Federation Assurance Level 3 - Revision history

Tom: /* References */

2023-03-20T03:46:44Z

‎References

Tom: /* References */

2022-07-03T19:51:07Z

‎References

Tom: /* Terminology */

2021-08-04T22:29:27Z

‎Terminology

Tom: /* Terminology */

2021-08-04T22:26:36Z

‎Terminology

Tom: /* Terminology */

2021-08-04T22:24:27Z

‎Terminology

Tom: /* Requirements for Today */

2020-12-18T22:45:26Z

‎Requirements for Today

Tom: /* Use Case */

2020-09-25T19:14:04Z

‎Use Case

Tom: /* Use Case */

2020-09-25T19:11:36Z

‎Use Case

Tom: /* Use Case */

2020-09-25T19:04:37Z

‎Use Case

Tom: /* Use Case */

2020-09-25T18:58:17Z

‎Use Case

← Older revision		Revision as of 03:46, 20 March 2023
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	[[Category: Standard]]		[[Category: Standard]]
		+	[[Category: Biometrics]]
	[[Category: Federation]]		[[Category: Federation]]

← Older revision		Revision as of 19:51, 3 July 2022
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	[[Category: Standard]]		[[Category: Standard]]
		+	[[Category: Federation]]

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-* [https://www.deadiversion.usdoj.gov/21cfr/cfr/1300/1300_03.htm 21 CFR 1300.03] subset of glossary
+* [https://www.deadiversion.usdoj.gov/21cfr/cfr/1300/1300_03.htm 21 CFR 1300.03] subset of glossary US DoJ DEA Diversion Control Division
 <pre>
 Authentication means verifying the identity of the user as a prerequisite to allowing access to the information application.

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 Private key means the key of a key pair that is used to create a digital signature.
 </pre>
 ===Use Case===

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 Public key means the key of a key pair that is used to verify a digital signature. The public key is made available to anyone who will receive digitally signed messages from the holder of the key pair.
-Public Key Infrastructure (PKI) means a structure under which a certification authority verifies the identity of applicants; issues, renews, and revokes digital certificates; maintains a registry of public keys; and maintains an up-to-date certificate revocation list.
+[[Public Key Infrastructure]] (PKI) means a structure under which a certification authority verifies the identity of applicants; issues, renews, and revokes digital certificates; maintains a registry of public keys; and maintains an up-to-date certificate revocation list.
 Readily retrievable means that certain records are kept by automatic data processing applications or other electronic or mechanized recordkeeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.

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 # If a common sub is used a privacy assessment is required.
 # Any tracking between RPs must only be permitted if all the RPs sharing the data are part of the Authority.
-# Complex rules are applied o assertion presentation that can all be avoided if bound tokens are required.
+# Complex rules are applied to assertion [[Presentation]] that can all be avoided if bound tokens are required.
 # Any solutiotion must allow for [[Self-issued Identifier]] or [[Self-Sovereign Identity]].

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 # Check the validity of the certificate holder's certificate by checking the Certificate Revocation List.
 # Check the certificate extension data to determine whether the sender has the authority to order the controlled substance.</blockquote>
-* 1311.55 Requiremens for RP = certified HSM and crypto, protection for password and private key (hardware does not appear to be required for signing, but for storage.) Anti-hammering, secure clock, logs, chem cert current.
+* 1311.55 Requiremens for systems of both holder and RP = certified security module and crypto, protection for password and private key (hardware does not appear to be required for signing, but for storage.) Anti-hammering, secure clock, logs, check cert current.
 ==Problems with 63-3C==

