THE GUARANTEES FOR THE PROTECTION OF PERSONAL DATA At today's meeting, in the presence of prof. Francesco Pizzetti, President, Mr.. Giuseppe Chiaravalloti, vice president, dr. Paissan and Mr. Mauro. Giuseppe Fortunato, Members, and Mr.. Daniele De Paoli, general secretary; Having regard to Legislative Decree 30 June 2003, n. 196, Code regarding the protection of personal data; In view of art. 99, paragraph 1, of the Code according to which the processing of personal data carried out for scientific purposes and 'considered compatible with the different purposes for which the data was previously collected or treated; In view of art. 110, paragraph 1, of the Code that allows you to process personal data disclosing for scientific research purposes health in the medical, biomedical or epidemiological, even without the consent of those concerned, when due to special reasons is not possible inform them and the research program is the subject of a reasoned opinion of the ethics committee at local level, and is authorized by the Guarantor, pursuant to art. 40 of the Code; Given the authorization of the Guarantor n. 2/2011 to the processing of data disclosing health and sex life (available on the website of the Authority 'www.garanteprivacy.it, Doc. No web. 1822577, published in Official Gazette no. 162 of 14.7. 2011) and, in particular, point 1.2 authorizing the processing of personal data revealing the state of health for purposes of scientific research aimed at protecting the health of, a third party or the community 'in the medical, biomedical or epidemiological, referring to the provisions of articles 106, 107 and 110 of the Code in relation to the need 'to acquire the consent of the persons concerned; Given the provisions of the code of ethics and good conduct for the processing of personal data for statistical and scientific purposes (Provv. N. 2 of 16 June 2004, in the Official Journal 14 August 2004, n. 190, Annex A.4 to the Code and available on the website of the Authority ', Doc. no web. 1556635) also apply to data processing for medical research purposes, biomedical or epidemiological not associated with activities' the protection of health carried out by operators health professions or health organizations, or with activities' comparable in terms of significant fallout it customized the data subject (Article 11 and Article 2, paragraph 2); Given the decision of 15 December 2011, by which the Guarantor has launched a public consultation on a document adopted on the same date laying down the model of 'development consent to the processing of data disclosing health status for retrospective observational studies "and published, together with the aforesaid resolution, on the website of the Authority 'and in the Official Gazette no. 2 of 3 January 2012; Given the comments and observations received to this Authority 'in particular on the part of universities', bodies, research institutes and companies' scientific, researchers, health care professionals, health care institutions, bodies representing health professionals and patient associations concerned, following the public consultation to which it was set a deadline of 31 January 2012; In view of art. 2 of legislative decree June 24, 2003, n. 211 defining "observational studies" studies in which "medicines are prescribed according to the instructions of the marketing authorization. The assignment of the patient to a particular therapeutic strategy is not 'determined in advance by a trial protocol but falls within current practice and the decision to prescribe the drug and' completely independent from that to include the patient in the study. Patients no additional diagnostic or monitoring procedure applies'; Considering that a large number of treatments of data disclosing health and 'made by different data controllers for conducting studies aimed at scientific research in the medical, biomedical or epidemiological, not containing significant affect that custom relapse, that use previously collected data for the purpose of cure of the concerned or for the execution of previous research projects, or obtained from biological samples taken previously for finalita 'the protection of health or to the execution of previous research projects; Considering that the studies in question does not only aim at evaluating the safety and effectiveness of drugs and medical devices in the clinical practice but also to verify its appropriateness prescriptive or to investigate the relationships between risk factors and human health, or health concern events diagnostic help, therapeutic or preventive, or on the use of social and health facilities; Considering that, in the context of these studies, the processed data is recorded in the clinical documentation (or in the documentation relating to previous studies in which they were collected) available at the participating care centers in accordance 'with the law, or are derived from biological samples removed and stored in the pathology archives of such centers or collected in previous research projects; Given the specific authorization procedures issued by the Authority ', in accordance with Articles 110, paragraph 1 (last part) and 41 of the Code, with whom and' was authorized, even without the consent of those concerned, the conduct of studies, not having significant fallout affect that custom, made with previously