Digital transformation – are you prepared?

Digital transformation is crucial for the NHS as it seeks a sustainable future and to meet expectations of high quality care. A number of different programmes are now in place to support this, including the NHS and industry ‘test bed’ partnerships, local STP and new care model projects and, most significantly, the Global Digital Examplar (GDE) programme.

Under the GDE programme NHS England is providing funding and partnership support to selected digitally advanced trusts – 16 acute trusts and seven mental health trusts (from the date of this publication), who will use the funding to create blueprints which can be rolled out across the NHS.

All acute trust exemplars are now partnered with ‘fast followers’ – trusts who will support the spread of best practice and innovation. Mental health GDEs will also partner with fast followers
over the next year. And in a separate but parallel funding stream, 12 trusts using DXC Technologies’ Lorenzo EPR system are participating in a new “Lorenzo digital exemplar programme”.

The GDE programme is seen as essential to achieving digital maturity and moving to a digitised environment, the benefits of which are clearly evident and include:

• better collation of patient data and an easier means of keeping that data accurate and up to date in ‘real time’
• improved access to data for both clinician and patient
• greater efficiencies, enabling clinicians to work more effectively, generating a better patient experience and improved outcomes.

Whether your trust is a GDE or fast follower or participating in its own local transformation programme, you will recognise that the road to digital maturity can be a bumpy one. Doing something
differently and for the first time often brings unexpected or new challenges. We have produced a full briefing on these issues available on request and this article outlines the key points that you will want to consider in the following areas:

• managing the innovation process
• procuring suppliers
• information governance requirements
• getting your workforce up to speed.

Managing the innovation process

Innovation is an integral part of any quest for digital maturity and technology underpins most innovative projects. Moving data and services from an offline, paper based environment to online necessitates a new way of thinking, new processes and procedures and often new methodologies and technologies to facilitate the transformation.

There are a number of routes to achieving digital transformation, but it is unlikely that the technical solutions that a trust requires will be available “off the shelf” and ready to go. It may instead need to either work with external suppliers to create bespoke solutions or use its own internal resources to develop a tailored solution.

Both approaches have benefits and disadvantages from a practical and commercial point of view, but both also raise an interesting legal consideration. What happens to any intellectual property (IP) that is generated as part of the innovation process?

With an external supplier, it is very likely they will want to claim ownership over any IP which may potentially be useful to future customers. How trusts respond to this may depend on a number of factors:

• how much of the cost of the development has been borne by the trust and how much by the supplier
• whether there are other trusts who also want to use the technology
• if there is a commercial value to the bespoke systems generated and whether the supplier – or someone else – is best placed to realise that potential and maximise income.

A well written contract at the start of a relationship is the way to ensure that ownership of IP is clear to everyone. Discussions need to cover:

• who owns any IP at the start of the relationship and who owns that created during it
• what right each party has to use IP owned by the other party
• what happens with third party software or systems and do they restrict any future use or roll out of the system
• what is the effect of using any open source software on systems in the future.

If an organisation is developing solutions internally, the situation with IP is generally clear: IP generated by employers is owned by the employer. However, this is not automatically the case if a trust employs a self-employed contractor or uses students or freelancers. To gain the IP from their work, the trust will need to have a contract in place which transfers the IP to the employer.

The start of a transformation project is the best time to ensure these issues are addressed and trusts are in the best position to exploit any resulting IP from projects. Often trusts will have an IP
policy which will provide an appropriate framework for dealing with these issues by providing a means for collating and assessing IP information. If not then the start of a transformation project, which will undoubtedly result in the generation of IP, is a good time to formulate such a policy. It is also a good time for trusts to review their existing policies and ensure that they are adequate and appropriate for what is likely to be a period of intense innovation.

IP law is complex and they may wish to seek advice on their particular circumstances.

Procuring technology

There have been predictions that the GDE and fast follower models could lead to a position where no NHS organisations will need to run IT system procurements again. However, this does not sit easily with the current procurement legislation and the  wider value for money requirements in the public sector. Trusts will need to find ways to lawfully procure their IT suppliers.

For any IT requirements over the relevant threshold (currently £106,047 for NHS trusts and £164,176 for FTs) a trust must procure its requirements under a set competitive procedure involving
advertisement in the Official Journal of the EU (OJEU). Alternatively a trust can make its purchase quickly and more efficiently through a compliant framework such as one of the many various frameworks set up by the Crown Commercial Service.

Trusts will be familiar with standard open or restricted procedures which may be for off-the-shelf purchases. But what about more complex requirements and/or where framework providers do not provide the system/software that are wanted by the trust? If you are a GDE and are in the process of trying to produce a blueprint for deployment to fast followers are you going to be able to do this without negotiating a solution? It seems unlikely and so the standard procedures in the 2015 Regulations are unlikely to assist. Trusts will need to consider alternatives.

Two options are competitive dialogue and competitive dialogue with negotiations. Both can be effective ways to procure with the choice of procedure depending on whether trusts see benefits in dialogue opportunities with a preferred bidder.

Another option may be what is termed an innovation partnership. Innovation is tightly defined under the 2015 regulations as: “the implementation of a new or significantly improved product, service or process, including but not limited to production, building or construction processes, a new marketing method, or a new organisational method in business practices, workplace organisation or external relations, including with the purpose of helping to solve societal challenges or to support the Europe 2020 strategy for smart, sustainable and inclusive growth”.

