On July 9, 2019, the Physician Clinical Registry Coalition (Coalition), with the support of the American Society of Hematology, the American Psychiatric Association, and the American Medical Association (AMA) Cancer Caucus, submitted a letter to the AMA Board of Trustees regarding the reconsideration of Report 26-A-19, “Research Handling of De-Identified Patient Information” (Report 26).
Report 26 contains valuable information, both about various uses of de-identified clinical data and the differences between individually identifiable health information or protected health information and de-identified data. However, Report 26 calls for the imposition of unprecedented limitations on the use of wholly de-identified data. In its letter to the AMA Board of Trustees, the Coalition expressed concern that such limitations may have adverse long-term effects that will harm patients by creating barriers to accessing information that provides critical insight to care delivery and health outcomes. The Coalition emphasized that limitations on the use of wholly de-identified data run counter to the Health Insurance Portability and Accountability Act and other well-established privacy and research protection laws and will curtail improvements in quality of care. The Coalition noted that a system in which individual patients could influence the creation, use or disclosure of a de-identified data set would exceed any current legal boundaries or authorities and would threaten the viability of the clinical data registries that hold so much promise for improving the quality of care.
The Coalition also expressed concern regarding a reference in Report 26 that appears to question the propriety of “patient record licensing contracts with exclusive rights.” The Coalition believes that such licensing agreements should not automatically be cause for concern as long as they are accompanied by appropriate safeguards and accountability to prevent re-identification of de-identified data and to allow registries to continue to advance their core missions. The Coalition requested an opportunity for further dialogue to better understand the nature of the concerns that prompted that remark in Report 26.
The Coalition looks forward to working with the AMA Board of Trustees to help ensure that appropriate protections for personal health information are in place, while supporting a strong registry environment that leads to critical insights about quality and patient outcomes.