of ISO 9001:2000 to computer software.

BS EN ISO 14971, Medical devices – Application of risk management to medical devices. This standard was used in the design of the ORCHA risk methodology.

PAS 277:2015: Health and wellness apps – Quality criteria across the life cycle – Code of practice and the Medical Devices Directive (CE mark for medical devices): Council Directive 93/42/EEC relevant to all sections.

User Experience

We cover the following areas:

  1. Customisation and navigations
  2. Cost
  3. Management of errors
  4. Goal management
  5. Language and terminology

ORCHA evaluates user experience based on best practice from a range of sources.

Not only should an app use best practice, but it is also important that a statement is made to this effect (in Terms & Conditions, About or somewhere else on the app).

Google Play and the Apple Store guidelines.

BS EN 62366:2008, Medical devices – Application of usability engineering to medical devices.

Web content accessibility guidelines http://www.w3.org/WAI/intro/wcag

And PAS 277:2015: Health and wellness apps – Quality criteria across the life cycle – Code of practice and the Medical Devices Directive (CE mark for medical devices): Council Directive 93/42/EEC relevant to all sections.

OTHER USEFUL STANDARDS

BS EN 62366:2008, Medical devices – Application of usability engineering to medical devices Web content accessibility guidelines http://www.w3.org/WAI/intro/wcag

DISCLAIMER

ORCHA (the Organisation for the Review of Care and Health Apps) is designed to provide the public with listings of general health and condition-specific apps, to help you identify the apps that scored better when reviewed.

This site is not intended to be used as a replacement for any health or medical professional. You should always consult your practitioner or seek advice from a healthcare expert before downloading and using any health or medical-related mobile applications.

ORCHA bears no responsibility whatsoever for the outcomes or effects that any reviewed app possesses as a consequence of being downloaded and used by any party or individual.

ORCHA does not specifically endorse or distribute any app or product listed on this site and no app is a substitute for professional medical advice. If you have any concerns about your condition you must seek professional advice.

In the event of any medical emergency, immediately dial 999. (In non-life-threatening or less severe situations, dial 111)