Under this procedure the trust would advertise its need for an innovative solution and select suppliers to set up a partnership – negotiations can take place. A partnership can be set up with one
or more providers and the partnership essentially goes through R&D stages. This process has the advantage of allowing, once a successful solution is found, the trust to purchase that solution without any further competition. Hempsons advised on one of the first innovation partnerships in Europe and so are uniquely placed to assist clients where this procedure may be an attractive option.

A competitive procurement is not necessary in every circumstance; the 2015 regulations allow waivers if certain conditions are met. This could include cases where the solutions have to integrate with existing systems. However, the exemptions around this are extremely complex and trusts need to be careful to avoid the prospect of a challenge.

It has been reported that the GDE organisations will form a new procurement framework where they will work with suppliers to sell digital transformation services to less advanced organisations. In theory this presents a neat solution to the procurement problem faced by fast followers and others – once the GDE organisation has a system which works a trust can simply “call off” that solution from a framework. BUT – the framework will need to be set up in accordance with the 2015 Regulations in order for the call off made by the Trust to be compliant with the legislation. There is no clear indication of how NHS England plans to do this yet.

Finally, we note that GDEs and fast followers will be receiving some funding from NHS England: it will be vital to read the terms of this carefully to see if there is any restriction or requirement related to procurement.

Data protection

As a GDE or fast follower you will undoubtedly be looking to digitise data which has previously been not held in electronic form. You may also be migrating electronic records to new systems or joining up or sharing data sets for the first time. All of these activities ring alarm bells for the information governance specialists whose immediate concern will be – can this be done within the law?

If you have anything to do with data or systems, it probably won’t have escaped you that there is a new data protection law coming into force in May 2018 – the General Data Protection Regulation or ‘GDPR’ as it is commonly referred to. This is heralded by many who work outside the NHS as a game changer, bringing much more stringent regulation to our everyday use of personal data.

However, those who work in the field of information governance will be aware that all too often data protection law will be cited as the reason why something can’t be done. In reality the problem is not usually the data protection laws, but because the proposed use of data is contrary to the NHS’s internal information governance rules. Those rules go beyond current data protection
legislation and even with the arrival of the GDPR, those who are used to complying with NHS information governance rules, will find its implementation far less radical than those operating in a non NHS environment.

But what are the key things to remember as you embark on your digital transformation project? It is important to bear in mind that the laws governing data protection are much less concerned
with the medium by which personal data is held (for example in paper or electronic form) and are much more focussed on how that data is used and protected, and how data subjects’ rights are
respected. The GDPR does not dictate the form in which personal data should be held, but sets the standards and rights that apply to that information.

The advent of the GDPR provides a key opportunity for healthcare providers to review how they store and protect records. Fears of hacking of digital records can and must be addressed by ensuring the right security measures are in place and maintained. But this does not mean that paper records are in any way ‘safer’ than digital records – one of the aspects of maintaining data security under the GDPR includes ensuring the integrity and availability of data services, and being able to show that these standards are being met.

Digital records provide an opportunity to streamline the steps needed to ensure GDPR compliance, and with changes such as the abolition of subject access fees, finding the most cost effective
way to store and share records will be a priority.

Digital records also provide a much greater opportunity for information sharing than previously possible – with access to information within and across organisations being much easier
than before. Balancing the increased opportunities to share and access information against the need to maintain NHS information governance principles will require care and practical advice.
Many of the benefits of digital records will be lost if organisations become too fearful of regulatory action to share data where it needs to be shared, while equally a failure to limit sharing in
accordance with patient’s expectations could be equally damaging.

We regularly advise NHS clients on the interface between data protection and NHS information governance obligations, and provide practical help and solutions to overcome perceived obstacles to valuable projects. Digital records also provide opportunities for research that are simply not practicable in paper records and we can advise on how such projects can work without infringing data protection law or NHS information governance rules.

Getting staff to adopt new ways of working

With the need to change and reconfigure the existing NHS workforce to meet the demands of new service models comes the need to ensure that the workforce are familiar with and are utilising new technology. A digitally fluent workforce is a necessity.

We anticipate that providers will need to recruit in to wholly new areas to provide the service required and it’s crucial that recruitment decisions are taken in an informed way. Pre-employment checks, the risks of discrimination and fair procedures are all areas that trusts need to consider. We also anticipate that there may be a need to engage with specialist recruitment agencies.

It’s likely also that existing service models need to be reorganised. This is likely to involve changes to terms and conditions, consultation, possible redundancies and general restructuring. It is important to ensure the changes are implemented with the minimum legal risk and in a way such as to be effective. Early consultation with individual employees and their representatives will be essential.

We anticipate that technological change will involve the increased use of temporary and agency staff in some new areas and it’s important to ensure that trusts are aware of the regulations around this and don’t encounter any pitfalls.

To some employees the advent of new technology will be a significant challenge and it will be important to ensure that valuable employees are managed so as to positively manage their resistance and minimise the risk of any claims arising. Our team of expert lawyers can advise on performance management, misconduct and dealing with resistance (individually and collectively) from employees as well as assisting trusts with the various issues raised above.

Our focus is on providing actionable advice that supports our clients in their decision making from recruitment through to robustly defending employment tribunals if necessary.