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Industry View: Digital Health Technology Standard published by NHSX

NHSX last month published a draft Digital Health Technology Standard and called for feedback from the industry before 22nd April.

The draft standard outlines 10 components on what the NHS expects. It’s based on existing standards and will support a process for reviewing, assessing and evaluating digital health technologies that meet the standard. It is also intended to speed up and streamline how health technologies are reviewed and commissioned by the NHS and social care.

Dr Indra Joshi, Rhod Joyce and Dr Nina Wilson from NHSX in a blog post said “We have developed the draft Digital Health Technology Standard, based on existing industry and health standards, to bring them together in a consistent, transparent and accessible way. This standard intends to consolidate and replace existing standards, rather than add new ones. This is part of our wider programme of work to speed up how health technologies are reviewed, commissioned and scaled across the NHS and social care, and to provide clearer guidance to support digital health technology developers.

In this Industry View feature sponsored by CCube Solutions, HTN asked leaders in health tech for their views:

Dilshan Arawwawala, Chief Clinical Information Officer, Mid Essex Hospital Services NHS Trust

The NHSX digital health technology standard draft document clearly outlines what has been sorely needed for some time. It covers the key areas relating to health tech ie user-centred design, protecting citizen’s rights, supporting a modular, open data approach and delivering objective value.

This high level document raises an important question – where will the responsibility lie to ensure these standards are adhered to? The exponential rise in health tech suppliers and product scope creep will place an increasing burden on suppliers and, more importantly, on purchasing organisations. How many healthcare organisations have a robust digital governance structure with the capacity to deal with the tsunami of data standards work that will be coming their way? Providing the resources and tools to support robust digital governance will be critical.

Data anonymisation and the risk of re-identification is an area which requires more detail. The ICO guidance on this is very clear – “it can be impossible to assess re-identification risk with absolute certainty”. A balance will need to be struck between suppliers revealing IP and ensuring data standards and ethical, unbiased approaches are maintained. How, where and by whom these decisions are made needs to be fleshed out.

There are clear opportunities here for collaborative partnerships between the NHS, its workforce and industry to produce robust solutions. A focus on long-term value, combined with fair commercial arrangements, will help get the right stakeholders working together towards common goals. Successful products, that adhere to the standards, are far more likely with this approach.

In summary, this is a welcome and timely draft document which sets a guidance framework to benefit the NHS, its workforce, citizens and suppliers.

Siten Roy, Senior Leader National Leadership Academy, Group Director of Surgical Services & Orthopaedic Consultant Sandwell & City Hospitals

NHS has tried different types of Digitalisation processes in last few years, without much success and at a huge cost. But, that should not deter us from re-visiting the area with more internal and global knowledge and learnings.

As a forward looking clinician, for me, the Technology Standards should have the following minimum components, many of which are already in this paper.
  1. Technology itself – it should be safe, simple, user-friendly, portable and low resource-hungry. And most important they should answer correctly and effectively the questions they are expected to. They should also be upgradable in future.
  2. People – with apology, I have to mention that not all clinicians are as tech-savvy as we will like them to be. In fact, there may be some resistance too. Hence, any new technology should be introduced after explaining all the advantages and the purpose, if necessary in stages. It should be ‘owned’ by clinicians, and not given to them.
  3. Environment – it goes without saying that the systems should meet all safety standards, including Data protection and External interference. However, there should also be enough flexibility to expand its use and create interfaces without much changes.
  4. Population Health – this paper does touch this important subject that though basically we will expect any Technology to deliver what it is supposed to in a specific clinical area, but it will be interesting to see how these changes and improvements can also link with the Social, Mental, Psychological and Economical improvement of the society. This will be a real test for any long-term success.

Vijay Magon, Managing Director, CCube Solutions

We strongly support use of a single digital health technology standard which consolidates a number of existing and overlapping standards, to ensure that the digitisation and life-cycle management of patient records can be carried out by approved suppliers who abide by the standard.

This is the only way to provide assurance to practioners that the digital record accurately replaces the paper record and the quality and integrity of patient information held in these records are not compromised. Once approved, in order to minimise burden on both customers and suppliers, the information provided must be made available to customers seeking to contract with suppliers without suppliers having to go through the process again. Clearly, the information provided must be verifiable and maintained over time.

The process should include checks on compliance and site visits to verify internal processes and compliance with standards. Such scrutiny may be repeated at agreed intervals to ensure that standards are maintained but should not be necessary each time prior to an award.

