During our recent attendance at HIMSS Europe 19 in Helsinki, ORCHA CEO, Liz Ashall-Payne, chaired and spoke in a number of sessions, as well as discussing ORCHA’s health app review process with HIMSS Consultant, John Crawford. Our contribution to HIMSS’ showcase of dynamic health-tech solutions, as featured in Healthcare IT News, highlighted the need to provide health app awareness, access and trust.

The interview for HIMSS TV began with Liz explaining that the initial idea for ORCHA came from thinking about ‘how we could improve efficiency and the quality of services to benefit more patients’ in the healthcare industry, which led her into digital health.

Liz went on to describe the opportunity that digital health brings, in that the provision of digital health solutions, such as apps, can help multiple patients at once. The challenge, however, is that there are over 300,000 unregulated health apps in app stores.

ORCHA addresses this challenge by creating a health app solution which increases awareness, access, trust and governance, in terms of encouraging digital health adoption. Liz emphasised the significance of ORCHA’s service by explaining that the journey to trusted digital health is ‘not just about [providing] clinical evidence, but also about [whether the app] data [is] secure’, which ORCHA takes into account by incorporating data privacy, clinical assurance and user experience into our review process.

Given that ‘trust is the biggest barrier’ to increasing the uptake of health apps, ORCHA’s ‘mission […] to distribute great health apps to people’ becomes primarily about providing users and healthcare professionals with a means of trusting digital health and, thus, seeing it as a viable healthcare option.

As Liz discusses in her interview, ORCHA’s robust app review process is the key to increasing trust in digital health. This review process begins with a data scrape of the health and fitness apps on Apple’s App Store, and Google Play. These apps are then filtered according to when they were last updated, before being curated into ORCHA’s 260 condition areas, and subsequently put into rank order from the most to least downloaded.

ORCHA’s filtration of the apps from app stores gives a queue that determines the order in which the apps will be reviewed by our Review Team. After the app queue has been generated, ORCHA then uses a classification system to assess the safety and quality of health apps, as well as finding out the apps’ functions and features.

But what makes ORCHA unique? Liz explains that ORCHA has ‘created a review accrediting engine that helps us process apps very quickly’, so we are unique in our very streamlined accreditation system and the consequent speed with which our reviews can be carried out. Not only do we review apps according to their ‘data security, data safety, clinical validity and clinical safety, and user design,’ we also understand the ‘continuous cycle’ of reviewing and rereviewing apps. Our system ensures that we are aware if an app has changed since it was last reviewed, meaning that the apps on our App Library are kept up-to-date with accurate information.

Furthermore, healthcare professionals can use ORCHA to find and prescribe the best apps to patients through the 87 local health app libraries that we provide. This app recommendation process is used so that professionals can ‘find a safe product and then use the system to prescribe via text message.’

Liz’s interview concludes with the notion that digital health can have the best success by being used alongside traditional healthcare services and products. Digital health is not intended to replace traditional methods, but to enhance them. For instance, sometimes a drug may be most effective, sometimes an app on its own, and sometimes a combination of the two. ORCHA believes that the way forward is for pharma and digital health companies to work together, rather than being in competition.

Watch Liz Ashall-Payne’s interview at HIMMS here: https://players.brightcove.net/1824526989001/default_default/index.html?videoId=6045583737001 

As a developer, staying up to date with the latest app regulations and standards is essential. We’d like to make this easier for you so that your apps can provide the best customer experience, whilst also meeting the standards required for safe, ethical and high-quality apps.

Important standards and regulations for app developers to be aware of include:

• National Institute for Health and Care Excellence’s (NICE) Evidence Standards Framework for Digital Health Technologies – These standards show the value of digital health technologies in the UK health and care system by requiring apps to provide evidence of their effectiveness. Due to the rapid development of digital health technologies, these standards require apps to demonstrate a high level of clinical effectiveness. According to Public Health England, this includes providing evidence that an app improves outcomes for patients and users, provides value for money, meets user needs, as well as that it is stable and simple to use, and that people actually use it.
• Medicines and Healthcare Products Regulatory Agency (MHRA) – If your app meets the definition of a medical device then it must be registered with and regulated by the MHRA to ensure the app’s quality and safety. The MHRA will enforce the following safety regulations under the Consumer Protection Act 1987: the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) and the General Product Safety Regulations 2005 (SI 2005 No 1803) – the MHRA can investigate apps’ compliance with these regulations in accordance with the Consumer Rights Act 2015.
• Care Quality Commission (CQC) – Your app is required to register with the CQC if it provides a health or social care service, as defined by the CQC’s ‘regulated activities’. As the independent regulator of health and social care in England, the CQC ensure that health apps are high-quality, safe and effective for consumers, patients and healthcare professionals.
• General Data Protection Regulation (GDPR) – As set out by the Information Commissioner’s Office (ICO), all businesses and organisations operating within the EU must comply with GDPR. If your app controls and/or processes personal information, you are accountable for the handling of this personal data and sensitive personal data. As such, GDPR requirements include: the need to be transparent about how personal data is processed; data must be adequate, relevant, accurate and kept up-to-date; data must not be kept for longer than is necessary, and must be processed such that there is appropriate security of the personal data.

