Good Recent Resources
- Office of The National Coordinator
- Delegated Signing Authority: http://wiki.siframework.org/AoR+SWG+3+-+Digital+Signatures+%26+Delegation+of+Rights
- Identity Proofing (Non-repudiation): http://wiki.siframework.org/AoR+SWG+2+-+Identity+Proofing
- Digital Credentials (Non-repudiation): http://wiki.siframework.org/AoR+SWG+1+-+Digital+Credentials
Research
- 2007 Interoperable Digital Identity Management in the Electronic Exchange of Health Information
http://www.safe-biopharma.org/infocenter/a-interoperable%20digital%20id%20managment%20report.pdf - 2007 Study Report on Biometrics in E-Authentication https://standards.incits.org/apps/group_public/download.php/24528/m1070185rev.pdf
o Hawaii has adopted UETA for its state law (this is good)
o Best Source (http://library.ahima.org/xpedio/groups/public/documents/ahima/bok1_045546.hcsp?dDocName=bok1_045546)
o Guidance that a customer used for their 2005
eSignature implementation
§ How eSignature should be captured
·
The “electronic impulse” that indicates
consent (21 CFR Part11) needs to be
o unique to
individual (21 CFR Part11)
o exclusive control
of individual (21 CFR Part11)
o in view of entire contract (scroll bars were strongly advised against)
§ How eSignature should be stored
·
“electronic impulse” that indicates consent
(21 CFR Part11)
Pontification Alert: Many opinions could be discussed on this, but ultimately the opinion of the attorney or corporate counsel potentially defending the repudiation challenge is the one that counts.
Pontification Alert: Many opinions could be discussed on this, but ultimately the opinion of the attorney or corporate counsel potentially defending the repudiation challenge is the one that counts.
·
Reproducible view of what signor saw when
they “eSigned”
***A copy of what the signor saw is preferable
***A copy of what the signor saw is preferable
·
Name of the Signer
·
Date and time of signature
·
Tamper evident hash
o Considerations
§ Not every “electronic impulse” that indicates consent (21
CFR Part11) is equally “unique” to an individual or practical.
