OAK BROOK, Ill. — Clinical data should be treated as a public good when it is used for secondary purposes, such as research or the development of AI algorithms, according to a special report published in the journal Radiology.

"This means that, on one hand, clinical data should be made available to researchers and developers after it has been aggregated and all patient identifiers have been removed," said study lead author David B. Larson, M.D., M.B.A., from the Stanford University School of Medicine in Stanford, California. "On the other hand, all who interact with such data should be held to high ethical standards, including protecting patient privacy and not selling clinical data."

The rapid development of AI, coming on the heels of the widespread adoption of electronic medical records, has opened up exciting possibilities in medicine. AI can potentially streamline and improve the analysis of medical images, but first it must be trained on large troves of data from mammograms, CT scans and other imaging exams. One of the current limitations of the advancement of AI-based tools is the lack of broad consensus on an ethical framework for sharing clinical data.
"Now that we have electronic access to clinical data and the data processing tools, we can dramatically accelerate our ability to gain understanding and develop new applications that can benefit patients and populations," Dr. Larson said. "But unsettled questions regarding the ethical use of the data often preclude the sharing of that information."

To help answer those questions, Dr. Larson and his colleagues at Stanford University developed a framework for using and sharing clinical data in the development of AI applications.

Arguments regarding the sharing of clinical data traditionally have fallen into one of two camps: either the patient owns the data or the institution does. Dr. Larson and colleagues advocate for a third approach based on the idea that, when it comes to secondary use, nobody truly owns the data in the traditional sense.

"Medical data, which are simply recorded observations, are acquired for the purposes of providing patient care," Dr. Larson said. "When that care is provided, that purpose is fulfilled, so we need to find another way to think about how these recorded observations should be used for other purposes. We believe that patients, provider organizations, and algorithm developers all have ethical obligations to help ensure that these observations are used to benefit future patients, recognizing that protecting patient privacy is paramount."

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