Contributed By Sidley Austin LLP
The UK cybersecurity legal system is well developed and is similar to the legal systems across the European Economic Area (EEA), rather than the USA ‒ although post-Brexit, divergence in approach to cybersecurity regulation by the EU and the UK are starting to emerge. Since the GDPR came into force in 2018, the enforcement of cybersecurity rules in the UK continues to be a focus, particularly by the UK data protection regulator, the Information Commissioner’s Office (ICO). In 2025, the UK looks set to introduce new legislation to address the changing cyberthreat landscape and more closely align UK law with developments in the EU (such as the Network and Information Systems Directive 2 (the “NIS 2 Directive”) ‒ see 2. Critical Infrastructure Cybersecurity for further detail.
The UK government has also signalled an overhaul of its ability to assist and promote cybersecurity through its national cyber strategy for 2022 (the “National Cyber Strategy”), as well as through its government-specific Government Cyber Security Strategy for 2022–30. The National Cyber Strategy takes a “whole of society” approach, with the aim of shifting the burden of cybersecurity from individual citizens to the organisations and professionals best placed to manage cyber-risks. The National Cyber Strategy is comprised of five pillars, which it is working to achieve by 2025:
The National Cyber Strategy also proposes a number of regulatory reforms, including but not limited to increasing the scope of the Network and Information Systems Regulations (the “NIS Regulations”) (see 2. Critical Infrastructure Cybersecurity for further detail).
The UK has a well-developed – and growing – network of civil and criminal laws relating to cybersecurity, contained in UK legislation, companion rules made under such legislation, decisions of UK courts, and a steady stream of regulatory guidance from UK regulators.
Key cybersecurity requirements imposed on organisations in the UK, or on organisations that are established outside the UK but are processing personal data of individuals located in the UK, are derived from the UK General Data Protection Regulation (the “UK GDPR”), as supplemented by the UK Data Protection Act 2018 (DPA).
The UK GDPR applies to the security of “personal data” (ie, any information relating to an identified or identifiable individual who can be identified ‒ directly or indirectly – by reference to an identifier such as a name, an identification number, location data or an online identifier). As such, only those cybersecurity incidents impacting personal data will be regulated by the UK GDPR (see also 6.1 Cybersecurity and Data Protection). The UK GDPR requires organisations to maintain “appropriate” technical and organisational security measures and to comply with certain notification obligations when “personal data breaches” occur. The DPA also allows for criminal prosecutions to be brought for certain cybersecurity-related breaches.
Secondly, the NIS Regulations currently apply to two categories of key infrastructure operators ‒ namely, “operators of essential services” (OESs) and “relevant digital service providers” (RDSPs). Like the UK GDPR, the NIS Regulations require organisations that are subject to them to implement certain cybersecurity measures and to report certain cybersecurity incidents that affect such organisations. On 17 July 2024, the UK government announced the Cybersecurity and Resilience Bill (the “CS&R Bill”), which would expand the remit of the NIS Regulations to protect more digital services and supply chains. Please see 2.1 Scope of Critical Infrastructure Cybersecurity Regulation for additional information on the proposed updates to the NIS Regulations via the CS&R Bill.
Thirdly, the Product Security and Telecommunications Infrastructure Act 2022 (the “PSTI Act”), which came into force on 29 April 2024, requires manufacturers, importers and distributors of UK consumer-connected products to meet certain cybersecurity standards. This includes more stringent security requirements (eg, default password requirements and minimum support periods for providing security updates) and requirements to investigate any compliance failures and take remediation action, as well as notify relevant authorities and other third parties about such compliance failures (see 4.2 Key Obligations Under Legislation).
Fourthly, the Computer Misuse Act 1990 (CMA) is the UK’s primary legislation with regard to criminalising unauthorised access to computers and other IT systems. It contains a number of cybersecurity-related offences. A key offence under the CMA (Section 1) is where a defendant obtains “unauthorised access” to a computer – ie, the defendant causes a computer “to perform any function with intent to secure access to any program or data held in any computer” or “to enable such access to be secured” where such access is “unauthorised” and this is known to the defendant at the relevant time.
Fifthly, the Privacy and Electronic Communications (EC Directive) Regulations 2003 (the “PECR”), the EU Notification Regulations 611/2013 (the “Notification Regulation”), and the Communications Act 2003 (the “CA 2003”) contain cybersecurity obligations applicable primarily to electronic communications networks and service operations (such as telecommunications systems operators).
