Regulatory & Standards Task Force

Mission

 

The mission of the Digital Pathology Association Regulatory and Standards Task Force is to advance digital pathology by bringing clarity to the regulatory pathway for digital pathology including its evolution and creating awareness thereof, and working towards the development and adoption of standards as well as promoting interoperability in digital pathology for clinical use.

 

Participation in this Task Force is open to Benefactor member representatives only.


The impact of European Union’s Artificial Intelligence Act on innovation in digital pathology - Global perspectives to guide compliance in the USA (Member Benefit)

 

EU AI Act Template Decision Tree (Member Benefit)
This Table should be read and used with the document “The impact of European Union’s Artificial Intelligence Act on innovation in digital pathology - Global perspectives to guide compliance in the USA”

 

DPA’s comments on Federal RN for having certain medical devices exempt (click to read the full comment letter)

 

Making Permanent Regulatory Flexibilities Provided During the COVID–19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements | Click HERE to access the federal register 


Task Force Members

 

Co-Chairs: Laura Chang + John Groth

 

  • Esther Abels, MSc, SolarisRTC LLC
  • Candice Bautista-Biddle, Artera
  • Scott Blakely, Hamamatsu Corporation
  • Marilyn Bui, MD, PhD, Moffitt Cancer Center
  • Ian Cadieux, Proscia Inc.
  • Laura Chang, PhD, Artera
  • Chhavi Chauhan, MS, PhD, ELS, American Society for Investigative Pathology
  • Amanda Coble, PA ASCP, Proscia Inc.
  • Cheng Cui, PhD, AstraZeneca
  • Shujah Das Gupta, CitiusTech
  • Wanderson dos Santos Trindade, Daiichi Sankyo, Inc.
  • Bryce Dzialo, JD, Hologic, Inc.
  • Eric Glassy, MD, Affiliated Pathologists Medical Group, Inc.
  • John Groth, MD, Endeavor Health
  • Staci Kearney, PhD, RAC, Elevation Strategic Development, LLC
  • Tom Kimpe, Barco, Inc.
  • Sunit Kolhe, CitiusTech
  • April Komplin, Leica Biosystems
  • Grace Lee, Agilent Technologies
  • Eunice Lee, Agilent Technologies
  • Hisani Madison, PathAI
  • David McClintock, MD, Mayo Clinic
  • Tamatha Melton, Leica Biosystems
  • Eric Merchant, MS, Endeavor Health
  • Rahi Modirnia, Philips
  • Hong-Phuong Nguyen, Barco, Inc.
  • Vered Nitzan Meilijson, Philips
  • Handy Oen, MBA, CT, MB (ASCP), Memorial Sloan Kettering Cancer Center
  • Anil Parwani, MD, PhD, MBA, Ohio State University Wexner Medical Center
  • Hanna Pulaski, PathAI
  • Jian Wang, AstraZeneca
  • Eric Wirch, Hologic, Inc.
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