Thursday, April 10, 2008

Consent

Most registries are opt-out while some are opt-in. This depends on the state law that governs the registry. Opt-out registries have processes to remove patients from the registry who do not want to be in the registry, and Opt-in registries have processes to include patients who want to be in the registry. The patients decision, as to whether be in the registry or not is generally called "consent". In opt-out registries consent is assumed to be given, and in opt-in registries consent is assumed to not be given.

How to send consent in HL7 messages

Consent can be sent in PD1-12 Protection Indicator. Here is the description from the CDC guide:
This field will be used by immunization registries to indicate whether or not consent has been given (or assumed) for record sharing. It can have 3 values with the following meanings:
  1. "" : Null will indicate that patient/guardian has not yet been asked to give consent to share or has not responded
  2. Y : Sharing is allowed (patient has given consent or consent is implied)
  3. N : Sharing is not allowed (patient has refused consent)
For opt-out registries do not populate this field for patients that are assumed to be consented. The registry will already assume the patient has consented. For patients that have explicitly requested to not be included in the registry send the value 'N'. The value 'Y' should only be sent if the patient explicitly indicated they wished to be part of the registry. It should not be set as default. If the patient has not consented to be in the registry then the data may or may not be sent to the registry depending on state policy. Some opt-out states have formal processes for removing all related patient records when a patient opts out and so require that the opt-out information be sent to the registry so this process can be completed properly. Other registries may require that these opt-out patients be not sent.

For opt-in registries record the patients decision to be in the registry in this field. Depending on registry policy this patients record may or may not be sent based on this status. Some registries will require that non-consented records be sent so that all related records can be removed from the registry. Others will require that the non-consented records should not be submitted.

For all registries it is important to verify that they support this field as you expect. Because of the name of this field many registry system may not realize that consent may be reported here and may not have processes in place to handle non-consented data. Sending systems may be required to filter out non-consented data.

2 comments:

Nathan Bunker said...

There is a inconsistency in what I wrote in this article. The guide says send Y when "patient has given consent or consent is implied" and but I say to send Y when "patient has explicitly given consent." The difference is that if consent is implied by the state laws (i.e. state laws indicate that all patients should be considered to have consented unless otherwise indicated) the consent field should be blank. Although the standard allows for this field to be valued as 'Y' I do not recommend this as it is better for the state registry to make this assumption rather than for the provider to always set to 'Y' unless told otherwise by the patient.

Unknown said...

I just noticed that PD1-12 is documented by CDC in the complete opposite fashion that HL7 documents it.

HL7 states:
Y protect access to information
N normal access

CDC states:
Y - sharing is allowed (patient
has given consent or consent is implied)
N - sharing is not allowed (patient has refused consent)

These appear to be completely contradictory statements to me. This may require configuration in each vendor's interface to support either semantic.