Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Bianca Piachaud-Moustakis

On 22 Sep. 2021, the Secretary of State for Digital, Culture, Media, and Sport (DCMS) published the United Kingdom’s National Artificial Intelligence (AI) Strategy (the ‘Strategy’). In its published form, the Strategy sets out a 10-year plan to make the UK “a global AI superpower” building on R&D successes in the field, as well as previous AI Sector Deal investment, and the establishment of AI bodies and structures, such as the AI Council and Centre for Data Ethics and Innovation (CDEI) (1).

The Strategy follows a raft of related plans, strategies, and roadmaps, such as the National Data Strategy (December 2020) (2), the AI Council’s AI Roadmap (January 2021) (3), the Plan for Digital Regulation (July 2021) (4), and the UK Innovation Strategy (July 2021) (5). The publication of the UK National AI Strategy follows guidance issued by the European Commission (EC), which published its own comprehensive proposals for regulating AI technologies in April 2021, and which regards health as an important application area (6).

The UK remains first in Europe and ranks third globally, behind the United States and China, for private investment in AI technologies (7). For its part, the UK government has invested more than £2.3 billion into AI since 2014, and the Strategy outlines the government’s vision to build on this progress. The Strategy reflects not just the UK’s ambition to use AI for regional prosperity and across sectors, but also to play a key part in addressing global challenges such as achieving net zero, health resilience, and environmental sustainability (8).

The Strategy notes that no definition of AI is suitable for every scenario and therefore differentiates AI as “machines that perform tasks normally requiring human intelligence, especially when the machines learn from data how to do those tasks” (9). This definition helps differentiate AI from other technology or digital policy.

The agenda for the next 10 years is shaped by the three core pillars of the Strategy, under which three key goals have been set.

To experience significant growth in the number and type of AI systems discovered in the UK

To benefit from the highest amount of economic and productivity growth due to AI

To establish the most trusted and pro-innovation system for AI governance in the world (9).

Investing in the long-term needs of the AI ecosystem

Ensuring AI benefits all sectors and regions

Each pillar is divided into short-term (three months) and long-term (3–12 months) outputs, where the Strategy introduces numerous policies and commitments that will be implemented. A summary of the key points is contained in 

. The three pillars identify ‘people’, ‘data’, ‘computing power’, and ‘finance’ as being key drivers to progress, discovery, and to achieving strategic advantage in AI, with the acknowledgement that governance and regulation will need to keep pace with technological development. As such, the Strategy specifies particular courses of action that will be pursued.

A summary of the three core pillars of the National AI Strategy.

Strategy for AI in health and social care

In August 2019, the National Health Service (NHS) AI Lab was created to accelerate the development of safe, ethical, and effective AI-driven technologies to deal with challenges in health and social care. The NHS AI Lab operates under the auspice of NHSX, a UK government body charged with the responsibility for setting national policy and developing best practice for NHS technology, digital and data, including data sharing and transparency. The NHS AI Lab, under the guidance of NHSX, is also charged with the responsibility for formulating a new National Strategy for AI in Health and Social Care, contained in Pillar 2 of the National AI Strategy, which places a strong emphasis on ensuring that the transition to an AI-enabled economy transcends all sectors and regions in the UK. A draft National Strategy for AI in Health and Social Care is expected in early 2022, which will set the agenda for AI in the health and social care sector towards 2030.

For companies operating in the AI, data-driven health, and life sciences sectors, it is clear that the interplay between factors such as R&D, digital technologies, data security and privacy, infrastructure, and ethics will mean that organizations will need to keep a holistic eye on the spectrum of related developments (both within the UK and abroad), particularly as the UK looks to navigate its new position post-Brexit (1).

Comparison with other national strategies

The UK National AI Strategy’s focus on economic growth is consistent with the national AI strategies adopted by countries elsewhere. Nevertheless, there are some features of the Strategy that differentiate it from approaches adopted by other countries, such as its aim to develop the UK’s compute infrastructure of AI applications (4). Despite the significance of such infrastructure to support the advancement of AI, the only other country to address compute capacity in its national AI strategy is the US.

