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.

Take a look at eGP Learning’s video on how to prescribe health apps safely using ORCHA. eGP Learning provides a range of services to help with technology-enhanced primary care and learning.

Describing ORCHA as ‘the BNF of applications’, eGP Learning’s YouTube video provides a walk-through of ORCHA’s App Finder and discusses how this can be used by health professionals in order to recommend the best apps for patients.

Hussain ‘DrGandalf’ Gandhi, founder of eGP Learning, demonstrates his use of ORCHA’s app prescription service, including the ease with which he is able to search for and subsequently recommend suitable apps for his patients’ individual health needs.

It is great to see that clinicians and patients are benefitting from our extensive App Library which aims to make digital health accessible to all. ORCHA helps to increase mHealth adoption in healthcare delivery by providing healthcare professionals with the necessary tools to incorporate excellent digital health into everyday practice.

Watch Dr Gandhi’s review of prescribing apps using ORCHA below: