We are proud to share the news that we are supporting Nordic Innovation’s work to launch a new Nordic Digital Health & Medication Platform.

Nordic Innovation has co-funded the Nordic Digital Health & Medication Platform project, which will establish and operate a Nordic marketplace for accreditation and distribution service for digital health apps within the healthcare and the preventive care segment in the Nordic region.

The project, which is run by a strong Nordic consortia, aims to help the citizens access quality health apps through channels they can trust, increase the uptake of digital solutions for both treatment and preventive health, and boost the digital health industry through the access to a Nordic wide marketplace for accredited solutions.

The Nordic accreditation model will be based on international, national and if needed regional or local regulations for digital health apps.

To learn more, click here.

We were delighted to feature in Karen Evennett’s recent article in the Waitrose Weekend Newspaper.

With so many exercise apps, which one is best for you?

Many gyms are now open, but during lockdown, millions of us discovered a new way to work out using smartphone apps. Waitrose asked fitness experts James Griffiths and Sammy Margo to test some of their favourites.

Click the link below to download a PDF of the full article, featuring ORCHA scores for each app.

85% of Health Apps in the U.S. Do Not Meet Quality Thresholds

WASHINGTON, DC and DARESBURY, UK, OCTOBER 15, 2020 – The American Telemedicine Association (ATA) today announced a new partnership with ORCHA (Organisation for the Review of Care and Health Apps) to create a review process for the U.S. to enable healthcare providers, insurers, and employers to give patients access to safe and effective health apps. ORCHA’s automated, intelligent review engine allows healthcare organisations to assess thousands of apps against more than 300 measures in order to build and manage a health app program. The partnership was announced today during the ATA’s special half-day event at the HLTH VRTL conference.

“The proliferation of health apps has created challenges for healthcare providers and patients seeking to find the most appropriate, safe, and effective health apps to monitor their health and wellness, maintain a healthy lifestyle, and securely collect and transmit personal health information. We are delighted to partner with ORCHA to address this critical need and give both patients and providers greater confidence in selecting safe and effective apps,” said Ann Mond Johnson, CEO, the ATA. “Chat-based interactions and asynchronous tools are an important component of telehealth offerings and can help ensure that everyone has access to safe, effective, and appropriate care when and where they need it.”

The ATA will work with ORCHA to develop a review process and criteria that meet the specific needs of the U.S. market. App developers will be able have their app reviewed against ORCHA’s more than 300 measures. If the app meets the criteria, it will be added to the ATA library of approved apps. Health providers, insurers and employers will be able to use this trusted platform to build their own dedicated health app library with high quality apps suitable for their patients.

“This partnership will enable healthcare providers to better spot the best health apps from the hundreds of thousands available in app stores. It can also arm clinical staff with the software that will enable them to connect the right apps with the right patients at the right time,” added Liz Ashall Payne, CEO, ORCHA.

ORCHA has evaluated more than 4,000 health apps currently available in the U.S. against its criteria and found only 15% meet quality thresholds. Most apps fail to meet healthcare, security or usability standards established to safeguard patients.  Such quality standards apply across apps for all health conditions, from fitness to heart conditions.  For example, ORCHA has assessed 584 apps designed to support people with mental health conditions and found only 29.6% meet quality thresholds.

“There are many safe and effective health apps built by U.S. innovation companies that have the potential to help individuals create and sustain healthy habits, monitor health conditions, and share important personal health information with their providers, family members, and caregivers,” said Joseph C. Kvedar, MD, President of the ATA; Professor, Harvard Medical School; and Editor-in-Chief, npj Digital Medicine. ”The mission of the ATA is to create access to quality care for all individuals and this is another important step, ensuring people have access to safe and appropriate digital health apps.”

Health apps offer immediate and convenient access to personalized and engaging health support. Thanks to the rise in smart phone ownership, 19% of Americans have downloaded or used health care apps and more than 8 in 10 rate health apps as either very or somewhat helpful. Yet, app stores have no regulation or criteria in place to help patients and providers select health apps that best suit their needs.

About the ATA

As the only organization completely focused on advancing telehealth, the American Telemedicine Association (ATA) is committed to ensuring that everyone has access to safe, affordable, and appropriate care when and where they need it, enabling the system to do more good for more people. The ATA represents a broad and inclusive member network of health care delivery systems, academic institutions, technology solution providers and payers, as well as partner organizations and alliances, working to advance industry adoption of telehealth, promote responsible policy, advocate for government and market normalization, and provide education and resources to help integrate virtual care into emerging value-based delivery models. Visit the ATA COVID-19 Resource Center. @americantelemed #telehealthishealth #ATApolicy

About ORCHA

The Organisation for the Review of Care and Health Apps (ORCHA) is the world’s leading, independent digital health evaluation and distribution organisation. It helps health and care organisations to deliver the right digital health apps, to the right people, at the right time. Its unique insight, assessment, and implementation services are improving the health of the population, the health of our health systems and the health of the health app ecosystem. ORCHA conducts reviews for government organisations across Europe, the Middle East, and Australasia.  In the UK, ORCHA conducts reviews for the NHS and is part of the NHS National Innovation Accelerator Programme.

_{The unprecedented challenges that the COVID-19 crisis has thrown up for the world’s health and care systems and wider society have, in many ways, created equally climactic opportunities for many aspects of digital health. Cometh the hour cometh the technologies, to horribly paraphrase the classic line. But it was immediately clear that digital health solutions were uniquely placed to provide support to a world in lockdown.}

_{The obvious need to switch to remote consultation approaches were at the vanguard of this. Whilst excellent telehealth and telecare provision has been available for many years, and in recent times this has extended to mobile versions of these models, the traditional slow rate of adoption within healthcare of new technology and new systems of work has meant that these solutions have remained at the periphery of health and care delivery; until now. The rate of adoption over the past few weeks has been nothing short of miraculous, with self-isolation providing the stimulus for digital adoption.}

_{What is however more significant is the growing reports of clinicians and professionals acknowledging that these models of care are not just suitable for the strictures of the COVID-19 challenge. COVID-19 or not, these models and approaches to care delivery are likely to have provided significant patient and health service benefits, had they been the norm long before now. The recent uptake of digital health solutions also suggests these may be a central element of care going forward, beyond the unique circumstances of COVID-19.}

_{The adoption of these models in other care settings has often been slower even than primary care. As outpatient clinics, psychological therapies, diagnostic services and routine ‘check-ups’ become increasingly inaccessible to not just the ‘shielded’ and vulnerable, but all; the value of extending access to these types of activities via digital health, is clear. In fact, the use of digital health technologies may for some time be the only means of ensuring that we remain on the right side of our need to provide equal access for equal need, and ensuring that wider health and care systems remain functional during this unprecedented crisis.}

_{But digital health is much more than online consultation. Properly considered digital health is capable of transforming pathways of care and delivering not only significant efficiency into working processes, but also extending access and availability of limited resources. It is also capable of even improving the quality and reliability of the therapeutic options selected and ultimately the quality of a patient’s health and care outcomes. A classic example of this is the growing array of solutions that support the self-management of acute conditions, thereby enabling the remote monitoring of patients by healthcare teams. From an efficiency perspective, there are innumerable examples of where this type of solution can assist healthcare teams to streamline face to face engagement, by identifying only those within a particular patient population that need that level of intervention. This not only offers the opportunity to save vast numbers of unnecessary appointments and free up capacity for those who really need it, but also improves quality of life for those patients who are not required to attend.}

_{Yet even the amazing opportunities that self-management and remote monitoring solutions offer are dwarfed by the emerging array of evidence-based diagnostic or ‘risk-management’ tools now on offer. These solutions, often using cutting edge AI approaches, typically provide extended diagnostic evaluation; often directly into the hands of the patient themselves. They are capable of automating or semi-automating aspects of the diagnostic journey to enable much earlier interventions in many key disease and condition areas, whilst at the same time reducing the burden on already stretched traditional diagnostic functions. Again, it is to be hoped that these solutions are more rapidly embraced as a result of the considerable issues with delivering traditional diagnostic models in the COVID-19 world. But once embraced and road tested with patients and healthcare providers as part of our temporary ‘routine care’ shift, there will come a question that requires answering, as to whether or not these technologies should become mainstream components in future health and care delivery.}

