Europe's Data Privacy Regulations - Are You Compliant and Why It Matters for US Medical Affairs and Beyond

Europe’s Data Privacy Rules: Always Changing — Are You Compliant?

In an era of accelerated global data flow, European data privacy laws—especially the General Data Protection Regulation (GDPR)—remain in flux. In 2025, they continue to sharpen enforcement, expand interpretations, and introduce new frameworks to govern data transfers across borders. U.S.-based Medical Affairs teams interacting with EU-origin data must treat compliance not as optional, but as a strategic imperative. As a Woman Owned Small Business, I need to stay on top of our compliance with regards to client and patient data. This thought leader post is to share some of what I have learned and how I see the risk-mitigation we all need to be aware of.

GDPR applies to any entity that collects, processes, or stores personal data of EU citizens—even if the entity is located in the U.S. The HIPAA Journal+1 This includes health data, which is categorized as a sensitive data type requiring stricter legal bases and safeguards. Bond, Schoeneck & King PLLC+1 EU rules also restrict cross-border data transfers unless mechanisms like Standard Contractual Clauses (SCCs) or Binding Corporate Rules (BCRs) are in place. PMC+1

Importantly, GDPR continues to evolve. The recently adopted EU–US Data Protection Framework (DPF) aims to simplify U.S.–EU transfers, but does not resolve all complexities—especially for health/medical data. OUP Academic Each EU country also layers in its own health data law, creating national variances in consent, secondary data use, registries, and patient rights. Public Health

Why This Matters for U.S. Medical Affairs

Medical Affairs is one of the few functions that commonly touches real-world patient data, KOL inputs, registry databases, post-market surveillance, and cross-regional scientific exchange. Any mishandling of EU-origin data can trigger legal exposure, reputational risk, and regulatory scrutiny.

For example:

• A U.S. Medical Information team responding to a query from an EU-based clinician must confirm that the data transfer, the identity of the requester, and the content of communication comply with GDPR’s legal bases and documentation requirements.

• In real-world evidence (RWE) and pharmacovigilance projects, pooling EU patient data requires rigorous anonymization, clear patient consent, and proper governance.

• New AI tools, digital health analytics, or external partnerships in medical affairs must be evaluated for GDPR risk—especially when models incorporate EU-sourced data or predictive analytics.

Compliance isn’t just about avoiding fines (which can reach up to 4% of global turnover). It’s about maintaining patient trust, scientific credibility, and operational continuity. A noncompliant data breach or audit can stall or derail clinical programs, delay launches, or force suspension of cross-border initiatives.

How to Stay Ahead: 5 Practical Steps

1. Conduct a Data Map & Gap Audit Identify all touchpoints where EU-origin data is collected, stored, processed, or shared. Map legal bases, retention periods, and responsible parties.

2. Legal Mechanisms for Transfers Ensure you have valid transfer mechanisms in place (e.g. SCCs, BCRs). Review them regularly, especially in light of new DPF or regulatory changes.

3. Consent & Transparency Controls Use clear, specific consent language when capturing health data. Inform data subjects of their rights (access, erasure, portability).

4. Pseudonymize or Anonymize Whenever Possible Where direct identifiers aren’t needed, apply data de-identification techniques. This reduces legal risk and often simplifies regulatory compliance.

5. Integrate Privacy into Medical Affairs Design Build privacy by design: when designing protocols, registry models, or digital tools, embed privacy controls and consult your legal/data-privacy partners early rather than retrofitting.

Final Thought

In 2025, EU data privacy is not a static wall—it’s a dynamic landscape. For Medical Affairs teams, compliance is less a checkbox and more a capability. Protecting data rights isn’t just about avoiding penalty—it’s about enabling global collaborations, innovation, and patient respect.

If your organization is evaluating cross-border data projects, medical communications involving EU data, or real-world evidence initiatives, reach out. Let’s assess your medical affairs privacy posture and accelerate compliant, patient-first pathways together.

Book a call with Dr. Anne Arvizu at Corelife Group to schedule a free RFP consultation.

Author: Anne Arvizu, PharmD, FASCP, PCC