Key Benefits:
See the copyright notice Conditions of use .
In accordance with the decision of the Parliament:
The purpose of this law is to support research using samples of human origin, to promote transparency in the use of samples and to safeguard privacy and the right to self-determination in the handling of samples.
This law provides for:
(1) the establishment of a biopsy, the conditions for the exercise of biopantic activities and the requirements to be met;
(2) the collection of samples and samples of samples or related to biobanks, the use of these samples and other treatment;
(3) control of the storage and handling of samples;
(4) the rights of the data subjects and the arrangements necessary to protect the data;
5) from registries for biobanking research.
For the purposes of this law:
(1) Biobank The unit maintained by the biobank operator is collected, collected and stored for samples and associated information for future biobanking research;
(2) Sample Human material or the technical storage of such material;
(3) With an identifiable sample A sample which is accompanied by the individual information identifying the natural person or to which the processor may return the information identifying the natural person;
(4) With a coded sample A sample whose connection to the natural person and the information on the sample is identified by a unique identifier that does not contain any information identifying the natural person;
(5) With a code key Information which links the unique identifier referred to in paragraph 4 to a natural person;
(6) With an unidentified sample A sample which is not accompanied by a natural person's individual information or whose connection to the information has been permanently interrupted;
(7) Registered The one from which the identifiable sample was taken;
(8) With a biopsy study Research using samples or associated data to be stored in a bio-tank and intended to promote health, an understanding of disease mechanisms or products or treatment practices used in health and medical treatment; Development;
(9) The treatment of samples The collection, receipt, storage, storage, storage, analysis, analysis, use, transfer, disposal, disposal, disposal, disposal and other information on the sample and related information. Measures.
Subject to this or other law, personal data law shall apply to the processing of personal data (523/1999) . Public access to information, confidentiality and disclosure of information held by the authorities shall be governed by the law of public authorities (18/09/1999) (hereinafter ' the Public law And the rest of the processing of personal data.
The conditions for the conduct of medical research and the ethical prior assessment of the research plans are laid down in the Law on Medical Research (488/1999) (hereinafter ' the Research law .
The conditions for the transfer of organs, tissues and cells, in the course of an autopsy, and of organs, tissues and cells, to be used for the purpose of biopsy, and to use biopantic studies, provide for human organs, tissues and cells. The Law on Medical Use (101/2001) .
The treatment of samples taken for medical examination shall be regulated separately.
Biopank's job is to serve biobanking research.
In order to carry out the task, the biopanc may:
(1) collect and receive samples and related information;
(2) keep samples and associated data and hand them over to biobanking research;
(3) analyse, examine or otherwise deal with samples.
The Biopanc publishes data on samples, their use in biobank research and the results of their studies.
Biopank may be set up by a private or public body, entity, foundation or other legal entity with economic and operational potential, as well as legal and research conditions for the maintenance and operation of the biopsy Treatment. The founder must have the necessary personnel, facilities and equipment.
In addition, the creation of a biopank shall be subject to a favourable opinion from the National Medical Committee. The request shall be accompanied by the following information and documents:
(1) the name or other symbol of the biopsy;
(2) the owner of the bios, the business name of the owner and the principal contributors to the biopsy;
(3) the place of storage and storage of the samples and the data relating to the samples and the organisation of the management of the registers;
(4) a description of the research area or research areas of the biopank and a description of the principles, conditions and the use of samples for the collection, transfer of samples and associated data; Restrictions;
(5) use the consent form and the model of the written report to be given in the context of the request for consent, or a description of the content of the report and the description thereof;
(6) an indication of whether non-consented samples and associated data are to be maintained in a biobank;
(7) a statement as to whether non-biopsy-owned samples and associated data and, where appropriate, information on the owner of the samples are to be maintained in a biobank;
8) an action plan which will determine the scope, organisation and responsibilities of the biopsy.
The National Medical Examination Committee shall deliver its opinion within 60 days of receipt of the request referred to in paragraph 2. Time shall be calculated from the receipt of any additional information and reports requested. For its opinion, the Ethics Commission shall establish whether or not a biopsy fulfils the conditions for the protection of privacy and the exercise of self-determination under this or other law, and provide a reasoned opinion on the ethical conduct of the activities Acceptability.
