What is the Health Data Oversight Committee (HDOC)?
UC Office of the President has established a formal process to actively manage requests to share UC health data with third parties. The policy requires a UC Health campus committee is to handle data sharing requests according to UCOP guidelines. The UCSD Vice Chancellor of Health Sciences has established the UCSD Health Data Oversight Committee (HDOC) to perform this function. The committee has been a required approval for sharing of health data since October 2020.
When do I need HDOC approval?
If you are requesting to share "health data" from UCSD Health as part of research with any third party, regardless of whether the data is identified or de-identified.
How is "health data" defined in the policy?
"Health Data" includes two categories: Source Health Data, which is the primary and original data set, and Derived Health Data, which represents some transformation of the original source data. Source Health Data is any information pertaining to the health, care, and treatment of UC Health patients and plan members which:
Derived Health Data
- Results in a report used in treatment or monitoring of a patient OR;
- Generates a claim or bill for services provided OR;
- Is used for operations, financial management, population health activities, or quality metrics.
is any derivation of source Health Data irrespective of how trivial or complex the derivations may be.
We also seek to clarify one possible area of ambiguity – clinical trials.
For purposes of these guidelines, research data created exclusively for a sponsored clinical research study pursuant to Institutional Review Board (IRB) approval and collected pursuant to a patient authorization or consent that is approved by the IRB is not Health Data. Disclosure of such research data to the sponsor would be governed by law and existing UC policy, not these guidelines. However, instances of such data that are contained in the medical record (in whatever form) are Health Data within the scope of this governance framework and require HDOC review and approval.
In addition, clinical trial data that is considered excluded from the Health Data definition and out of scope is limited only to the data acquired as part of the IRB‐specified clinical trial. Any other Health Data associated with the subjects participating in that clinical trial will be considered Health Data as defined above. Research data that is generated pursuant to a protocol that is exempt or excluded from full IRB review, or involves a waiver of authorization, will be considered Health Data and within scope of this governance framework.
How do I request HDOC review and approval?
Complete this form. If you have any questions, please contact the HDOC Committee Chair, Dr. Hogarth – email@example.com
How long does it take?
This often depends on the nature of the sharing (identified vs. de-identified data). HDOC committee meets monthly but often adjudicates low-risk requests (ie, de-identified data to be shared with another academic institution) through an expedited process. The average turnaround time for most requests is 1-2 weeks.
Do I need to do anything else once I have HDOC approval?
Yes, data sharing with an external entity requires a data use agreement (DUA) between UCSD and the external entity. This is done by the Office of Contracts and Grants (OCGA). OCGA staff work closely with the committee and often coordinate requests to HDOC for data sharing. Contact OCGA (firstname.lastname@example.org) as soon as you are aware that the research project will require data sharing with an external entity.
Do I need HDOC approval to share data with another UC Health campus?
No, sharing of health data between UC campuses is accomplished through an intra-UC process managed locally by the Office of Grants and Contracts (OCGA).
What if I have questions or need assistance with my HDOC request?
Please contact the HDOC committee Chair, Dr. Hogarth – email@example.com