There are also sector-specific laws that contain cybersecurity obligations – for example, Financial Conduct Authority (FCA) rules (applicable to FCA-regulated firms), the Payment Services Regulations 2017 (PSRs) (which transposed the Second EU Payment Services Directive into English law and apply to payment service providers), and the Official Secrets Act 1989 (OSA) (which is applicable to certain official government information). Similarly, the Investigatory Powers Act 2016 (IPA) and the Regulation of Investigatory Powers Act 2000 (RIPA) regulate electronic surveillance and interception in the UK and contain associated safeguards.
These laws are increasingly being enforced by UK governmental authorities – including the ICO and sector-specific regulators such as the FCA – and private individuals and organisations. Regulators are also increasingly collaborating on cybersecurity enforcement; examples include the ICO teaming up with the Competition and Markets Authority, the Office of Communications (Ofcom) and the FCA to form the Digital Regulation Co-operation Forum (DRCF).
In addition to legislation, English “common law” contains rules that are relevant to cybersecurity. There is a legal and ethical duty of confidence where information is shared in confidence and must not be disclosed without legal authority. The duty applies to information not already in the public domain and is subject to a number of exceptions, including where disclosure:
The FCA rules, the PSRs, the OSA, the IPA, the RIPA and other sector-specific or specialised laws or the common-law duty of confidence are not further considered in this guide.
There are different UK regulators for each of the key UK cybersecurity legislations under consideration.
UK GDPR and DPA
In the UK, the ICO is responsible for monitoring the application of the UK GDPR and the DPA and taking enforcement action against organisations for non-compliance with such legislation, including investigating personal data breaches and inadequate security measures. The ICO may initiate an investigation of its own accord or on the basis of a complaint submitted by, for example, a private individual or organisation. The ICO also has the power to conduct both off-site and on-site audits. Please note that prosecutions under the DPA can only be brought by the ICO or by (or with the consent of) the Director of Public Prosecutions (DPP).
NIS Regulations
With regard to the NIS Regulations, the “competent authority” is determined on an industry-by-industry basis through the Department for Science Innovation and Technology (DSIT), which oversees the implementation of the NIS Regulations across the UK. For OESs in the oil sector, for example, the competent authority in England, Scotland and Wales is the Secretary of State for Business, Energy and Industrial Strategy – whereas in Northern Ireland it is the Department of Finance. The ICO is the competent authority for RDSPs.
Competent authorities may be reactive or proactive in terms of the incidents they choose to investigate and they are supported by the National Cybersecurity Security Centre (NCSC), which offers technical advice (except in healthcare, where this support is offered by NHS Digital). Certain organisations are also subject to regular compliance audits from their relevant competent authority – failing these audits can lead to fines of up to GBP17 million.
PECR and CA 2003
As regards the PECR, the ICO may audit the compliance of service providers pursuant to Regulation 5A of the PECR. Notifiable personal data breaches under Regulation 5A of the PECR must be reported to the ICO. The ICO is, in turn, responsible for investigating the breach and taking any subsequent enforcement action.
However, with regard to the CA 2003 (which is a companion legislation to the PECR), Ofcom is the primary regulator. Pursuant to Section 105C of the CA 2003, Ofcom may carry out an audit of the security measures taken by a network provider or a service provider under Section 105A. Notifiable security breaches under Section 105 of CA 2003 must be reported to Ofcom, which is in turn responsible for investigating the breach and taking any subsequent enforcement action.
CMA
Although there is no regulatory authority with oversight of the CMA per se, the provisions of the CMA are enforced by the UK Crown Prosecution Service (CPS), which is the public authority responsible for prosecuting the majority of criminal cases in the UK. The CPS is notified of CMA investigations and potential offences by the police and other investigative organisations in England and Wales. See 4.2 Key Obligations Under Legislation for more information.
PSTI
The Office for Product Safety and Standards is responsible for enforcing the PSTI Act. Non-compliance with the PSTI Act can result in fines of up to GBP10 million or 4% of a company’s global turnover (whichever is greater), as well as up to GBP20,000 per day in the case of an ongoing contravention.
