Digital Pathology: The Future is Here

We live in a world of rapid digital transformation, where innovations such as quantum internet, AI, autonomous vehicles, and the metaverse are evolving at breakneck speed, and even the most tech-savvy struggle to keep pace. Yet despite these advances, integrating the latest digital pathology solutions into routine diagnosis remains a slow and often resisted process.

Although digital pathology was developed decades ago, it wasn't until April 2017 that the U.S. Food and Drug Administration (FDA) permitted the marketing of the first whole-slide imaging (WSI) system, the Philips IntelliSite Pathology Solution (PIPS).

PIPS represented a major advancement as an automated digital slide-creation, viewing, and management system, enabling pathologists to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin-embedded  (FFPE) tissue. Although this was significant progress, the evolution of digital pathology workflows has not kept pace with broader technological advances in healthcare.

"Unique circumstances are stunting the growth of digital pathology," said Tony Oganesian, LigoLab's Chief Technology Officer. "This includes a combination of overregulation, tight reimbursement, and a lack of investment within the healthcare system. However, pathology's dwindling workforce and increasing caseloads have made complete digitization inevitable."

Case Study: Pathology Lab Management Guide - The Future of Digital Pathology

How the Pandemic Opened the Door for Digital Pathology Solutions

From Slowdown to Innovation Boom

Over the years, U.S. pathologists pondered what it might take for digital pathology to become the industry standard. Many small steps were taken, but real momentum remained on the distant horizon until the COVID-19 pandemic arrived in 2020.

"At first, when the pandemic hit, and stay-at-home orders were enacted, it seemed that pathology would suffer from a slowdown," said Oganesian. "As hospitals closed their doors and non-essential medical treatments were halted, pathologists began to worry. However, the FDA loosened its grip and began issuing waivers and emergency use authorizations for advances that had been stuck in the review pipeline. From that, digital pathology experienced an innovation boom."

Remote Work Authorization Changes the Game

One key example of this shift occurred in April 2020, when the FDA granted a waiver allowing the use of consumer monitors at home as part of the Philips digital pathology workflow. Pathologists unable to work on-site due to the pandemic could now review anatomic pathology cases remotely. The benefits of digital pathology played a crucial role in preventing delays in patient care during this time.

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Less Digital Pathology Regulation Equals More Innovation

This marked a major milestone for digital pathology solutions in the U.S. At its core, digital pathology was designed to enable remote collaboration, enabling pathologists to share and review high-resolution images across laboratories.

The Regulatory Shift That Accelerated Adoption

Before the pandemic, the U.S. was decades behind other developed countries in adopting digital pathology solutions. Strict regulations from the FDA and CLIA under CMS oversight had initially slowed progress. However, the pandemic prompted the FDA to ease certain requirements, accelerating the approval of digital pathology technologies to address urgent clinical needs.

CMS also temporarily waived restrictive CLIA regulations, enabling pathologists to work remotely using digital platforms. This shift expanded the use of digital pathology for remote diagnosis and accelerated its acceptance for clinical use.

"Now that our healthcare system has experienced the benefits of digital pathology and rapid innovation, there is hope that some of the legacy roadblocks that slowed progress will continue to be a thing of the past," said LigoLab CEO Suren Avunjian. "Technologies that enable pathologists to work more efficiently and effectively will ultimately lead to better patient care and reduce healthcare costs."

Case Study: OnePath - Transforming Pathology Lab Management Through Digital Innovation

Digital Pathology Solutions and the Role of Laboratory Information Systems

LigoLab as the Foundation for a Digital Pathology Ecosystem

LigoLab's future-ready LIS laboratory information system software provides an end-to-end pathology lab management solution for anatomic pathology labs of all sizes. The all-in-one LigoLab medical LIS & lab billing informatics platform is a pathology software that supports all image management systems (IMS) and has done so for well over a decade.

"An ideal digital pathology ecosystem is one where all laboratory software systems are interoperable, connecting as an integrated digital lab workflow," said Oganesian. "The LigoLab platform, specifically its interface engine, is interoperable with every laboratory software system a lab works with, including all digital pathology solutions."

The Three Major Components of a Digital Pathology Ecosystem

LigoLab provides the foundation for a digital pathology ecosystem consisting of three major components: the laboratory information system (LIS software), the digital pathology system, and the digital pathology system tools. The primary components of the digital pathology system itself include the whole-slide scanner, the whole-slide image viewer, and the display monitor.

How These Components Work Together

Modern scanners create high-resolution digital replicas of traditional glass slides, which can be stored locally or in the cloud and accessed from any location with an internet connection. These advanced systems support high-throughput scanning, processing thousands of slides efficiently and accurately while requiring minimal manual intervention. Digital archives also offer significant advantages over analog storage, making it easier to retrieve and review prior cases without the logistical challenges of shipping or storing physical slides.

