This insight is published as part of Capsticks’ Medical malpractice insurance: half-year review 2025.

The NHS 10 year plan: opportunities for the independent, technology and life sciences sectors 

The government’s plan for NHS reform in England was published on 3 July 2025 and includes continuing “to make use of private sector capacity to treat NHS patients”. The government has indicated its intention to use the private sector to address health inequalities and provide all patients (via the NHS App) the ability to search for and choose providers based on quality data. 

The plan describes the NHS as tapping into a network of technology and “working in partnership” with a wider network of organisations, including life sciences. Five “transformative technologies” will be used to drive change: data, AI, genomics, wearables and robotics. Proposals include an NHS App which “by 2028…will be a front door to the entire NHS.” 

Comment: The 10 Year Plan creates opportunities for advancement in medicine and technology, as well as increased independent sector involvement. With opportunity comes risk and any technology or life sciences organisations working for or in partnership with the NHS will need to ensure that their NHS contracts set out clearly the indemnity position should the product’s end user come to harm. Whether you are an individual or an organisation, it is vital that insurance and/or contract documentation is checked carefully at the inception of any new working relationship. Independent sector clinicians working in the NHS will need to ensure that they have appropriate indemnity in place for non NHS work.  The independent provider they work for may be covered by NHS Resolution’s Clinical Negligence Scheme for Trusts, and surgeons should check if they are covered within that and obtain direct confirmation. If not, they will need to ensure that their own indemnity cover extends to NHS related work. 

Surgeons need to check that their indemnity policy has product liability cover  

For surgeons who regularly use implants of one sort or another, checking that you have adequate indemnity cover in place seems an obvious point, but ensuring the cover extends beyond clinical negligence and includes product liability is prudent in the event that a claim is brought for any implant failure against the surgeon rather than a developer or supplier. A Medicines and Healthcare Products Regulatory Agency (MHRA) investigation has identified several concerns with cobalt chrome-containing Profemur modular neck hip stem components. These range from increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery. There have also been media reports of a potential group action involving Zimmer Biomet Next Gen knee replacements. The affected components were the subject of a recall in December 2022. 

Comment: Group actions for failed prosthetic implants are becoming more common. While any claims should be directed to the manufacturer and/or supplier of the implant, surgeons could find themselves exposed (as the ‘end supplier’) if the manufacturer/supplier is uninsured or denied cover by their insurers or otherwise does not have the means to pay. 

In the silicone breast implants litigation against French manufacturer Poly Implant Prothèse (PIP), the implants were manufactured with non-medical grade silicone. PIP became insolvent and its insurers were able to avoid responsibility for claims from women outside France. Although some claimants were compensated eventually, as a result of a French appeal court decision that the German safety body TUV Rheinland was negligent, the case illustrates the need for everyone in the ‘supply chain’ to be adequately insured against the risk of a medical device’s failure. 

Proposals for a new cosmetic licensing scheme for England 

The government has published its response to the Department of Health and Social Care consultation on the design of a new scheme. The new framework uses a RAG rating (red, amber and green) to categorise procedures according to the level of risk associated with them: 

• Green (low risk) procedures, which could be carried out by any licensed practitioner who meets agreed standards 
• Amber (medium risk) procedures. These could be performed by licensed non-healthcare practitioners, but only with the oversight of a named regulated healthcare professional. Qualified healthcare professionals could carry out the procedure alone, subject to the required standards being met. 
• Red (high risk) procedures, for example, breast or buttock augmentation. These could only be performed by suitably qualified and regulated healthcare professionals and would be subject to Care Quality Commission (CQC) regulation. 

The government intends to prioritise its work on regulating high-risk procedures. The licensing scheme for green and amber procedures would be administered by local authorities. The government has also indicated that procedures being delivered to under 18s will be restricted, except where approved by a doctor and carried out by a healthcare professional. The response highlights interlinked issues requiring further consideration: education and training standards, insurance, infection control and hygiene qualifications, and a fee model. 

Comment: The new framework represents a ‘sea-change’ in the regulation of non-surgical aesthetic procedures. Clinics offering these services will need to ensure that they comply fully i.e. ensure staff delivering the treatments are appropriately trained, supervised (where applicable) and that the organisation has the correct licenses in place. They will also need to be satisfied that they have suitable indemnity insurance in place. CQC regulation means that clinics offering high risk procedures could face CQC enforcement notice and/or prosecution for non-compliance. 