The use, preservation and other handling of samples to be collected in Biopank should be justified, taking into account the research using samples.
The Biopanc owns the samples in its possession, unless otherwise expressly agreed in the agreement on the transfer of samples.
The Biopank must draw up, prior to its activities, written submissions on the processing of samples, data protection and data security, and procedures for monitoring them.
The decisions taken in this Act concerning biopanc are carried out and the obligations imposed on biobanks are borne by the owner of the biopsy. The Biopank owner should name the person responsible for the biopsy.
The Biopanki person shall be responsible for:
(1) quality control of the samples to be stored;
2) the maintenance, integration and protection of registers and databases;
(3) ensuring the protection of privacy in the processing of samples and related data;
(4) the preservation and control of the code key;
(5) the right to information;
(6) other tasks assigned to the person responsible under this law.
The person responsible for Biopank must have the necessary scientific competence and practical experience.
A written declaration of receipt and management shall be signed by the person responsible for the reception of the task before the mission.
The Decree of the Ministry of Social Affairs and Health may lay down more precise provisions on the content of the insurance.
The Biopank shall announce the initiation of the operation to the National Agency for Social and Health Authorisation and Control for a national biobank register before commencement of operation. The notification shall include the information referred to in Article 6 (2) and any other information necessary to assess the legality of the action. The initial notification shall be accompanied by:
(1) the statutes and the trade register of biobanks, or any other similar statement, if the biobank is a company or a similar entity;
(2) opinion of the National Medical Research Committee;
(3) information on the person responsible for the biopank, the assurance given by the person responsible and the training and experience of the person responsible;
4) a description of the quality system;
5) a description of risk management;
(6) organisation chart, number of staff, qualifications and responsibilities;
(7) registration certificates for the maintenance of bios in person registers;
8) a list of operational guidelines.
In the event of changes in the data reported in the national register of biobanks, the biopsy shall include the amendment to the Social and Health Authorisation and Control Agency. If the notification concerns a person responsible for biopanc, the notification shall be accompanied by a declaration by the person responsible and the training and experience of the person responsible. Where the amendment has been requested by the opinion of the National Medical Committee, it shall be attached to the notification. The initiation and implementation of the biopank shall be subject to the inclusion of information in the biobanking register.
The Decree of the Ministry of Social Affairs and Health may provide more specific provisions for the notification referred to in paragraphs 1 and 2.
The Biopanc may give it the rights and obligations laid down in this law, partly or entirely to another biobank.
Biopanc or any part thereof may be combined with another biobank if it is justified by their research area.
The management or combination of activities referred to in paragraphs 1 and 2 shall be agreed in writing and notified to the Agency for Social and Health Authorisation and Control.
The right to treatment of samples shall be based on consent, unless otherwise provided in this or elsewhere in law.
Person may give his consent to the maintenance of samples taken or taken from him in a biopank and for use in biopantic research, the transfer of his personal data, the pooling of the data on him, and the sample and sample , to the extent required for other treatment of the information obtained from him. The consent shall be given in writing.
On behalf of the underage, consent to the custody of her guardian. If, in the absence of sickness, mental disability or other reasons, an adult is not subject to an assessment of the meaning of the consent, the consent may in turn be given by the close family or other person. The consent shall be in accordance with the presumed will of the minor or the disabled. In addition, if the age and maturity of a minor are able to understand the meaning and nature of the biopsy research, his written consent shall be required.
Prior consent to the consent shall be provided to provide a sufficient explanation of the nature, potential damage, the purpose of the sampling and preservation of the samples, the owner and the samples of the samples to be retained. The voluntary nature of the biobanks, the voluntary nature of consent and the possibility to limit or withdraw consent without any adverse consequences. The report must be clear and comprehensible. An underage or underage study shall be carried out in response to his/her understanding. The report shall be provided in an appropriate manner and in addition to this in writing.
The decree of the Council of State may provide for the content, signature and maintenance of the consent document referred to in paragraph 2 above. The archiving obligation is laid down in the Archives Act (181/1994) .
