When is an Algorithm a Medical Device?
Regulatory Issues in the Era of Computation in Biology

DATE:     Wednesday, September 24, 2014
TIME:    1 – 4 p.m.
PLACE:    DeLuca Forum, The Discovery Building, UW-Madison Campus
Free and open to the public. Registration will open in mid-August.

Registration is closed. A video of the symposium will be available soon on the Morgridge website.

This symposium will provide information on the current and potential regulatory framework for medical software development, guidelines for identifying when software becomes a medical device, and guidance on how to integrate the required practices into biomedical research.

Not long ago, patient information requiring computational analysis to direct therapy was obtained by medical instruments. For instance, a novel central venous catheter had a sensor that acquired data and that data was computationally analyzed before being displayed to caregivers. Those medical devices, and by inference the performance of the computational algorithms they operated on, had to be evaluated and approved before widespread use.

As computation gains importance in medicine, characterized as the “Big Data” revolution, genomic or other data are gathered and analyzed via computational algorithms. The output of those algorithms can be used to guide therapy. Is this different from the example given above? It is possible a faulty algorithm will yield inaccurate or harmful therapies being given?

Hence the question, “When is an algorithm a medical device?”

Symposium Program:

Brad Schwartz, MD, CEO, Morgridge Institute for Research

Introductory Remarks
David DeMets, PhD, Professor, Biostatistics and Medical Informatics

Brief Case Studies in Computation in Biology
David Page, PhD, Professor, Biostatistics and Medical Informatics

FDA Regulations for Medical Software
Seth Mailhot, JD
Michael Best and Friedrich, Washington, D.C.
Panel Discussion: Regulatory Issues in Computation in Biology
Moderator: David DeMets
Seth Mailhot, JD
David Page, PhD
Pilar Ossorio, JD, PhD, MIR Bioethicist, Professor of Law and Bioethics
Rock Mackie, PhD, Professor of Medical Physics and Biomedical Engineering

UW-Madison Resources

Graduate School - Office of Research Policy and Compliance


The Morgridge Institute for Research
The Department of Biostatistics and Medical Informatics, UW-Madison
The UW Carbone Cancer Center
The UW Institute for Clinical and Translational Research
The Wisconsin Alumni Research Foundation