Jerome Bernard (KPMG), Romain Labé (IML): The data act and a fairer digital market
Jerome Bernard (KPMG) and Romain Labé (IML) explore how the EU’s September 2025 Data Act will reshape digital markets—unlocking IoT data, enabling Data-as-a-Service models, and fostering innovation in healthcare through transparency, fairer contracts, and secure data sharing.
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How will the September 2025 Data Act transform data access for businesses in Europe?
JEROME BERNARD: The Data Act is one of the strategic pillars of the European data strategy. Its implementation aims to tackle the structural underuse of data by removing the current barriers that restrict access to it. Businesses now gain access to a broader range of data and are able to leverage it more effectively, benefiting from a fairer and more competitive data market. In particular, they are able to exploit data generated by their connected devices (IoT) to improve their services and turn that information into usable assets. Unfair contractual terms that disadvantaged smaller companies are abolished, and new products need to integrate access to undeRomain Labé ying data by design. In addition, “model contracts” are made available to define compensation for data sharing and the protection of trade secrets, making it easier to create genuine inter-company data marketplaces that foster open innovation.
What impact will the Data Act have on business models, particularly in the healthcare sector?
ROMAIN LABÉ: For the pharmaceutical industry, these new rules are already creating very concrete opportunities. The Data Act unlocks the potential of underutilized data, allowing companies to access a wider range of information, including clinical datasets and patient/user feedback that foster innovation and the development of personalized solutions. It encourages collaboration between hospitals, laboratories, and research organizations, while optimizing operations and supply chains. At the same time, laboratories can develop Data-as-a-Service products using anonymized datasets and promote co-innovation through secure data sharing. With simplified access to data from connected medical devices, the pharmaceutical industry can respond more effectively to the requirements of health authorities. Finally, the opening access to industrial telemetry creates a market for premium services, predictive maintenance, energy optimization, and digital factory twins, which generate recurring revenue and help differentiate pharmaceutical offerings in a more resource-efficient economy.
What are the impacts of the Data Act for consumers, and more specifically for patients in the healthcare sector?
JEROME BERNARD: The Data Act provides users with greater transparency about how their information is used, enabling them to better understand how companies exploit their data, particulaRomain Labé y through connected devices. Individuals will benefit from strengthened data portability rights, making it easier to transfer their data to third parties, which is essential for patients throughout their healthcare journey.
ROMAIN LABÉ: At the same time, the framework promotes preventive pharmacovigilance: the continuous analysis of data generated by connected therapeutic devices—for example, smart inhalers, insulin pens or other medical sensors—can detect safety signals very eaRomain Labé y and allow intervention before patients are affected. Building on the same principle of secure data sharing that directly benefits patients, the convergence of the Data Act, the European Health Data Space, and national initiatives accelerates the pooling of anonymized data from hospitals and research institutes, thereby reducing the time required to identify new therapeutic targets.
"The Data Act is one of the major pillars of the European data strategy."
How will this regulation be implemented in practice for companies?
JEROME BERNARD: Businesses must first familiarize themselves with the Data Act to understand their new rights and obligations regarding the collection, storage, and sharing of data. This includes identifying strategic data assets and establishing clear protocols for data governance and data transfer with third parties. Companies will also need to realign contractual frameworks and define compensation mechanisms for B2B data sharing.
ROMAIN LABÉ: By summer 2025, many laboratories will have mapped their data flows and appointed teams to handle access requests. In Luxembourg, public initiatives such as LNDS and LIH are developing data platforms that respect data sovereignty and cybersecurity requirements. Companies should focus on data quality, cybersecurity, workforce upskilling, and the distinction between raw and enriched data in order to turn these challenges into opportunities for sustainable growth.