collected data for purposes 'of protecting the health of those concerned or derived from biological samples taken earlier for the same purposes'; this', because, as a result of proven special reasons, and 'documented the inability' to provide them with the information on the data and its research program has received a final favorable opinion of the ethics committee has territorial jurisdiction; Given that the data concerned treatments may be authorized by the Guarantor of its own motion with general measures relating to certain categories of holders or treatment (art. 40 of the Code); Therefore it considered it appropriate, in the light of experience gained, release a general authorization pursuant to art. 40 of the Code, relating to the processing of data disclosing health status for purposes of scientific research, carried out without the consent of those concerned, preordered the conduct of studies, not containing significant affect that custom relapse, with data collected in previously for purposes 'of health protection thereof concerned or derived from biological samples taken earlier for the same purposes', harmonizing the already 'given with individual authorization already' released specific requirements; Considered altresi 'appropriate, in accordance' with art. 110 of the Code (last part), taking into account for the purposes of this authorization treatments for scientific research purposes preordained to conducting studies that are the subject of reasoned favorable opinion of the ethics committee at local level, being not sufficient for this purpose the formation of silence / consent following the notification of the study in that committee; Considering that, by virtue 'art. 11 of the mentioned code of ethics for the processing of personal data for statistical and scientific purposes, consent is not 'necessary when, pursuant to art. 110 of the Code, not 'can inform interested parties for "ethical reasons", or to "methodological reasons", or for "reasons of inability' organization '; Considering that, in the authorization requests so far submitted to Authority ', the inability' to inform interested parties and 'found to be warranted on the basis of "ethical reasons" or to "reasons of inability' organization '; Therefore considered it appropriate, in the light of experience, that the processing of data disclosing health for scientific research purposes preordained to conducting medical studies, biomedical or epidemiological where the inability 'to inform interested parties it is justified by 'methodological reasons "are subject to specific authorization of the Guarantor; Considered that the authorization of a general nature is an appropriate instrument to lay down unified safeguards for the benefit of the parties and makes it unnecessary to request individual authorization decrees for many data processing easier in this way, significantly, the fulfillment of the obligations relating to data processing operations for the driving of medical research, biomedical or epidemiological; It held that the object of this authorization treatments should also apply caution in the general authorization of the Guarantor n. 2/2011 and in the code of conduct mentioned above, in particular for this' regards the criteria to be taken into account to avoid making identifiable stakeholders in the later stages of the study the extrapolation of data and rules of conduct for those responsible and any controllers; It found that even the possible collection and storage of biological samples, so 'as the processing of data generated therefrom, shall be made in accordance' with the fundamental principles of protection and data security (v. Recommendation of the Council of Europe no. R (92) 3 on genetic testing and genetic screening for health-related purposes; working Document on genetic data of Group Art. 29 of Dir. 95/46 / EC, WP 91/2004); As the use of biological samples as part of scientific research involving the extrapolation of genetic information it must be made in accordance with the limitations and conditions contained in the specific general authorization of the Guarantor to the processing of genetic data, released June 24, 2011 pursuant to art. 90 of the code (OJ 11 July 2011 n. 159 and available on the Internet Authority 'website, Doc. No web. 1822650); View altresi 'the Council of Europe Recommendation No. R (2006) 4 which identifies the conditions and limitations in respect of which 'allowed the use of biological material for activities' research, also belonging to deceased persons, taken for a purpose other than that of its conservation for research purposes , including that taken for the execution of a previous research project; considered that this Recommendation states that the biological material collected for purposes other than those for research conservation can 'be made available for activities' research with the necessary consent and that, to this end, it should be done every reasonable effort to contact the person concerned, and where such contact is not possible, the biological material can 'be used for activities' research only if it meets specific requirements (articles 10, 12, 21 and 22); Given the Code of Medical Ethics of 16 December 2006 in that it provides for the obligation of professional secrecy by the physician also with reference to the deceased patients (art. 10); Given that this authorization takes into account the residual hypothesis, admitted by the Code (art. 110), where the necessary consent of data subjects for the processing of personal data for purposes of scientific research in the medical, biomedical or epidemiological not been previously collected by the holders of the treatment, there is the special and proven circumstances from which derives the inability 'to inform stakeholders and the research can not be achieved by processing anonymous data or data referring to individuals that you can contact in order to make the information on article. 