08.-Megadonnées / Megadata — CHURCH OF FRANCE / États généraux de la bioéthique — States General on Bioethics

http://eglise.catholique.fr/sengager-dans-la-societe/eglise-et-bioethique/comprendre-les-enjeux/

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Scientific and legal elements

UNESCO’s Inter­na­tion­al Bioethics Com­mit­tee (IBC) adopt­ed a report on mega­da­ta on 15 Sep­tem­ber 2017, which con­sti­tutes an impor­tant syn­the­sis on this subject[1]. Mega­da­ta are very large-scale data col­lect­ed on a dig­i­tal medi­um. They have five char­ac­ter­is­tics: their very large vol­ume, the vari­ety of their sources, the speed with which they are processed, their valid­i­ty, i.e. the rel­e­vance of their con­tent and their degree of pre­ci­sion and their val­ue, i.e. their use­ful­ness. These mega­da­ta are used in par­tic­u­lar in the health field. Their treat­ment pass­es through algo­rithms and can reach indi­vid­u­als through appli­ca­tions relat­ed to man­age­ment, pre­ven­tion or lifestyle.

To date, there is no spe­cif­ic nation­al or inter­na­tion­al frame­work for mega­da­ta. The reg­u­la­tion of their use may nev­er­the­less be based on the rules relat­ing to the pro­tec­tion of per­son­al data. For exam­ple, Arti­cle 12 of the Uni­ver­sal Dec­la­ra­tion of Human Rights states: “No one shall be sub­ject­ed to arbi­trary inter­fer­ence with his pri­va­cy, fam­i­ly, home or cor­re­spon­dence, nor to attacks upon his hon­our and rep­u­ta­tion. Every­one has the right to the pro­tec­tion of the law against such inter­fer­ence or attacks. The Unit­ed Nations adopt­ed author­i­ta­tive guide­lines for the reg­u­la­tion of com­put­er­ized records in 1990[3].

In 1978, France adopt­ed a law relat­ing to com­put­ers, files and freedoms[4].

It has under­gone sev­er­al changes. In Feb­ru­ary 2018, a draft law is dis­cussed in the Nation­al Assem­bly, notably to adjust our law to the Euro­pean Gen­er­al Reg­u­la­tion on the Pro­tec­tion of Per­son­al Data[5] applic­a­ble on 25 May 2018. This “GDPR[6]” requires, among oth­er things, that no data be col­lect­ed with­out explic­it and pos­i­tive con­sent (art. 7), that the per­son has the right to know what his data are used for (art. 13 and 14), that he has the right to request that his data be delet­ed (art. 17), that they be man­aged sole­ly for a cer­tain pur­pose (art. 5).

Accord­ing to the IBC report: “Mega­da­ta in the health field can be under­stood as com­pre­hen­sive and per­son­alised med­i­cine based on evidence[7], med­i­cine called pre­ci­sion med­i­cine based on pop­u­la­tion strat­i­fi­ca­tion, med­i­cine that com­bines the best avail­able sci­en­tif­ic knowl­edge with the pro­fes­sion­al expe­ri­ence of health pro­fes­sion­als for the ben­e­fit of the indi­vid­ual patient” (§22). The idea is to gath­er bio­log­i­cal data (results of med­ical analy­ses), med­ical imag­ing (radio, scan­ner), behav­iour (sport, food), social envi­ron­ment (fam­i­ly, work), to bet­ter pre­vent and treat dis­eases. One of the expect­ed ben­e­fits is to pro­mote per­son­al­ized med­i­cine, includ­ing pre­ven­tion and remote treat­ment (telemed­i­cine, data trans­mit­ted on smart­phones). Mega­da­ta pro­cess­ing should also assist pub­lic health policies.