National Cybersecurity Security Centre
The NCSC is the key UK cybersecurity agency, co-ordinating UK cybersecurity policy and technical standards, particularly with regard to the NIS Regulations and the UK GDPR. The NCSC acts as the national computer security incident response team (CSIRT) under the NIS Regulations and supports organisations that suffer cybersecurity incidents. It also acts as a “single point of contact” for competent authorities under the NIS Regulations. Following Brexit, the UK has forfeited its position on the EU Agency for Cybersecurity (ENISA); however, some operational co-operation continues in order to allow for improved cybersecurity across Europe.
The regulation of cybersecurity for critical infrastructure in the UK is primarily governed by the NIS Regulations. See 1.2 Cybersecurity Laws for a summary of the scope of the NIS Regulations.
On 17 July 2024, the UK government introduced the CS&R Bill, intended to strengthen UK defences against cyber-attacks and protect critical infrastructure. The briefing note on the CS&R Bill suggests it will update the UK’s cyber regulatory framework by:
It is expected that the CS&R Bill will be introduced in Parliament in 2025.
OESs and RDSPs are required under the NIS Regulations to implement appropriate and proportionate technical and organisational measures to ensure a level of security appropriate to the risk posed.
RDSPs
For RDSPs, these requirements are supplemented by the Commission Implementing Regulation (EU) 2018/151 (the “DSP Regulation”). In summary, RDSPs must take account of the following.
The ICO notes that examples of appropriate standards may include ISO/IEC 27001 on information security management systems and ISO/IEC 22301 on business continuity management systems, as well as any other related standards.
OESs
OESs are subject to similar requirements as RDSPs in that they must also take appropriate and proportionate technical and organisational measures to manage risks posed to the security of the network and information systems on which their essential service relies, and subject to guidance from the relevant competent authority (which, as noted in 1.3 Cybersecurity Regulations (NIS Regulations), is on a sector-specific basis).
Under the NIS Regulations, different incident reporting obligations apply to OESs and RDSPs respectively.
For OESs, cybersecurity event notification is required when any incident has a “significant impact” on the continuity of the essential service that the OES provides. Determining this requires a fact-specific analysis of the number of users affected by the disruption of the service, the duration of the incident, and the geographical area affected by the incident, as well as any other relevant guidance issued by their designated “competent authority”.
For RDSPs, notification is required where there will be a “substantial impact” on the provision of any relevant service. As from 12 January 2022, the ICO (which is the lead regulator for RDSPs) must be notified by an RDSP where there is an incident that has a substantial impact on the provision of any digital services, including online marketplaces, online search engines and cloud computing services. It should be noted that, in comparison with the UK GDPR, notifiable incidents under the NIS Regulations need not always involve personal data – that is, cybersecurity incidents that do not involve personal data (such as cyber-attacks on industrial control systems) could be notifiable under the NIS Regulations, but would not be notifiable under the UK GDPR if they do not involve personal data.
Under the NIS Regulations, as with the UK GDPR, OESs and RDSPs must notify their relevant competent authority and the ICO respectively of an incident “without undue delay” and, in any event, no later than 72 hours after the OES or RDSP (as applicable) becomes aware of the incident.
The NIS Regulations require that OESs and RDSPs adopt “appropriate and proportionate” technical and organisational security measures, as well as “appropriate” measures to prevent and minimise the impact of incidents affecting those systems (taking into account the state of the art), so as to ensure the continuity of the essential services that the OES provides. Although serious incidents must be reported under the NIS Regulations, the ICO has also explained that software vulnerabilities – ie, weaknesses in a system that can be exploited by an attacker – may also need to be reported, as per the “additional information” required in the ICO’s NIS reporting form.
This not applicable in the UK.
In the UK, operational resilience in the financial sector is primarily addressed by the FCA, the Prudential Regulatory Authority (PRA) and the Bank of England in their rules and guidance on requirements to strengthen operational resilience in the financial services sector ‒ for example, the FCA’s rules on operational resilience under Chapter 15A of its Senior Management Arrangements, Systems and Controls Sourcebook and the PRA’s supervisory statement “Operational resilience: Impact tolerances for important business services” (SS1/21) (collectively, the “Operational Resilience Requirements”), which were published on 31 March 2022 and address how firms identify, map, test and enhance their important business services to withstand disruptions. The requirements for UK firms to have performed mapping and testing so that they are able to remain within impact tolerances for each important business service are required to be in place by no later than 31 March 2025. The rules are intended to align closely (albeit not entirely) with international standards and other regimes, such as the EU’s Digital and Operational Resilience Act (DORA).
