Subject: Re: open source medical software
From: Benjamin Rossen <b.rossen@onsnet.nu>
Date: Fri, 28 Jan 2005 03:20:31 +0100

Gentlemen, 

There seem to be separate issues here that are getting tangled because of 
assumptions that have been made, that perhaps should not be made. 

(1) Donnal Walter would not like the software to be defined as a medical 
device because of the difficulties that this would entail with respect to the 
FDA review. (Do I understand this correctly?)
(2) The software is is exempt because "licensed practitioners, including 
physicians, dentists, and optometrists, who manufacture or otherwise alter 
devices solely for use in their own practice." [Code of Federal Regulations 
21 CFR] and Donnal Walter would like to make sure that it remains exempt by 
restricting its use in the license. 
(3) Can it still be licensed under the OSD if (2) is satisfied? 

The answer to question three was given by Richard Schilling, and it is 'no', 
because the OSD requires that there be no restrictions for field of use or  
groups of people. (Do I understand that right?)

That brings us back to the second issue. Is it necessary to use this ploy to 
avoid FDA review. I wonder if this ploy is a good one anyway... after all if 
you make a license saying that only licensed practitioners, including 
physicians, dentists, and optometrists and so on may use the software, would 
not such a license become the proverbial red flag for the FDA? And since the 
software would be altered by known and unknown opensource contributors, it 
would no longer be something manufactured or otherwise altered solely for use 
in the private practice by the physicians concerned. It would be out of 
control. It would be on the web. So, there must be another way of getting 
around this problem. 

There are many possible uses for this kind of software. Surely it is 
interesting for veterinary practitioners, agricultural scientists, animal 
breeders and as I mentioned elsewhere, academics engaged in the study of 
medical decision making, and so on. Is the software was only useful for 
keeping track of patient information and to calculate parameters used in 
medical decision making, drug dosing and so on? Can it be altered to keep 
track of salmon weight, age and growth rate to calculate parameters in food 
allocation and similar. Perhaps by adding defining the parameters differently 
the software is can become an tool for much more general use. How much would 
have to be added / changed to make it useful for keeping track of diesel 
engine parameters and maintenance decision making, lubricant delivery and so 
on. After all, at a the meta-system modelling level, the program structures 
for these applications is going to be the same. The principles of testing 
theory, risk assessment and decision making are the same irrespective of 
which field you apply them.  

Thinking in generic terms has often helped me to make much better systems, 
which would be a side benefit of doing this. Separate the layers of: 
(1) Object Definition (patient/salmon farm/diesel engine or what ever)
(2) Measurement / Diagnosis /Testing
(3) Maintenance / Treatment 
(4) Monitoring  ... and so on. 

So, perhaps a better strategy is to redefine the software as a generic 
decision making tool, which can be configured by licensed practitioners, 
including physicians, dentists, and optometrists in their own practices for 
medial purposes, but can also be configured by other users for their 
purposes. Now this solves two problems. 
(1) Generic decision making software is not interesting to the FDA
(2) Generic decision making software can be licensed under the OSD

But even this may not be necessary, for as Richard Schilling has said, the FDA 
would apply the exemption irrespective of what is written in the license. (Do 
I understand that correctly?)  

Now it might be interesting to examine another assumption. What if the FDA 
decided that the software is a medical device because of the ability to 
configure it for medical decision making applications. Is that indeed such a 
terrible thing? What are the arguments for getting it licensed as a medical 
device? What are the arguments against? 

Benjamin Rossen