Gary Birks, General Manager, UK and Ireland, Orion Health

It is important that healthcare technology is developed to standards and that those standards continue to be assessed and developed in collaboration between the NHS and industry.  It is good to see NHSX recognising the importance of standards and the role they play.

As this draft recognises, most healthcare technology developed today must adhere to the many standards already in place, whether that be with respect to technology design, patient safety or security. The draft standard is useful in bringing these together in a consolidated view and is a helpful guide for the NHS and industry.

One consideration for NHSX and the industry is to work to ensure that standards do not prohibit or slow down innovation.  What the draft standard does reference but should make a priority is that innovation should focus on delivering benefits to patients and clinicians and that healthcare technology is not simply looking to align to technology standards, that technology is not for technology’s sake.  If the standard ensures that safe, effective technology gets in to the hands of clinicians and patients and delivers clear and defined benefits whether they are subjective or otherwise, that will be very welcome.

Orion Health works collaboratively with the NHS and the market to ensure that new standards are recognised, developed and done so with innovation in mind.  We are a founder member of INTEROPen and continue to support positive activities to ensure that standards work in practice through the regular INTEROPen hackathons.  These hackathons have created an environment of open collaboration, and it is collaboration in the development of standards that will ensure that they deliver benefit to the NHS.

The success of this standard should not be judged by whether companies comply, because reputable vendors will already be developing to the standards and approaches recognised.  It should be judged by whether it helps organisations to find, procure and adopt the technology they need to deliver clear and defined benefits for patients.

Martin Bell, Independent Consultant, The Martin Bell Partnership

There is much to be welcomed in the draft NHS Digital Health Technology Standard, and it’s certainly welcome that there is an element of consultation and discussion on this, from both within the NHS and the supplier community.

If one reads through the document, there is little one can disagree with, if anything. Helpfully, perhaps, all of the various elements one might want to see are brought together in one place, this is useful. It’s a good base from which to move forward. However, much or most has been discussed before.

Key to “moving forward”, versus previous NHS central technology strategies and approaches will be:

  • Will the amount of funding for Digital Health/IT/NHS IT/Technology/Informatics – call it all what we will – increase to levels that allow deeper, faster penetration across all areas of the NHS and Social Care – Acute, Mental Health, Community, Primary Care, Social Care etc – and allow the scaling of technologies that we know work, but through lack of funds, have not got out there?
  • Will NHS X / NHS Digital / Department of Health and Social Care “enforce” (can they enforce?) that any new contracts signed from a certain day forward must comply with the standard, or at least have a sensible period in which to comply with the standard, or that supplier/solution cannot service the NHS?
  • Will the technology standard still allow swift innovation from small, agile start ups and SMEs, as well as support greater interoperability and greater innovation and partnership working from more established players, who may have dominant or even near monopoly/duopoly positions in certain areas of the markets?
  • How will the transformational and human change support be embedded, to support the expansion of “tech” and crucially, will it be funded?
  • Perhaps for the wider context, and given the “drop the AND” campaign around health AND social care that started at DH ReWired last week, perhaps it should include the words “Social Care” too in the title – at least to the extent that it can?
  • How will citizens be genuinely involved in supporting the development of services, supported by technology, in the future – as it’s the delivery of services that is it important first, the underlying technology second?

Liz Ashall Payne, CEO, ORCHA

Regulation is essential to enable NHS professionals to trust digital health. One of the greatest challenges with regulations are that they need to strike the right balance between rigour and relevance.  When we look back, the NHS have been working on their approach to Digital Health Technology standards for around 5 years, the initial iteration had standards which were too low, exposing the NHS to risk, following which the bar was set too high, preventing all apps, even those actively used and built by NHS departments, to pass.

For the past 18 months we’ve seen the DAQ achieve significant improvements and greater proportionality – measuring the right things and setting the bar at an appropriate level for the specific digital health solution, however as with everything further improvements are always welcomed.

Looking at the new standard, the DAQ forms a part of the new standard alongside many additional sets of standards and requirements, some of which appear duplicative and do not show the proportionality which is critical in this work.  As such the new approach looks to be less streamlined and I do hope this doesn’t cause unnecessary cuts to the use of good apps for patients in the NHS.

As an assessor of DHTs across UK, Europe and Middle East, we await confirmation about what this final standard is and will work with the NHS to identify and turn any new elements in the standard into actionable and measurable processes that developers will be able to follow.  But first, it would be good to clarify what the current issues are with the DAQ, so that the modifications can directly address those in the first instance.

