Key Benefits:
See the copyright notice Conditions of use .
In accordance with the decision of the Parliament:
The purpose of this law is to improve patient and medical safety and to facilitate and improve the prescription and delivery of a medicinal product by means of a system in which the patient's prescriptions can be stored electronically at national level. The prescription centre and where the prescriptions deposited with the receptor can be delivered to the patient at the time of his choice of the pharmacy of his choice. The prescriptions deposited in the Centre shall enable the patient, with the consent of the patient, to determine and take account of his/her total medication when carrying out medical treatment. In addition, the information collected at the receptor centre and the receptor archive can be used by the health authorities.
This law provides for an electronic prescription.
Subject to this law, the preparation, transmission and handling of an electronic prescription shall be carried out in accordance with the place of the patient's status and rights, the patient's linguistic rights, the prescription of the medicinal product, and Concerning the supply of personal data, the processing of personal data, public authorities' activities, electronic communications and business, and electronic signatures.
For the purposes of this law:
(1) By an electronic prescription A prescription for a data-processing device that is transmitted by computer networks using a prescription centre; (28.3.2014/251)
(2) Prescribing the medicinal product Doctors, dentists and other legitimate health professionals; (21.5.2010)
(3) Supplier of the medicinal product Pharmacist and pharmacist supplying the medicine;
(4) The receptor centre A database consisting of electronic prescriptions sent by the prescribers of a medicinal product, on the basis of the criteria set out in Article 12 of the pharmacies and on the basis of the criteria mentioned in Article 23 of the healthcare providers, The information on medicinal products and the supply data attached to prescriptions; (28.3.2014/251)
(5) The Record Archives The database to which the information at the receptor centre is transferred at the end of the retention period provided for in this Act; (28.3.2014/251)
(6) Pharmacovigilance database A database containing the information necessary for the prescription and delivery of the medicinal product for the medicinal product, the price and the substitutability of the medicinal product, the substitutable medicinal products, the primary lubricants to be substituted and the clinical dietary product And other product types as defined by the Ministry of Social Affairs and Health Regulations; (28.3.2014/251)
(7) By electronic signature Electronic information, which is connected or logically related to other electronic data, used to verify the identity of the signatory and to provide an electronic message as a means of ensuring the integrity of the electronic message; (28.3.2014/251)
(8) PkV medicinal product Medicinal product:
(a) is defined as pkv in the marketing authorisation;
(b) is listed in a list of pkv-medicinal products established by the Pharmaceutical Safety and Development Centre; and
(c) contained in a list established by the Centre for the Safety and Development of the Medicinal Products for Medicinal Products which may be supplied with a prescription only and which are listed in that list; Forward Annexes Z, ZA, P and PA; and
(28.3.2014/251)(9) Drug drug use, Drug law (373/2008), List I, II and IV of the 1961 Single Convention on Narcotic Drugs referred to in Article 1 (1) (a) and the 1971 Convention on Psychotropic Substances referred to in point (b) of that paragraph And medicinal products containing substances referred to in Article 3 (1) (5) (e) of the Narcotic Drugs Act. (28.3.2014/251)
The patient must be informed about the electronic prescription and the related rights of the patient before issuing the prescription. In addition, the patient should be informed about the national information system services related to the electronic prescription, their general policy principles and the organiser of these information systems services, the release of medical prescription data The conditions, the protection of data and other matters related to the treatment of the patient.
The healthcare provider must inform the patient personally in writing or orally. The information may also be provided through the patient's individual electronic service. Where information is provided in a manner other than in writing, the patient shall have access to the information in writing. The information provided should be entered in the patient's information management service as established in Article 16a. If the patient has already received the above information, it may be necessary to deviate from the obligation to provide information in the same way as the (523/1999) Article 24 Provides.
Details of the procedures and content of the information may be provided by a decree of the Ministry of Social Affairs and Health.
The prescription shall be drawn up electronically. Where electronic prescription is not possible due to a technical failure, the prescription may also be made in writing or in a telephone prescription. A written or telephone prescription may also be issued at the request of the pharmacist if the pharmacy is unable to provide an electronic prescription due to a technical failure. In addition, a prescription may be made in writing or by telephone if the need for medical treatment is urgent and the prescription cannot be made by electronic means because of the exceptional circumstances of the circumstances or for any other specific reason.
