An IP lawyer's perspective for life science executives, founders, investors and innovation leaders.
For decades, discussions regarding intellectual property in the life sciences have focused primarily on patents, regulatory exclusivities, trade secrets and technical know-how. Today, however, another asset class is rapidly emerging as a strategic source of competitive advantage: health data.
In the United States, an extensive ecosystem has developed around the aggregation, licensing and commercialisation of clinical, pharmaceutical, genomic and real-world health data. Companies such as IQVIA, Optum, TriNetX and others have demonstrated that data itself, when curated and structured appropriately, can become a valuable commercial asset capable of generating substantial recurring revenue streams.
Europe has not yet witnessed a similar development. This is not because Europe lacks data. Quite the contrary. Many of the world's most comprehensive patient registries, biobanks and longitudinal healthcare datasets are located in Europe, particularly in the Nordic countries. Instead, the development of a European health data market has been constrained by fragmentation, regulatory complexity and the absence of a common infrastructure for cross-border access and reuse. The recently adopted European Health Data Space (EHDS) seeks to address these challenges precisely by establishing a harmonised framework for the use and reuse of electronic health data throughout the European Union.
The EHDS may prove to be one of the most significant developments in the European life sciences sector since the introduction of the General Data Protection Regulation (GDPR). For European companies and investors, it raises an important question: how can organisations position themselves today to participate in tomorrow's health data economy?
Europe's untapped advantage
The common assumption is that the United States dominates health data because it possesses more data than Europe. In reality, the opposite may often be true.
The Nordic countries stand out by having long-maintained national healthcare systems with extensive registry infrastructure. Sweden, Denmark and Finland possess uniquely rich datasets covering prescription records, disease registries, hospital treatments, cancer outcomes and other patient-level information. The ability to link records over extended periods using national identifiers has created datasets that are exceptionally valuable for epidemiology, pharmacovigilance, health economics, precision medicine and real-world evidence generation.
Yet despite their value, these assets have rarely been commercialised in the same way as comparable data assets in the United States. Much of the data is controlled by public-sector institutions, universities, healthcare providers or research organisations rather than private companies. Access is often subject to complex approval procedures, ethics reviews and national legal requirements. As a result, Europe possesses extraordinary health data resources without having developed a similarly mature market for health data transactions.
What is notable is that whereas five years ago, discussions about health data in Europe often centred on compliance, privacy and ethics, the industry conversation has become substantially more commercial. Today industry bodies are increasingly discussing how investment in AI and data-driven innovation can turn into revenues.
Why Europe has lagged behind
The causes are both structural and legal.
First, Europe has historically lacked a single health data market. Organisations seeking access to patient data frequently encounter different procedures, governance structures and legal requirements in each individual Member State. Even where GDPR applies uniformly, national implementations and interpretations concerning health data and scientific research have created practical divergence.
Second, health data constitutes a special category of personal data under GDPR, requiring additional legal safeguards. GDPR does not prohibit innovation or secondary use of health data, but it does impose significant governance requirements concerning lawful processing, purpose limitation, data minimisation and international transfers.
These requirements often increase transaction costs and complexity. For multinational projects, legal analysis may become almost as important as scientific research itself.
Third, European healthcare systems have traditionally adopted a more cautious approach toward commercialisation of patient information. Public trust remains central. Even where a proposed use is lawful, decision-makers may hesitate if they perceive a significant reputational risk.
Consequently, Europe has evolved toward a model focused on regulated access and public-interest reuse rather than the development of large-scale commercial data brokers.
Current state of the health data market
Despite these constraints, it would be incorrect to conclude that no European health data market exists.
Today, substantial economic activity already takes place around health data, although transactions are typically structured differently from conventional sales of datasets.
Pharmaceutical companies routinely enter into arrangements to access disease registries, biobank resources, imaging databases and real-world evidence datasets. Health technology companies train algorithms using clinical datasets. Research organisations license access to curated repositories. Contract research organisations build value-added services around data analytics and evidence generation.
What is often being commercialised, however, is not ownership of data itself but rather access rights, research rights, analytical capabilities or generated insights.
This distinction is increasingly important. In practice, many successful health-data businesses are not selling raw patient information. Instead, they provide access to curated and governed environments that enable customers to derive value from the underlying data.
The emergence of data analytics providers, real-world evidence platforms and AI-focused health technology companies demonstrates that a market already exists. It is simply a more fragmented and access-based market than its American counterpart.
The EHDS: building a European health data infrastructure
The principal objective of the European Health Data Space (EHDS) is to unlock the potential of health data throughout the European Union while maintaining a strong framework for privacy, security and individual rights. The EHDS creates a common legal and technical framework governing both primary and secondary use of electronic health data and aims to facilitate cross-border access for research, innovation, policymaking and regulatory purposes.
EHDS is not a future proposal anymore but an existing legal framework. It entered into force on 26 March 2025, following publication of Regulation (EU) 2025/327, with the implementation being phased over several years.
Perhaps the most significant aspect of the EHDS is not any individual legal provision but rather its attempt to create infrastructure. However, the EHDS is not without controversy. Critics express concerns regarding privacy, governance and the commercial use of data originating from publicly funded healthcare systems. The ultimate success of the EHDS will therefore depend not only on technical implementation but also on maintaining public trust in how health data is accessed and used.
Historically, one of the greatest obstacles for organisations seeking health data has been identifying what data exists, where it is located and how access may be obtained. The EHDS seeks to improve discoverability, interoperability and administrative processes while establishing Health Data Access Bodies responsible for facilitating secondary use requests.
