With the implementation of phase 2 of the 21st Century Cures Act in October, HealthLink users should be aware that more data previously available only in Health Link or via Release of Information request is now visible to subjects via the patient portal, MyChart. This includes research data documented in HealthLink. As before, any research data that is recorded in HealthLink must be approved by the IRB and described in consent documents- this is not changing. However, this data is now more easily accessible to subjects. Although the details of what research data may be viewable in MyChart is not generally included in consent forms, study teams are encouraged to review language in the consent form to confirm that it accurately reflects research data that will be placed in HealthLink. If revisions are necessary, study teams should submit a change of protocol for review and approval by the IRB before making changes to the types of data recorded in HealthLink.

For questions related to Health Link documentation and research data, please reach out to Ann Wieben, wieben@wisc.edu and review guidance on clinical research documentation requirements: https://uconnect.wisc.edu/clinical/tools-resources/ehr/health-link/research/documentation/resources/name-20960-en.file

For questions related to whether or not a change in consent form language may be necessary, please email asktheirb@hsirb.wisc.edu.