Learn more about the Office of the National Coordinator for Health Information Technology’s eConsent.
Learn more about the Office of the National Coordinator for Health Information Technology’s eConsent Trial Project, which addressed patient questions surrounding consent and provided a way for patients to exercise their consent decisions electronically.
Overview of the eConsent Trial Project – learn about the context, purpose, and approach of the eConsent Trial Project.
Understanding the Patient Experience in eConsent and Electronic Health Information Exchange – see an example of a typical eConsent patient experience.
Trial Project, which addressed patient questions surrounding consent and provided a way for patients to exercise their consent decisions electronically.
eConsent Trial Project Overview and Patient Experience – see the complete eConsent overview and example eConsent patient experience.
View the eConsent Trial Project’s patient educational materials.
Consent Decision Overview – learn about the overall context of the patient’s consent decision in eConsent, from what a Health Information Exchange (HIE) is and what the consent options are, to what health information could be shared, who could access the information, and how the information is protected.
HIEs and HEALTHeLINK – view an introduction to the Health Information Exchange (HIE) context in general and the Western New York HIE “HEALTHeLINK” in particular.
Why Give Access? – see an overview of the benefits patients could experience if they consent to the sharing and accessing of their health information in eConsent. [In gallery only, add “Visit HealthIT.gov/econsenttoolkit to learn more.”]
What Can Be Accessed? – view the types of information that could be shared or accessed through an HIE if a patient grants consent in eConsent.
Who Can Access? – learn about the types of organizations and personnel who could have access to health information in the eConsent HIE and under what circumstances.
Is My Information Secure? – learn about the laws and policies, as well as the technical and administrative safeguards, that are in place to protect health information in an HIE.
Can I Change My Mind? – view instructions on how patients can change their consent decision in eConsent.
More Consent Decision Info – learn about additional details related to making a consent decision in eConsent (e.g., your doctor will treat you regardless of your decision, your proxy can make a consent decision for you).
View the eConsent Story Engine from the developer’s perspective.
Part 1 of 4: Getting Started – learn about the Story Builder and Story Presenter components of Story Engine, and view a primer on how to get started with Story Builder, the story authoring tool.
Part 2 of 4: Creating Pages – see an overview of how to upload assets and create, edit, and update pages in Story Builder.
Part 3 of 4: Building Stories – view instructions for creating story paths, developing story conditions, and publishing, importing, and exporting stories in Story Builder.
Part 4 of 4: Viewing Stories – learn about the story-viewing and story statistics features of Story Presenter.
- What is the eConsent Trial Project?
The eConsent Trial Project, funded by the Office of the National Coordinator for Health Information Technology (ONC), developed and implemented electronic and innovative ways to:
- gather patients’ input on areas in which they want to learn more about consent,
- educate patients in a provider setting about the electronic sharing of their health information through a Health Information Exchange Organization (HIE), and
- capture and record choices patients make.
The eConsent project provided specially designed patient education materials and electronic decision capture technology at four health care provider offices that participate in a regional clinical information exchange. Patients at these offices had the option to use tablet computers to review the interactive educational material and electronically make their consent choice.
- What is the eConsent Toolkit?
The eConsent Toolkit presented here provides samples of the tools, resources, and educational materials used in the project. They represent just one method of enabling patient education and engagement for meaningful consent.
The Toolkit is divided into categories of Planning Resources; Educational Materials, Texts, and Sample Stories; and Technical Tools.
In gathering information from patients about what they need to know to make a meaningful consent choice, the eConsent Trial Project distributed a regional patient survey and conducted regional patient focus groups. The “eConsent Patient Input Survey” is available in the Toolkit as one example of how to design a survey to gather information on patients’ educational needs. The “Focus Group Facilitator’s Guide” provides an example of how to use a focus group approach to gather patient input.
When planning to implement the patient education and engagement part of meaningful consent, there are many factors to consider. While each consent program is different, the Toolkit’s “Practical Implementation Tips for Meaningful Consent” document, which was informed by the eConsent Trial Project, provides implementation insights that may be helpful.
