Foreword from the Ombudsman
When people bring complaints to us about NHS services, they describe problems with access, communication, delays, follow-up and continuity of care. They rarely mention commissioning. But in practice, our experiences of the NHS are shaped by how services are designed, contracted and overseen, and the overall effectiveness of the commissioning process.
The main commissioners of NHS services are the integrated care boards (ICBs), which translate national policy into local service delivery. They must balance patient choice, quality and consistency of care against limited resources and workforce, in a changing national system. These are complex and sometimes competing demands. How they strike that balance has a direct impact on the experiences of patients and families.
These tensions are felt deeply in ADHD (attention deficit hyperactivity disorder) and autism services. For many, the experience begins with a wait – often a very long one. For a child at school without a diagnosis, an adult struggling in the workplace, or a family trying to access the right support, the consequences of that wait can be profound.
National research has called for earlier diagnosis, more personalised support and more seamless pathways of care. But the reality for many people remains long waits for assessments, wide variation in access depending on where they live and fragmented service provision. These are not simply capacity problems – they are also symptomatic of a commissioning system that is not able to meet the needs of service users. By investigating complaints in detail, we are able to establish where failures are isolated or part of a wider issue emerging from a system under pressure.
The Government’s independent review into mental health conditions, ADHD and autism, and NHS England’s independent ADHD taskforce report, reflect a growing recognition that the current situation is not sustainable. Our findings and recommendations aim to complement this work, drawing on the experiences of people who have brought complaints to us as a vital source of intelligence.
The issues we see in casework cannot be resolved by ICBs alone. National leadership is needed to improve services. Many of the difficulties people experience arise from a failure to join up policies, guidance, regulation and commissioning arrangements. Commissioning is both part of the problem and central to the solution. These challenges are not unique to ADHD and autism – we see similar dynamics wherever demand has grown rapidly and commissioning arrangements have struggled to keep pace. We will explore these overarching issues in future reports over the coming year.
To address these challenges, we need to work together to find solutions. In developing this report, we spoke with patient and third-sector organisations, policymakers, ICBs and clinical experts. I found these conversations valuable. Their insights have helped to shape our findings and I am hugely grateful for their engagement. An Ombudsman brings a unique perspective: we impartially see the system through the eyes of patients. The people who come to us are not just seeking redress for themselves – their experiences contain important lessons for the whole system, and it is our responsibility to make sure those lessons are heard.
The new strategy I have set for my office is about bringing these insights together, so we can better support practical, system-wide improvement that puts patient voice at its centre. At its core, commissioning must be there to support people to get quality care, wherever they live, when they need it.
Paula Sussex CBE
Parliamentary and Health Service Ombudsman
Executive summary
About the report
This report uses evidence from our casework to show how patients are affected by poor and inconsistent commissioning when seeking the assessment and treatment of ADHD and autism.
We looked at 3,000 complaints related to ADHD and autism from the past six years across all stages of our casework process, with a more detailed focus on 95 recent complaints. We also engaged with a broad range of external stakeholders to understand the experiences of patients and how the commissioning system operates.
The report considers the growing tension in strategic commissioning between national ambitions and local delivery of ADHD and autism services. Patients are facing long waiting times, variations in access and fragmented care. At the same time, services must be delivered in a way that is safe, sustainable and affordable. This is all set in the context of rising demand and an expanding provider market operating alongside the NHS. Where these expectations and realities are not well aligned, patients can fall through the gaps.
Our complaint evidence most frequently highlights challenges relating to access, assessment and diagnosis, particularly in ADHD services. However, diagnosis is only one stage in a person’s journey and outcomes depend on the wider system of support available afterwards.
We found that the most common issues reported by patients and families were:
- not being given clear, accessible information about their Right to Choose a provider under the NHS Constitution, meaning they are unaware of available assessment and treatment options, and are disadvantaged when trying to navigate the system
- having to wait a very long time for an assessment for adult ADHD and autism and experiencing significant delays when accessing ongoing care and support (these are commonly reported by advocacy organisations, such as Neurobetter, the National Autistic Society and ADHD UK)
- inconsistent recognition of diagnoses by the NHS following assessments by Right to Choose providers, affecting children, young people and adults
- difficulties accessing medication following diagnosis, including through shared care arrangements where GPs may take over responsibility for prescribing from a specialist
- poor communication and disjointed coordination across providers or between areas.
