The changing face of healthcare delivery – reducing environmental impact within a complex regulatory framework

Many large organisations, including the NHS in the UK, have committed to reach net zero carbon emissions within the next 15 years - innovative technologies can assist with this. 

For example, healthcare software (including apps) when used to deliver remote consultations impact on the size and type of premises required by healthcare providers. If healthcare can be delivered remotely with both the medical provider and patient at alternative venues, then no or smaller physical premises are required to host the consultation and house the equipment. There is also a reduction in the environmental impact of travelling to and from consultations if patients do not need to leave home in order to attend their appointment and the added efficiency for the health service that often more patients can be seen in the same timeframe.

As well as remote consultations, the use of healthcare software can reduce the number of appointments needed altogether, for example, where the software permits remote monitoring of a patient by a healthcare professional.

With NHS Digital reporting that travel emissions account for around 18% of the total carbon footprint in the UK health sector, the use of technology seems like a win-win situation for the environment, patients, and healthcare providers.

Regulatory bodies have been developing guidance to enable healthcare technologies to be used in this way over the past 10 years. However, the rapid acceleration of technology capabilities and their use in society has led to a need for many bodies to refresh or draft new guidance in these areas. Companies’ innovative technology solutions, often first conceived in the private sector, can find themselves operating in an area which lacks regulatory guidance and where expert legal advice is vital in terms of the regulatory compliance.

The delivery of healthcare services in England is regulated by the Care Quality Commission (“CQC”) (with other bodies undertaking a similar function in the other UK nations, for example the Care Inspectorate in Scotland). As a regulatory body, the CQC have reduced the number of inspections since 2015 to 2022 demonstrating a reduction of around 97%. The CQC have recently introduced a ‘desktop’ inspection for some registrants which allows assurances as to the safe delivery of services to be provided in the absence of an in-person inspection. Whether this reduction in environmental impact will result in an impact on patient safety will be seen in due course.
 

Whilst the use of healthcare apps and other software may seem like a great opportunity for companies and healthcare providers to reduce their impact on the environment, it is important to consider the regulatory obligations that apply.

Firstly, a provider should consider whether the software will require registration with bodies such as the CQC, and if so, who should hold that registration.  The key question as to who is delivering the healthcare can often be complex depending on the functionality and specific requirements of the specific software and the level of involvement of the developer. These areas can be clarified in the planning stages of development and are vital to understand as failure to register with a body such as the CQC, if required, is a criminal offence.

Another key point companies need to consider is the regulatory status of any software used in this context.  Depending on the functionality of the software, it may be classified as a medical device, in which case a CE mark or UKCA mark will be needed before the software can be lawfully marketed or supplied in the UK.  To breach this requirement is a criminal offence.

The fundamental question is whether the software has a “medical purpose”, as set out in the Medical Devices Regulations 2002, which apply in the UK.  If it does, it will be classified as a medical device.  It is not only the strict functionality of the software, which is relevant, but also any claims made about the software in e.g. promotional materials.  The medical purposes we encounter most frequently in the context of SaMD assessments include diagnosis, monitoring and treatment, which can be broadly interpreted.  Monitoring general fitness, health and wellbeing does not amount to a medical purpose, but this is not always an easy distinction to draw. 

The UK Medicines and Healthcare Products Regulatory Agency (“MHRA”) has guidance on SaMD which gives examples of medical device and non-medical device functionality.  We also know that more detailed guidance is coming, as revealed in the MHRA’s “Software and AI as a Medical Device Change Programme – Roadmap” updated in October 2022 (see our article here).  Draft guidance was expected before the end of 2022, but none has been published yet.  This is a key area of focus and development for the regulator and the industry.

The regulatory framework should be borne in mind from the initial development stages. It is important to consider whether the functionality proposed is likely to constitute SaMD and/or if registration with the CQC in England (or their equivalent in the other nations) will be required.  If so, which entity/entities will take on these additional responsibilities, and are they willing to do this or is this something you would like to design around?  

As well as increased legal responsibilities once the product has launched, bringing the product to market is likely to take longer for SaMD, depending on the risk classification of the product. CQC registration can also take a number of months.  It’s helpful to ensure all stakeholders are aware of this from the start, so appropriate product launch dates can be planned.

The widespread use of innovative technologies to deliver healthcare remotely has changed the landscape for us all.  There is a huge potential for the environment to benefit from a system where online medical consultations, online prescribing and the use of software in the delivery and monitoring of healthcare are the ‘norm’.

Regulatory bodies have been required to ‘get on board’ with these changes quickly and consider measures for their safe delivery. The regulatory landscape is evolving at pace to account for the increased speed of innovation and developers and users of new technologies should bear in mind the regulatory requirements from the early stages of development to ensure compliance is achieved throughout their lifecycle.