13 of the Code; It found that, in accordance with the principles, referred to in art. 2, paragraph 2, of the Code, simplification, harmonization and effectiveness of mode 'exercise of the rights of the parties and the fulfillment of obligations on the part of data controllers, and' desirable that the information on the processing of data disclosing state of health for purposes of scientific research is provided to the person simultaneously with that on data processing for the purposes of care, especially on the part of data controllers who pursue purposes 'scientific research activity together with' hospitalization and treatment; It considered that, as part of that report, given to, of course, must be distinguished by reference to the indication of the elements of art. 13 of the Code, the processing carried out for scientific research purposes other than those ordained to protect the health, emphasizing in particular the voluntary 'participation in research, in order to enable the person, to consciously manifest a free and specific consent with respect to the different aims (articles 13, 23, 78, paragraph 5, and 105, paragraph 2, of the Code); It detected the opportunity 'that this general authorization is provisional and temporary, in accordance with art. 41, paragraph 5, of the Code and, in particular, effective for the period until 31 December 2012; In view of art. 11, paragraph 2, of the Code, which states that the data processed in violation of the rules on the processing of personal data can not be used; Having regard to Articles 31 et seq of the Code and the Technical Specifications contained in Annex B) to the same regarding minimum security measures Code; Having regard to Articles 20, 26, 40, 41, 98, 107 and 110 of the Code; Having regard to Article 167, paragraph 2, and 170 of the Code that sanction the unlawful processing of personal data and non-compliance with provisions of the Guarantor; Having regard to official records; Having regard to the considerations made by the Secretary General pursuant to art. 15 of Regulations n. 1/2000; Rapporteur Dr. Mauro Paissan; Authorizes the processing of personal data revealing the state of health of the persons concerned, even in the absence of informed consent, for purposes of scientific research in the medical, biomedical or epidemiological within the limits and conditions specified below. 1. Scope. This authorization and 'granted: a) to universities', other bodies and research institutes and companies' scientific as well as' to researchers working within those universities', bodies, research institutes and to members of such company 'scientific; b) those carrying out the health professions and the medical institutions within the limits of art. 2, paragraph 2 of the code of ethics and good conduct for the processing of personal data for statistical and scientific purposes (Annex A.4 to the Code). Processing of the data covered by this authorization can 'be altresi' performed by individuals or legal persons, entities, associations and private organizations as well as' by those specifically responsible for handling such charge or processors (researchers, monitor, expert committees, organizations contract research, analysis laboratories, etc.) (article 4, paragraph 1, letter f), 28, 29 and 30 of the Code). 2. Purpose 'treatment: scientific research in the medical, biomedical or epidemiological. 1. This authorization and 'released when: the treatment of data to reveal the state of health carried out for scientific research purposes in the medical, biomedical or epidemiological and' necessary for the conduct of studies, not containing significant fallout on customized ' concerned, made with data previously collected for the purpose of health care or for the execution of previous research projects or obtained from biological samples taken previously for finalita 'the protection of health or to the execution of previous research projects and research and 'made on the basis of a project, subject to a reasoned opinion of the ethics committee at local level, according to the procedures' in art. 3 of the code of ethics and good conduct for the processing of personal data for statistical and scientific purposes (Annex A.4 to the Code). The object of this authorization studies may also cover the relationships between risk factors and human health, or aim to evaluate the safety and efficacy of drugs or medical devices in clinical practice, or to verify the appropriateness of prescribing, or concern diagnostic type of health events, therapeutic or preventive, or on the use of social and health facilities. 2. This authorization does not concern the purposes of research that can be achieved, in a specific case, by means of: the treatment of anonymous data; Treatment of affected data that you can contact in order to make the information and obtaining their consent. 