In November 2024, the FCA and the PRA published a joint policy statement, “Operational resilience: Critical third parties to the UK financial sector” (PS16/24) (the “CTP Policy Statement”). This confirmed that operational resilience remains a priority for the regulators and focuses, among other things, on further defining obligations with resgard to critical third parties (CTPs) (see 3.2 ICT Service Provider Contractual Requirements for further detail).
As noted in 3.1 Scope of Financial Sector Operation Resilience Regulation, CTPs are a key focus of UK financial services operational resilience. The CTP Policy Statement introduces new rules that will apply to a CTP designated under the regime.
Under the applicable rules, CTPs will need to:
The new regime for CTPs was created under the Financial Services and Markets Act 2023, which amended the Financial Services and Markets Act 2000 (FSMA). The relevant provisions allow the UK Treasury to designate a person who provides services to regulated firms and financial market infrastructures as “critical”. CTPs will typically be service providers that provide certain outsourced and third-party services to large numbers of financial institutions and whose services are very difficult to substitute. Although the concepts in FSMA are broadly analogous to DORA, the criteria for designation and the scope of regulatory powers differ in several important respects.
The FCA has demonstrated a strong focus on cybersecurity in the context of the financial services industry. This is particularly relevant in the context of:
In relation to Principle 11, the FCA has confirmed that regulated firms must report material cyber-incidents. The FCA considers that an incident may be material if it:
The FCA goes on to require that where such an incident is deemed to be material:
The FCA also recommends that firms refer to the NCSC guidance on reporting incidents and reports should be shared on the Cyber Security Information Sharing Partnership (CiSP) platform. The CiSP is a key information-sharing organisation in the UK. It is a joint industry and UK government initiative managed by the NCSC. The CiSP allows members to voluntarily exchange cyber-risk information in a secure environment, such that there are reductions to the impact of cyber-risks for UK businesses in general.
More generally, and as part of the FCA’s goal to assist firms in becoming more resilient to cyber-attacks, it recommends that firms of all sizes should develop a “security culture” and be able to identify and prioritise information assets and constantly evolve to meet new threats.
In addition, certain categories of FCA-regulated firms have additional reporting requirements. By way of example, payment services providers are required to report major operational and security incidents pursuant to the PSRs.
For CTPs, the rules established by CTP Policy Statement introduce a phased approach to notifications in relation to incidents affecting CTP services, such as those that impact the availability, authenticity, integrity, or confidentiality of assets. This reporting will consist of:
Looking forward, the Operational Resilience Requirements will require financial services firms to comply with a number of obligations around operational resilience, including:
On 13 December 2024, the PRA and FCA published further consultation papers – respectively, “Operational resilience: Operational incident and outsourcing and third-party reporting” (PRA CP17/24) and “Operational Incident and Third-Party Reporting” (FCA CP24/28). These propose a framework for reporting operational incidents and notification and reporting of material third-party arrangements. Under the proposals, the PRA and FCA will expect firms to report incidents meeting certain thresholds. The consultation papers are open for comments until 13 March 2025.
The FCA and PRA have a broad legislative mandate and powers to enforce rules made under the CTP regime against designated CTPs. As this is a new regime, it remains to be seen how such powers will be exercised.
This is not applicable in the UK.
See 3.3 Key Operational Resilience Requirements for the upcoming Operational Resilience Requirements, which will include testing requirements.
In addition, the CBEST programme is a cyber-assessment tool to assist UK firms with assessing the cyber-resilience of key financial institutions through security testing performed in “live” corporate environments. On 13 December 2024, the FCA (together with the Bank of England and the PRA) published their annual CBEST thematic report (the “CBEST Report”). The CBEST Report contains cyber-resilience good practice recommendations and insight, including from the NCSC, for firms to help them maintain their operational resilience. The good practice recommendations are the result of a programme that assesses the cyber-resilience of systemic financial institutions through live testing. The report highlights the importance of building a strong foundation of cyberhygiene to prevent common cyber-incidents, including training and awareness and robust authentication.
The key areas of focus based on the 2024 CBEST Report are:
As outlined in 1.2 Cybersecurity Laws, there are a number of laws that supplement the UK’s cyber-resilience strategy alongside the NIS Regulations. Please refer to 4.2 Key Obligations Under Legislation for more information.
