During the Disrupt Synergies event held during Almedalen Week in 2017, digital transformation was already a key concept in healthcare. At that time, we spoke about potential, whereas today in 2026 it constitutes a regulated landscape with significant implications for corporate strategy, ownership value, and governance. This follow-up analyzes what actually existed in 2017, what has been built since, and how evolving EU regulations are creating a new playing field for companies and owners.
2017: E-Health as Potential and an Early Regulatory Framework
Digital transformation as a concept
In 2017, digital transformation was a central strategic concept for the healthcare sector globally. It was about viewing technology as an enabler of better care, more efficient processes, and lower costs — rather than an established reality.
In the report The value of digital technology in Swedish healthcare, the potential was described as significant, estimated at approximately 25% of healthcare costs if the right digitalization were implemented. This figure was used as evidence of the business and innovation potential within e-health.
EU regulatory framework 2017
The most important regulatory frameworks that existed or were underway were:
GDPR (General Data Protection Regulation) – an EU regulation on data protection adopted in 2016 and applied from May 2018. Already in 2017, GDPR was fully decided and discussed as the foundation for all data handling within the EU, including health data.
Medical Device Regulation (MDR) – adopted in 2017 but not fully applied until 2021. MDR replaced previous directives and introduced stricter requirements for classification, CE marking, and post-market obligations for medical devices.
What did not exist in 2017 were concrete regulations for broad health data management such as:
European Health Data Space (EHDS) – first proposed in 2022 and adopted in its final form in 2025.
NIS2 and the AI Act – decided in the late 2020s and not part of the framework in 2017.
Reference cases 2017
In 2017, there were few real European reference cases where digital transformation had led to large-scale interoperability, cross-border care, or systematic secondary use of data. Initiatives were often local pilot projects within regions, university hospitals, or procured system solutions.
Summary 2017
Digital transformation was strategically articulated, regulatory frameworks were relatively general and fragmented, and reference cases were limited. This made it difficult for many companies to translate vision into business and regulatory reality.
2026: A Regulatory and Technological Reality
During the period 2018–2026, the EU has implemented significant regulatory reforms affecting the entire healthcare sector.
2025/2026: Key regulatory frameworks
1. European Health Data Space (EHDS)
A new EU regulation (EU) 2025/327 establishes a common European health data space. It entered into force on 26 March 2025 and creates a framework for how electronic health data may be used, shared, and reused for care, innovation, research, and policy development.
EHDS aims to:
- Give individuals control over and access to their electronic health data
- Facilitate cross-border data sharing within the EU
- Enable lawful secondary use of data for research and innovation
Implementation is gradual but already underway (2025–2027), and is based on technical standards and interoperability requirements.
2. Data Act (2023) and AI Act (2024)
In addition to EHDS, the EU has adopted:
Data Act (2023) – promotes access to and use of data in the EU economy, including sectors such as healthcare.
Artificial Intelligence Act (2024) – a framework for AI systems, including risk classification and requirements for transparency and safety. This plays an increasingly important role in AI-supported clinical tools and decision support.
Technological maturity 2026
Technologies that were in pilot phases in 2017 are commercially established in 2026:
- Interoperable EHR systems (Electronic Health Records) with European standards
- AI-driven decision support in diagnostics and treatment planning
- Remote monitoring and sensor technology at scale
- EU-wide data access platforms
Reference cases in Europe in 2026 include systems where health data is securely exchanged between member states, research networks using EHDS infrastructure for real-world data, and medtech companies designing products for EHDS compatibility.
Strategic analysis for companies, owners, and boards
1. From potential to regulatory reality
In 2017, the potential of digital transformation was discussed. In 2026, the transformation is regulated:
- GDPR remains fundamental for personal data
- EHDS has become a new pillar for health data management
- The AI Act and Data Act impact AI solutions and data sharing
This shift changes business models. Companies that previously viewed digitalization as a technology investment must now see it as an integrated part of regulatory compliance and market access.
2. The three barriers from 2017 – have they decreased?
Cautious approaches and procurement
Regulatory requirements have forced more structured standards and procurement processes, making innovation more scalable — but also more complex and costly to comply with.
Few strong reference cases
The limited reference cases from 2017 have expanded by 2026, but they are often regulatory-driven rather than market-driven, which affects how companies in the segment are valued.
Limited pressure for change
The limited pressure for change in 2017 has shifted to regulatory pressure in 2026: companies must adapt or risk losing market access.
3. Impact on company value and ownership strategy
Regulatory compliance is now value-driving, not just cost-driving:
- Market access in the EU requires EHDS and AI Act compatibility
- GDPR-compliant data handling is a minimum requirement
- Companies that can manage real-time data flows are stronger in valuation discussions
- Boards must include regulatory risk as a central strategic parameter
4. Formulating a governance strategy in 2026
For owners and boards, this means:
- Regulatory horizon scanning as a strategic function
- Integration of EHDS compliance into the business model
- Data governance and cybersecurity as value creators, not just costs
- Active work with AI risk management in accordance with the AI Act
From digital potential to strategic reality
In 2017, digital transformation was about opportunity.
In 2026, it is about regulated reality.
For owner-led companies, boards, and governance-level stakeholders, the insight is clear:
The strategic question is no longer whether to digitalize —
"The strategic question is no longer whether to digitalize — but how to do so within the regulatory frameworks that define value, market access, and competitiveness in 2026"
