In 2019 the American College of Radiology (ACR) created a data-sharing work-group to develop best practices for sharing radiological healthcare data. The work-group identified five issues key to sharing a patient's imaging data:
- Informed consent
- Standardization of data elements
- Vendor contracts
- Data valuation
The work-group notes the compelling need for sharing imaging data. The specialty of radiology, they note, is at the forefront of the artificial intelligence (AI) transformation of health care across multiple areas, from patient selection to study acquisition to image interpretation. Large data sets are needed to develop and train AI algorithms.
In Part 1 of their report, the work-group provides a useful summary of relevant ethical and legal requirements for such data sharing. The report addresses the complexity of data sharing and annotation of data sets. Anonymization and privacy concerns can prove difficult to navigate, they note, but compliance with these requirements is essential to the successful and effective use of these data sets.
Part 2 addresses the need to assure that de-identified medical records and images cannot be reidentified and traced back to individual patients. Those seeking to share data must take the appropriate steps to curate the data in a way that organizes the clinically relevant information so as to be useful to the data sharing party, assessing the ensuing value of the data set and its annotations.
Importantly, the work-group highlights the use and importance of data-sharing contracts that will govern the use of the data. The work-group has drafted and shared a template data sharing contract, the most commonly used data-sharing agreement. It is offered by the work-group to provide the "basic framework for the data share and therefore contains the critical language that may protect all parties involved in the agreement, including the patients who underlie the medical records at hand."
Kudos to the ACR for having the insight to convene this work-group, and kudos to the members of the task force for contributing their time and expertise to developing this important guidance for the imaging industry.