Challenges we see in the system
Our casework shows that many of the difficulties experienced by patients, clinicians and commissioners are not caused by isolated service failure, but by a series of connected factors. These factors can create a gap between what patients and families are told they should be able to access, and what local systems can deliver. We found that increased demand, reduced funding and workforce pressures can make this situation harder.
Poor information about pathways and waiting times affects patients’ understanding and expectations
Patients, families and carers do not always have access to clear, consistent and up-to-date information about referral routes, waiting times, provider options, patient choice and shared care arrangements. Information can be fragmented across different organisations and systems, making pathways difficult to understand and navigate.
Data on demand, referrals, waiting times and patient need remains incomplete and inconsistently recorded. This can make it difficult for patients, GPs and commissioners to understand the variation in access and waiting times, as well as what level of service patients should reasonably expect.
National guidelines and evidence base have not kept pace with a rapidly changing provider market
ADHD and autism services are increasingly delivered through a diverse mix of NHS and independent providers, which has expanded access in many areas. However, this has created new challenges for commissioners, clinicians and policymakers in ensuring consistent standards, quality and oversight across the system.
Rapid market growth has also coincided with growing use of digital technologies in assessment and other service delivery models. The evidence base and national guidelines have not always developed at the same pace. Variation in assessment approaches and shared care arrangements can contribute to inconsistent experiences and outcomes for patients as well as uncertainty for clinicians.
Gaps in oversight, accountability and coordination create uncertainty for patients and commissioners
ADHD and autism pathways operate within a complex landscape of commissioning, contracting, regulation and patient choice requirements. ICBs must balance local needs, patient safety, financial pressures and commitments to patient choice under the NHS Constitution.
Provider oversight and quality assurance arrangements are not always clear, and there is no consistent view across the system of provider performance, referral activity and emerging risks. This can make it harder for commissioners, clinicians and patients to understand how services are performing and where responsibility lies when problems arise.
Together, these challenges can contribute to variation, uncertainty and delays for patients. Stronger coordination, greater transparency and consistent regulation could support more effective decision-making, improve system learning and help patients navigate pathways with greater confidence.
What needs to change
Reform to the health system, including the 10 Year Health Plan for England, NHS Modernisation Bill and Strategic Commissioning Framework, creates a timely opportunity to address these tensions. We make the following recommendations.
Recommendation 1: New national commissioning guidance and an implementation framework on ADHD and autism are developed to support ICBs to make commissioning decisions that improve patient experience and access to care.
It is important that ICBs understand how their responsibilities in different areas fit together so they can make commissioning decisions that meet the needs of local populations, against a backdrop of rising demand and fewer resources. The Strategic Commissioning Development Programme, led by NHS England, should support ICBs to develop the capabilities and skills to deliver effective ADHD and autism pathways.
Recommendation 2: The evidence base for digital diagnostic technologies is developed and strengthened to support future updates to National Institute for Health and Care Excellence (NICE) guidance on ADHD and autism assessments.
The market for digital and artificial intelligence (AI)-enabled diagnostic technologies is developing rapidly, but the evidence base has not kept pace. It is important that NICE guidelines are informed by robust evidence on the use of digital technology so that ICBs and providers can make effective decisions about the technologies they use to support clinical assessments.
Recommendation 3: Health and Social Care Act regulations are updated so that the Care Quality Commission (CQC) can improve oversight and accountability mechanisms for NHS-funded providers that only deliver ADHD and/or autism assessments.
Improved quality assurance and oversight mechanisms will help increase the visibility, transparency and monitoring of NHS-funded providers and referral pathways.