3. Categories of data subject to processing. Before initiating or continuing the processing, information systems and programs are configured to minimize the use of personal data and identification data, so as to exclude the treatment when the purpose 'sought in the individual cases can be achieved by means of, respectively, anonymous data or mode 'that allow identifying the person concerned only in case of need' in compliance 'art. 3 of the Code. The treatment can 'relate solely to strictly relevant personal data to the above mentioned purposes, including those derived from biological samples, except that these do not constitute' genetic data 'within the meaning of the authorization of 24 June 2011 issued by the Guarantor by virtue' of ' art. 90 of the Code (available on the corporate website: www.garanteprivacy.it, Doc. No web. 1822650). The processing of genetic data is in fact entitled to the limits and conditions identified in the aforementioned authorization. 4. Inability 'to inform interested parties. The consent covers the use of data of the persons concerned to be included in research that is not 'can contact in order to provide information on data processing as a result of existence of one of the following reasons, considered quite unusual or unique, documented in the research project: 1. ethical reasons due to the fact that the person ignores his condition. This category searches for which the information on the processing of data to be provided to interested parties would result in the disclosure of information concerning the conduct of the study, knowledge of which might cause material damage or psychological persons concerned themselves (can fit into this hypothesis, for example, epidemiological studies on the distribution of a factor that preaches or can predict the development of a morbid condition for which there is no treatment). 2. Reasons of impossibility 'organizational attributable to the fact that the failure to consider the data referring to the estimated number of interested parties that is not' can contact to inform them, compared to the total number of persons who will be involved in research, would have significant consequences for the study in terms of alteration of the results; what 'having regard in particular to the inclusion criteria of the study, the mode' of signing on, the numerosity 'statistical sample chosen, as well as' the period of time elapsed from the time when the data relating to the persons concerned were originally collected (for example, in cases where the study concerned with regards to high incidence of diseases mortality 'or terminal phase of illness or age' advanced and serious health conditions). With regard to those grounds of impossibility 'organization, and' authorized the use of data of those who, following the outcome of every reasonable effort to contact them, including by checking the status in life, searching the data reported in the clinical documentation , the use of any information provided telephone numbers as well as' the acquisition of contact data at the registry of assisted or of the resident population are found to be at the time of study: deceased or not contactable. The obligation to collect informed consent to the processing of the interested parties included in the search in all cases where, in the course of the study, it is possible to make them adequate information and acquire the relevant consent and, in particular, where these are requested from the treatment center, even for checkups. 5. Mode 'treatment. The processing of personal data covered by this authorization and 'made in accordance with the provisions of the code of ethics and good conduct for the processing of personal data for statistical and scientific purposes (Annex A.4 to the Code) and only strictly necessary to run operations of study. Where research can not achieve its goals without identification, even temporary, of those concerned, the treatment following the retrospective collection of data shall be adopted encryption techniques or identification codes used, or other solutions, given the number of data processed, make them not directly attributable to the parties concerned, identifying them only in case of need '. In these cases, the codes used are not deducible from the personal identification data of the persons concerned, except that this 'proves to be impossible due to the particular characteristics of the treatment or require a disproportionate use of means and is motivated, altresi', in writing, in the project of research. Combining the research material concerning these identification data, provided it is temporary and essential to the search result, and 'motivated, also in writing. 6. Communication and dissemination. The individuals identified in paragraph 1) that act in quality 'of data controllers, also jointly with other holders, may communicate with each other personal data, object of this authorization to the extent that are of the role of promoter, coordinator of the center or center participant and the communication operation is essential for the conduct of the study. The data to reveal the state of health of those concerned used for the conduct of the study may be disseminated (Articles 22, paragraph 8, and 26, paragraph 5, of the Code). The research results can be disseminated in aggregate form, ie according to mode 'do not report identified also by indirect identification data, even within publications. 