_{Given the current role digital health solutions are playing in the COVID-19 crisis, and the increasing switch to digital care processes, the question remains as to why these technologies have not been routinely adopted previously, and perhaps more importantly, what barriers remain to their adoption even with the huge impetus that the COVID-19 lockdown offers. The answer is multi-layered, but in short, is centred on the issues of assurance, evidence and governance.}

The Assurance Gap

_{Digital health has for a long time been viewed as a lesser science in many health and care quarters. It is often considered light weight and superficial, and even where solutions are developed by very respected institutions and individuals with evidence analogous to the standards expected of pharmaceutical medicine, the spectre of the overall digital health landscape remains a barrier. It is perhaps unsurprising that a concept such as digital health, which spans such a breadth of solution types including very functionally ‘simple’ products, will suffer from an overall brand confusion. For example, does digital health include such mega brands as FitBit, MyFitnessPal or Strava? Are Calm and Headspace really part of the digital health club? In essence this simply highlights the age-old debate, of ‘when does wellbeing become health?’ and ‘what is the line beyond which digital health becomes something more weighty and more significant?’} 

_{The coexistence of hugely complex and sophisticated products and services with extremely basic and simple solutions is not unique to the digital health space. Medical devices and the regulations underpinning them – which are largely respected and relied upon by the health and care systems that engage with it – cover latex gloves and surgical gowns (and dare we say PPE?), right through to MRI scanners and robotic surgical assistants. It is therefore not the fact that digital health exists on a similar spectrum of functional difference and complexity that is perhaps the key issue. It is – and this is reflected in numerous studies and surveys – the fact that unlike medical devices, or pharmaceuticals, ‘digital health’ does not have a clear and reliable regulatory or assurance framework.}

_{Of course, digital health is still subject to many of the surrounding regulatory processes and procedures that govern other health and care products and services. An increasing number of digital health products are for example, classified as medical devices and this trend will be accelerated and magnified in the EU jurisdictions, when the Medical Devices Regulations eventually come into full effect. Most ‘digital health’ products are governed by data and privacy regulations such as GDPR, and solutions that deliver ‘virtual healthcare’ services will usually have similar licencing or certification requirements to traditional ‘bricks and mortar’ operations.} 

_{However, these pre-existing regulatory structures do not apply uniformly to the myriad array of ‘digital health’ solutions, and in many instances are not well designed for these new models of health and care delivery. A good example is the issue of evidence which is a key requirement under most medical device regulations. For well-established products and services, the relevant expected standards of evidence are relatively clear. For digital health however this is less obvious, and there remains a relatively large vacuum in understanding what ‘types’ of evidence are required in what circumstances. Initiatives such as the Evidence Standards Framework for Digital Technologies (ESF) developed by the UK’s National Institute for Health and Care Evidence (NICE), illustrates the need for new thinking in this space, that will in turn support the interpretation of existing legislation that was crafted in a time pre ‘digital’.}

_{Even though existing regulation does often apply to digital health, this does not seem to be enough in and of itself to satisfy health and care systems, bodies and professionals that these tools are safe and effective. There remains an ‘assurance gap’ that continues to inhibit the progress of digital health technologies. For an increasing number of health and care systems across the world this assurance gap has led to the development of specific and targeted digital health accreditation regimes which have been challenging to develop, deliver and scale.}

Challenging but not impossible – digital assurance for a digital age

_{It can be tempting to think that closing the assurance gap in the world of digital health is just too hard.}

_{However, that is not the case. Digital health assurance can be effectively delivered and maintained by adopting new and novel approaches to the traditionally conservative field of regulation and certification. What is required is a digital Assurance model to deal with digital products and services. A key element in this is the effective collation, management, and analysis of ‘assurance’ data. Digital solutions have a data footprint like no other. Most drugs cannot tell you whether they have been taken and if so when and by whom. Similarly, most medical devices do not habitually capture information on how they are being used and what users’ experience of that is. Digital solutions can do all of this and more.}

