In the rapidly evolving landscape of health data regulation, the European Health Data Space (EHDS) initiative marks a transformative moment for the biopharma industry. As the EHDS promises to revolutionize the way health data is accessed, shared, and utilized across Europe, it also raises significant challenges, particularly regarding data protection and compliance with the General Data Protection Regulation (GDPR). For biopharma companies, these developments signal a need for increased efforts to ensure full compliance with GDPR, as data protection authorities (DPAs) will likely intensify their enforcement activities.
A New Era of Health Data Sharing
The EHDS will facilitate the cross-border exchange of health data within the European Union (EU). One of the key goals of the EHDS is to create a unified framework that enables health data to be accessed, shared, and utilized across EU member states. This initiative is designed to improve healthcare services, foster innovation, and support medical research by making health data more accessible to authorized parties across borders.
Key aspects of cross-border data exchange under the EHDS include:
- Interoperability: The EHDS will promote interoperability standards, ensuring that health data from different countries and systems can be easily shared and understood across borders.
- Secure Access and Use: Health data will be accessible to healthcare providers, researchers, and policymakers through secure portals, ensuring that data protection and privacy are maintained. Data sharing will comply with GDPR, meaning that personal data protection remains a top priority.
- Research and Innovation: The EHDS will enable researchers and biopharmaceutical companies to access health data from diverse populations across Europe, enhancing opportunities for innovation in medical treatments, drug development, and healthcare policies.
- Patient Empowerment: Patients will have greater control over their health data and the ability to make it available for cross-border healthcare services, which can lead to better care and treatments when traveling or living in different EU countries.
Why Biopharma Companies Must Act Now
The launch of the EHDS will bring health data into the spotlight for regulators. As DPAs increase their focus on health data processing, biopharma companies must take proactive steps to align their practices with GDPR requirements. Key areas that demand attention include data minimization, lawful data processing, and patient consent, all of which are foundational to GDPR compliance.
1. Enhanced Data Governance and Risk Management
The increased use of health data under the EHDS will necessitate stronger data governance frameworks within biopharma companies. This includes ensuring that data is only processed for specific, legitimate purposes, adhering to data minimization principles, and conducting regular Data Protection Impact Assessments (DPIAs).
DPIAs will be critical in identifying and mitigating risks associated with the processing of sensitive health data. Companies must also maintain thorough documentation of their data processing activities, demonstrating their compliance with GDPR to regulators.
2. Strengthening Security Measures
Given the sensitivity of health data, robust security measures are essential. The EHDS will likely lead to a greater exchange of data across borders, increasing the risk of data breaches. Biopharma companies must invest in advanced security protocols such as encryption, access controls, and regular monitoring to protect against unauthorized access.
In the event of a data breach, GDPR mandates timely reporting to both regulators and affected individuals. Preparing contingency plans for data breaches will be crucial to minimize the impact and ensure compliance with these reporting requirements.
3. Managing Cross-border Data Transfers
One of the major benefits of the EHDS is the ability to share health data across EU borders. However, this also presents compliance challenges, as biopharma companies will need to navigate GDPR’s strict rules on international data transfers. Ensuring that data sharing agreements and transfer mechanisms, such as Standard Contractual Clauses (SCCs), are in place will be essential for lawful cross-border data exchanges.
4. Collaboration with Regulatory Authorities
As the EHDS framework matures, collaboration between biopharma companies and regulatory authorities will become more important than ever. Companies must be prepared for audits, inspections, and ongoing engagement with DPAs to demonstrate their compliance efforts.
Proactively engaging with regulators and staying updated on evolving guidance around the EHDS will help companies anticipate regulatory expectations and adjust their compliance strategies accordingly.
5. Revisiting Consent Mechanisms and Patient Rights
GDPR places a strong emphasis on patient rights and informed consent, particularly in the context of processing health data. Biopharma companies must review their consent mechanisms to ensure they are providing patients with clear, transparent information about how their data will be used, stored, and shared.
In addition to obtaining explicit consent, companies must also have processes in place to handle patient requests to access, rectify, or delete their data. Failure to respect these rights could lead to increased scrutiny from DPAs, as well as potential legal challenges.
Data for Secondary Use: The Need for Careful Compliance
The EHDS will facilitate the secondary use of health data for research, innovation, and policy development. While this creates significant opportunities for biopharma companies, it also requires careful compliance with GDPR. Companies must ensure that data is appropriately anonymized or pseudonymized and that they have the necessary legal basis for processing sensitive data for secondary purposes.
By maintaining strict adherence to GDPR’s data protection principles, companies can leverage health data for innovation while minimizing the risk of regulatory violations.
Preparing for Increased Enforcement
As the EHDS expands the use and sharing of health data, DPAs are expected to intensify their enforcement activities. Non-compliance with GDPR could result in severe financial penalties, with fines reaching up to 4% of a company’s global annual revenue.
To avoid these penalties, biopharma companies must allocate sufficient resources to compliance efforts. This includes conducting regular compliance audits, providing training to employees on GDPR requirements, and implementing strong data protection policies across the organization.
Conclusion: A Strategic Approach to Compliance
The EHDS presents a unique opportunity for biopharma companies to advance research and innovation through the use of health data. However, with this opportunity comes the responsibility to ensure full compliance with GDPR and other data protection laws.
By taking proactive steps to strengthen data governance, enhance security, and engage with regulatory authorities, biopharma companies can position themselves for success in this new era of health data sharing. As DPAs focus their attention on the processing of health data, the cost of non-compliance—both in terms of financial penalties and reputational damage—makes it imperative for companies to act now.
Biopharma companies that prioritize compliance will not only mitigate legal risks but also build trust with patients, regulators, and partners, paving the way for long-term success in an increasingly data-driven healthcare ecosystem.
Diana is the Founder & Managing Director at RD Privacy and a contributing columnist, specializing in privacy for the pharmaceuticals and life science sectors, particularly small biopharma companies, with extensive experience as a European qualified privacy attorney and Data Protection Officer (DPO).