Underwriters will need to consider the impact of the changes on how they assess risk and how this affects the cover that they can offer. 

Consent to treatment: rare and serious complications 

It has been 10 years since the Supreme Court decision in Montgomery (2015), which brought about a new era for consent to treatment – one where discussion of the material risks of treatment and any alternatives are crucial elements of obtaining informed consent.  

In Tosh v Gupta (2025), the High Court was asked to determine whether the Claimant had given informed consent for a routine haemorrhoidectomy, which sadly resulted in anal stenosis (a rare but serious complication). The parties’ testimonies were at odds on the key issues of whether the Defendant had adequately explained the risks and benefits of the procedure and had offered non-surgical alternatives. In addition to a discussion about the procedure, the Claimant was given an information leaflet which set out alternatives to treatment and risks. The Claimant’s expert accepted that the leaflet was comprehensive as to the risks of surgery. Anal stenosis was mentioned as a risk on the consent form, which the Claimant signed in the presence of the Defendant and was countersigned by a nurse.  

The judge held that the Claimant’s knowledge of the importance of certain issues to her claim had affected her recollection such that at the time she recreated her view of what happened, consciously or subconsciously. She had been “particularly affected by…hindsight… (and) by the terrible outcome”. The judge accepted the Defendant’s evidence based on the discussions at consultation, the medical records (although they were “not as detailed as might have been expected”) his ‘standard practice’, the information in the leaflet and the consent form. The claim was dismissed. 

Comment: This decision demonstrates the benefits of a multi-faceted consent process: a discussion supplemented by an information leaflet, plus a witness being present at the final discussion when the form was signed by all three. It is best practice to make a comprehensive note of any discussion with a patient. Reliance on ‘standard practice’ can be of assistance when defending a claim (as here) but may not have come to the Defendant’s aid had the consent process not been so comprehensive. Further information on obtaining informed consent can be found in this Capsticks' guide. 

Managing risk around the use of ambient scribe software 

‘Ambient scribes’ or Ambient Voice Technology (AVT) software uses AI and natural language processing to listen to doctor/patient conversations, auto generate clinical notes/ summaries and integrate them into electronic health records. The use of AVT is becoming more common and is likely to increase further following a recent study by Great Ormond Street Hospital. It found that checking and editing rather than making clinical notes meant doctors had more time for patient care. In addition, the reduction in admin left doctors less stressed. The research also revealed that the deployment of AVT in emergency departments saw a 13.4% increase in patients seen per shift. Although not mentioned in the research, the potential for a more accurate record, more time spent with patients and reduced stress could all have a positive impact on reducing adverse incidents/claims. However, as a result of concerns around information governance and patient safety risk, the NHS England (NHSE) Chief Clinical Information Officer (CCIO) has sent a letter to GP practices and NHS Trusts. 

The NHSE letter: 

• Prohibits the use of AVT solutions which are not compliant with NHS standards 
• Reminds recipients that solutions which generate summaries require at least Medicines and Healthcare Products Regulatory Agency (MHRA) Class 1 medical device status.  
• Mandates providers to complete a clinical safety risk assessment and data protection impact assessment before using these tools. 
• Organisations using non-compliant AVT will be liable for any adverse consequences. 

Comment: Although the letter is directed to NHS organisations, we suggest that independent sector healthcare organisations using AVT should review their compliance with NHSE’s letter. They should also check the indemnity position with the supplier/manufacturer, as a situation could arise where a provider has taken the steps outlined in the NHSE guidance, but a patient suffers harm due to a software defect/malfunction.  

Clinical negligence reform 

The financial sustainability of the NHS is one of the key planks of the government’s 10 year plan. It has been announced that David Lock KC has been appointed to advise on clinical negligence reform/costs of clinical negligence claims. The announcement suggests that the recommendations would be made at the same time as the government announces how it will deliver the 10 year plan. They are awaited, although the government indicated at the launch of the 10 year plan that the timeframe would be “later in the summer.” 

Comment: It will be interesting to see the shape of the proposals for clinical negligence reform and whether this means the historic proposal for fixed costs in Lower Damages Fixed Recoverable Costs (LDFRC for claims worth up to £25,000) are taken forward or even extended to claims of a higher level of value. Further information on LDFRC can be found in Medical Malpractice Insurance Forward View 2024.