_{In addition, other assurance data is more than ever available ‘online’ with a growing array of APIs and other feeds available to support both the initial evaluation and the ongoing monitoring of any product or service. Customer, user, or patient feedback has never been more readily available and with the rapid progression of natural language processing and machine learning technologies, these vast arrays of data can be manipulated and organised to support assurance regimes and processes.}

_{Models such as the NICE ESF are also emerging to fill the gaps in some key assurance domains and similar initiatives are evolving in areas such as security and user or patient experience.}

Case Study – the ORCHA Assessment Model in action

_{All of these elements are already coming together to support hundreds of health and care organisations and professionals in the UK and the EU through the ORCHA Review methodology. Our solution adopts a layered approach to assessment and builds the critical assurance data up gradually through distinct phases. It uses a combination of data, technology, and expert human evaluation to deliver highly effective assessment at pace and at a fraction of the traditional assessment cost.}

_{The foundation layer for all we do is known as the ORCHA Review and this covers a significant proportion of the key compliance elements of a review; analysing a digital solution against over 300 distinct ‘compliance’ metrics ranging from data and privacy through to usability and accessibility, and of course clinical/professional assurance.}

_{The ORCHA Review incorporates all of the proposed compliance and conformity assessment components of the emerging draft CEN/ISO Technical Standard that we have been closely involved in developing but builds on it.}

_{The ORCHA Review already supports hundreds of NHS and other health and care bodies in the UK to identify and promote digital health solutions to their populations, and provides a foundation ‘digital health formulary’ for thousands of health and care professionals. It has also been adopted by the British Dietetic Association (BDA), The Society of Occupational Medicine (SOM), and the Chartered Society of Physiotherapy (CSP) to support the development of Libraries and Formularies for their members.}

_{The second layer in our model is an ‘Enhanced Review’ layer and this is made up of Enhanced Review Components that our clients can select as part of their own assessment build.}

_{The combination of the ORCHA Review and the Enhanced Review Components has been adopted by the GGZ/MIND organisation in the Netherlands to underpin its own digital health assessment model and to support the associated App Library [appweizier] that will promote solutions to its member bodies and through them to the relevant patient populations in the Netherlands.}

_{Many other national bodies are now building this layered approach into their own thinking, recognizing as they do that by doing so they are sharing the assessment burden very effectively and leveraging the most advanced analysis available in this still relatively new market.}

_{In the meantime, however, there is alongside the opportunity that the COVID-19 scenario affords digital health, also a significant threat. The threat is that in the rush to ‘fast track’ solutions into front line delivery, assurance is pushed too far  away, and that potentially substandard and dangerous products are actively promoted to vulnerable populations.}

Assurance doesn’t have to be slow if done right

_{Whilst the assurance gap is still a reality, there are, as we have seen, mechanisms and approaches that can still be utilised to both support the adoption of these technologies at pace, and maintain a reasonable standard of oversight and accreditation.}

_{ORCHA can deliver a robust review and assessment of a digital health product within hours. There is therefore no real excuse for a wholesale relaxation of all elements of assurance, which will ultimately risk the gains that digital health might well make in these unusual times.}

_{You can view how we are enabled to do this work via our Review Accreditation Engine in this video link below.}

An opportunity not to be lost

_{The COVID-19 crisis is a truly terrible situation for the world to face, and for health and care systems in the front line of this the challenge must be truly daunting. However, if there is any silver lining to be found, one such element could be the acceleration of the use of digital health in a manner that simply would not have been possible in ‘normal’ times. If this is to be done safely and effectively and if it is to be maintained beyond the immediate crisis, it is crucial that sensible assurance is not forgotten in the rush, and that the accreditation gap that has been such a barrier to adoption to date, is not rapidly re-established post crisis to roll back the progress made.}

_{If you want to learn more about how we can work together, please do contact us at hello@orcha.co.uk}