General Surgery Coding Alert - 2018 Issue 10
Industry Note: Check Your GDPR Compliance Protocols
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Article Overview
This industry note explains why organizations involved in medical research should review privacy and compliance protocols in light of the European Union’s General Data Protection Regulation. It discusses the potential reach of GDPR for human-subjects research, the relevance of guidance from HHS and SACHRP, and the kinds of research settings and technologies that may raise cross-border privacy concerns. The article is intended for researchers, providers, compliance staff, and other health care stakeholders who need a high-level understanding of international privacy obligations.
Why This Topic Matters
GDPR can create significant privacy and compliance obligations for research activities that involve personal data, including studies that use connected devices or involve participants traveling across borders. Understanding the article helps organizations identify when additional review of research privacy practices may be warranted.
What You Will Learn
- Why GDPR awareness matters for medical research and human-subjects privacy
- How cross-border research activities can raise compliance questions
- The role of HHS and SACHRP guidance in interpreting privacy obligations
- What types of research scenarios may warrant a protocol review
Who Should Read This
- Medical researchers
- Clinical study coordinators
- Healthcare compliance teams
- Privacy and research administration staff
- Providers involved in human-subjects research
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