Another distinguishing feature of the Strategy is its focus on international technical standards as a mechanism for governing AI. In this instance, the UK (along with Australia) appears to be more focused on influencing technical standards for AI systems, such as requirements for documentation and reliability testing, rather than developing the legislation itself (8). This approach underscores the British government’s intention to establish the UK as a ‘safe harbour’ for the development of AI technologies and that less regulation will encourage innovation in the sector. However, this position is in stark contrast with the EC’s own position on AI regulation, where it proposes to strictly regulate certain types of ‘high risk’ AI technologies (6).

Furthermore, divergence from the EU on key points, such as those relating to data, may also make it harder for AI developers and companies using AI technologies in the UK to operate in the EU (and vice versa). More importantly, it could also risk the continuity of the 28 June Data Adequacy Decision (DAD) granted by the European Union (EU) when the UK left the EU, which was designed to avoid any conflict between British and European data protection legislation. The DAD ensures the continued and unimpeded transfer of data from the EU to the UK (10).

The UK’s National AI Strategy, which contrasts markedly with the EU’s own proposed AI rules, indicates that the country is keen to ensure it gains an economic boost, post-Brexit. To this end, the UK government is trying to strike a balance within the middle (11). At a national level, this will indeed be helpful to start-ups and smaller businesses, focused initially on the UK market. However, for international businesses and those looking to scale, there will be increased costs involved in ensuring compliance across borders, the greater the divergence between regulatory environments (12).

While the EC has also set out a plan to boost AI innovation, it will strictly regulate applications that could impinge on fundamental rights and product safety and includes bans for some ‘unacceptable’ uses of AI such as government-conducted social scoring (11). However, implementing this approach in healthcare will be more difficult as it will require the careful balancing of core values with a detailed consideration of nuances of health and AI technologies (13). To this end, the EC needs to consider AI’s ability to adapt to different users and contexts, as a ‘one-size-fits-all’ approach may not yield the necessary outcomes in the context of healthcare, a notion recognized by the US Food and Drug Administration (FDA) amongst others (14).

Ultimately, the timelines for AI regulation are also crucial. The EC’s AI proposal is currently undergoing legislative scrutiny in the European Parliament and Council. If the EU adopts its legislation before the UK formally adopts theirs, the EU will have first mover advantage, depriving the UK of the opportunity to act as a trendsetter for AI regulatory standards. Instead, the UK could find itself obliged to align with EU standards (15). Nevertheless, the formulation of the UK’s National AI Strategy, and within it the anticipated new National Strategy for AI in Health and Social Care, underpins the UK government’s long-term commitment and ambitions to supporting and enhancing the country’s digital ecosystem. It also signals the vital importance of the health and life sciences sectors as a pivotal contributor to meeting these aims.

1. E. Keeling, “The UK’s National AI Strategy: Setting a 10-year Agenda to make the UK a ‘Global AI Superpower’,” 

, Digital Hub Blogs, 24 Sep. 2021.
2. UK Gov., 

Digital Regulation: Driving Growth and Unlocking Innovation

UK Innovation Strategy: Leading the Future by Creating It

 (22 July 2021).
6. O. Yaros, A.H. Bruder, and O. Hajda, “The European Union Proposes New Legal Framework for Artificial Intelligence,” 

, 5 May 2021.
7. Business Wire, “The UK Leads Europe and Ranks Third Globally in Artificial Intelligence,” Press Release, 15 Dec. 2021.
8. CMS Law-Now, “‘National AI Strategy’: Step Change for the AI Economy in the UK,” Article, 11 Oct. 2021.
9. HM Government, 

, Policy Paper (September 2021).
10. T. Reilly, “Data Divergence: A Brexit Dividend?” 

, Inside Privacy Feature, 8 Sep. 2021.
11. M. Heikkila, “UK Charts Post-Brexit Path with AI Strategy,” 

, 22 Sep. 2021
12. C. Eastham, “UK AI Strategy Focussed on Economic Growth, Resilience and Ethics,” 

Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)

, Discussion Paper and Request for Feedback, 

 (2020).
15. D. Cooper, et al., “The UK Government Publishes its AI Strategy,” 

When referring to this article, please cite it as B. Piachaud-Moustakis, “An Overview of the UK’s National AI Strategy,” 

Articles

The UK’s National AI Strategy underpins the government’s long-term commitment and ambitions to enhancing the country’s digital ecosystem, with the health and life sciences sectors seen as pivotal contributors to meeting these aims.

