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e-Consent: The Design and Implementation of Consumer Consent Mechanisms in an Electronic Environment

Affiliations of the authors: Centre for Health Informatics (EC); Baker Cyberspace Law & Policy Centre, University of New South Wales (RC), Sydney, Australia

Correspondence and reprints: Enrico Coiera, MBBS, PhD, The Centre for Health Informatics, The University of New South Wales, UNSW, NSW, 2055, Australia; e-mail: <ewc{at}pobox.com>.

Received for publication: 10/20/03; accepted for publication: 11/06/03.

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 his or her 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 his or her 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 also are 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 probably will need to be some form of data object that is associated with patient information. This e-Consent object (or e-Co) will contain the specific conditions under which the data to which it is attached can be retrieved. Given the complexity of clinical work and the substantial variation we can expect in an individual's desire to make his or her 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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