Informed Consent in Healthcare

Informed consents, either for treatment or sensitive information use/disclosure, that protect the privacy of patient/participant information subject to law that in certain circumstances may override patient wishes, are mandatory practice in healthcare. Similarly, for protecting and respecting research participants, informed consents are also prerequisite for human subjects research. Although the healthcare industry has widely adopted Electronic Medical Record (EMR) systems, consents are still obtained and stored primarily on paper or scanned electronic documents. Integrating a consent management system for different purposes into an EMR system involves various implementation challenges. A case study, informed consent for genetic services, is used to show how genetic informed consents placed new challenges on the traditional ethical standards of informed consent, and how appropriate consents can be electronically obtained and automatically enforced using a system that combines medical workflows and hierarchically, ontologically motivated rule enforcement. Finally, this chapter describes an implementation that uses the open-source software-based addition of these components to an open-source EMR system, so that existing systems do not need to be scrapped or otherwise rendered obsolete.