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HIPAA and 21CFR11 overlaps

October 12th, 2009

Both HIPAA and 21 CFR Part 11 are concern with safeguarding Data. While 21CFR11 applies to Life Sciences Organizations (LSO), HIPAA applies to Healthcare Providers (HCP) and other "covered entities", such as insurance companies.

21 CFR Part 11 sets out the procedural and system requirements for controlling and auditing electronic records and signatures. It requires employing procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records.
Similarly HIPAA security rules are described as followed:
Physical Safeguards
Facility access controls
Work station use
Work station security
Device & Media controls
Technical Safeguards
Access control
Audit control
Integrity controls
Person or entity authentication
Transmission security
Administrative Safeguards
Security and access management
Secure incident handling
and implement policies and procedures to prevent, detect, contain and
correct security violations.
There are obvious requirement overlaps around
- Operational policies and SOPs 
- System and Record Access Control
- Audit trail
- Record keeping and retention
It just makes sense to start consolidating these requirements into one set. 
This has to happen sooner or later as we start sharing standardized medical records between healthcare providers and Pharmaceutical companies for Clinical Trials or Adverse Events reporting.

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