Andrew,
I was very interested to read your article on liability for open source
medical software.
http://www.salonmagazine.com/tech/feature/1999/08/05/anesthesia/index.html
I agree that if individual programmers could be found liable for
failures in software they wrote, that it would have a chilling effect on
the development of open source medical software.
I think the likely answer to that comes from the models for the
deployment of Linux. Those health care organizations for whom
theoretical liability is less important than low cost and high
reliability will take advantage of free software distributions. Such
organizations might include many in the developing world.
The other deployment model follows the example of Red Hat Software
(www.redhat.com). Red Hat packages a distribution of Linux and sells it
for a nominal fee. They add value in several ways. By testing all
components of the operating system at selected levels, they assure that
the distribution is stable. They provide some technical support as part
of the package. The bulk of their revenue comes from the sale of
additional technical support and services.
This model separates the development of software from its implementation
and support. I believe it will prove practical in the medical arena.
The medical version of Red Hat would provide extensively tested software
distributions and support services. In addition, it would submit its
distributions for FDA certification as appropriate and would assume
liability for the quality of the distributions. It would charge
accordingly for these additional services. As you point out, the degree
of liability to be assumed by any software company for its products is
still being determined; this model merely suggests that it will possible
to play by the same rules for open source software in the medical arena
as for open- or closed-source software in any other arena.
Any company that markets software is dependent on the quality of the
development effort to produce software that has a minimal number of
flaws and to respond quickly to problems. The paradox of open source
development is that results can be better when the company does not
directly control the development effort than when it does. All other
things being equal, a company that re-markets open source software and
services may therefore have a lower liability exposure than one that
markets closed software.
The strength of the open source development model begins at the
technical level, and rests on improved quality, reliability, and lower
cost. I believe that successful companies will be built that take
advantage of these technical strengths while meeting the needs of the
commercial market for medical software.
Steve Doubleday
[EMAIL PROTECTED]
Kaiser Permanente Information Technology
"My opinions are not necessarily those of my employer"
