eSignature v1.1

The technical mechanisms for digitally signing clinical documents are well supported by international standards. However, a digital signature alone is not always sufficient as a complete personal electronic signature mechanism. There is a range of trade-offs between the cost and complexity of implementation and use of personal electronic signatures, and the assurance they provide of the signer’s identity. The Agency’s Electronic Signatures Recommendations document explores the legal context for electronic signatures on clinical documents, explains key concepts relating to electronic signatures, and analyses the clinical and business risks associated with the signer’s identity in order to draw conclusions about the most appropriate signature mechanisms to use on different types of clinical documents.