Multicenter patient records research: security policies and tools

Area of Science:

• Health Informatics
• Medical Research Policy
• Data Privacy

Background:

• The growth of health information infrastructure enables new medical knowledge discovery from patient records.
• Fulfilling this promise necessitates addressing policy concerns for patient and institutional data rights.
• Existing approaches to patient data privacy, such as anonymity, are insufficient due to the richness of medical information.

Purpose of the Study:

• To analyze the intersecting interests of patients and institutions regarding the use of patient records in research.
• To evaluate policy frameworks and institutional needs for managing sensitive health information.
• To propose solutions for ethical and secure conduct of multicenter patient record studies.

Main Methods:

• Analysis of patient and institutional interests in the context of public policy and institutional requirements.
• Evaluation of the "anonymity" concept in relation to the informational content of patient records.
• Assessment of the role of Institutional Review Boards (IRBs) in multicenter studies.
• Identification of necessary computer security tools for managing multicenter patient record studies.

Main Results:

• Multicenter studies, when approved by Institutional Review Boards at each site, effectively safeguard the interests of both patients and institutions.
• True anonymity of patient records is not feasible due to the detailed nature of the data.
• Computer security tools are crucial for administering multicenter patient record studies.
• Simple, implementable security approaches exist using commercial database products.

Conclusions:

• Multicenter studies with robust Institutional Review Board oversight provide a viable framework for medical research using patient records.
• Researchers must prioritize building public trust through responsible data stewardship.
• Implementing appropriate computer security measures is vital for the ethical and effective management of patient data in research settings.