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| Regulation, Specification, or Guidance
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Requirement
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45 CFR Part 164 Subpart E
ACMG Technical Standards for Clinical Genetics Laboratories G17.2
ASTM E1578-18 S-5-1
CAP Laboratory Accreditation Manual
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36.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions.
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10 CFR Part 20.2106 (d)
45 CFR Part 164.105
45 CFR Part 164 Subpart C
45 CFR Part 170.315 (d)
ASTM E1578-18 S-5-2
ICH GCP 2.11
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
WADA International Standard for Laboratories (ISL) 5.3.8.3
WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)
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36.2 The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.
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45 CFR Part 164.514
ACMG Technical Standards for Clinical Genetics Laboratories C5.5
CAP Laboratory Accreditation Manual
WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3
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36.3 The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.
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45 CFR Part 164 Subpart E
NIST 800-53, Rev. 5, AC-6
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36.4 The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.
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| NIST 800-53, Rev. 5, SI-19(7)
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36.5 The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.
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