What the system can learn from our complaints and engagement
In recent years, we have seen a significant increase in complaints relating to ADHD and autism services. In 2025 to 2026, we received 1,257 complaints compared with 410 in 2021 to 2022, which represents an increase of over 200%. The issues raised span national, regional and local levels of the NHS, showing there are system-wide challenges that need national leadership and coordinated action across policy, commissioning and delivery.
These challenges affect both children and adults. There are also pressure points when people move from children’s and young people’s services to adult services.
The increase in complaints has happened at the same time as rising referrals for ADHD and autism assessments and more people waiting for assessment, treatment and support. This can be seen in various reports, such as the NHS ADHD Management Information, the NHS Autism Waiting Time Statistics, Nuffield Trust’s ‘Access to services for autism and ADHD’ and a research briefing for the House of Commons on ADHD statistics (England).
While complaints often relate to a single organisation, our investigations frequently point to underlying issues that span multiple parts of the NHS.
We have also engaged with a wide range of stakeholders to test, challenge and refine the findings in this report, including national policymakers, commissioners, NHS England teams, regulators, professional bodies, providers, advocacy organisations and independent experts. This reflects the fact that ADHD and autism services operate within a highly complex and rapidly evolving system where complaints are only one part of the picture. Our engagement highlighted the different pressures, perspectives and responsibilities across the system while reinforcing many of the themes emerging from complaints.
The issues and opportunities identified through these conversations and learning from our casework should also be viewed in the context of the Government’s independent review into mental health conditions, ADHD and autism. While the review is broader in scope, there is significant overlap between its emerging themes and our findings. Both point to a system struggling to keep pace with rising demand, including:
- the need to move away from service models focused primarily on diagnosis towards services that offer clear and practical support to help people live well
- the importance of providing help while people wait for assessment
- the challenges created by variation in local commissioning, service design and access to support.
Stakeholders also highlighted a shared concern that lasting improvement will require wider system reform, stronger coordination across organisations and a clearer vision for how ADHD and autism services should develop in the future.
Patient case studies
Our investigations give us a unique view of ADHD and autism assessment, diagnosis and treatment. The following case studies show the consequences of poor information for patients, inconsistent quality of assessments and how delays and disruption in these services impact on people’s lives.
Diagnosis is not the end point of the pathway. Longer-term outcomes for people depend on their ability to access support across health, education, employment and beyond.
In some of our investigations, we identified service failings and made recommendations for improvement. In many cases we did not find failings but still saw the wider system pressures and tensions. This means commissioners, providers and clinicians may each be acting appropriately, but due to limited coordination across the system, these actions can cause delays, inconsistent access and fragmented care.
Poor information and understanding about patient choice affects access to assessment and care
Our complaints show there are barriers to accessing ADHD and autism pathways, including a lack of information about options and entitlements, referral delays, and long waiting lists. We also see gaps in communication, signposting and needs-led support for people waiting for an assessment.
Patient case study: exercising the Right to Choose
The complaint
Mr L complained that his GP practice incorrectly insisted that he be referred to a locally commissioned ADHD service rather than allowing him to choose an alternative NHS-funded provider under Right to Choose (patients’ legal right to choose which provider carries out their NHS-funded care). He believed this delayed his access to assessment and treatment, forcing him to fund his own private assessment.
He also complained that NHS South East London ICB failed to tell him or his GP about his right to choose an ADHD service. Mr L said the lack of timely care affected his mental health and made him lose confidence in the NHS.
‘It has been extremely distressing to be denied healthcare needlessly… The GP and commissioners attributed significant problems to myself instead of appropriately considering system failings.’ Mr L
The outcome
We found that the GP practice failed to refer Mr L to his chosen provider and the ICB failed to facilitate his care under patient choice arrangements. The ICB did not make sure that the GP practice was aware of alternative ADHD service options, wrongly refused Mr L access to NHS-funded care through his chosen provider and subsequently delayed his treatment.
We recognised that the GP practice had already apologised to Mr L and had made changes to its process to help prevent similar mistakes happening again.
We recommended the ICB make a financial payment to Mr L to recognise the distress caused and reimburse the costs of his private ADHD assessment and treatment.