Louise Morpeth PhD, CEO, Brain in Hand

We welcome the standards and the intention to speed up and streamline the review of DHTs. We have three hopes. First that they will be applied proportionately – an app that motivates children to brush their teeth for two minutes can’t be expected to meet the same standard as one that manages diabetes. Second that they will encourage and not stifle innovation. There is no point in setting the bar so high that virtually all apps fail to make the grade. Third, that there will be a shift from a binary system of being ‘on or off the App library list’ to one where technologies are scored on the different dimensions (e.g. effectiveness, safety) akin to the Which? Magazine approach. By publishing the scores, the commissioner or purchaser can make an informed decision safe in the knowledge that the innovation had been independently scrutinised.

Sara Nelson, Programme Director DigitalHealth.London Accelerator programme

We warmly welcome this attempt by NHSX to standardise how health technologies are reviewed and commissioned by the NHS and social care. It is absolutely right that the NHS sets the highest standards for digital health technology to ensure patients and staff get the best possible care and services. Until now there has been no national standard of expectations of how to review, assess and evaluate digital technologies. This has meant time costly duplication, variations of processes and requirements and ultimately delays to digital innovations making a difference to people’s lives and work. NHSX have asked for feedback and input to these recently published standards and I would encourage our Accelerator companies, partners and NHS staff to contribute.

Chris Gibbons, Innovation Lead, UK health, Accenture

The Digital Health Technology Standard draft is a welcome starting point in providing greater clarity to developers in health and social care tech on the standards their products must meet. Having a common approach will speed up the review and commissioning of technologies; attracting more developers to contribute to providing people across health and social care with the tools they need.

We are pleased to see NHSX openly publishing early drafts of standards and co-developing the further detail and clarity required for the standard to be successful. Greater clarity will be needed on the linkages between existing standards and simplification of the steps developers must take; we look forward to discussing and contributing to NHSX’s continued development of the standard.

Rory Cameron, CEO, Gendius

Over 30,000 people have downloaded our diabetes app, currently over 1,000 a day, but we know we will help even more people by being part of a digital NHS system.  We agree that the NHS must set standards for apps, and we are currently undergoing the DAQ process, but as a technology start-up, it is frustrating to discover the process we are currently going through may be replaced not by a simpler process, but the same one with many more hurdles added.  To review and digest the proposed new standards will cost hundreds of thousands, budget we just don’t have – it will take about a month’s worth of manpower. In addition there is so much duplication with other standards we have achieved such as ISO27001.

David Kwo, Digital Health Specialist 

This document is a helpful collection of existing standards, guidance and regulations associated with digital health technologies (DHTs). It serves as a handy reference to know what relevant standards exist for DHTs in the UK.

It could be clearer about who is its intended audience. Is it the wider health and social service, to assure them that such DHT standards exist, or is to the DHT developers, or both?

As a compilation of DHT design principles, this document is useful. However, at times it also reads like a checklist for DHT developers to follow to demonstrate compliance. As a checklist though, it’s not clear precisely to which body (or bodies) the DHT developers need to prove their standards adherence (or how or when).

It could be clearer about the type of DHT products to which these standards are meant to apply. On page 3 it talks about “…health apps and tools.” But it then mentions “Digital Health Technologies” which is a wider concept. For instance, do shared care EPR systems and provider organisation EPRs come into this scope as they are different in nature and scale from “apps and tools”. It would be good to have examples of the range of DHTs for which this standard is intended.

Bias is mentioned in the first paragraph as something to be avoided in DHT design. It may be an idea to make more explicit reference to the need to avoid potential gender bias, as raised so well by Caroline Criado-Perez in her book “Invisible Women: Exposing Data Bias in a World Designed for Men” and in her excellent presentation at Rewired last week.

This document does add its own new standards for DHT developers to meet. For instance, there is now a need for DHT developers to “publish performance against KPIs openly and regularly alongside the assessment methodology” including “cost savings”. But it is not clear which standards body these standards must satisfy. Is it NHSD/E/X/or I?

I counted over 80 different standards, guidance articles and regulations being referenced in this document. Could a DHT developer company have to complu with them all in adhering this “standard”? Is that practical and facilitative of agile innovation? Will existing DHTs need to retrospectively demonstrate adherence?


– Thank you to the contributors –