Challenges Posed by GDPR Requirements in Exchange of Imaging Data Among Europe, United States, and Other Countries
| Topic | Key challenge |
|---|---|
| Definition of personal data | Imaging data and other clinical measures (e.g., clinical features and biomarkers) linked to identifiable individuals (e.g., MRIs with patient metadata) are considered personal data under GDPR, requiring compliance with its regulations |
| Legal basis for transfer | GDPR mandates specific lawful bases for data processing, especially for exporting and handling processes outside EU; organizations must establish lawful basis for data transfer, such as obtaining explicit consent or using public interest justification, complicating process |
| Data transfer mechanisms | Transferring data outside EU is permissible only under specific conditions, such as presence of adequacy decision by European Commission that recognizes non-EU country’s data protection regime as equivalent to GDPR; United States does not have such adequacy decision, meaning organizations must rely on mechanisms such as standard contractual clauses or binding corporate rules, which can be complex to implement and manage |
| Monitoring of compliance | Organizations must ensure ongoing compliance with GDPR, including conducting data protection impact assessments and monitoring data practices, which can be resource-intensive |
| Potential for data breaches and liability | Discrepancies in regulatory standards raise concerns about data breach liabilities; organizations face heavy fines under GDPR, even for breaches that occur abroad |
| Cross-border access and subpoenas | U.S. laws may compel organizations to disclose data, potentially conflicting with GDPR obligations, creating challenges for cross-border data sharing |
| Cultural differences in data privacy | There are differing attitudes toward data privacy between EU and U.S.; European entities may be more cautious about sharing data, impacting trust |
| Technical and organizational measures | GDPR requires robust technical and organizational measures for data protection, necessitating changes in data handling practices when sharing across borders |
EU = European Union.