Confusing “Consent” Terminology Emerges

In its August 19th letter to the Office of the National Coordinator, the HIT Policy Committee creates the term “meaningful consent” related to the coming choices patients will be asked to make about the sharing and use of their clinical data. In the recommendations, the committee clearly states that the recommendations apply to exchange of identifiable health information in order to meet Stage 1 meaningful use requirements. So now is the perfect time to ensure that the difference between the two types of consent remain distinct in the mind of the patient population. As discussed here previously, clinicians are already expected to obtain “informed consent” from patients relative to treatments.

The Policy Committee recommendation states:

When the decision to disclose or exchange the patient’s identifiable health information from the provider’s record is not in the control of the provider or that provider’s organized health care arrangement (“OHCA”), patients should be able to exercise meaningful consent to their participation. ONC should promote this policy through all of its levers.

According to the recommendation, “meaningful consent” is defined by these attributes:

  • Allows the individual advanced knowledge / time to make a decision. (e.g., outside of the urgent need for care.)
  • Is not compelled, or is not used for discriminatory purposes. (e.g., consent to participate in a centralized HIO model or a federated HIO model is not a condition of receiving necessary medical services.)
  • Provides full transparenty and education (i.e., the individual gets a clear explanation of the choice and its consequences, in consumer-friendly language that is conspicuous at the decision-making moment.)
  • Is commensurate with the circumstances. (i.e., the more sensitive, personally exposing, or inscrutable the activity, the more specific the consent mechanism. Activities that depart significantly from patient reasonable expectations require greater degree of education, time to make decision, opportunity to discuss with provider, etc.)
  • Must be consistent with reasonable patient expectations for privacy, health and safety; and
  • Must be revocable. (i.e., patients should have the ability to change their consent preferences at any time. It should be clearly explained whether such changes can apply retroactively to data copies already exchanged, or whether they apply only “going forward.”)

Note how closely this mirrors the concept of informed consent already sought for clinical procedures. Education, autonomy and lack of coercion are hallmarks of the process. This is really just a variant of informed consent, made specific to the flow of personal information. Calling them two different things will create confusion. The HIT Policy Committee can play an important role in alleviating confusion early in the process by recognizing the similarity between what it calls “meaningful” consent and “informed” consent. The Committee should modify its language to reflect this.

In earlier posts (Technology Muddies Informed Consent and Technology Muddies Informed Consent 2), I wrote that the phrase “informed information consent” might be appropriate, and should be introduced; now however, it seems a bit redundant. “Informed data consent” would be more accurate. Paired with “informed clinical consent,” providers and patients alike will have clear terminology to describe the kind of decisions being made. They are related, yet distinct concepts that will be an integral part of the interface between patients, their providers, and the healthcare “system” as a whole.

-Rod Piechowski

Copyright © 2010, Rod Piechowski, Inc., Consulting

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