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LigoLab’s Powerful Interface Engine  

Seamless Connectivity Between LIS Systems and Digital Pathology Solutions

An imaging viewer integrates with the LigoLab platform through LigoLab's interface engine to create a seamless digital pathology workflow. A real-world demonstration from a longtime LigoLab customer (video linked below) illustrates how this integrated solution streamlines case management, image access, pathologist review, and diagnostic reporting through the following capabilities: 

• The contextual launch of Philips IMS within LigoLab's LIS system module
• How the LIS and IMS user interfaces operate in tandem
• Shared accession numbers
• How to use the LIS software for case assignments
• Voice-to-text transcription and notes support
• Importing slide snapshots into the LIS system
• Custom report generation

Built for Maximum Interoperability

The LigoLab platform unifies all aspects of digital pathology within the broader health IT ecosystem through its powerful interface engine, which supports data exchange across multiple formats, including FHIR, HL7, XML, X12, CSV, PDF, Flat File, ASTM, and RESTful APIs.

Behind this robust engine is an expert interface team with deep knowledge of pathology lab reporting software, offering integration services tailored to each customer's needs.

"If an electronic device has interface capabilities, our team can connect to it," said Oganesian. "Our interface engine supports any level of interface customization, and our core mission is to be a complete, all-in-one enterprise pathology lab software solution for laboratories and their partners."

Real-World Benefits for Early Adopters

The ongoing transformation in digital pathology brings several advantages to both pathologists and patients. Early adopters who utilize the LigoLab platform to support digital pathology operations report tangible efficiency gains, improved case allocation across digital networks, and increased scalability.

LigoLab’s Award-Winning Laboratory Information System Software 

As a comprehensive enterprise-grade medical LIS and lab billing solution, the all-in-one LigoLab Informatics Platform includes modules for anatomic pathology, clinical laboratory, molecular diagnostics, laboratory revenue cycle management (lab RCM), and direct-to-consumer lab testing (TestDirectly), all on one powerful and integrated lab organization software that supports every role, department, and case.

Ready to Take Your Lab to the Next Level?

By embracing digital pathology solutions now, your lab can leverage proven techniques to drive efficiency and improve patient outcomes, reinforcing the article's argument that digital pathology is an essential step for modern labs.

Act Now: Contact a LigoLab Product Specialist Today!

Frequently Asked Questions About Digital Pathology Solutions and Lab Information System Integration

What is digital pathology and how does it differ from traditional microscopy?

Digital pathology converts glass slides into high-resolution digital images using whole-slide imaging scanners. These images can be stored, accessed, shared, and analyzed remotely, eliminating the need for physical slide handling and enabling pathologists to review cases from any location with an internet connection. Unlike traditional microscopy, digital pathology supports remote collaboration, AI-assisted analysis, and scalable high-throughput workflows.

When did the FDA first approve a whole-slide imaging system for clinical use in the U.S.?

The FDA approved the first whole-slide imaging system, the Philips IntelliSite Pathology Solution, in April 2017. This was a landmark moment that gave pathologists a regulatory-approved digital alternative to traditional light microscopy for reviewing surgical pathology slides.

How did the COVID-19 pandemic accelerate digital pathology adoption?

The pandemic prompted the FDA to issue waivers and emergency use authorizations for digital pathology technologies that had been stuck in the regulatory review pipeline. In April 2020, pathologists were permitted to use consumer monitors at home for remote case review as part of the Philips digital pathology workflow. CMS also temporarily waived restrictive CLIA regulations, enabling remote work and accelerating the clinical acceptance of digital pathology solutions nationwide.

What are the three major components of a digital pathology ecosystem?

A complete digital pathology ecosystem includes three core components: the laboratory information system (LIS), the digital pathology platform, and the tools that support digital pathology workflows. Within the digital pathology platform, key elements include the whole-slide scanner, whole-slide image viewer, and diagnostic display monitor. LigoLab's platform, powered by its interface engine, serves as the connective layer that seamlessly integrates and orchestrates these components, creating a unified and efficient digital pathology workflow. 

How does LigoLab's interface engine support digital pathology integration?

LigoLab's interface engine seamlessly integrates with whole-slide imaging viewers and leading digital pathology platforms, enabling secure data exchange through FHIR, HL7, XML, X12, CSV, PDF, Flat File, ASTM, and RESTful API standards. Backed by a dedicated team of interface specialists with extensive expertise in pathology informatics, LigoLab delivers highly configurable integrations tailored to each laboratory's unique workflows, systems, and operational requirements. 

What benefits do early digital pathology adopters report with LigoLab's platform?

Labs that use LigoLab to support their digital pathology operations consistently report efficiency gains, improved case allocation across digital pathology networks, and greater operational scalability. The platform's unified infrastructure eliminates the need for disconnected systems, allowing digital pathology workflows to operate seamlessly alongside clinical, billing, and reporting functions.

What regulatory barriers remain for digital pathology in the U.S.?

While digital pathology gained significant momentum during the COVID-19 pandemic, LigoLab CTO Tony Oganesian notes that broader adoption has continued to face obstacles, including regulatory complexity, reimbursement challenges, and limited healthcare investment. Even so, mounting workforce shortages and rising case volumes are accelerating the need for digital transformation across pathology. As regulatory barriers have gradually eased and confidence in digital workflows has grown, the industry is moving steadily toward a more fully digitized future.