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.
Any extracts from the website that are reproduced for non-commercial purposes should be supported by a full acknowledgement and reference to ORCHA.
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.
The ORCHA Review and Service
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.
The ORCHA Baseline Review (“OBR”) is ORCHA’s first level of assessment and involves a detailed ‘desktop’ analysis of Digital Health solutions looking across all of the key areas of regulation and compliance. The OBR is largely undertaken proactively as part of ORCHA’s ongoing assessment and monitoring of the whole Digital Health market place and we review the most downloaded and most recently updated Apps and related Digital Health solutions across over 250 health and care categories and conditions.
The OBR is primarily an assessment of an Apps compliance with current standards, regulation and good practice (together “Standards”).
A standard is an agreed way of doing something. It could be about making a product, managing a process, delivering a service or supplying materials – standards can cover a huge range of activities undertaken by organizations and used by their customers.
”Standards are the distilled wisdom of people with expertise in their subject matter and who know the needs of the organizations they represent – people such as manufacturers, sellers, buyers, customers, trade associations, users or regulators.” (British Standards Institute)
They can be of regulatory significance or form non regulatory requirements or required best practice in a given jurisdiction or area.
The Standards we currently look at in the OBR are:
- Freedom of Information Act 2000 http://www.legislation.gov.uk/ukpga/2000/36/contents
- General Data Protection Regulations (GDPR) and associated local laws implementing this within the EU
- ISO/IEC 27001 – Information security management Data protection Act
- DD ISO TS 25237, Health informatics – Pseudonymization
- GSMA: Privacy Design Guidelines for Mobile Application Development.
- GSMA: Mobile & Privacy Guideline TCC2, TCC3, DRS4
- AQUA: Best Practice Guidelines for producing high quality mobile applications version 2.3 – June 2013
- BS EN ISO 14971, Medical devices – Application of risk management to medical devices
- The medical devices directive (CE mark for medical devices): council directive 93/42/EEC.
- MHRA guidance on CE marking for software and apps
- PAS 277:2015: Health and wellness apps – Quality criteria across the life cycle – Code of practice and the Medical Devices Directive
- The Consumer Protection Act 1987. London: The Stationery Office.
- APP QUALITY ALLIANCE: Accessibility Testing Criteria for Android Applications version 1.2: July 2015
- AQUA BEST PRACTICE GUIDANCE 2015
- Apple UX guidance. Available at https://developer.apple.com/app-store/review/guidelines/
- Google play developer UX standards. Available at: https://play.google.com/about/developer-content-policy/
- W3C guidance. Available at: https://www.w3.org/WAI/intro/usable
- eEurope2002: “Accessibility of Public Websites and their Content”
The OBR seeks to assess an Apps performance through its compliance with these Standards. Our Review is regularly updated to reflect changes in these Standards. The higher the ORCHA Score achieved the more compliant the App is with these Standards and vice versa.
Whilst a high scoring App is not guaranteed to be effective or safe, or a poorly scoring App is not necessarily ineffective or unsafe, it does mean that the relevant Developer has taken more or less care over the Apps compliance with these key Standards than other similar Apps. In the critical area of health and care, we believe that developers should take compliance with Standards extremely seriously.
Some Apps are technically medical devices and for class iia, iib and iii devices, require full assessment and Approval in the EU through processes overseen by the national regulatory bodies such as the MHRA in the UK and HPRA in Ireland and in other jurisdictions by similar regulatory bodies. An App of this nature should not be made available to the general public until it has been assessed and appropriately certified and any Apps that we identify as being an uncertified medical device is excluded from our general search.
If you become aware of any inaccuracy in the information presented in our Reviews or have any other concerns, please report this to us immediately at firstname.lastname@example.org.
ORCHA are not promoting or recommending any particular Apps through this process but are providing impartial information about an Apps compliance with Standards and a mechanism for end users to easily identify those Apps that best meet those Standards and to check which ones don’t.
Inaccurate or misleading information
ORCHA Reviews are based on the information provided by App developers the App itself and/or available in the public domain via a connected website or the relevant ‘app store’. We are reliant on this information in undertaking our reviews and are not responsible for inaccuracies or errors in the information provided. App Developers are governed in most jurisdictions by laws that require them not to make misleading or inaccurate statements about their products and if you believe that any information provided via our reviews is inaccurate or misleading please contact us at email@example.com and we will immediately investigate this.
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. We accept no responsibility for any adverse effects of the App or Digital Health solution in question.
Data & Privacy
All data is held in accordance with the terms of the General Data Protection Regulations (GDPR) and all associated national Data Protection laws within the EU.
Medical/Professional Care and Advice
The content on our website is not intended to be a substitute for professional medical care by a qualified doctor or other suitable healthcare professional (“Professional“). You should always check with your Professional if you have any concerns about your health, your condition or any treatment you may be taking or planning to take.
If you receive an App Recommendation from a Professional via an ORCHA powered platform, the Recommendation is being made based on that Professionals judgement about the suitability of an App for your specific needs and the information provided by ORCHA upon which the Professional is relying upon. The ORCHA Review and Score is in turn reliant on the accuracy of the information provided by the App Developer themselves.
Neither the Professional or ORCHA are responsible for inaccuracies or errors in that information. Even where the information provided is accurate, the ORCHA 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 and neither the Professional or ORCHA can be held responsible for issues arising in these circumstances.
If you are a healthcare professional, this website is intended to support and enhance, but not to replace your own judgment and knowledge.
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.
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.
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