There are many other standards and regulations that form part of ORCHA’s accreditation regime, several of which we will expand on in future newsletters. If you would like more information about how we accredit apps for our App Library and NHS Digital, please contact hello@orcha.co.uk

Featured in international journal, npj Digital Medicine, a study into digital health validation solutions by American research university, Johns Hopkins University and its affiliates, directly parallels ORCHA’s vision for validated health apps.

The study, which can be read here, outlines the existing digital health landscape, explaining that ‘Although some digital health products have been rigorously studied to determine clinical effectiveness, such evaluation is not widespread.’ (p. 1) It then goes on to describe Johns Hopkins University’s proposed solution to the problem of unregulated mHealth: a ‘digital health Scorecard’ (p. 4) that can meet the ‘need for [a] requirements-driven approach.’ (p. 4) Such a concept is of particular interest to ORCHA, as our 180-point app review process compiles multiple measures within a scorecard for each app. Our method of reviewing and thus scoring apps provides a robust framework, contributing to the aspired landscape of validated digital health apps.

Johns Hopkins University cites the ‘Broad criteria for [health app] approval, defined by NHS Digital and National Institute for Health and Care Excellence’ (p. 4) as ‘pertain[ing] to clinical effectiveness, regulatory approval, clinical safety, privacy & confidentiality, security, usability & accessibility, interoperability, technical stability, and change management.’ (p. 4) Similarly, the ORCHA Review measures each app’s Data Privacy, Clinical Assurance, and User Experience, as well as outlining its specific functions and features.

ORCHA addresses the key barriers to digital health adoption – access, awareness, trust and governance – by providing an App Library in which consumers and healthcare professionals can search for and download health apps which have been reviewed according to ORCHA’s multifaceted framework. We also give clinicians the opportunity to digitally recommend apps to patients by using an ORCHA Pro Account. This satisfies the point raised in Johns Hopkins University’s study: in reference to ‘clinician workflow’, the study advises that ‘digital health solutions […] must pay attention to ease of accomplishing the expected tasks.’ (p. 6) By making it easy for healthcare professionals to not only understand the safety and effectiveness of health apps, but also to quickly recommend apps to their patients, ORCHA saves time for busy clinicians during what would otherwise be a lengthy validation process.

ORCHA takes action against the hundreds of thousands of unregulated health apps on the market by taking a structured and methodical approach to providing mHealth validation. We keep up with the rapidly changing digital health landscape by constantly evaluating and revising the way in which our App Review framework can make accessing trustworthy digital health even easier for patients, professionals and populations.

Through our understanding of the digital health landscape as one that is both complex and dynamic, we choose to be innovative in our solutions and their delivery. In doing so, we facilitate trust in a characteristically uncertain environment. ORCHA is expanding beyond the UK, implementing digital health solutions across national and international health and care organisations, thereby allowing access, trust and understanding to continue evolving on a global scale.

Just as Johns Hopkins University emphasises that overcoming the digital health challenge will not be instant as ‘The road to validating digital health will take resources, collaboration, and time’ (p. 7), ORCHA realises that the journey to complete digital health validation is ongoing. The increasing demand for digital health solutions illustrates a market that is far from static. ORCHA’s solution offers a strong starting point for enacting the necessary change to sustain the expanding and evolving need for digital health.

Brian O’Connor, Non Executive Chairman, with Liz Ashall-Payne, ORCHA CEO

The world’s leading Organisation for Review of Care and Health Applications, ORCHA, is delighted to announce the appointment of Brian O’Connor as Non Executive Chairman.

Brian brings a wealth of international business experience and Connections globally. He founded the European Connected Health Alliance (ECHAlliance), the global connector in digital health, which through its many collaborations covers 78 Countries with a population of 4.6bn.

ORCHA has grown to provide digital health advice and services to Government health bodies across five countries and in the UK delivering services to more than 20% of the NHS, serving a population of 200,000 people.  Brian will ensure ORCHA continues and accelerates this growth, enabling more organisations to unlock the power Digital Health has to offer.

Brian joins a strong management team, including co-founders Liz Ashall-Payne, CEO and Tim Andrews, COO and an advisory board of individuals that have helped change and grow industry, including Sir Terry Leahy, Bill Currie, Dr Chris Mimnagh and Andy Davidson.

Commenting on the appointment, Liz Ashall-Payne said:

“We are thrilled that Brian is joining us.  He is such a force for good.  Throughout his career he’s enabled organisations to drive through the adoption of technologies to help organisations and consumers.  He understands cultural and other barriers and works with Governments and organisations to deliver the best outcomes.”

Also commenting on the appointment, Brian O’Connor said:

“ORCHA meets a very real need in the market place right now, not only in the UK but globally.  Letting consumers use untested health apps poses a real risk to health. Health services are not yet tapping into the economic and health improvements that can be made with apps.  But things are changing, ORCHA’s growth is a sign of this, and I look forward to helping ORCHA help deliver even more change across health services in the future.”

Brian O’Connor Biography

Brian O’Connor was born in Belfast, Northern Ireland and has developed his career as a consultant, manager and/or investor in both private and public companies.

Brian has founded a number of companies in the healthcare services area in the UK, Ireland and Hong Kong.

He has gained significant experience as a company director in a variety of industries and professions, and has raised significant sums for companies through both private equity structures and stock exchange listings.

Brian founded and is Chair of the European Connected Health Alliance organisation www.echalliance.com, the rapidly expanding not for profit membership organisation.

He is a shareholder, director, investor in a number of private companies in the health and care sector.