Regulating Digital Pathology: An Insider’s View

| August 31, 2011

Digital-Pathology-Association The rapid increase in the usage of digital pathology for clinical applications creates unique challenges for regulatory agencies such as the FDA. The Pathology Visions Conference will tackle the debate about how to regulate the instruments and software that comprise a digital pathology system as medical devices. David Mongillo, M.P.H., M.S., will share his perspective at the 7th annual conference Oct. 30 – Nov. 2 in San Diego, CA.

Mongillo is one of 40 distinguished industry leaders who will present at the international conference. He’ll provide insight into the latest thinking from the FDA and CMS on the regulation of laboratory-developed tests and how new initiatives may impact digital pathology. The Pathology Visions conference will also host a special FDA panel on Nov. 2 that will focus on the digital pathology approval process for primary diagnosis. More details on the FDA panel discussion will be coming soon.

“Current uncertainty surrounding the FDA approval process for primary diagnosis has had a chilling effect on the industry’s ability to promote the patient care benefits of digital pathology,” said Dirk Soenksen, President of the Digital Pathology Association and Chair of the Pathology Visions Program Committee. “Dr. Mongillo’s presentation and the FDA panel are great examples of DPA’s efforts to assemble world experts on this important topic, and to provide a common understanding of uses and potential risks, while sharing perspectives regarding potential regulatory paths for industry and potential guidelines for pathology laboratories.”

Webster will discuss the evaluation and integration of histology pattern recognition software in investigative pathology. The audience will learn how pattern recognition can enhance the quantitative and morphometric ability of pathologists.

Dr. Ochs will share his findings on the evolution of teaching pathology and histology to medical students exclusively on the Web. Students and faculty will be intrigued and inspired by the discoveries from a study conducted at the University of Pennsylvania.

Attending any of the Pathology Visions speakers’ presentations will allow physicians to earn up to 13 CME credits. The three day meeting will include presentations in the clinical, research and education settings. The Pathology Visions Conference has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Indiana State Medical Association and the Digital Pathology Association.Click here for more information about earning CME credits at the conference.

The conference is the perfect learning environment for all types of health care professionals and service providers interested in learning about digital pathology solutions and deployment strategies. Conference attendees will also have access to cutting-edge industry workshops covering innovative topics in digital pathology, DPA white papers and scientific poster sessions, roundtable discussions, the latest product solutions, and networking events.

About the DPA: The mission of the Digital Pathology Association is to facilitate education and awareness of digital pathology applications in health care and life sciences.


Category: Digital Pathology News, Histology, Pathology News

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