Patient case study: coordination and communication of prescribing
The complaint
Ms R complained that South London and Maudsley NHS Foundation Trust removed her from the ADHD medication titration waiting list without warning or valid reason and left her without the support she needed for around six months. Titration is the process of adjusting medication to find the right balance between improving symptoms and minimal side effects. She said this affected her ability to perform daily tasks at home and at work and caused her financial hardship.
‘After almost four years of waiting lists, I am back at square one, with no treatment or titration for ADHD… The NHS has a duty to treat my condition, and my medication is currently not working well for me, which means I struggle with daily tasks, my work and employment.’ Ms R
The outcome
We found service and pathway failings around communication, coordination and continuity of care. This included failure to communicate with the GP about the purpose of a referral to its services, Ms R’s removal from the waiting list, medication shortages and the decision not to prescribe to new patients. There was also a missed opportunity for safe monitoring and titration by a specialist.
The Trust had already started to review waiting list procedures, referral and communication processes, patient information and operational policies in response to wider pressures on ADHD services.
We recommended an apology, a payment of £400 to Ms R to recognise the distress and frustration caused, and for the Trust to continue the service improvements it had started making.
Variation in quality of assessments driven by gaps in guidance and oversight
Our complaints show that people can receive very different experiences of care depending on the individual provider carrying out their assessment and the technologies used. We have seen variation in the quality and structure of assessments, differing interpretations of NICE guidelines and cases where diagnoses have not been accepted by other NHS organisations, forcing patients to re-enter waiting lists or seek further assessments.
Evidence from NHS services suggests that remote ADHD and autism assessments became substantially more common during and after the COVID-19 pandemic. However, there is no national data on the proportion of assessments conducted remotely. Many Right to Choose and independent providers conduct most of their assessments remotely.
Patient case study: assessment quality and robustness
The complaint
Miss T complained about the way an NHS-funded independent provider, Psychiatry UK, had carried out her autism assessment online. She said the assessment felt rushed, did not consider her poor working memory or masking behaviours, and did not give enough attention to information given by her parents. Miss T told us this experience negatively affected her mental health and confidence and left her concerned about accessing support at university.
‘The whole process was rushed and paid no consideration to us [the parents] or importantly our daughter [Miss T].’ Complainant’s parent
The outcome
We found that the provider did not carry out a comprehensive assessment in line with NICE guidance. The assessment lasted about 50 minutes. It did not use a recognised structured autism assessment tool, explore evidence of masking or appropriately consider information from Miss T’s parents. We found these were failings in the assessment process.
We found that the failings undermined confidence in the assessment and left Miss T without answers about whether autism could explain the difficulties she was experiencing. This caused ongoing uncertainty, distress and a loss of trust in the assessment process.
We recommended that the provider apologise, arrange a new autism assessment, make a financial payment to recognise the impact on Miss T, and review its assessment processes in line with relevant guidance.
The impact of delayed diagnosis
Our complaints show that people can experience significant delays in diagnosis, and in accessing broader support, when assessment findings are not communicated clearly, when NICE guidelines are not followed consistently, and when people and their families are left unclear about what NHS services will provide.
These delays can have lasting impacts on education, wellbeing and access to appropriate services. Consistent, transparent and high-quality assessment pathways are essential for ADHD and autism services to work effectively for patients, families and clinicians.
Patient case study: impact of delayed autism diagnosis
The complaint
Mr C complained that James Paget University Hospitals NHS Foundation Trust missed opportunities to identify autism and failed to provide his family with important information from his autism assessment. Although the Trust told his parents he did not meet the criteria for an autism diagnosis, it did not share important assessment findings that indicated a stronger possibility of autism. The Trust discharged Mr C from its services rather than keeping him under review or offering a second opinion. Mr C said this delayed his autism diagnosis by several years, affected his social, emotional and mental wellbeing, and meant he missed opportunities for support including access to a specialist college course. Concerned about the impact on his development, his parents ultimately paid for a private assessment because they felt they had no alternative.