The person shall have the right, at any time, to withdraw or amend the consent referred to in Article 11 or to prohibit the use of the sample referred to in Article 13 in the investigation or to restrict the use of the sample when the sample is kept in a biopantic identifier. The cancellation, modification or prohibition of consent shall be communicated to the person responsible for the biopanc. The notification shall be in writing.
When the notification of the withdrawal of consent or the prohibition of the use of the sample has arrived in a biopanc, the sample and related information shall no longer be used or transferred to the biopic examination. Where the notification concerns the modification or restriction of consent, the sample and information may be used or otherwise processed only in accordance with the consent. If the use of variable consent is not possible, the sample and related information shall no longer be used or transferred to the biopsy study.
Prior to the arrival of the notification referred to in paragraph 1, the results of the studies carried out on the sample and related information, the information contained in those results, and the material and information obtained from the sample and information, shall be used for the purposes of this Act. Restrictions.
The person responsible for Biopank shall, upon request, issue a certificate of receipt of the notification referred to in paragraph 1 and an explanation of the measures to which the withdrawal of the consent or the prohibition of the use of the sample has led. The receipt of the notification and the resulting measures shall not be charged.
A health care unit which, at the time of entry into force of this Act, maintains biological samples of the patient's research and treatment ( Diagnostic samples ) And patient documentation related to the samples, may transfer samples and associated data without prejudice to confidentiality provisions. The transfer shall not compromise the organisation and implementation of patient care.
The University, Research Institute, Health Care Unit or other entity may transfer samples collected and analysed prior to the entry into force of this Act, and the related information, without prejudice to confidentiality provisions.
The transfer referred to in paragraphs 1 and 2 shall be subject to the opinion of the Regional Ethics Committee referred to in Article 16 of the Law on the use of samples for biopantic studies. The opinion shall be given by the committee in whose territory the samples are. The transfer shall not be carried out if the granting of consent is authorised to prohibit the transfer of samples or information, or where there is reason to believe that a person in his life has objected to the examination of his samples or the Ethics Commission does not maintain the transfer of samples. Biobanks to be ethically acceptable. If the Ethics Commission does not consider the transfer of samples to biobanks ethically acceptable, the Social and Health Authorisation and Control Agency shall take a decision on the application. Before the transfer, information on the change in the purpose of the samples and related information shall be communicated to the data subjects. The communication shall indicate that samples and data may be used for biobanking research if their use is not prohibited. The communication shall be accompanied by a statement and guidance concerning the nature of the biopanc study, or the implementation of the right to a prohibition, an indication of the biopank, the processing of the Ethics Commission and the timing of the transfer; and The contact information of the person to which you can contact to obtain further information.
Where the acquisition of the age of the samples, the high number of samples or any other comparable reason is not reasonably practicable, the notice referred to in paragraph 3 shall be published in the Official Journal, And, where appropriate, in one or more daily newspapers. The Agency for Welfare and Health shall decide on the application whether the conditions laid down in this paragraph are fulfilled. The publication of the notice shall be carried out by the person holding the samples.
The Regulation of the Ministry of Social Affairs and Health may provide more specific provisions on the content of the communication referred to in this Article.
When collecting or transferring samples to a biopank, the data shall be attached to the data subject to the consent of the person referred to in Article 11, as well as to the information on the determinants of his health and of the factors affecting his or her health. In addition, in the case of old samples, the provisions of Article 13 apply.
If the samples have been collected on the basis of the agreement referred to in Article 11, the samples and the associated data shall be required to transfer samples and data to the biobank before they are used in the study. However, if the samples were collected as part of an individual examination, the data related to the samples may be transferred to the biobank after the end of the study.
In the case of transfer of the old samples referred to in Article 13, the transferring samples shall be transmitted to the receiving biopanc on the opinion of the Regional Ethics Committee referred to in paragraph 3 of that paragraph and the communication The content and publication. The samples to be transmitted and samples of the receiving biopsy must be agreed in writing on the transfer of samples.
In addition to the provisions of Articles 5 and 6 of the Personal Data Act, care shall be taken to ensure that:
(1) the sample and the related information shall be coded with a code of the sample and the storage, storage, analysis, testing and use of the sample and data;
(2) samples and related information shall be kept separate from the code key;
(3) the information systems allow the verification of the safe preservation, use, monitoring and identification of the samples and personal data stored in biobanks.
