Chain of custody in the digital pathology revolution

Last year doctors at Yale New Haven Health announced progress on turning tens of thousands of histology glass slides into digital whole slide images. And they’re just getting started. The conversion will further clinical and educational work at Yale New Haven Hospital and collaborating institutions by helping pathologists see, share, and store vital specimen information.

Yale is not alone in this endeavor. Analysts expect the global digital pathology market to develop at a compound annual growth rate of 7.7% from 2023 to 2030, citing its potential for extraordinary workflow efficiencies and integration with artificial intelligence.

The emerging discipline of digital pathology is already prompting operational changes for laboratories and other healthcare organizations. Since glass slide production is a prerequisite for digital imaging, most facilities are appending their existing processes to support digital image acquisition. Now they must answer new questions:

• How do we label or otherwise identify digital assets?
• How do we map digital files to their physical counterparts?
• How do we track modifications or annotations to digital files?

Finding a ‘solid foundation’

What doctors need at this point is an assurance of data consistency and interoperability as they move between digital images and physical slides. They need confidence in the information. They need quality control, standards, and visibility—an audit trail or chain of custody. As one recent pathology journal article pointed out, there’s a need for “a solid foundation … upon which to build a robust digital pathology interoperable ecosystem.”

Robust systems run on consistent and accurate data. Any data management, whether it’s finance or government or public safety or healthcare, calls for a proper chain of custody.

A chain of custody is the complete, documented, chronological history of the possession and handling of a piece of information or a record from the time of its creation through its destruction. It provides visibility at every step, verifying who accessed the data and how and where it was stored. This auditable record of custody proves necessary for evidence, regulatory compliance, and data security.

As logical and perhaps simple as it sounds, the chain of custody in a digital pathology practice becomes quite complex.

Whole slide scanners scan a microscope slide at high resolution to create an image or digital version of the slide. The images must be compressed to manageable sizes in a way that also optimizes image quality and network bandwidth usage. Digital pathology images are about ten times the size of radiology images, requiring more storage management throughout their lifecycle.

The requirements go beyond scanning and storage. A digital pathology system must be able to retrieve, display, and manage images and metadata such as patient information. The digital files must remain linked to the physical slides. Often these systems use a unique bar-code for the digital image to ensure a valid electronic chain of custody. Finally, when the pathologist views the images and adds annotations, their notes must also be linked to the digital images.

Managing the movements of and amendments to large pathology files while ensuring data integrity and patient privacy—it’s quite an endeavor. Those building or adapting digital pathology workflows don’t need to start from scratch. There are precedents across industries that offer best practices.

Use cases for chain of custody

Pathology data can be understood as an asset. Leaders in any business sector understand that assets must be managed for accountability, risk mitigation, and security.

Take hazardous materials, for example, where chain of custody requirements ensure a secure exchange of chemicals. In the financial services sector, chain of custody regulations prevent loss in electronic data exchanges. For healthcare, chain of custody protocols block unauthorized access to patient information.

Any time an asset is unaccounted for would be considered a break in the chain of custody, one that could invite malicious activity or compromise the asset’s integrity. The U.S. Cybersecurity and Infrastructure Security Agency (CISA) developed a model of five concurrent and continuous functions for avoiding breaks in the chain of custody. It includes the following core activities:

• Identify: Understand critical assets and risks to systems, people, assets, data, and capabilities.
• Protect: Create a chain of custody plan and safeguards to secure assets in transit and in storage.
• Detect: Put measures in place to identify any breach in the chain of custody.
• Respond: Develop a plan to determine impact and consequences in the event of a breach.
• Recover: Maintain plans for resilience and restore any assets or systems impaired by a chain-of-custody breach.

This framework is familiar to scientists in the field of forensic medicine, where an auditable chain of custody protects the integrity and validity of police evidence. Those who manage evidence must follow strict procedures, tracing its movement and handling from a crime scene. Over time, forensics work has evolved in a digital transformation of its own. The need to deal with digital data has led forensic medicine researchers to call for internationally validated guidelines.

Like the Yale pathologists, leaders in forensics are confronting the modern era with concerns about data security and authenticity. They too see the need for harmony and interoperability between physical evidence and digital data. In both cases and within industries advised by CISA, an auditable chain of custody addresses many crucial concerns.

Chain of custody will be a key factor in digital pathology and every other successful healthcare digital transformation. It will support pathologists in their work to collaborate, educate, and conduct research while keeping patient information safe and accurate.

The experts at Iron Mountain understand data management, data security, chain of custody and digital pathology conversion. They have guided many organizations through digital transformation to help them achieve efficiency and competitive advantage. To learn more about the benefits of a digital pathology program from a trusted source, explore the Iron Mountain Digital Pathology solutions. Or reach out to an Iron Mountain expert.