A regulatory science initiative to harmonize and standardize digital pathology and machine learning processes to speed up clinical innovation to patients

Hetal Desai Marble¹, Richard Huang¹, Sarah Nixon Dudgeon², Amanda Lowe³, Markus D Herrmann⁴, Scott Blakely⁵, Matthew O Leavitt⁶, Mike Isaacs⁷, Matthew G Hanna⁸, Ashish Sharma⁹, Jithesh Veetil¹⁰, Pamela Goldberg¹⁰, Joachim H Schmid¹¹, Laura Lasiter¹², Brandon D Gallas², Esther Abels¹³, Jochen K Lennerz^1
1 Department of Pathology, Center for Integrated Diagnostics, Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA
² Division of Imaging, Diagnostics, and Software Reliability, Center for Devices and Radiological Health, Food and Drug Administration, Office of Science and Engineering Laboratories, Silver Spring, MD, USA
³ Visiopharm Americas, Westminster, CO, USA
⁴ Department of Pathology, Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA
⁵ Hamamatsu Corporation, Pittsburgh, PA, USA
⁶ LUMEA, Salt Lake City, UT, USA
⁷ Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO, USA
⁸ Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA
⁹ Department of Biomedical Informatics, Emory University School of Medicine, Atlanta, GA, USA
¹⁰ Medical Device Innovation Consortium, Arlington, VA, USA
¹¹ Roche Tissue Diagnostics, Santa Clara, USA
¹² Friends of Cancer Research, Washington, DC, USA
¹³ PathAI, Boston, MA, USA

Correspondence Address:
Dr. Jochen K Lennerz
Department of Pathology, Center for Integrated Diagnostics, Harvard Medical School, Massachusetts General Hospital, 55 Fruit Street, GRJ1015 Boston, MA 02114
USA

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/jpi.jpi_27_20