PSTI Act
Under this new act, manufacturers (the person responsible for manufacturing a product, designing a product or otherwise marketing the product under their own name or trade mark) of “UK consumer connectable products” are required to comply with new obligations to manage cybersecurity risk for connected products made available in the UK. Similar obligations also apply to importers and distributors. These include:
The PSTI Act provides for the power of the Secretary of State to deem compliance with security requirements. This is further elaborated in the Product Security and Telecommunications Infrastructure (Security Requirements for Relevant Connectable Products) Regulations 2023 (the “PSTI Regulations”), which set out conditions for deemed compliance with security standards, including compliance with relevant parts of ETSI EN 303 645 or ‒ in some cases ‒ ISO/IEC 29147.
Schedule 1 of the PSTI Regulations includes the following security requirements for manufacturers:
CMA
As mentioned in 1.2 Cybersecurity Laws, a key offence under the CMA (Section 1) is where a defendant obtains “unauthorised access” to a computer. Although the CMA primarily applies to offences committed within the UK, it allows for prosecutions to be brought in the UK where some or all of the offending acts were committed outside the UK – reflecting the trans-border nature of many cybersecurity-related offences. By way of example, Section 1 of the CMA can apply to offending acts committed outside the UK and can – as a result – be prosecuted in the UK where there is “at least one significant link with the domestic jurisdiction”. A significant link can include where:
An offence committed under the CMA is prosecuted through the UK courts by the CPS. When determining whether to bring a prosecution under the CMA, the CPS must be satisfied that there is enough evidence to provide a “realistic prospect of conviction” against each defendant and that the public interest factors tending against prosecution outweigh those tending in favour. Offences under the CMA can carry imprisonment or a fine (or both). In addition, a serious crime prevention order can be made against an individual or an organisation in relation to a breach of the CMA.
The UK government continues to progress amendments to the CMA, as for many years commentators have stated that the CMA has failed to keep pace with the cybersecurity landscape. Commentators highlight issues with the ambiguity around the meaning of “authorisation” and its subsequent impact on cybersecurity professionals, as well as issues with the current jurisdictional scope of the CMA, given the international nature of many cybersecurity incidents. In November 2023, the UK government published responses to a consultation on proposed CMA reforms, noting that work will continue on engagement with private and public sector organisations to understand further impacts and mitigations in this area before it is considered for legislation.
PECR and CA 2003
Regulation 5(1A) of the PECR requires service providers to:
Service providers are also required to retain a log of the personal data breaches pursuant to Regulation 5A(8) of the PECR.
Guidance on Security Requirements published by Ofcom in relation to the CA 2003 states that it is necessary to establish “clear lines of accountability, up to and including board or company director level, and sufficient technical capability to ensure that potential risks are identified and appropriately managed”. The guidance further states that “a level of internal security expertise, capacity, and appropriate accountability mechanisms, sufficient to provide proper management of (security risks)” must be maintained. The guidance also references the following:
Regulation 2(1) of the PECR defines a “personal data breach” as a breach of security leading to the accidental or unlawful destruction, loss, alteration, or unauthorised disclosure of – or access to – personal data transmitted, stored or otherwise processed in connection with the provision of a public electronic communications service. The security and breach notification requirements under Regulation 5 of the PECR apply to personal data.
Under Regulation 5A of the PECR, service providers are required to notify the ICO in the event of a personal data breach (as defined under Regulation 3 of the PECR). Pursuant to Article 2(2) of the Notification Regulation, such notification must be made where feasible, no later than 24 hours after the detection of the personal data breach. A notification to the ICO is not required where an organisation is responsible for delivering part of the service but does not have a direct contractual relationship with end users. In such cases, the organisation must notify the organisation that does have the contractual relationship with end users and that organisation must then notify the ICO. The service provider is also required to notify (without undue delay) the concerned subscriber or user where the breach is likely to adversely affect their personal data or privacy, unless the service provider can demonstrate to the ICO that the data was made unintelligible (eg, encrypted).
The security breach notification requirements under Section 105K(1)(a) of the CA 2003 apply to public electronic communications networks and systems: network and service providers must notify Ofcom of security breaches that have a significant impact on the operation of a public electronic communications network. Section 105(A) of the CA 2003 broadly defines a “security compromise” as including “anything that compromises the availability, performance or functionality of the network or service”. In determining whether the effect that a security compromise has – or would have – on the operation of a network or service is “significant”, certain matters should be considered, including the length of the period during which the operation of the network or service is or would be affected, the number of affected persons, the geographical size and location affected, and the extent to which activities of persons who use the network or service are or would be affected by the effect on the operation of the network or service.