7. Retention of data and samples. In compliance with the obligation referred to. 11, paragraph 1, letter e) of the Code, the data and biological samples used for the search is executed are stored using encryption techniques or use of identification codes or other solutions that, considering the number of data and samples preserved, does not make them directly attributable to the interested parties, for a period of time not exceeding that necessary for the purposes for which the data were collected or subsequently processed. To this end, and 'indicated in the research project the retention period, following the conclusion of the study, after which the said data and samples are processed anonymously. 8. Custody and security. Subject to the requirement to adopt the minimum security measures provided by the Code (articles 33-35 and App. B) to the Code), they are used by the / the owner / s of the treatment, each for the part of concern in relation to the role in data processing and the consequent responsibility ', specific measures and technical measures to increase the level of data security handled for the execution of the study in accordance' with the instructions contained in the "Guidelines for the processing of personal data in ' scope of clinical trials of drugs "adopted by the Privacy Authority Provision of 24 July 2008 (Doc. No web. 1533155). What ', both in the data storage or storage (and possibly the collection and storage of biological samples) and in the next phase of processing the same information as well as' in the next step of transmitting data to the sponsor or external parties that cooperate with the first for the conduct of the study. They are adopted, in particular: a. suitable measures to ensure the protection of data from the study of the risks of unauthorized access to data, theft or partial or full loss of storage media or portable or fixed computer systems (for example, the partial or full implementation of cryptographic technologies a file system or database, or through the adoption of other computer security measures to make the data unintelligible to non-entitled persons) in the recording and storage of data carried out by electronic means; b. secure protocols based on the use of cryptographic standard communication in the electronic transmission of data collected as part of the study to a centralized database where they are stored or archived, as well as' in the transmission electronically of the study data to the sponsor or external parties of which the promoter himself uses for conducting the study. Where such transmission is effected by means of optical media (CD-ROM) and 'designate a person in charge of the reception at the promoter and is' used for the sharing of the data encryption key, a different transmission channel from that used for the transmission of content; c. labeling techniques, storage, and transmission of biological samples, using identification codes, or other solutions, given the number of samples used, make them not directly attributable to the parties concerned, identifying them only in case of need '; d. taking care to use credentials with specific reference to the study data processing operations stored on a centralized database, and 'necessary to adopt: suitable authentication and authorization systems for those responsible according to the roles and needs of access and treatment, validity 'limited to the duration of the study and turn them off at the end of the same; procedures for the periodic review of the quality 'and consistency of authentication credentials and authorization profiles assigned to processors; Audit log systems for the control of the accesses to the database and for the detection of any abnormalities. 9. Transfer abroad. Where it is essential for the result of research to transfer data disclosing health status of those concerned in the study in non-EU countries, in the absence of express consent, in writing, of the interested parties (art. 43, paragraph 1 , letter a) of the Code), the transfer and 'authorized by the Guarantor in the presence of the additional requirements of Article. 43 of the Code, and in accordance 'with Articles 44 and 45 of the Code. 10. Requests for permission. Holders of treatment falling within the scope of this authorization are not required to submit an authorization request to this Authority ', if the treatment you will do is in accordance with its provisions. Requests for authorization received or that are received, even after the date of adoption of this provision shall be regarded as granted insofar as referred to in that provision. The Guarantor will not take 'into account requests for authorization, pursuant to art. 110 of the Code (last part), for treatments to be made in difference 'to the requirements of this provision, unless, in accordance with art. 41 of the Code, taking them to be justified by circumstances or situations not considered in this authorization. 11. Effectiveness. This authorization shall be effective as from 1 March 2012 until 31 December 2012. This authorization will be 'published in the Official Gazette of the Italian Republic. Rome, 1 March 2012 President: Pizzetti The rapporteur: Passan The Secretary-General: De Paoli