API Joins FDA's Network of Experts

“The Association for Pathology Informatics (API) Twice-Tapped by the FDA to Join its Network of Experts and its Network of Digital Health Experts” (August 2021)

(Pittsburgh, PA)  API has built an internationally recognized reputation for bringing together top experts in the field of Pathology Informatics. The Association for Pathology Informatics (API) was founded in 2000 and offers a broad array of expertise in the primary informatics pillars of: 1) information fundamentals; 2) information systems; 3) workflow and process; and 4) governance and management. API supports clinical laboratory operations, enterprise informatics and IT initiatives, academic research, and education.

Consisting of nearly 750 members and 27 Teaching Institution and Non-Profit Program members across the world, it is a leader in promoting the field of Pathology Informatics as an academic and clinical subspecialty of Pathology and Laboratory Medicine. Thanks to the unparalleled dedication of its members, it continues to host highly successful annual meetings, workshops, educational initiatives, and outreach activities featuring cutting-edge content. As a result, the Food and Drug Administration recently tapped the Association of Pathology Informatics to join its esteemed Network of Experts and its Network of Digital Health Experts.

The FDA created the Network of Experts in 2012 to establish rapid access to expertise beyond that which is housed within its Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER). Currently, the Network consists of a select group of nearly 100 professional 501(c)(3) non-profit status organizations that can identify relevant member experts and connect them to FDA program members with timely feedback (not opinion or recommendation) on newly emergent health technologies.

The CDRH’s Network of Experts also recently announced the formation of a similar network of experts, but one that targets its solicitation of knowledge and experience to fields related to digital health. By joining the FDA’s Network of Experts, API members will also have the opportunity to avail their expertise in Pathology Informatics by providing feedback to the FDA Network of Digital Health Experts. Recognizing the prominence of its members in digital pathology and artificial intelligence, API has been asked to assist the FDA in the early stages of this network’s development.

When asked about the announcement, API President S. Joseph Sirintrapun remarked, “The FDA's Network of Experts provides the API community a unique opportunity to improve health and healthcare on a national scale.” He added, “The API community is proud to be part of the FDA's Network of Experts as a trusted source of evidence-based informatics expertise. We look forward to facilitating the FDA's understanding in leveraging informatics to address emerging technologies and help foster innovation and intelligent regulation to protect public health and safety, simultaneously.”

As the voice of the nation’s top pathology informatics professionals, API and its members continue to play a leading role in assessing the effect of technological innovations on health policy. API President-Elect Toby Cornish emphasized that “The rapid advance of laboratory technology in areas like molecular, digital and computational pathology creates unique new regulatory challenges, and the API is well-positioned to support the FDA’s mission with regard to emerging technology.” API is excited for the opportunity to further substantiate pathology’s relevance into the future as the most critical component for precision patient care.