From a commercial perspective, this may significantly reduce transaction costs.
Markets function efficiently when assets are identifiable, discoverable and accessible through predictable processes. The EHDS therefore has the potential to transform health data from a largely local and fragmented resource into a more scalable European asset class.
The emergence of new business models
One misconception surrounding health data is that the future market will primarily involve buying and selling datasets.
A more likely scenario is the emergence of businesses built around access, curation, analytics and derivative assets.
The commercial value of raw data is often limited. Health data is frequently incomplete, heterogeneous and difficult to utilise without substantial preprocessing. Value arises when information is standardised, cleaned, linked, harmonised and contextualised.
This suggests that some of the most successful future businesses may be organisations that facilitate the use of health data rather than organisations that merely possess it.
Companies specialising in data harmonisation, metadata generation, secure processing environments, synthetic data generation, AI training infrastructures and disease-specific knowledge platforms may become critical intermediaries within the European ecosystem.
Similarly, life science companies generating health data as part of clinical trials, patient support programs, diagnostics or digital health solutions may increasingly discover that their true commercial asset is not the underlying data itself but rather the curated datasets, predictive models and specialised insights generated from it.
For European pharma and biotech companies, and SMEs in particular, the primary opportunity arising from EHDS is unlikely to be becoming a "data seller". Very few SMEs possess the scale, infrastructure or regulatory positioning to compete with major data aggregators. Rather, the opportunity is to become a data-enabled life science company, where proprietary datasets, data-derived know-how and AI-ready assets enhance product value, support partnerships and generate additional revenue streams.
What investors should be looking for
Data assets can be just as valuable as traditional intellectual property portfolios.
Due diligence is still to a large extent focused on patents, licences and freedom-to-operate analyses. Increasingly, investors should be asking questions regarding data provenance, usage rights and governance structures.
In the future, the commercial value of a health data asset may depend less on its technical characteristics and more on the strength of the associated legal framework.
A sophisticated investor may wish to understand whether a company can demonstrate a clear chain of rights to the data, whether agreements permit secondary use and commercialisation, whether derived datasets can be licensed and whether machine learning models may be trained and commercialised using the available information.
Companies that can answer these questions confidently are likely to command significantly greater strategic value than those relying on uncertain assumptions regarding data ownership.
The health data economy will not reward organisations that merely collect information. It will reward organisations that possess legally robust and commercially usable data assets.
Structuring health data and adopting legal frameworks
Traditionally, health data has been viewed primarily through the lens of privacy and regulatory compliance. While these disciplines remain critically important, an exclusive focus on compliance risks overlooking broader commercial opportunities.
Many of the key questions surrounding health data are fundamentally questions of asset creation, ownership and commercialisation.
Who owns a dataset generated during a collaboration? Who controls enriched or annotated versions of that dataset? Who may train machine-learning models using the underlying information? Can analytical outputs be licensed independently? What rights survive termination of a research collaboration?
These questions closely resemble the issues intellectual property lawyers have addressed for decades in relation to patents, software and know-how.
Indeed, health data may increasingly require legal frameworks comparable to traditional Background IP and Foreground IP structures. Contracts will need to distinguish between source data, derived datasets, analytics outputs, machine-learning models and future commercial uses.
Significant value creation can be derived from combining and licensing data assets. Therefore, identifying and mapping health data assets for understanding the company’s data portfolio is a highly recommended exercise. To ensure that data can be used in future commercial activities and partnerships, due care should also be taken to review agreements, in particular IP-related and data-centric agreements.
Preparing for the next decade
For European life science companies, the most promising opportunity may not be to emulate American data brokers. Rather, it is to leverage Europe's unique strengths by developing trusted, high-quality and well-governed data assets capable of supporting research, innovation and evidence generation on a global scale.
The organisations best positioned to succeed are likely to be those that start preparing now. They will establish robust contractual frameworks, clarify ownership rights, document data provenance, invest in interoperability and think strategically about how data contributes to competitive advantage.
Crucially, they will recognise that health data is not merely a compliance issue.
It is an asset class.
As the EHDS begins to reshape the European landscape, the winners may not necessarily be the organisations with access to the greatest volume of data. Rather, they may be those that best understand how to transform legally generated health information into scalable, licensable and defensible business assets.
The greatest beneficiaries of the EHDS may not necessarily be healthcare providers or pharmaceutical companies. As occurred in other digital markets, substantial value may ultimately accrue to organisations that help discover, curate, harmonise, govern and analyse health data.
For life science companies and investors across Europe, that transition has already begun.
References
- European Health Data Space Regulation (EHDS), European Commission, Public Health Directorate. [health.ec.europa.eu]
- European Health Data Space (EHDS), Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space. [eur-lex.europa.eu]
- European Commission, "Reuse of Health Data" (secondary use of health data under EHDS). [health.ec.europa.eu]
- Lalova-Spinks, T., Valcke, P., Ioannidis, J.P.A. et al. EU-US data transfers: an enduring challenge for health research collaborations. npj Digit. Med. 7, 215 (2024). [nature.com]
- Tschider, Corrales Compagnucci & Minssen, "The New EU-US Data Protection Framework's Implications for Healthcare", Journal of Law and the Biosciences, Volume 11, Issue 2, July-December 2024, lsae022. [academic.oup.com]
- Bradford, Aboy & Liddell, "International Transfers of Health Data Between the EU and USA", Journal of Law and the Biosciences, Volume 7, Issue 1, January-June 2020, lsaa055 [academic.oup.com]
- European Commission, "EU-US Data Transfers". [commission.europa.eu]
