EU Payment Services Directive (PSD2) for Healthcare
Hospitals, pharmaceutical companies, medical device manufacturers, health insurers, and clinical research organisations face some of the strictest compliance requirements globally. Here is how EU Payment Services Directive (PSD2) helps healthcare organisations build and maintain compliance.
Why EU Payment Services Directive (PSD2) Matters for Healthcare
Hospitals, pharmaceutical companies, medical device manufacturers, health insurers, and clinical research organisations face some of the strictest compliance requirements globally. Patient data protection, clinical trial integrity, and medical device safety demand rigorous governance frameworks.
Healthcare organisations typically navigate HIPAA, FDA regulations, GxP requirements, and regional data protection laws simultaneously. A structured compliance framework helps consolidate these overlapping obligations into a manageable programme.
EU Payment Services Directive (PSD2) provides 19 controls organised across 6 domains that can be mapped to healthcare-specific regulatory requirements. This structured approach helps organisations avoid compliance gaps while reducing the overhead of managing multiple overlapping obligations.
Healthcare Compliance Challenges
Healthcare organisations implementing EU Payment Services Directive (PSD2) commonly face these challenges:
Protecting electronic health records (EHR) and patient data across distributed systems
Meeting multiple overlapping regulations (HIPAA, FDA 21 CFR, GxP, GDPR for clinical trials)
Securing connected medical devices and IoT endpoints in clinical environments
Managing third-party vendor risk across supply chains for pharmaceuticals and devices
Balancing rapid digital health innovation with data protection requirements
Implementation Approach for Healthcare
1. Assess Current State
Conduct a readiness assessment against EU Payment Services Directive (PSD2) to identify gaps specific to your healthcare environment. Our AI-powered assessment takes 5 minutes and produces a prioritised action plan.
2. Map Regulatory Overlap
Use cross-framework mapping to identify where EU Payment Services Directive (PSD2) controls satisfy other healthcare regulations. This reduces duplicate effort and accelerates compliance.
3. Implement Priority Controls
Focus on high-risk gaps first, using healthcare-specific threat intelligence to prioritise controls that address your most material risks.
4. Monitor & Improve
Establish continuous monitoring and regular reassessment cycles. Healthcare regulations evolve frequently, so compliance is an ongoing programme, not a one-time project.
EU Payment Services Directive (PSD2) in Healthcare by Role
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Frequently Asked Questions
Why is EU Payment Services Directive (PSD2) important for Healthcare?
How do Healthcare organisations implement EU Payment Services Directive (PSD2)?
What are the biggest EU Payment Services Directive (PSD2) compliance challenges in Healthcare?
Does EU Payment Services Directive (PSD2) satisfy Healthcare regulatory requirements?
How long does EU Payment Services Directive (PSD2) implementation take in Healthcare?
How ready is your Healthcare organisation for EU Payment Services Directive (PSD2)?
Answer 25 questions and get a professional readiness report with gap analysis, maturity scores, and prioritised action items tailored to healthcare. Results in 5 minutes.