An Overview of the UK’s National AI Strategy

The shared goal of the European Commission (EC) Digital Markets Act (DMA) and Digital Services Act (DSA) is to transform how digital content is ranked, advertised, and removed with the aim of restricting the monopoly held by large multinationals in the digital space. Tech companies such as Google, Amazon, Facebook, and Apple (GAFA) operating in the European Union (EU) will have to follow a new set of rules that will apply to all digital services, including social media, online marketplaces, and other online platforms. For pharmaceutical companies and digital therapeutic manufacturers, this would affect how products are digitally marketed and advertised, and the management of personal data sourced from a core platform which falls under the remit of Article 5(a) which “prohibits combining personal data sourced from a core platform service with data from other services offered by the gatekeeper or from third-party services” (1).

The legislative proposal was submitted by the EC to the European Parliament and to the Council of the EU on 15 Dec. 2020. Together with the DSA, the DMA is part of the European Digital Strategy entitled “Shaping Europe’s Digital Future” (2). This proposal is not expected to be implemented until 2023, as it must be approved by the European Parliament and Council.

The DMA is a legislative proposal designed to place significant obligations on the largest tech companies operating in the EU. The aim of the legislation is to create a fairer business environment and to encourage competition by allowing new players to enter the market. The DMA covers eight different sectors that are referred to as ‘core platform services’ that include:

number-independent interpersonal communication services

advertising services offered by a provider of any of the other core platform services (3).

The EC views that these services are characterised by “extreme scale economies that result from nearly zero marginal costs to add users, a significant degree of user lock-in and dependency, and data driven advantages” (4). From the EC’s perspective, this has allowed a small number of large tech companies to wield considerable economic power, thereby assuming the role of ‘gatekeepers’ that determine how smaller companies engage with online consumers.

Under the proposed rules, business users must be granted access to any data they generate when using the gatekeeper’s platform; while companies advertising on the gatekeeper’s platform will have the legal right to access tools and information to conduct independent verification of their ads and will be allowed to manage contracts with customers outside of that platform (3). In addition, gatekeeper platforms will not be allowed to ‘self-preference’, which means ranking their own services more favourably than similar services offered by third parties. Furthermore, gatekeepers will also be prohibited from preventing customers from linking to other businesses outside of their platforms or prevent users from removing any pre-installed software or apps.

The DMA designates gatekeepers using qualitative criteria as well as quantitative criteria. Qualitative criteria are laid down in Article 3(1) of the DMA, while quantitative criteria are presented in Article 3(2). In terms of quantitative criteria, two broad tests are used to identify gatekeepers:

Size of undertaking test: This includes any company providing (a) core services in at least three EU member states; (b) has earned European revenues of more than €6.5 billion in the last three financial years, or which has an average market capitalisation of at least €65 billion; and

Core platform service test: the relevant core platform service has 45 million monthly active end users in the EU and more than 10,000 yearly active business users in the last three years (5).

Companies that meet any of the above criteria can be deemed a gatekeeper as it enjoys an “entrenched and durable market position, either at present or in the foreseeable future” (6). However, the EC may also designate as gatekeeper a company that does not meet all these quantitative thresholds but poses similar risks to the fairness of the market, based on a qualitative assessment. The intention of the DMA is that the regulation will apply to such gatekeepers, where the users of their services are established or located in the EU. According to de Streel, given the fast-paced nature of the internet economy, these obligations would apply ‘ex-ante’ instead of ‘ex-post’, which is usually the case with competition policy (7).

The DSA has a much broader scope than the DMA and is aimed at updating the EC’s e-Commerce Directive of 2000 by introducing new rules and enhanced responsibilities for online intermediaries and platforms regarding content, safety of users online, audit, reporting, traceability, and transparency requirements for all digital providers, as well as certain specific rules for very large online platforms (1). Under the terms of the DSA, the largest organizations (i.e., those that reach more than 10% of 450 million consumers in Europe) will be required to give regulators and external groups greater access to internal data. The DSA will “uphold exemptions from liability enshrined in the e-Commerce Directive, but will impose new due diligence obligations, transparency requirements and establish an EU-wide board for digital regulators” (4). While the DMA focuses on the competitive conduct of digital intermediaries, the DSA aims to regulate the way in which they interact with their customers, with obligations towards preventing the dissemination of harmful or illegal content.

