Meaningful Choice: Patient-Centered Decision Making in Electronic Health Information Exchange

Kathryn Marchesini | October 3, 2012

Health Care Providers, Key Agents of Trust for Patients

A key purpose for developing a secure private computer network in the health care industry is establishing the capability for health care providers to access and share patient health information electronically and securely over the Internet to support patient care, often referred to as a health information exchange (HIE).

However, the success of the exchange of this information – known as electronic health information exchange (eHIE) – is heavily dependent upon patients recognizing and being willing to participate in the sharing of their health information. As noted in its Federal Health Information Technology (Health IT) Strategic Plan, the Office of the National Coordinator for Health IT (ONC) works to inspire health care provider and patient confidence and trust in health IT and eHIE by protecting the confidentiality, integrity, and availability of health information. Informed patient choice is one way to ensure a trust relationship with patients for the success of eHIE. The Individual Choice principle of the Nationwide Privacy and Security Framework (“Privacy and Security Framework”) emphasizes that the opportunity and ability of an individual to make choices with respect to the electronic exchange of their health information is an important aspect of building trust. (See the Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Information.)

As key agents of trust for patients, providers are responsible for maintaining the privacy and security of their patients’ health information. In turn, patients should not be surprised about or harmed by their provider’s collections, uses, or disclosures of their health information.

Meaningful Choice for Patients and the Exchange of Health Information

Meaningful choice ensures patients understand how and with whom their provider can share their information and the impact of their choices. ONC’s Health Information Technology Policy Committee (HITPC) recommends [PDF – 119 KB] that the person who has the treating relationship with the patient (in most cases, this is the patient’s doctor) be responsible for educating patients about how information will be shared and with whom, as well as obtaining and tracking the patient’s choice. (See the HITPC’s Individual Choice Recommendations [PDF – 119 KB] and the National Committee on Vital and Health Statistics (NCVHS) Privacy and Confidentiality in the Nationwide Health Information Network Recommendations.)

In March 2012, we released the State HIE Privacy and Security Program Instruction Notice (PIN) [PDF- 258 KB],  outlining a common set of privacy and security rules of the road for State HIEs. This guidance provides that HIE entities should ensure patients have the opportunity for meaningful choice (either directly, or by ensuring that the providers they serve offer such choice) as to whether to participate in certain types of eHIE.  The PIN defines a patient’s meaningful choice as a decision:

  1. Made with advance knowledge/time,
  2. Not used for discriminatory purposes or as condition for receiving medical treatment,
  3. Made with full transparency and education,
  4. Commensurate with circumstances for why health information is exchanged,
  5. Consistent with patient expectations, and
  6. Revocable at any time.

The guidance also notes patients should be provided a reasonable opportunity and capability to make informed decisions about the collections, uses, and disclosures of their health information.  Patients should be able to designate someone (a family member, caregiver, domestic partner or legal guardian) to make these decisions on their behalf.  (See pages 6-8 of the Privacy and Security Framework [PDF- 59.79 KB] to learn more.)

ONC shares the belief of the HITPC that when providers give patients a choice about whether their health information can be shared, it should be a meaningful choice. Patients should understand their choice options and the impact of the choices they make about sharing their health information through an HIE.

Paper-Based v. Electronic Consent Collection

According to studies, the most popular way to capture a patient’s consent is paper, and in general, patients sign a consent form, either in person or on the telephone. Research indicates any method used to collect patient consent in electronic health information exchange must be capable of recording the patient’s preference in a manner that will continually reflect the patient’s preference and is actionable by other providers, thus honoring the patient’s preference. This is likely to prove difficult with respect to paper-based consent in an electronic exchange environment. (See ONC’s Consumer Consent Options for Electronic Health Information Exchange: Policy Considerations and Analysis [PDF – 713 KB].)

Concerns about the limitations of paper-based consent have led to support for electronic methods of obtaining and managing consent in other contexts. To date, some providers rely on an electronic mechanism to capture a patient’s consent for particular medical procedures. Experience from U.S. Department of Veterans Affairs (VA) medical centers indicates that when accompanied by clear communication (e.g., provider and patient sit together in front of the computer screen as the provider points out the information that needs to be discussed), electronic consent Exit Disclaimer (eConsent) can facilitate patient understanding of the procedure and ease tracking of consent. The VA’s electronic consent process, part of the VA’s Electronic Support for Patient Decisions (ESPD) Initiative, walks providers through the informed consent process, displays detailed educational materials, develops and stores consent forms, and incorporates electronic signatures.

Also, a survey of patients in the Atlanta VA medical center found that 96 percent of patients surveyed preferred the use of an eConsent process (over a paper one) to collect and document consent for medical procedures. The VA’s eConsent process was standardized, legible, and understandable, with patients’ consent forms easily stored and retrieved, while the paper-based consent forms were often incomplete, illegible and/or misleading.

While the VA’s eConsent process is primarily used to manage consent for medical procedures or treatment and not for eHIE, it demonstrates the potential benefits of utilizing electronic consent for patients and the exchange of health information.

What is ONC Doing to Help Address Meaningful Choice Challenges?

With the growing interest in electronic consent mechanisms Exit Disclaimer, and the role of meaningful choice in the success of eHIE, ONC’s Office of the Chief Privacy Officer (OCPO) is carefully looking at a potential solution to address some of the challenges surrounding meaningful choice in an electronic environment.  The HITPC recommendations state that ONC should provide resources and educational materials to providers to demonstrate and implement meaningful choice for patients.  (See the HITPC Individual Choice Recommendations [PDF – 119 KB].)

In addition to our recent release of the meaningful choice guidance pertaining to State HIEs [PDF – 258 KB], and our Data Segmentation for Privacy Initiative (DS4P) demonstration Exit Disclaimer, our eConsent project team is designing, developing, and planning to pilot an innovative way to:

  • Gather patients’ input and identify what patients feel they require to make an informed decision, including conducting patient evaluation and integration into the educational material design and development process;
  • Educate patients in a health care provider facility about their option to make an individual choice (or patient consent) about whether or not their health care provider can access their health information through an HIE;
  • Assess patients’ knowledge gained and their individual satisfaction with the educational material and associated electronic delivery method; and
  • Electronically capture and record a patient’s choice.

As a result of our efforts, we hope to help identify some innovative resources and sample educational materials to help health care providers and HIEs ensure any choices patients make with respect to sharing their health information are indeed, meaningful.

How Can You Learn More about ONC’s eConsent Project?

As patients become more engaged in their health care – and in an effort to keep patients more engaged – communication with patients becomes even more important. Providers should be able to provide clear, comprehensive, concise, and easily understood education to patients about their choice.

Stay tuned to read more about what we are learning are key areas of interests to patients and the live pilot of our eConsent educational material and consent decision capture technology at select health care facilities later this month.