There are numerous cybersecurity frameworks that are expressly or implicitly recognised by UK cybersecurity regulators. By way of example, the ICO recommends that organisations review the UK Cyber Essentials scheme (a UK government- and industry-backed scheme), which provides basic guidance to organisations on how to prevent and limit the impact of cyber-attacks.
Similarly, Ofcom repeatedly references the International Standard for Organization (ISO) standards in its Guidance on Security Requirements. In addition, Ofcom comments that the controls in the UK’s Cyber Essentials scheme should be implemented and exceeded; according to Ofcom, obtaining the Cyber Essentials Plus certification is “a powerful way to demonstrate this”.
Regarding the NIS Regulations, the NCSC has published 14 cybersecurity and resilience principles that provide guidance in the form of the Cyber Assessment Framework (CAF). The CAF is particularly relevant to OESs that are subject to the NIS Regulations.
Lastly, the most used account and payments data security standard, the Payment Card Industry Data Security Standard (PCI DSS), was revised. Version 4.0 was published on 31 March 2022.
As mentioned in 1.2 Cybersecurity Laws, the UK GDPR and the DPA contain cybersecurity obligations in relation to the processing of personal data. The UK GDPR and the DPA apply to:
The UK GDPR requires that controllers and processors implement “appropriate” technical and organisational security measures, taking into account the state of the art, costs of implementation, and the nature, scope, context and purposes of the processing of personal data, as well as the risks of such processing to the data subject’s rights (eg, from accidental or unlawful destruction, loss, alteration, or unauthorised disclosure of ‒ or access to – personal data transmitted, stored or otherwise processed by the organisation).
The UK GDPR itself sets out examples of “appropriate” security measures, which are:
Importantly, according to the ICO, there is no “one size fits all” approach to “appropriate” security and recommends that ‒ before taking a view on what is “appropriate” ‒ organisations should assess the level of risk by reviewing the type of personal data held, whether it is sensitive or confidential, and the damage caused to data subjects if compromised (eg, identity fraud).
In addition, when considering which cybersecurity measures to adopt, the ICO recommends that organisations consider:
The UK GDPR and the DPA continue to be enforced by the ICO, including with regard to cybersecurity matters, but only to the extent that they impact personal data. The ICO is required to adhere to specific procedures before undertaking enforcement action – for example, before imposing an administrative fine on an organisation for:
Where applicable, the ICO is required under Section 149 of the DPA to first issue the organisation with a written “enforcement notice”, which requires the organisation to take steps specified in the notice and/or refrain from taking steps specified in the notice. If the ICO is of the view that the organisation has failed to comply with the enforcement notice, the ICO will then issue a written notice (penalty notice) imposing a monetary penalty on the organisation of up to the greater of 4% of annual worldwide turnover or GBP17.5 million. When determining the monetary penalty amount, the ICO will consider a number of aggravating or mitigating factors. These factors include the nature, gravity and duration of the infringement – for example, personal data breach or inadequate security measures – and the intentional or negligent character of the infringement.
In determining whether to undertake a criminal prosecution under the DPA, the ICO must reference the Code for Crown Prosecutors and the ICO’s own prosecution policy. Although the ICO has a number of enforcement tools available to it (including providing a caution to offending organisations), the ICO’s Prosecution Policy Statement requires the ICO to consider aggravating factors in order to bring a prosecution instead of a caution. These include the accused breaching the law for financial gain, abusing a position of trust, or damage or distress being caused to data subjects.
The maximum penalty for criminal offences under the DPA is an unlimited fine. Imprisonment is not available for conviction under any of the DPA offences. Defendants are entitled to normal rights of appeal against a conviction or sentence in the legal system.
On 26 November 2023, the US Cybersecurity and Infrastructure Security Agency (CISA), together with the UK’s NCSC, published joint Guidelines for Secure AI System Development (the “AI Guidelines”). The AI Guidelines aim to ensure that developers take a “secure by design” approach, integrating cybersecurity into the development process from the outset and throughout. The AI Guidelines cover secure design, secure development, secure deployment, and secure operation and maintenance. Relatedly, in its annual review published on 3 December 2024, the NCSC noted the significant advances in AI that will enable and enhance existing challenges associated with cybersecurity.