On 23 Nov. 2021, the DMA legislative proposal was endorsed with an overwhelming majority by the European Parliament’s Committee on the Internal Market and Consumer Protection (IMCO), which was to be later voted on in the December plenary session. While the quantitative thresholds were increased slightly (rising to €8 billion in annual turnover in the European Economic Area [EEA] and a market capitalisation of €80 billion), the number of digital markets considered was kept to just one (8). The involvement of national competition authorities was also enhanced, as these legislative bodies are viewed as vital sources of advice to the EC, and which will contribute to future investigations. In addition, the list of digital markets was also extended to include connected TVs, virtual assistants, and web browsers.

The legislation was also amended to include additional rules on the use of data for targeted or micro-targeted advertising except in instances where there is a “clear, explicit, renewed, informed consent”, in line with the General Data Protection Regulation (GDPR) (8). Furthermore, the updated guidance prohibits the use of personal data of children from being processed for commercial purposes under any circumstances. This stipulation is also mirrored in the DMA’s sister legislation, the DSA. Other fundamental additions to the DMA were provisions against “killer acquisitions”, which would be employed in cases of systematic non-compliance. In such instances, the commission would temporarily block takeovers of relevant companies. The fines for systematic non-compliance have been made harsher, with the minimum set at 4% of a company’s annual turnover and the maximum doubled to 20% (9).

The approved text will become parliament’s mandate for negotiations with EU governments, planned to commence under the French presidency of the council in early 2022. The council of the EU has also confirmed its negotiating position on the DSA, a parallel proposal to the DMA intended to regulate illegal content and algorithms online.

The DMA heralds a shift by the EC to a more interventionist regulatory stance by allowing the commission to impose prescriptive rules regulating the conduct of the largest tech firms simply by virtue of their market position (

). More importantly, the DMA is also serving to create another important tool in the EU’s regulatory landscape, following in the example of the GDPR legislation that was formulated in 2018. Although the scope of the DMA at this stage is to some extent relatively narrow, as it is designed to capture only the largest players in the market, smaller businesses may expect to reap the benefits of some of the measures in favour of transparency and competition, as well as gain greater rights and bargaining power vis-a-vis gatekeeper firms (3). In the healthcare domain, companies that act as gatekeepers in the life sciences and digital therapeutics sectors will also be impacted. This is especially relevant in areas relating to Big Data, the creation of digital tools designed to support research and better patient care, and digital marketing.

 A ‘step-change’ in the European Union’s digital regulation.

1. Talking Tech, “EU Digital Services Act and Digital Markets Act: What are the Implications?” 

, Expert Briefing, 21 Jan. 2021.
2. EC, Shaping Europe’s Digital Future: The Digital Services Act Package (last updated on 21 Oct. 2021).
3. J. Peters, “The EU’s Proposed Digital Markets Act,” 

, Competition and Consumer Insight Blog, 23 July 2021.
4. L. Ardill, “Details of the Digital Services Act Revealed,” 

, Article, 15 Dec. 2020.
5. W. Leslie, L. Prompers, and A. Michailidou, “The European Commission’s Digital Markets Act Proposal: Regulating Systemically Important Digital Platforms,” 

, Article, 18 Dec. 2020.
6. A. Portuese, “The Digital Markets Act: European Precautionary Antitrust,” 

Information Technology & Innovation Foundation (ITIF)

, Report, 24 May 2021.
7. A. de Streel, et al., “The European Proposal for a Digital Markets Act: A First Assessment,” 

, Assessment Paper, 19 Jan. 2021.
8. Pinsent Masons LLP, “EU Parliament Prepares for Vote on Digital Markets Act,” Out-Law News, 26 Nov. 2021.
9. L. Bertuzzi, “EU Parliament’s Key Committee Adopts Digital Markets Act,” 


Vol. 34, No. 2
February 2022
Pages: 7–8

When referring to this article, please cite it as B. Piachaud-Moustakis, “Updated Guidance to the EU’s Digital Markets Act,” 

The Digital Markets Act is transforming the use of digital content by the pharmaceutical industry.