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Which regulation constitutes security and data privacy with respect to medical records of trial participants? 

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Survey data reveal what healthcare professionals who have access to sensitive medical records believe are the greatest threats to patients' privacy.
Further, our paper highlights the importance of protecting the privacy of medical records of patients in terms of information privacy.
In particular, unnecessarily restrictive interpretation of the law may be a serious impediment to identification of potential participants for a trial, access to records to confirm events, continued follow-up of patients after the trial has been concluded, and secondary use of the trial data for purposes not directly related to the original purpose of the study.
Respect for trial participants who often run a personal and unknown risk by participating in trials requires that they - and therefore also the society at large that they represent - be seen as the ultimate owners of trial data. Data sharing would lead to tremendous benefits for patients, progress in science, and rational use of healthcare resources based on evidence we can trust.
We incorporate differential privacy, which offers strong guarantees on the likelihood that a subject could be identified as a member of the trial.
These obstacles could be overcome by better informing patients of the uses of records for medical research purposes, by using informed consent procedures that explain the nature of the research and the uses of the data, and by the use of identifiers, such as social security numbers that allow central follow-up.

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