UPDATE September 2019 : Sympto won his battle against Swissmedic !
“An application that is used to determine a user fertility status by interpreting her personal data is considered a medical device and should be subject to a conformity assessment procedure to be marketed in Switzerland”. This is the decision of the Federal Administrative Court Swiss made late September 2018 dernier.
In & rsquo; s legal case that & rsquo; opposes the & rsquo; health authority Swissmedic, SymptoTherm foundation and its mobile application sympto So just lost to the Federal Administrative Court.
At the end of January 2016, Swissmedic, the Swiss authority for health products, declared "non-compliant" mobile app sympto which allows women to ecologically manage their fertility through modern symptothermie. The foundation then denounced SymptoTherm “ethical drift in a medicalization of fertility context”. It was against this ranking by taking the case to the Administrative Court for its didactic tool is not qualified medical device, as intended to impose Swissmedic, based on an interpretation of European recommendations (To see the press release of the foundation and Article “Why Sympto n & rsquo; is not a medical device“).
Here is my analysis of the situation on this issue that I know particularly. As that & rsquo; former communications officer of the foundation SymptoTherm, I was able to follow this information.
It n & rsquo; is not obvious to a legal authority to grasp the specific completely unique from & rsquo; digital tool sympto. Harri Wettstein, its creator, wanted to play the card & rsquo; a procedure the court to raise public players in this debate to his heart, as philosopher… C & rsquo; was a gamble. This could still call a necessary distinction between a con(between)medical or assisted by & rsquo desk, one hand and a con(between)knowledge-based ception on the other hand.
new context : l & rsquo; development of natural contraception fiable
The case sympto is part of an unprecedented evolution of symptothermie, contraceptive method or green design. This is the first time in the history of the emancipation of women that the fundamental knowledge of symptothermia, discovered in the years 1960, is located :
1. Free access, with a manual easilydownloadable everywhere worldwide and freely licensed. Other symptothermal schools have so far not dared to make it as accessible method. With the audacity SymptoTherm, women now have the "manual" of their fertility unveiled in the manualFull Symptothermie.
2. supported by an accurate numerical tool, freeing women of a whole bunch tedious calculations on paper, source of errors and that made it even hermetic method, reserved only for the most motivated.
In my opinion, beyond the legal debate, it s & rsquo; d & rsquo is, a problem in the field of & rsquo; ethics. The question is: will regulatesympto, that does nothing other than apply the rules that the paper symptothermie, do not send women to the laundries by prohibiting the washing machine?
En effet, l & rsquo; mobile application numerically because that & rsquo; a woman can do it manually from known methodological rules. For example, if you want to wash wool, you will choose a cool program, with a gentle spin. You don & rsquo; will not mix colors and white. All that you know because you have enough washing your clothes by hand, and your grandmothers ... Only, despite this knowledge, you don & rsquo; have not necessarily want to go back to the manual method… But you might.
It n & rsquo; is not the case for most other mobile apps on the market that work with secret algorithms. In other words, these machines do not tell you how they treat your personal data and you can not treat yourself to the hand. The latter do not participate in & rsquo; s final independence & rsquo; user can, avec sympto, happen completely… sympto.
The Federal Court n & rsquo; not go into these subtleties and s & rsquo; merely applying the legislation on medical devices (see definition at the end of & rsquo; Article) : any software that talks about design or contraception is considered a medical device. For the court, the fact that sympto displays different colors depending fertility phases shows that even when the tutorial processes data for you and, Therefore, he must return to this legal framework.
Swissmedic position can also understand the extent of contraception and conception are sensitive areas, closely related to health. The judgment in the case sympto versus Swissmedic should date and probably a large ad on household blinds app & rsquo;…
D & rsquo; other mobile apps have the worry about
The response of the Swiss court could set a precedent and force other applications to come into line if they are “identified”.
Currently, on blinds, is the great "soup" software, "SOUP" according devoted Acronym : Software of unknown pedigree (Wikipedia Article), a term used for medical software systems of a safety critical, developed through an unknown process or methodology, and whose quality criteria are not transparent.
There are hundreds of smartphone applications on fertility. Often, c & rsquo; is the old method Ogino behind the calendar applications. Women do not know really recognize this method of grandmother who finds a second digital youth, Large marketing reinforcement… Not only n & rsquo; is not progress, But these apps are like especially to medical devices because they make “Picks” or some “diagnostics”, predicting ovulation or your rules. What does not sympto. It is also here that the foundation was arguing about the specificity of its “tutorial”. Also in the crosshairs of potential formal notices, all these apps that are based on the temperature curves.
D & rsquo; other mobile applications have understood this legal problem and have put in nails. This is the case of Natural Cycles, whose & rsquo; algorithm is secret, or of MyNFP, comparable application sympto with a transparent algorithm (Symptothermal method Sensiplan). The limit, c & rsquo; is that & rsquo; we can finally get easily the medical device certification, without proposing a very safe tool for contraception (cf. l & rsquo; case of unwanted pregnancies with Natural Cycles).
What future for SymptoTherm and its application sympto?
“The foundation has asked for time to do this accreditation in order to comply with European legislation. Everything continues as normal”, explique Harri Wettstein. SymptoTherm therefore does not plan to appeal the decision.sympto faces a fine of 50.000 Swiss Francs s & rsquo; n & rsquo it; not perform this procedure as soon as the judgment of the court, sympto is marketed illegally since March 2016.
Failing & rsquo; fine, the approach will necessarily have a cost. The foundation will it have a pretty solid budget knowing that the maintenance of & rsquo; such an application already mobilizes resources?
Modern symptothermie continues its path
sympto is considered the & rsquo; one of the best mobile apps for learning symptothermie and digitally manage her fertility (study FACTS). But many symptothermiciennes, concerned d & rsquo; full autonomy, prefer to practice on paper cyclogram, and to manually do what sympto done digitally! They use the app manual, Full Symptothermie, whose & rsquo; editing was revised in 2018 for readability and ease of & rsquo; learning.
Training dedicated to this knowledge freely available and manual or practical sympto also emerge. It is time that women conquer their true autonomy!
The Swiss definition of a medical device is given to art. 1 al. 1 l 'Order on medical devices (Odim).
For medical devices, means all instruments, appliances, amenities, software, substances, accessories and other technical medical utensils, used alone or in combination, including software to be used specifically for diagnostic or therapeutic purposes, and necessary for the operation of these:
at. intended for application to humans;
b. whose desired main action in or on the human body is not obtained by pharmacological means, immunological or metabolic, but whose action can be supported by these means; and
vs. Who serves:
1. to recognise, prevent, monitor, treat or mitigate disease,
2. to recognise, monitor, treat or mitigate injuries or disabilities or compensate for disadvantages,
3. to analyze or alter the anatomic structure, to replace portions of the anatomical structure to be analyzed or, modify or replace a physiological process,
4. regulating the design or diagnoses related to design.
Keywords: application mobile, natural contraception, medical device, Symptothermal method, sympto, symptothermie
dear Pryska! Bravo for this superb synthesis and formulation! THANKS and next…With all my heart,