Anthropological and Ethical Issues

The use of mega­da­ta for research rais­es many hopes, par­tic­u­lar­ly in the health field, even if cau­tion is called for with regard to what could become a “glob­al promise mar­ket”, i.e. mak­ing mon­ey on promis­es of treat­ments and pos­si­ble cures in an uncer­tain future. In this regard, the IBC report, while stress­ing the ben­e­fi­cial poten­tial of the use of mega­da­ta in health, notes: “The enthu­si­asm gen­er­at­ed by the phe­nom­e­non of mega­da­ta is like­ly to lead to over­es­ti­ma­tions and unre­al­is­tic fore­casts, as well as to the mar­ket­ing of prod­ucts and ser­vices that have not yet proved their rel­e­vance. Fur­ther­more, it can lead to an imbal­ance in health pol­i­cy pri­or­i­ties, which can have par­tic­u­lar­ly harm­ful effects for coun­tries where access to essen­tial ser­vices is not guar­an­teed” (§45).

A key issue is con­sent. To facil­i­tate research, the prin­ci­ple of “glob­al con­sent” is envis­aged, i.e. con­sent to the use of data “in the con­text of the var­i­ous research projects like­ly to be con­duct­ed in a par­tic­u­lar branch or field”[8]. Accord­ing to this mod­el, after surgery for exam­ple, a patient would con­sent to the use of sam­ples tak­en from his body at one time for all types of research like­ly to use the data from these sam­ples. Anoth­er pro­posed mod­el is the “dynam­ic con­sent” mod­el. Here, “the sub­ject gives his ini­tial con­sent, but is kept informed of the use that is made of his data and may choose to refuse or autho­rize cer­tain uses.

These pro­pos­als should be con­sid­ered with great cau­tion so as not to weak­en atten­tion to respect for the per­son pro­tect­ed by the prin­ci­ple of informed con­sent. Fair inter­na­tion­al reg­u­la­tion should ensure that the data are not used in such a way that the per­son is affect­ed (dis­crim­i­na­tion in care and insur­ance con­tracts, for exam­ple). In this sense, the appli­ca­tion of the “GDPR” on the basis of a strict inter­pre­ta­tion, or the fol­low-up of Rec­om­men­da­tion CM/Rec (2016)6 of the Com­mit­tee of Min­is­ters of the Coun­cil of Europe, which calls for recourse to the con­sent of the per­son hav­ing pre­vi­ous­ly trans­ferred bio­log­i­cal mate­r­i­al to research in the event of a change of pur­pose or man­age­ment of bio­log­i­cal data, is desirable[10].

Encour­ag­ing bio­med­ical research does not mean giv­ing in to the log­ic of the “cap­i­tal body”, where the body becomes the stake of eco­nom­ic and finan­cial choic­es. That cit­i­zens renounce the prin­ci­ple of informed con­sent would con­sti­tute a rever­sal of the moral con­science that led to the “Nurem­berg Code” in the after­math of the Sec­ond World War[11]. It is not the per­son who must renounce the full exer­cise of his free­dom in the face of the ambi­tions of a med­i­cine “of the promise”.

Rather, it is the ambi­tions of such med­i­cine that must con­form to respect for the free­dom of each indi­vid­ual to be sure to be at the ser­vice of the per­son­al good and the com­mon good.

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[1] On trou­ve le rap­port sur la page http://www.unesco.org/new/fr/social-and-human-sciences/themes/bioethics/international-bioethics-com­mittee/reports-and-advices/

[2] Nations Unies, 1948.

[3] Cf. http://hrlibrary.umn.edu/instree/french/Fq2grcpd.html

[4] Loi n°78–17 du 6 jan­vi­er 1978.

[5] http://eur-lex.europa.eu/legal-content/FR/TXT/PDF/?uri=CELEX:32016R0679&from=FR

[6] « Gen­er­al Data Pro­tec­tion Regulation ».

[7] Evi­denced Based Medicine.

[8] Rap­port du CIB, §52.

[9] Rap­port du CIB, §55.

[10] Cf. https://search.coe.int/cm/Pages/result_details.aspx?ObjectId=090000168064e900

[11] Cf. C. Lafontaine, Les enjeux de la bioé­conomie du corps humain, in D. Folscheid, A. Lécu, B. de Mal­herbe (dir.),

Cri­tique de la rai­son tran­shu­man­iste, Cerf/Collège des Bernardins, 2018, p. 55–65.