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

DATE:     Wednesday, September 24, 2014
TIME:    1 – 3:30 PM
PLACE:    DeLuca Forum, The Discovery Building, UW-Madison Campus
Free and open to the public. Registration will open in mid-August.

This symposium will explore 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 care givers. 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 becomes more important 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 that a faulty algorithm will yield inaccurate or harmful therapies? How should algorithms that guide therapy ultimately be reviewed or approved?


Seth Mailhot
Michael Best and Friedrich, Washington, DC


David DeMets
Professor, Biostatistics and Medical Informatics (BMI), UW-Madison

Thomas “Rock” Mackie
Professor Emeritus, Medical Physics, UW-Madison
Director, Medical Engineering, Morgridge Institute for Research

Pilar Ossorio
Professor, Law and Bioethics, UW-Madison
Bioethics Scholar in Residence, Morgridge Institute for Research

C. David Page
Professor, BMI and Computer Science, UW-Madison


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