WHO ARE ORCHA?
ORCHA are the world's leading provider of health and care App reviews and digital activation solutions. We uniquely provide a comprehensive and dynamic monitoring of the fast paced and ever changing health and care app market. Our team includes experts from all aspects of the health and care App world and the combination of these skills and capabilities ensures that the ORCHA Review Process and Score is based on a fully rounded and rich analysis of each App.
We are part of NHS England's National Innovation Accelerator programme and support many NHS and local government organisations to drive the uptake of digital health amongst their populations. We also support other organisations in the UK and further afield who wish to energise and activate their target audiences around the use of digital health solutions, including schools and universities, charities, pharmacies and major employers.
Our ORCHA Pro solutions empower health and care professionals to fully embrace the world of digital health and embed these solutions into their day to day clinical and professional practice. With thousands of Professionals already accessing these services we have gained a unique insight into the challenges and opportunities that this raises.
ORCHA's ultimate vision is to revolutionise health and care provision through the full integration of digital health solutions into all aspects of health and care support and provision. We believe that digital health products are one of the major weapons in the fight that all advanced health systems face, to provide support for an ever ageing population with more complex long term conditions.
Our aim is to help remove the barriers that currently inhibit the true potential of digital health solutions and prevent the wider spread adoption of great products and services by end users, health and care professionals and health and care systems. In achieving this we also aim to create a new global market place dedicated to health and care Apps to ensure that a commercially sustainable foundation for this still nascent industry is established to support the creation of the next generation of health and care Apps and digital services that will truly revolutionise the world of health and care.
ORCHA is one of the leading providers of Health and Care App evaluations and reviews. It 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 App's 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 App's 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 that we identify as being a non 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 App's 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.
STAGE ONE - EXCLUSION FILTERS
Our review process starts with a weekly analysis of all the Apps available on the App Store or Google Play in the ‘health, wellbeing/fitness and medical’ sections. We then filter out Apps that are not designed for use in a supported Language and Apps that have not been updated for 18 months or more. Of the remaining Apps we organise these into over 350 health and care condition categories and queue them within their category by most downloaded.
- Where there are Android and iOS versions of the same App we link these and they queue together. We review the next highest downloaded App in the queue, category by category, on a cyclical basis to ensure that we cover the full breadth of solutions available.
- We do offer an expedited review process for Apps that are unlikely to reach the top of the queue in their category area for some time - this is particularly the case in popular areas such as mental health Apps, Diabetes, Asthma, COPD, Sleep etc - and this enables newer Apps to gain an ORCHA score and presence on our platforms without having to wait for increased user downloads or the review team to move through the queue sufficiently to pick them up.
STAGE TWO - LEVELS
There are a huge array of different types of health and care Apps available with an equally wide array of functionality and sophistication. At ORCHA we believe that just because an App offers more functionality it doesn’t mean it is automatically better than a functionally simple App. Apps that for example simply provide information and guidance – similar to health ‘leaflets’ – can be very useful in certain circumstances and this isn’t impacted by their relative functional simplicity.
Apps in this area are also focused on a wide array of areas. Some are clearly health focused and within that are often targeting specific conditions or diseases, others however are more general and many are actually focused on wellbeing rather than health. A focus on wellbeing would include areas such as exercise and fitness and diet and these Apps are really important and offer really valuable support in the maintenance or improvement of overall wellbeing which is crucial for overall health.
- Against this very varied backdrop, having a one size review process does not work and it is important that the review itself is responsive to the type (in terms of focus and functionality) of the App in question.
- It is for this reason that we developed the ORCHA App Classification system which categorises Apps in one of 5 Levels (0-4) based on their area of focus and their functional capabilities. The more ‘health’ focussed and functionally rich an App is the higher its Level and the more areas of investigation are enabled in relation to it.
- Very simple wellbeing focused Apps (typically L0 or L1) are not for example assessed based on their clinical assurance because they are not really delivering a clinical solution. Level 4 Apps on the other hand are at the top end in terms of focus and functionality and are often required to establish compliance with other regulatory environments such as medical device regs or the equivalent in other jurisdictions.
The Orcha Levels are as follows:
|Level 0 - Simple Wellbeing||These apps are designed to support general wellbeing and have limited feature sets and don’t collect any data. Because they are not health focussed and do not collect data we only assess their compliance in the User Experience domain.|
|Level 1 - Advanced Wellbeing||These apps are focussed on general wellbeing but they can collect data and they are likely to have a number of more advanced features. Because they are not health focussed we only assess their compliance in the Data and Security and User Experience domains|
|Level 2 - General Health||These apps are focussed on general health. They may collect data and they may have a number of more advanced features. Where they collect data we assess their data use policies and compliance with relevant standards. Because they are health focussed we also assess their compliance in the Clinical Effectiveness as well as the User Experience domains.|
|Level 3 - Condition Management||These apps can be focussed on general health or supporting specific health conditions. They may collect data and they may have a number of more advanced features. Where they collect data we assess their data use policies and compliance with relevant standards. Because they are health focussed we also assess their compliance in the Clinical Effectiveness as well as the User Experience domains.|
|Level 4 - Regulated||These Apps can be focussed on general health or specific conditions and contain advanced and complex features that are subject to formal regulation. Where they collect data we assess their data use policies and compliance with relevant standards. Because they are health focussed we also assess their compliance in the Clinical Effectiveness as well as the User Experience domains.|
STAGE THREE- FUNCTIONS
As part of our evaluation of an Apps Level, we also capture all of the Apps key functions and features. We have over 14 features that we regularly check for and we are constantly updating this as App develop new features and functions. The Functional assessment also dynamically changes the lines of enquiry that our Reviewers follow during the Review proper again to ensure that the assessment is as tailored to the type of App as possible.