The outcome
We found that the Trust failed to follow NICE autism guidance when it withheld relevant assessment findings, changed information contained in the assessment feedback and discharged Mr C without keeping him under review or offering a second opinion. We found that these failings delayed access to a full understanding of his needs, created uncertainty about whether he could have received an earlier diagnosis and caused distress for Mr C and his family.
We recommended an apology, reimbursement of the costs of the private assessment, and that the Trust develop an action plan to make sure similar failings do not happen again.
‘Had he received an earlier diagnosis, he could have secured a space on this course which would have met his needs however he was out of full-time education for eight months whilst we worked tirelessly to secure a suitable setting at an autism specialist school. [He] flourished at this setting, with his needs met and known.’ Mr C’s mother
Challenges we see in the system
ADHD and autism pathways rely heavily on specialist assessment and treatment. Workforce shortages and global medication supply issues add further strain, placing sustained pressure on the health system. Several stakeholders told us that clinical guidance envisages specialist teams focusing on complex cases only. To achieve this, the wider mental health and primary care workforce needs support to develop its capabilities to assess and manage ADHD and autism where appropriate.
These challenges are made worse by financial pressures on ICBs, organisational change and mergers (outlined in the NHS Implementation of ICB Mergers Phase 1 and the Strategic Commissioning Framework). Our casework shows this is affecting patient choice, experience and outcomes.
Patients are entitled to, and can reasonably expect, consistent access and provision across the NHS, while ICBs must commission services based on local need with limited capacity and funding. Our analysis suggests there are opportunities to reduce duplication and pressure through clearer alignment between legislation, policy, regulation, clinical guidance, commissioning levers and patient-facing information. The diagram on the next page shows the core tensions between national frameworks and local commissioning and delivery.
Core tensions between national frameworks and local commissioning and delivery
Tensions between Right to Choose and ICB discretion
| Right to Choose | ICB discretion |
| The NHS Constitution (2009), Constitution Handbook (2025) and NHS England website state that when a patient is referred for non-urgent, specialist care, they have the right to choose any NHS-funded provider offering that service. This creates a clear expectation for patients (and often referring GPs) that they can select where their ADHD or autism assessment (and initial treatment) takes place. | The Health and Care Act 2022 gives ICBs responsibility to commission services based on local population need and available resources, while also promoting the NHS Constitution and enabling patient choice. In practice, this means ICBs must balance competing duties, manage finite capacity and funding, and exercise discretion over which providers and pathways they commission. |
| Patient expectation: choice is nationally guaranteed and works consistently everywhere. | Potential impact: local commissioning decisions can, even unintentionally, limit the national promise of patient choice. |
Tensions between shared care and GP discretion
| Shared care | GP discretion |
|
National clinical guidance (NICE 2018) states that ADHD medication should be started by specialists and then safely transferred to GP care once treatment is stable. National policy encourages long-term prescribing to move into primary care to keep care closer to home and reduce pressure on specialist services. This is also a core shift in the 10 Year Plan, from hospital to community. |
GMC prescribing standards require GPs to take responsibility only for care they feel clinically competent and safe to provide. Accepting shared care arrangements, including prescribing ADHD medication, therefore remains a clinical judgement rather than an obligation. |
| Patient expectation: GPs will continue prescriptions after diagnosis and stabilisation. | Potential impact: even where national guidance expects shared care, patients may not receive ongoing prescriptions if GPs judge arrangements unsafe or unsupported locally. |
The NHS gives people a right to choose their care provider, but our casework suggests this is not always supported by the way services are commissioned, funded and overseen in practice. We have identified a number of tensions between national policy and local implementation, which make it harder for patients and families to navigate the system, and for clinicians and commissioners to make effective local decisions that lead to positive patient outcomes.
We have explained below the main system challenges we see in our casework and the impact they have on patients. If we address these challenges, patients will be able to make informed decisions about the care they can expect to receive from the NHS and independent sector, at a time of high demand and pressure on the system.