In addition to the provisions of Article 32 of the Personal Data Act, the samples shall be kept and the information systems implemented in such a way as to:
(1) secure access to and availability of data on samples and data processing criteria;
(2) the information on the consent and other criteria and conditions for the use of the samples shall remain intact and unaltered throughout their retention period.
The provisions on the creation and implementation of sound management of public law are also applied to a biobank that is not a public authority.
Biopank sample, the sample from the sample and related information may be analysed, examined and used, or otherwise processed, if the treatment is in accordance with the criterion of the Research Area and the use of the sample and complies with this or other law Of the Directive.
Irrespective of the public authorities' right of access to confidential information elsewhere by law, the sample of the sample to be retained by the biopank and the related information or the samples and information obtained from biobanks shall not be disclosed or used. Criminal investigation, and not in the administrative or other decision-making process. Sampled samples and information stored in Biopank shall not be used for the assessment or detection of the working capacity of an individual or for the decision-making of credit and insurance institutions.
Biopank shall have the right to maintain personal registers for biobanking purposes as set out below.
The sample and data register shall, through the processing of electronic data, be kept in order to permit the maintenance, monitoring and evaluation of the samples and related information.
The sample and information register shall be collected and deposited:
(1) information on samples to be stored in a biopank for the use of the general sample;
(2) data related to the sample analysed or otherwise obtained from samples to be stored in a biopank;
(3) information on the person from whom the sample was taken.
The Regulation of the Ministry of Social Affairs and Health may provide for more detailed provisions on the content of the sample and data register and the technical implementation of the register in order to ensure the compatibility of the information systems.
The register of consent shall be used by means of the processing of electronic data to manage the basis of the use of samples and to safeguard the integrity of the right to self-determination. The register of consent may be combined with a sample and information register using the code register.
Information shall be collected and stored in the consent register:
(1) the content and scope of the consent, the date of issue, the report referred to in Article 11 (4) and the communication referred to in Article 13 (3);
(2) the cancellation and modification of the agreement, date and time of arrival;
(3) the prohibition and limitation of the use or disposal of the sample or data, the date of the notification and the date of arrival;
(4) the justification and conditions for the use of the sample if the criterion is not based on the consent referred to in Article 11;
(5) from the transferred unit of the sample or from the will and the conditions for the use of the transferred samples.
In order to ensure the protection of privacy, the Registry shall, by means of the processing of electronic data, hold a personal register with which the information in the sample and data register and the consent register may be aggregated.
The Registry shall be collected and deposited:
(1) the name and identification number of the person;
2) the code key.
If consent is withdrawn or otherwise the sample is terminated, the data shall be deleted from the code register.
The body, the undertaking, the entity or the person concerned shall have the right to obtain the information referred to in Article 21 (2) (1) of the sample and data register required for samples and data to be stored in a biopank. To assess the availability and do not contain the information referred to in Article 11 of the Personal Data Act.
The need to maintain samples and the associated data should be evaluated regularly, however, at least every 10 years. Samples and data that are not biopsied and, taking into account the test basis of the sample, are disposed of.
If the ownership or control of the sample and related information is transferred to another biobank or a sample is disposed of, the information in the registers referred to in Articles 21 to 23 concerning the sample is deleted. The transferred biopsy should be re-encoding the samples.
If the activity of the biopsy ends, the samples and associated data shall be deleted and the register of consent and the sample and data register shall be transferred to the repository, as provided for in the Personal Data Act, unless samples and associated data are transferred to another To the biopsy. At the end of the Biopank operation, the person responsible for biopanc shall dispose of the code register.
The Biopanc may release, examine and otherwise deal with the samples and information which it holds, if:
(1) the intended use corresponds to the research area determined for biopank, the basis and conditions for the treatment of the sample;
(2) the investigation and the processing of samples and data shall be subject to the conditions and limits laid down in this or elsewhere by law and by a biopsy;
(3) the recipient of the sample or information has appropriate professional and scientific competence for the treatment of samples and information and is linked to the tasks of the recipient.
Samples and related information shall be encoded prior to the release, unless there is a particular reason to proceed otherwise.
