Patient health data has become a valuable commodity, helping researchers develop artificial intelligence tools, identify and prevent diseases, and discover novel treatments. The proliferation of such data, however, has made it clear that current patient consent approaches are inadequate.
That’s according to a group of radiologists from top institutions across the U.S., who recently argued that trust between patients and providers is key to truly realizing the power of patient health information. They called on their field to help develop a new patient-centered approach for data consent, in a Jan. 1 opinion piece published in JACR.
“As radiologists, we should acknowledge that we must become more sophisticated about both the technology and business models of sharing imaging data,” Amy L. Kotsenas, MD, chair of clinical digital imaging at the Mayo Clinic’s Department of Radiology, and colleagues wrote. “We should recognize that our current generic authorization and consent process is inadequate to fully inform our patients of the potential secondary use of their data.”
What’s specifically wrong with current approaches? For one, Kotsenas et al. explained, HIPAA regulations guiding such forms were enacted prior to the current internet landscape, including Google and Facebook’s existence.
Additionally, such authorization forms—often still paper attached to a clipboard—typically don’t directly address imaging data. And they’re often too long, complex, and rarely detail how developers plan to use such information.
“It is likely that many patients do not understand that they have given passive consent for secondary use of their imaging data,” the authors added. “Patients who do understand this may have serious and legitimate concerns about how their health care information may be used, who will have access to it, and if assurances of anonymity can be trusted.”
It doesn’t have to be this way, however, Kotsenas and colleagues wrote. They proposed a new tiered system of consent that would give patients control over who has access to their PHI and for what purposes.
Under this approach, patients could opt out of sharing certain types of data or portions of their health record, various types of nonclinical use, and specific data-use partners. Patients could deny sharing their information for AI development or even with specific researchers, such as those from outside their primary care organization.
In terms of imaging data permissions, the authors suggested using an entirely separate form giving patients the option to opt out of research or commercial development. Radiology practices must also get used to contacting patients to ask permission for specific use cases if consent hasn’t been previously given.
Most patients want to help realize the benefits of data in healthcare, but it is a two-way street, the authors explained.
“In return, healthcare providers and organizations have a duty to be trustworthy stewards of those data, helping individual patients and society, distributing benefits and harms equally among patient groups, specifically groups traditionally underrepresented or actively discriminated against,” Kotsenas et al. wrote. “A next step is to work with our patients to develop ethical guiding principles for obtaining specific consent to use their imaging data before it is too late and we lose patient trust,” they concluded.
Read the entire piece published in the Journal of the American College of Radiology here.