- There is limited clear and up-to-date patient information on NHS referral pathways, Right to Choose and shared care arrangements. This can leave patients and carers uncertain about what options are available and what to expect at each stage.
- There is fragmented data on demand, referrals, waiting times and patient need, despite improvements such as the neurodevelopmental data hub. It is also unclear which waiting time standards apply to ADHD and autism services. These gaps cause issues with service planning and make it difficult for patients, families and GPs to understand why access and waiting times differ between areas. Inconsistencies in how providers capture and share waiting time data, at ICB and national level, add to this issue.
- The ADHD and autism provider market has expanded rapidly with many independent providers entering the system in response to growing demand. While this additional capacity has helped improve access for patients, it has also created new challenges for ICBs in quality assurance, oversight of provider performance and maintaining transparency of provider capacity and resilience. Recent work by the Independent Healthcare Providers Network has highlighted the importance of stronger national coordination between the NHS and independent sector, supported by clearer service standards, data collection and oversight arrangements.
- NICE ADHD guideline (NG87) is informed by guidance from regulatory bodies (such as the General Medical Council’s (GMC) Good Medical Practice and the Nursing and Midwifery Council’s Code) and allows diagnosis by an ‘appropriately qualified healthcare professional with training and expertise in ADHD’. However, it does not name a single national accreditation, training standard or professional background for assessors. The ADHD taskforce recently recommended that relevant Royal Colleges work with NHS England, the Department of Health and Social Care (DHSC) and professional bodies relevant to mental health nursing and psychology to identify and co-develop core competencies and curricula for training and continuing professional development (CPD) in recognising and supporting ADHD.
- NICE guidance (HTG729) was developed in 2024 to evaluate the use of digital technology in ADHD assessments. Based on the available evidence, NICE recommended that one digital technology (QbTest) could support assessments for 6- to 17-years-olds, but concluded that there was not enough evidence to support its use in adults and younger children and more research was needed. These evidence gaps make it harder for commissioners and policymakers to make informed decisions as new digital technologies and AI-enabled technologies enter the market.
- Shared care prescribing arrangements for ADHD medication are informed by GMC’s guidance in prescribing and managing medicines and devices. However, Shared Care Protocols are not in place everywhere and GPs’ confidence to prescribe varies, contributing to inconsistencies in prescribing, ongoing care arrangements and access to medication. This could be addressed through the Single National Formulary, which is being developed as part of the 10 Year Health Plan for England.
- The Health and Care Act (2022), the Strategic Commissioning Framework (2025) and the Health Bill (2026) expect ICBs to commission for local population need. This is at the same time as ensuring patient safety, upholding the NHS Constitution and supporting patient choice. These objectives are difficult to bring together with the challenges of demand, ICB mergers and workforce cuts.
- Contracting and funding arrangements can show up tensions between patient choice, financial control and service sustainability, especially where demand is greater than planned capacity. Processes in the NHS Standard Contract and the NHS Provider Selection Regime, such as implied contracts, direct award processes, indicative activity plans and activity management plans, can influence how quickly and consistently patient choice is carried out across the country.
- NHS-funded ADHD and autism service providers are not consistently visible through national systems, such as the NHS Electronic Referral Service (e-RS).The NHS Standard Contract guidanceonly requires them to make ‘reasonable endeavours’ to register and list services. This reduces transparency about available providers, services, and referral activity, which may make it harder for people to navigate the system and make informed choices.
- Although diagnosis and screening are regulated activities by law, CQC guidance based on current regulations says diagnostic-only providers of ADHD and autism assessments are not required to register with CQC. This creates a regulatory gap, risks variations in quality and affects the confidence of commissioners, clinicians and patients in assessments.
- While NHS England regional teams can escalate issues locally and nationally, mechanisms to support ICBs in raising concerns, such as engagement with independent providers or contract management, are not applied consistently. As a result, opportunities for system-wide learning, improvement and coordination may be missed. This raises the question of whether there should be greater responsibility at a national or regional level to collate intelligence on provider performance and emerging risks in the market.