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 # The certificate holder must report the loss, theft, or compromise of the private key or the password, via a revocation request, to the Certification Authority within 24 hours of substantiation of the loss, theft, or compromise. Upon receipt and verification of a signed revocation request, the Certification Authority will revoke the certificate. The certificate holder must apply for a new certificate under the requirements of Sec. 1311.25.
 # (.35) A purchaser of Schedule I and II controlled substances must obtain a separate CSOS certificate for each registered location for which the purchaser will order these controlled substances.</blockquote>
-* 1311.50 Requirements for recipients of digitally signed orders.<blockquote>
+* 1311.50 Requirements for recipients of digitally signed orders.<blockquote> The recipient of a digitally signed order must do the following before filling the order:
-# The recipient of a digitally signed order must do the following before filling the order:
+# Verify the integrity of the signature and the order by having the system validate the order.
-## Verify the integrity of the signature and the order by having the system validate the order.
+# Verify that the certificate holder's CSOS digital certificate has not expired by checking the expiration date against the date the order was signed.
-## Verify that the certificate holder's CSOS digital certificate has not expired by checking the expiration date against the date the order was signed.
+# Check the validity of the certificate holder's certificate by checking the Certificate Revocation List.
-## Check the validity of the certificate holder's certificate by checking the Certificate Revocation List.
+# Check the certificate extension data to determine whether the sender has the authority to order the controlled substance.</blockquote>
-## Check the certificate extension data to determine whether the sender has the authority to order the controlled substance.
+* 1311.55 Requiremens for RP = certified HSM and crypto, protection for password and private key (hardware does not appear to be required for signing, but for storage.) Anti-hammering, secure clock, logs, chem cert current.
 ==Problems with 63-3C==

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 #Nonrepudiation: The system must ensure that strong and substantial evidence is available to the recipient of the sender's identity, sufficient to prevent the sender from successfully denying having sent the data. This criterion includes the ability of a third party to verify the origin of the document.
 # Message integrity: The system must ensure that the recipient, or a third party, can determine whether the contents of the document have been altered during transmission or after receipt.</blockquote>
-* 1311.30 Requirements for storing and using a private key for digitally signing orders.<blockquote>
+* 1311.30 Requirements for storing and using a private key for digitally signing orders.<blockquote> (n.b. This appears to equate the public key with the holder's ID.)
 # Only the certificate holder may access or use his or her digital certificate and private key.
 # The certificate holder must provide FIPS-approved secure storage for the private key, as discussed by FIPS 140-2, 180-2, 186-2, and accompanying change notices and annexes, as incorporated by reference in Sec. 1311.08.
 # A certificate holder must ensure that no one else uses the private key. While the private key is activated, the certificate holder must prevent unauthorized use of that private key.
 # A certificate holder must not make back-up copies of the private key.
-# The certificate holder must report the loss, theft, or compromise of the private key or the password, via a revocation request, to the Certification Authority within 24 hours of substantiation of the loss, theft, or compromise. Upon receipt and verification of a signed revocation request, the Certification Authority will revoke the certificate. The certificate holder must apply for a new certificate under the requirements of Sec. 1311.25.</blockquote>
+# The certificate holder must report the loss, theft, or compromise of the private key or the password, via a revocation request, to the Certification Authority within 24 hours of substantiation of the loss, theft, or compromise. Upon receipt and verification of a signed revocation request, the Certification Authority will revoke the certificate. The certificate holder must apply for a new certificate under the requirements of Sec. 1311.25.
 ==Problems with 63-3C==

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 This use case is abstracted from [https://www.deadiversion.usdoj.gov/21cfr/cfr/2111cfrt.htm 21 CFR PART 1311 —REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONS]
 * [https://www.deadiversion.usdoj.gov/fed_regs/rules/2020/fr0421_3.htm Federal Register Notices > Rules - 2020 > Electronic Prescriptions for Controlled Substances] accepted change requests through 2020-06-22. No new rule is known at this time.
-! 1311.05 Standards for technologies for electronic transmission of orders. <blockquote>A registrant or a person with power of attorney to sign orders for Schedule I and II controlled substances may use any technology to sign and electronically transmit orders if the technology provides all of the following:
+* 1311.05 Standards for technologies for electronic transmission of orders using digital signatures and PKI. <blockquote>A registrant or a person with power of attorney to sign orders for Schedule I and II controlled substances may use any technology to sign and electronically transmit orders if the technology provides all of the following:
 #Authentication: The system must enable a recipient to positively verify the signer without direct communication with the signer and subsequently demonstrate to a third party, if needed, that the sender's identity was properly verified.
 #Nonrepudiation: The system must ensure that strong and substantial evidence is available to the recipient of the sender's identity, sufficient to prevent the sender from successfully denying having sent the data. This criterion includes the ability of a third party to verify the origin of the document.
 # Message integrity: The system must ensure that the recipient, or a third party, can determine whether the contents of the document have been altered during transmission or after receipt.</blockquote>
 ==Problems with 63-3C==