The surrender codes shall be established on the occasion of the donation by project. The code used for the storage of samples and data shall not be released from the biobank. Personal data shall be disclosed only on the basis of consent to the registration of the data subject or other consent, unless otherwise provided for in this law.
Any request for samples or data from a biopane shall be accompanied by a research plan to the written request for a biobank, the opinion of the competent ethics committee referred to in the Law on Ethics or other conditions for the release. And a report on the processing of samples and data.
Biopanc may limit the donation of samples and data only if justified by:
(1) the bios research area and other restrictions on the transfer of samples and associated data referred to in Article 6 (2) (4);
(2) safeguarding the preservation of intellectual property rights linked to research, the implementation of the research project referred to in Article 15, or the preservation of samples or samples;
(3) ensuring data protection; or
4) the reasons for the investigation.
The extradition and its terms shall be subject to a written extradition agreement. The holder of the donation shall be subject to the obligation to publish the results of the biopanc study based on samples or data derived from biopank. Article 28 of the Law on Public Access, which provides for the right of an authority to grant access to a confidential document in an individual case, also applies to a biobank which is not a public authority.
The provisions of this section on the procedures and restrictions on the transmission of samples and information shall also be carried out in the study project of the biopsy.
The Biopank may release the necessary personal data to the health and welfare institution or to any other controller, provided that the combination of the records of the personal data held by it in the samples or data of the biopsy is justified by the And the supply satisfies the conditions laid down in Article 26 (1).
The health and welfare institution or other controller shall encode the records of the data relating to personal data relating to personal data with the project-specific codes obtained by the biopank before they continue to be released for research, unless: The transfer of personal data is subject to the express consent of the data subject or other consent.
The donor shall retain and use the samples and associated data obtained from a biopane during the period of time which the study plan referred to in Article 27 of the study shall take, unless the extradition agreement referred to in Article 27 (3) contains: Agreed on a longer retention period. If, on the basis of an extradition agreement, the transferee has the right to retain samples for future research, the provisions of this Act shall apply to the conditions for the treatment of samples.
Sampled samples and information obtained from a biopanc may disclose the samples and information received within the limits laid down in this Act, where the right to information is based on the law.
Public access to information, access to information for citizens and researchers and the monitoring of activities is a public national register of biobanks. The register shall be maintained by the Social and Health Authorisation and Control Agency.
The register contains information on the biobanks set up in Finland, the biobank owner and the person responsible for biobanks. In addition, the register shall contain general information on the number of samples to be stored in biobanks and on the research area, on the conditions for access to the samples and on other aspects of the availability of the samples and related information, as well as information Possible regulatory decisions and solutions.
More detailed provisions may be laid down in the register of the Ministry of Social Affairs and Health.
The supervision and control of the activities provided for in this law are covered by the Ministry of Social Affairs and Health at the Ministry of Social Affairs and Health.
As expert authorities and bodies in the field of Biopanka, the Institute for Health and Welfare and the Centre for Safety and Development in the pharmaceutical sector are active in their respective fields of activity.
The tasks of the Data Protection Supervisor are also laid down in the Act on Data Protection and the Law on Data Protection (389/1994) .
The Social and Health Authorisation and Control Agency shall have the right to inspect the premises and activities of the biopsy and the necessary documents for the purposes of monitoring the provisions and regulations adopted pursuant to this Act.
The inspector nominated by the Agency for Social and Health Authorisation and the Agency shall have access to all premises of the biopsy and shall, without prejudice to the secrecy provisions, present all documents requested by the inspector, which are necessary In order to carry out the inspection. However, the inspection shall not be carried out in the premises used for permanent housing. The inspector shall be provided free of charge with copies of the documents necessary to carry out the inspection. The inspector also has the right to take photographs during the inspection.
At the latest 30 days after the date of submission of the inspection, a copy of the inspection minutes shall be communicated by the Social and Health Authorising Office to the person responsible for the biopank and for the person responsible for the biopanc. The inspection shall be deemed to have ended when the copy of the inspection protocol has been served on the parties.
