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PERMISSION ONTOLOGY FOR INFORMED CONSENT AND HIPAA COMPLIANCE
Maria Adela Grando PhD
Division Biomedical Informatics, University California San Diego
CTSA ONTOLOGY WORKSHOP- Febrary 11st 2013, Orlando-
STATE OF THE ART
• Mostly, the research enterprise relies on paper-based Informed Consent documents which contains permissions given by subjects to share specimens and clinical data for future research.
• It is rare that consent forms are collected electronically.
• There is potential to use electronic Informed Consents for:• providing compliance with subject’s permissions, while maximizing
access to resources
informed CONsent for clinical record and Sample use in research (iCONS)
Electronic ICI authorize U to perform operation O over my data D or sample S under certain constraints C
Look-up RegistryI can check publications generated from my data and samples
Patient I
Clinical Data Warehouse
QueryUser U requests Data D and sample S to perform operation O on subjects like I under constraints C
User U
Research Institution
HealthcareInstitution
ResultsUser U receives data D and sample S in compliance with subject’s permission
Home
Permission Repository
Info
rmed
Co
nse
nt
Man
agem
ent
Sys
tem
BioSample Repository
I share my blood samples with non-profit US researchers
As a Stanford researcher can I get
blood samples?
Res
ou
rce
Me
dia
tor
Permission Ontology
PERMISSION ONTOLOGY• For describing permissions obtained from subjects who
signed an Informed Consent or HIPAA form, in a uniform, machine-interpretable, implementation-independent way
• To enable interoperability and sharing of Informed Consent permissions and HIPAA constraints between clinical data warehouses and bio-repositories, independently of their implementation choices.
SNAPSHOT PERMISSION ONTOLOGYA <subject> has <permission> or <obligation> to perform an <operation> over <biological specimens> or <medical records> under constraints
RESOURCE MEDIATOR
• We have built for UCSD Moores Cancer Center Biorepository a Resource Mediator Prototype, for:• Providing researchers access to clinical data and biospecimens
resulting from the research study “Collection and Banking of Tissue, Blood and Urine for Use in Cancer Research”
• We have tested the prototype with:• de-identified patient cases (700 patients, 2635 medical record
entries)• 8 randomly chosen (from 33) researchers’ requests for data and
samples
RESOURCE MEDIATOR GUI
RESOURCE MEDIATOR
Can I have access to blood
samples and diagnostic data
from patients with breast cancer?
1) Are the resources available?
2) Is in compliance with subject’s permissions and HIPAA constraints?
RESOURCE MEDIATOR
We have provided ontology-reasoning for determining compliance with IC permissions and HIPAA constraints:
User U request access to patient treatment history
User U is denied by HIPAA access to alcohol abuse treatment history
User U has IC permission to access cancer treatment history
User U has IC permission to access cancer treatment history
CONCLUSIONS• There is a need for:
• a standard to maximize the availability of resources while providing compliance with subject’s Informed Consent permissions and HIPAA constraints
• We propose:• an Electronic Informed Consent Management System,• a Permission Ontology,• a Resource Mediator based on an hybrid approach combining the
proposed Permission Ontology and a XACML-policy engine
FUTURE WORK
QueryUser U requests Data D and sample Sto perform Operation O on subjects like I under constraints C
User U
Research Institution
ResultsUser U receives data D and sample S in compliance with subject’s
Institution A
BioSample Repository
Res
ou
rce
Me
dia
tor
Clinical Data
Warehouse
PermissionRepository
IC Form+
HIPAA
Institution B
BioSample Repository
Clinical Data
Warehouse
PermissionRepository
IC Form+
HIPAA
Permission Ontology
ACKNOWLEDGEMENT
5 year NIH-founded National Center for Biomedical Computing, started in September 2010.
CollaboratorsDevelopment Team
• Aziz Boxwala (Project management) • Joanne Barker (Health Communications)• Mona Wong (App Development)• Jeff Sale (App Development)• Elizabeth Johnstone (Literature review)
Advisors• Richard Schwab (MCC Biorepository)• Michael Caligiuri (HRPP chair)• Scott Vandenberg (Director, Tissue Repository)• Michael Kalichman (Director, Center for Ethics)• Angela McMahill (Research Compliance Officer)
QUESTIONS?
MATERIAL FOR THOUGHT…• Permission Ontology available at NCBO Bioportal:
http://bioportal.bioontology.org/
• M. A. Grando, R. Schwab, A. Boxwala, N. Alipanah, ”Ontological approach for the management of informed consent permissions“ (2012), accepted for 2nd IEEE Conference on Healthcare informatics, Imaging, and Systems Biology, September 27-28, UCSD, San Diego.
To appear. Available on request.