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First published December 7, 2003 as JAMIA PrePrint; doi:10.1197/jamia.M1480
Journal of the American Medical Informatics Association 2004;11(2):129-140
© 2004 American Medical Informatics Association


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Submitted on October 20, 2003
Accepted on November 6, 2003

e-Consent: the design and implementation of consumer consent mechanisms in an electronic environment

Enrico Coiera MBBS, PhD1* and Roger Clarke2

Affiliation of the authors: 1 Centre for Health Informatics, University of New South Wales, Sydney, Australia; 2 Baker Cyberspace Law & Policy Centre, University of New South Wales, Sydney, Australia

* To whom correspondence should be addressed.

The effective coordination of health care relies on communication of confidential information about consumers between different health and community care services. However, consumers must be able to give or withhold `e-Consent' to those who wish to access their electronic health information. There are several possible forms for e-Consent. In the general consent model, a patient provides blanket consent for access to their information by an organization for all future information requests. Conversely, general denial explicitly denies consent for information to be used in future circumstances and in each new episode of care, a new consent would be needed to obtain information. In the general consent with specific denial model, a patient attaches specific exclusion conditions to their general approval to future accesses. In contrast, in the general denial with explicit consent model, a patient issues a blanket block on all future accesses, but allows the inclusion of future use under specified conditions. There are also several alternative functions for an e-Consent system. Consent could be captured as a matter of legal record. E-Consent systems could be more active by prompting clinicians to indicate that they have noted consent conditions before they access a record. Finally, the record of patient consent could be fully active, and used as a gatekeeper in a distributed information environment. There will probably need to be some form of data object that is associated in some way with patient information. This e-Consent object (or e-Co) will contain the specific conditions under which the data it is attached to can be retrieved. Given the complexity of clinical work, and the substantial variation we can expect in an individual's desire to make their personal medical details available, it is unlikely a one size fits all approach to e-Consent will work. Consequently, with a well-chosen consent design, it should be possible to balance the specific need for privacy of some of the population against the desire by others to err on the side of clinical safety, and clinicians desire to minimize the burden that an electronic consent mechanism would impose.







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