The person responsible for Biopank shall immediately initiate the necessary measures to remedy the deficiencies found in the inspection. The person responsible shall inform the Social and Health Authorisation and Control Agency of the measures to be taken, the timetable and details of their implementation, no later than 30 days after the inspection report has been submitted to him For information.
The Social and Health Authorisation and Control Agency shall be entitled to receive, free of charge and without prejudice to the rules of confidentiality, the information necessary for the purpose of supervision by a biopbank, State and municipal authority, other public-law bodies, health and A community or body engaged in nursing care and conducting a biopantic study.
If, in the event of an inspection of the biopsy or for the treatment of the samples, any shortcomings or otherwise related to the protection of personal data or to the protection of data security or a biopanc fail to comply with the obligations laid down in this Act, The Agency for Social and Health Authorisation and Control may:
(1) issue an order for the correction of incompletes or the removal of grievances;
(2) order the biopsy to provide data relating to samples or samples which it maintains;
(3) prohibit or restrict the treatment of samples to be stored in biobanks.
The decision referred to in paragraph 1 shall set a deadline within which the necessary measures shall be taken if the information on biopanc and its operation is to continue to be kept in the national biobank register. The time limit shall not be less than 60 days.
If a failure to perform a biopsy is likely to endanger the privacy or rights of the person from which the sample originates, the Social and Health Authorisation and Control Agency may delete data concerning the activity of the biopsy. The national biobanking register temporarily or prohibits the processing of samples until the matter has been finally resolved.
The Agency for Social and Health Authorisation and Control may delete data on the activity of a biopsy from a national biobanking register if, in the course of the treatment of the biopsy, the protection of personal data or the processing of samples or related information is Serious failings in the field of information security, or the biobank repeatedly commits the infringement procedure, and the measures referred to in the Decision referred to in paragraph 1 have not led to the fulfilment of the obligations. The Biopank operation ends if the Social and Health Authorisation and Control Agency removes a biopsy from the national biobank register. At the same time, the Agency for Social and Health Authorisation and Control shall decide on the transfer or destruction of samples and related data.
The Social and Health Authorisation and Control Agency shall process the declarations made in the national register of biobanks as soon as possible. The Agency for Social and Health Authorisation and Control may request further clarification as appropriate.
The Office for Social and Health Authorisation and Control shall be entered in a national register of biobanks in the event of a favourable opinion within the meaning of Article 6 of the National Medical Examination Commission, and Fulfil the conditions laid down in this and other law.
In the absence of any obstacle to the inclusion of information in the register, the notified information shall be in the register no later than 60 days after the notification has been received by the Office for Social and Health Authorisation and Control. The processing time shall not include the time taken to obtain any additional information or report.
If the biopanc intends to partially or partially transfer its biobanking activities abroad, it shall apply for authorisation from the Social and Health Authorisation and Control Agency. The transfer of biopantic activity shall not be regarded as a transfer of samples and data for the necessary analyses to the research facility. The application shall be accompanied by a statement of the way in which the transfer and the transfer of the rights of the persons from which the sample was taken shall be safeguarded. The application shall be accompanied by an opinion from the owner of the samples if the transfer concerns samples other than those owned by the biopsy.
The authorisation shall not be granted if the transfer of samples and information prevents the exercise of the rights provided for by law to protect privacy or self-determination. The Agency for Social and Health Authorisation and Control shall issue a decision not later than 60 days after receipt of the application. The processing time shall not include the time taken to obtain any additional information or report.
The Agency for Social and Health Authorisation and Control may give more detailed provisions on the procedure to be followed in applying for authorisation.
The health care unit shall forward to the Social and Health Authorisation and Control Agency without delay the information on the diagnostic samples transferred to the biobank and the data attached thereto. The health care unit shall attach to the notification a copy of the transfer agreement and the documents referred to in Article 15 (2).
The health care unit shall keep a list of the prohibition referred to in Article 13 (3) for the use of diagnostic samples for biobanking research. The list of health care units and biobanks may be used to ensure the exercise of the right to prohibition.
The health care unit shall provide a request for an explanation as to whether the diagnostic samples have been transferred to the biobank pursuant to Article 13. If the transfer is carried out, he shall be informed of the biopank that has received the sample.
The Agency for Social and Health Authorisation and Control may provide more detailed provisions for the notification referred to in paragraph 1.