Recommendations
Recommendation 1: New national commissioning guidance and an implementation framework on ADHD and autism are developed to support ICBs to make commissioning decisions that improve patient experience and access to care.
It is important that ICBs understand how their responsibilities in different areas fit together so they can make commissioning decisions that meet the needs of local populations, against a backdrop of rising demand and fewer resources. National commissioning guidance would help provide the foundations for a future Modern Service Framework. However, national guidance should be complemented by practical support from NHS England and DHSC. This should promote cross-system learning and strengthen commissioning capabilities and local expertise through the Strategic Commissioning Development Programme. These measures should build on national improvement support, data and lived experience to help areas develop accessible, joined-up pathways that respond to local need while enabling patients, carers and professionals to better understand and use their right to choose.
We recommend that NHS England and DHSC publish national commissioning guidance to set out how patients’ right to choose, commissioning responsibilities and local contract arrangements should operate together within ADHD and autism pathways in ICBs. This should support improvement on strategic issues that affect multiple NHS regions so commissioners can plan, procure and oversee services that reflect population need, patient choice, clinical quality and sustainable use of resources.
We recommend that through the Strategic Commissioning Development Programme, NHS England and DHSC support ICBs to build local strategic commissioning capabilities across ADHD and autism pathways. This should include strengthening local strategic commissioning expertise, supporting the sharing and application of good practice and facilitating peer learning across ICBs.
This should support ICBs to:
- use learning from complaints so that patient experiences and feedback inform the design of pathways
- prioritise resources to meet local population need and support the design of sustainable services
- provide information and support to help patients navigate pathways, managing expectations around choice of provider and waiting times for assessment
- strengthen data capabilities and reporting so ICBs have visibility of provider performance to help shape market planning and procurement.
Recommendation 2: The evidence base for digital diagnostic technologies is developed and strengthened to support future updates to NICE guidance on ADHD and autism assessments.
Digital technologies are playing an increasing role in ADHD and autism assessments and could offer opportunities to improve access and consistency. However, as the market continues to rapidly expand and becomes more fragmented, data collection and evidence generation on digital technologies is expected to become more challenging across manufacturers and providers. This will make it harder to assess the safety, diagnostic accuracy and effectiveness of technologies at a population level and across different NHS settings.
While manufacturers are responsible for generating evidence to meet the regulatory requirements for health technologies, a more coordinated approach bringing together DHSC, NHS England, the Medicines and Healthcare products Regulatory Agency (MHRA), NICE, researchers, providers and manufacturers could help strengthen the evidence base on digital diagnostic technologies. Improving how evidence is generated, collected and evaluated in clinical settings could lead to a better understanding of efficacy and impact on patient outcomes. This would provide greater assurance for patients, clinicians and commissioners, and ensure that NICE has the evidence needed to determine whether emerging technologies are clinically and cost effective for use in NHS-funded services.
We recommend that DHSC and NHS England establish a process to strengthen the evidence base around the use of digital and AI technologies in the assessment of ADHD and autism, in addition to manufacturers generating appropriate evidence. This could include commissioning new research and evaluating the findings of independent reviews.
We recommend that NICE use this expanded evidence base, when available, to assess the clinical and cost-effectiveness of digital and AI diagnostic technologies and update its guidance.
Recommendation 3: Health and Social Care Act regulations are updated so that the Care Quality Commission (CQC) can improve oversight and accountability mechanisms for NHS-funded providers that only deliver ADHD and/or autism assessments.
Although diagnostic and screening procedures are regulated activities, the wording of current regulations means that diagnosis of ADHD and autism does not currently fall into scope of CQC registration and inspection. As such, diagnostic-only providers of ADHD and autism assessments are not required to register with CQC. This creates varying levels of confidence for commissioners, clinicians and patients. We believe this regulatory gap should be addressed urgently. Improved quality assurance and oversight mechanisms will help increase the visibility, transparency and monitoring of NHS-funded providers and referral pathways.
We recommend that the Government considers seeking revisions to the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 to bring diagnosis of ADHD and autism into scope of CQC registration and inspection.