Work is currently underway by the DSIT to produce a sector agnostic Code of Practice on Cyber Security of AI (the “AI COP”) to establish the minimum cybersecurity standards that developers and system operators should incorporate when building and using AI solutions. The AI COP, which is voluntary, is based on the AI Guidelines and is intended to sit alongside the UK government’s 2023 White Paper “A pro-innovation approach to AI regulation”, which includes “Safety, Security and Robustness” as one of the five key principles – the focus of the AI COP. The AI COP is structured around 12 principles and stakeholders to which each principle primarily applies are identified. Requirements include AI security awareness training, system design and dataset considerations, incorporating threat-modelling into the risk management process, and evaluation and testing. The consultation on the AI COP closed on 9 August 2024 and the UK government’s response is anticipated – although no timeline has been set.
Under the NIS Regulations, NHS trusts, foundation trusts, integrated care boards, and certain other healthcare providers are designated as OESs. Consequently, these healthcare providers are required to comply with the obligations of an OES as described in 2.2 Critical Infrastructure Cybersecurity Requirements.
Medical devices in scope of the Medical Devices Regulations 2002 are expressly excluded from the PSTI Act. However, the UK government is expected to continue its overhaul of the UK’s medical devices legislative framework following the application of the Medicines and Medical Devices Act 2021 (the “MMD Act”). The MMD Act includes powers for the Secretary of State to introduce regulations in relation to the manufacture of medical devices. In February 2024, the Department for Health and Social Care (DHSC) confirmed that it would be introducing a package of legislative reform for UK medical devices. In December 2024, the Medicines & Healthcare products Regulatory Agency (MHRA) issued a revised roadmap for reform (the “Roadmap”), which stated that new guidance will be published on cybersecurity requirements for software included as part of a medical device.
The MHRA has produced a number of work packages in their proposed Software and AI as a Medical Device Change Programme, with Work Package WP5 dedicated to “Cyber Secure Medical Devices”. This work package focuses on ensuring that cybersecurity is adequately reflected in software as a medical device (SaMD) requirements and explains that secondary legislation will be developed to impose cybersecurity and IT requirements to guard against cybersecurity risks in medical devices and in vitro diagnostics (IVDs) that may result in device malfunction, loss or tampering with personal data, damage to the device, and ultimately injury to the patient. Guidance will be developed on cybersecurity issues in the life cycle management processes of medical devices and IVDs and on the reporting of cybersecurity vulnerabilities.
NHS Digital (the body responsible for information, data and IT systems in health and social care in the UK) has published a variety of guidance, including the Data Security and Protection Toolkit, which is an online self-assessment tool that all organisations must use if they have access to NHS patient data and systems. This includes an incident reporting tool that incorporates the notification requirements of the UK GDPR and the NIS Regulations. There is also a GDPR-focused document entitled “Respond to an NHS Cyber-Alert”, which explains the intersection between medicine, personal data, and cybersecurity.
At an EU level (albeit highly persuasive, rather than legally binding, from a UK perspective), the Medical Device Co-Ordination Group published updated guidance in June 2020 on cybersecurity for medical devices, which is intended to assist medical device manufacturers in meeting the cybersecurity requirements in the EU’s Medical Devices Regulation and the In Vitro Diagnostic Regulation. According to the updated guidance, manufacturers must consider safety and cybersecurity throughout the life cycle of a product – that is, they must integrate security “by design”. This concept closely aligns with the requirement of privacy by design under the UK GDPR. Manufacturers must also perform increased post-market surveillance and vigilance. Such post-market surveillance should address the following:
The MHRA clearly stated in its Roadmap the regulations will move the UK towards greater alignment of the cybersecurity requirements for medical devices with the approach taken by the EU and other international regulators.
Lastly, it is worth mentioning that – rather than taking a separate approach to any AI-enabled product – the UK’s approach to regulating cybersecurity risks resulting from AI is sector-specific. In the healthcare space, the MHRA has announced in its Policy Paper “Impact of AI on the regulation of medical products” of April 2024 that it will follow a principles-based approach in order to avoid constraining innovation, including the guidance on cybersecurity for AI as expected to be published in spring 2025.
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