Educational Stories, Materials, and Texts
The interactive educational materials (also called “stories”) created in Story Engine were delivered to eConsent patients through tablet computers. These “Sample Stories” are available for downloading in the Toolkit, but should be customized to a user’s specific environment before being used in a patient education scenario.
The video (non-interactive) versions of what patients viewed on the tablets are available for downloading in the Toolkit (“Educational Materials”). The text (“Texts for the Stories/Educational Materials”) used to create the materials can be downloaded from the Toolkit as well.
The eConsent Trial Project used an open-source, web-based application, called Story Engine, to develop and present its interactive, electronic patient education material.
The Toolkit contains the eConsent Story Engine download as well as the technical standards needed to download/house the tool (“Architectural Analysis and Technical Standards”) and guides for installing and using the tool (“Installation Guide” and “User Guide”).
- Can I Use eConsent Story Engine?
Story Engine can be used by providers, Health Information Exchange Organizations (HIEs), and other health IT implementers across the country to educate their patients on various topics in an interactive manner. Story Engine’s open-source nature allows it to be used without additional licensing fees. Because non-technical authors can develop content, Story Engine can be used for types of patient education that require more than simple text and images, for example:
- Patient education on consent in electronic health information exchange (eHIE)
- Health Insurance Portability and Accountability Act (HIPAA) patient education – what HIPAA is, patient rights under HIPAA, delivery of Notice of Privacy Practices (NPP)
- 42 Code of Federal Regulations (CFR) Part 2 patient education
- Patient pre- or post-procedure education (e.g., how to take care of stitches)
Implementers can use the Story Engine to help patients understand various topics such as those above. However, if they plan to transmit patient information (e.g., a consent decision) to an HIE, they will need to develop custom interfaces that are compliant with applicable laws and regulations. Due to the variability in methods for HIE data transmission, the HIE interface is not part of the Story Engine tool.
Before getting started, be aware that the contents of the eConsent Toolkit are provided as example means of supporting meaningful consent. The information presented may not be applicable or appropriate for all providers, HIEs, and other health IT implementers. We encourage implementers to seek expert advice when evaluating these resources. The eConsent Toolkit is not intended to be an exhaustive or definitive source on electronic consent approaches. It is also not intended to serve as legal advice or offer recommendations based on an implementer’s specific circumstances.
- Planning Resources
- eConsent Patient Input Survey [PDF - 180 KB] – an example of a survey to gather information on what patients need to know before they make a meaningful consent decision.
- Focus Group Facilitator’s Guide [PDF - 473 KB] – an example of how to use a focus group approach to gather information on what patients need to know before they make a meaningful consent decision.
- Practical Implementation Tips for Meaningful Consent [PDF - 160 KB] – things to consider when implementing the patient education and engagement part of meaningful consent.
- Educational Stories, Materials, and Texts
- Sample Stories – the interactive educational material that patients viewed on a tablet prior to making a consent decision. The sample stories contain functionality (e.g., patient navigation, e-signature) and are available for download below.
- Texts for the Stories/Educational Materials [PDF - 545 KB] – the language for all the eConsent patient educational material.
- Technical Tools
- eConsent Story Engine Tool [ZIP - 1.5 MB] – combination of the authoring tool used to create stories and the interface used to view created stories. The tool has the ability to display educational material and electronically enable signature capture of patients.
- Architectural Analysis and Technical Standards [PDF - 586 KB] – the summary of the integration of computer software and hardware only as it pertains to Story Engine installation on a web server.
- Installation Guide for eConsent Story Engine Tool [PDF - 820 KB] – the instructions for installing the open-source Story Engine application/tool. Consider browser/mobile device compatibility as well as the availability of a server or other place to house the databases and reporting structures that go with the download of the tool.
- User Guide for eConsent Story Engine Tool [PDF - 2.6 MB] – the instructions for how to author/develop educational material using the Story Engine tool.