The decision of the Agency for Social and Health Authorisation and Control may be implemented in spite of an appeal, unless the Appeals Authority prohibits the execution of the decision, order it to be suspended or otherwise provided for in the order for implementation Otherwise quantity.
Police officers' obligation to provide administrative assistance (872/2011) Chapter 9 § 1.
Everyone has the right to be informed, on request, whether or not to keep samples of the biopank in the biobanks register, on the basis of the retention and on where the data relating to him have been obtained and the samples taken from him; and The data related to the samples have been disclosed or transferred from a biopanic. Access to information can also be achieved through an electronic view. Provision may be made for the provision of information which is equal to the cost of providing information.
Upon request, the data subject shall be entitled to receive the information specified in the sample of his/her health status. When providing the information specified in the sample, the person shall be offered an opportunity to report on the meaning of the information. In order to clarify the meaning of the information, a fee shall be charged which shall not exceed the cost of the reporting costs.
The request for information shall be made in writing to the biobank.
Confidentiality and confidentiality of the documents and information contained in this Act or in respect of the documents and information contained therein, as well as the confidentiality of the information obtained in respect of the management of these tasks, and Articles 22 to 24 and 35 of the Publicity Act shall also apply where the question is not of the documents of the authority referred to in that law.
The obligation of professional secrecy shall not prevent the notification of consent for the use of the sample, the withdrawal or modification of consent, or the prohibition of the use of the sample to the person who has been transferred or transferred Information.
A fee for the registration and modification of the national register of biobanks, of the information on the national biobank register and the maintenance of the biobank register shall be subject to payment in accordance with the State payment law (150/1992) And Article 34 of the Publicity Act.
The opinions of the National Medical Research Commission and the Regional Ethics Commission and the decisions, opinions and fees to be charged by the Office for Social and Health Authorisation and Control; and Service charges other than those referred to in paragraph 1 shall be laid down separately.
The receipt of samples shall not be guaranteed or paid to the person from whom the sample was taken or to his successors.
An appeal against a decision by the Social and Health Authorisation and Control Agency and a biopsy under this law is to be lodged in the form of a law on administrative law (18/06/1996) Provides.
The opinion of the National Medical Examination Committee and the Regional Ethics Committee referred to in this Act cannot be appealed against.
The payment by the State authority shall be subject to an appeal as provided for in Article 11b of the State Payment Act.
Every deliberate or gross negligence
(1) examine samples contrary to the provisions of Chapter 2 and Chapter 3 or fail to comply with the notification requirement laid down in Article 9;
(2) infringes the prohibition or order issued by the Authority pursuant to Article 33 (1);
(3) disclose the information on the code key or person to the wrongful or
(4) transfer or transfer the sample or related information in contravention of this law;
, thereby jeopardising the protection of the person's right to privacy or his rights, must be condemned, unless the law provides for a more severe penalty in the rest of the law, Infringement of the provisions on biobanks Fine.
Penalty report is punishable under criminal law (39/1889) § 8, penance for the offence of personal registration Chapter 38 of the Criminal Code Article 9 and the penalty for the violation of personal registration in Article 48 of the Personal Data Act. Penalty for breach of professional secrecy Chapter 38 of the Criminal Code 1 or 2, unless the offence is punishable under Article 5 (5) of the Penal Code or, in the rest of the Act, a heavier penalty.
This Act shall enter into force on 1 September 2013.
At the time of entry into force of this Act, the Ministry of Social Affairs and Health will decide on the transfer of samples to biobanks and the timetable for transplantation to be retained in the health and welfare establishment. The samples shall be carried out in accordance with the procedures laid down in Article 13.
A consortium of municipal hospitals, together with municipalities and associations of municipalities and municipalities with a special responsibility in the field of health care, may establish a regional biopsy as agreed Health care law (1326/2010) The health care plan referred to in Article 34 and the special medical care arrangements referred to in Article 43 or otherwise.
Before the law enters into force, action can be taken to enforce the law.
THEY 86/2011 , StVM 9/2012, EV 78/2012This Act shall enter into force on 1 January 2014.
THEY 16/2013 , HaVM 20/2013, EV 207/2013