The functional capabilities all become filterable search elements in the myriad ORCHA App Finders, allowing all users to tailor their searches appropriately to find Apps that actually do the things that they want support around.
|General Information - L0||The App provides general information or guidance|
|Alerts and Notifications - L0||The App provides alerts and notifications relevant to its area of focus|
|Social Support Networks - L1||The App has its own or provides access to social networks relevant to its area of focus|
|Wellbeing Tracking - manual or automatic – L1||The App allows you to record relevant wellbeing information either manually or automatically using connected Apps or devices|
|Goal setting and gamification – L1||The App allows you to set health and wellbeing related goals and may support games and challenges around achieving that|
|Environmental Data – L1||The App provides information about air quality, pollen levels and releated data.|
|Service Signposting - L2||The App provides links and suggestions for local or national services that are relevant to its focus area|
|Health Tracking - manual or automatic - L2||The App allows you to record relevant health information either manually or automatically using connected Apps or devices|
|Data Sharing – L2||The App allows you to share information in the App with others or other Apps/Systems|
|Carer Support – L2||The App provides features that help those caring for others|
|Online Appointments - L2||The App allows you to make appointments with health and care professionals using online booking|
|Personal Health Record - L3||The App allows you to create a personal health record|
|Remote Clinical Monitoring - L3||The App allows the remote monitoring of certain health data by health and care professionals|
|Online Prescriptions - L4||The App allows you to order and manage prescriptions online|
|Online Consultation - L4||The App supports online consultations with health and care professionals|
|Treatment Support - L4||The App provides support in the management of specific conditions and the related treatments|
|Automated Guidance - L4||The App uses the data it has to provide automated advice and guidance about your health|
STAGE FOUR - REVIEW DOMAINS
We look at an Apps compliance with standards, guidance and best practice in three distinct areas or domains. These are Data and Security, Clinical Assurance and User Experience. Each of these Review Areas has been designed by relevant experts and consists of a series of objective (Yes/No) questions which should be capable of being answered by our Reviewers from information in the App, on the relevant App Store or on a supporting website. If our Reviewers cannot find evidence to support an answer from these sources they will assume that the App is not compliant with or capable of satisfying the relevant requirement.
There are often cases where an App is in fact capable of satisfying particular requirements but that this is not made clear in any obvious publicly available place. In these circumstances Users are left with uncertainty as to the real position and our view is that in this circumstance they should proceed with caution.
|Data Security||What do we look for? - This Review Domain looks at what information an App collects from you, what it does with that information and how secure is its handling of that data. For some Apps this is only a minor issue as they don’t gather much information. Other Apps can gather lots of very personal and sensitive information and for these it is important to know how they go about handling this.|
|Clinical Assurance||This review area looks at what evidence there is that there is a suitably qualified professional or organisation behind the App or that it has been endorsed, accredited or underwritten by such an individual or organisation. It also assesses what evidence there is around user testing and the effectiveness of the App in terms of claimed health benefits. The higher the Level of the App and the more sophisticated its functions, the more crucial this becomes.|
|User Experience||This review area looks at what evidence there is that there is a suitably qualified professional or organisation behind the App or that it has been endorsed, accredited or underwritten by such an individual or organisation. It also assesses what evidence there is around user testing and the effectiveness of the App in terms of claimed health benefits. The higher the Level of the App and the more sophisticated its functions, the more crucial this becomes.|
STAGE FIVE- THE SCORE
This analysis results in an overall ORCHA score which is built up from the answers to each of the questions in the three Review Domains. Some questions earn positive points and some earn negative points. The ORCHA Score aims to deliver a meritocratic evaluation with all Apps being treated equally and fairly irrespective of their current popularity or the financial position of their Developers.
Any score below 65% would indicate that an App has some issues that users should investigate further prior to using this App. Scores below 45% indicate that an App has considerable issues or challenges and in its current form is potentially unhelpful or unsafe.
STAGE SIX- DEVELOPER NOTIFICATION & PUBLICATION
The final stage of the process is Developer notification and publication stage. When the review is complete, we send a notification to the relevant developer/publisher giving them an opportunity to preview the Review ahead of its publication. This gives them an opportunity to highlight any obvious errors or issues before we release the Review onto all our platforms. Once the notification period has expired, we publish the Review on all our platforms.
STAGE SEVEN– POST PUBLICATION REVIEW MONITORING & MANAGEMENT
All our reviews will remain valid until a new version of the App is produced. If a new version is not produced within 18 months of the current version, we mark the relating to the App as 'Out of Date' and the ORCHA App Score will start to degrade at the rate of 5% per month.
If the Developer implements a new version of this App we will automatically detect this via the relevant App Stores and we will mark the current review as being related to an old version of the App on all our platforms. The new version of your App will go back into the queue for a Re-Review and we will in time undertake this.