(Last update : Sun, 13 Feb 2000)
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From patrick.schouller@inria.fr Tue Feb 25 15:36 MET 1997
X-Sender: schoulle@nuri.inria.fr
Date: Tue, 25 Feb 1997 15:36:10 -0600
From: Patrick Schouller 

Dear National Contact person for Telematics Applications Programme,

Drugs and medical devices need to be accepted by authorities before they can
be sold to the medical market. For medical software and telematic services
this is not the case. Especially the Internet is becoming full of medical
services that are sold to clinicians even if the quality is totally
unexamined. We have a good reason to compare telematics services and medical
software to drugs. For drugs authorities register those products that are
safe, cost-effective and for which the benefits are clearly documented.
Other products remain unregistered. These unregistered products are for
example some homeopathic preparations and products of so called alternative

In my opinion both medical software industry and end-users would greatly
benefit from registration of medical services and software by an independent
authority. This will help physicians to find good medical software to be
used in their work. Furthermore it would make it possible to monitor more
closely the quality of the software products. For drugs pharmacolvigilance
is required for all registered drugs. In the same way =93serverovigilance=94
would be made compulsory for software products and telematics services.

I am organizing an international workshop entitled =93Registration,
Certification and Marketing of Medical Software and Multimedica Products=94.
The workshop will take place on the 14-15th of April 1997 in Turku Finland.
Please find more information in the Internet:

It has become evident that organizing software certification and
registration on a national basis would be quite a big task and on the other
hand it would not be in line with the European trend to have European wide
policies in some regulatory issues (e.g. EMEA for drugs). Therefore, we are
trying to develop European policy for medical software.

I am preparing a proposal for a concerted action for the Telematics
Applications Programme, Health Care Division. The aim is to promote the
ideas presented at the Turku workshop in an expert group collecting all key
players in this issue to a same project.

In the European Union there is no clear policy in this field. DG III is
responsible for the regulation of medical devices and device related
software. EMEA is responsible for human and veterinary drugs only. Software
does not belong to the field of either of these.

The project will consist of 6-8 meetings during a period of 18 months. Since
we are applying it as a concerted action all expenses can be covered by the
project. I will be the coordinator and I am looking for representatives from
each Member State. The aim of the project will be to write a recommendation
for a European policy for software certification and also to outline the
organization, that would be needed to carry out the evaluation of medical

I have reserved a meeting room from Arctia Hotel Brussels on Sunday
afternoon the 16th of March and Monday morning  the 17th of March to have a
meeting with the consortium partners.

The most suitable phase to write the proposal would be after the workshop in
Turku, but unfortunately the deadline for submission of the proposals is the
15th of April, and therefore the proposal has to made before the workshop.

I would be grateful if you kindly could pass this message to suitable
person(s) or organization(s) in your country. Most suitable are partners
that have some influence in national decision making in medical informatics
in their country and who would therefore be suitable to represent the
country's medical informatics community in the meetings.

Persons interested in joining the consortium should contact me as soon as
possible. My contact information is:

Jari Forsström, MD
Medical Informatics Research Centre in Turku (MIRCIT)
E-mail: jari.forsstrom@utu.fi
Tel: +358-40-544 1809
Fax: +358-2-2613 920
Address: Kiinamyllynkatu 4-8
        FIN-20520 Turku
                        Patrick SCHOULLER
	  Direction Generale des Strategies Industrielles
	     3/5 rue Barbet de Jouy 75353 PARIS  07 SP
Telephone : + 33 1 43 19 34 25
Telecopie : + 33 1 43 19 35 51