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| Regulation, Specification, or Guidance
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Requirement
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42 CFR Part 493.1231
45 CFR Part 164.312
45 CFR Part 170.315 (d-9)
ASTM E1578-18 S-4-1
CJIS Security Policy 5.6.4
CJIS Security Policy 5.8.2.1
CJIS Security Policy 5.10.1.2
CJIS Security Policy Appendix G.6
CLSI QMS22 2.2.3.2
EMA Guidance on Good Manufacturing Practice and Good Distribution Practice
NIST 800-53, Rev. 5, AC-17(2)
NIST 800-53, Rev. 5, MA-4(6)
NIST 800-53, Rev. 5, SC-8 and SC-8(1)
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35.1 The system should use secure communication protocols like SSL/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.
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42 CFR Part 493.1231
45 CFR Part 164.312
45 CFR Part 170.315 (d)
ACMG Technical Standards for Clinical Genetics Laboratories C1.6
ASTM E1578-18 S-4-2
CJIS Security Policy 5.5.2.4
CJIS Security Policy 5.10.1.2
CJIS Security Policy Appendix G.6
NIST 800-53, Rev. 5, CP-9(8)
NIST 800-53, Rev. 5, SC-13 and SC-28(1)
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35.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.
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42 CFR Part 493.1231
CJIS Security Policy 5.6.2.2.1
CLSI QMS22 2.4.2.2
NIST 800-53, Rev. 5, AC-3
NIST 800-53, Rev. 5, IA-2, IA-2(1–4), and IA-8
NIST 800-53, Rev. 5, MA-4
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35.3 The system should be able to support multifactor authentication.
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45 CFR Part 170.202
45 CFR Part 170.315 (h)
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35.4 The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.
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| NIST 800-53, Rev. 5, IA-7
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35.5 The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.
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| NIST 800-53, Rev. 5, SC-15
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35.6 The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.
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