A signed copy of the electronic prescription may be signed for the purchase of the electronic prescription. If a copy of the prescription is provided for the purchase abroad, the provision of the medicinal product by electronic prescription shall be technically prevented. In addition, a certified copy of the submitted electronic prescription may be provided by the prescriber or pharmacist if necessary for the rest of the patient's journey.
The written and telephone prescriptions shall state the reasons why it has not been submitted electronically. The Decree of the Ministry of Social Affairs and Health may provide more specific provisions on the grounds and content of a written or telephone prescription, on medicinal products to be prescribed and on a foreign purchase or a foreign journey Of the copy.
The electronic prescription shall include:
(1) the patient's name and identity number or name and date of birth, if he does not have a personal identification code;
(2) the composition of the medicinal product, or the composition of the medicinal product, in accordance with the medicinal product database;
(3) information necessary for the supply and use of the medicinal product;
(4) information necessary for the identification of the medicinal product and the health care unit;
(5) the information necessary to resolve any health insurance claim; and
6) identification of prescriptions.
In addition to the information referred to in paragraph 1, the prescription may contain other information relevant to the use and supply of the medicinal product.
If necessary, the detailed content and identifier of the electronic prescription may be laid down by a decree of the Ministry of Social Affairs and Health.
The electronic prescription shall be the certified electronic signature of the author. In addition, the electronic signature shall be carried out in such a way that the right of the prescriber to prescribe a medicinal product will be validated before the signature. All prescriptions related to the same patient population may be signed by a single signature function.
The Census Bureau is responsible for the certification service in accordance with the law on the electronic processing of customer information in social and health care (159/2007) in Article 14 Provides. The Decree of the Ministry of Social Affairs and Health provides for more detailed provisions on how the right to prescription and certification services are carried out by the author of a prescription. Before the adoption of the regulation, the Ministry of Social Affairs and Health must consult the Centre for Population Register, in so far as it relates to the purpose of the Population Register Centre referred to above. (19/11/98)
§ 8 has been repealed by L 28.3.2014/251 .
A separate account should be given to the patient on the electronic prescription ( Patient instruction ). However, the patient does not need to be provided if the patient is not present at the prescription for prescription. Furthermore, the patient instruction does not need to be provided if it is not possible for technical reasons or if the electronic prescription is designed with a device which does not have a fixed location. The patient's instructions must include at least the patient's name and date of birth, the name and the medicine of the medicinal product and its strength and pharmaceutical form, the purpose and the dosage, information on the amount of the medicinal product, the medical prescription, the prescriber or health care The contact details of the operation unit, the date on which the prescription is drawn up and an indication of the ban in accordance with Article 13, if the patient has done so. Patient information may be indicated for all patients at the same time as prescribed. In addition, a summary of prescriptions at the receptor centre can be provided.
The Regulation of the Ministry of Social Affairs and Health may provide more detailed provisions on the contents of the patient code and summary, and on the reasons why the patient should not be given a patient guide.
If the prescription in the prescribing centre is incorrect, the prescriber administering the prescription may make the necessary adjustments to the prescription. In addition, pharmacist and pharmacist can make the necessary technical corrections in connection with delivery. If the contents of the prescriptions are unclear or incomplete, the oral consent of the prescriber of the medicinal product shall be obtained.
The prescriber and the supplier of a medicinal product may, in agreement with the patient, invalidate the non-delivered or partially supplied prescriptions of the prescribing centre. The pharmacist or pharmacist responsible for the storage of the prescription referred to in Article 12 (4) may render invalidation without the consent of the patient, if the prescriptions have been drawn up intentionally by the patient Information or coercion. In addition, the prescription will be voided after the death of the person receiving the order.
The electronic prescriptions shall be renewed by drawing up a new prescription on the basis of a prescription at the receptor centre. The patient or, at the request of the patient, the pharmacy may make a request for renewal of a prescription to the prescriber and the health care unit. However, the prescribing of a medicinal product may be prevented by the prescribing of a prescription on medical grounds and when the prescription is made up of incorrect information provided by the patient Or by compulsion.
The correction, cancellation or renewal of a pharmaceutical order referred to in paragraphs 1 to 3 shall be accompanied by a justification for the measure. The correction, cancellation and renewal of a medical prescription shall be signed by electronic means.
More detailed provisions may be laid down by a regulation of the Ministry of Social Affairs and Health concerning the correction, cancellation, renewal and prevention of an electronic prescription.
The patient or person acting on his behalf ( Purchaser purchaser ) At the oral request, pharmacies are entitled to receive a prescription from the centre of the patient:
(1) information on the electronic prescriptions necessary for the identification of the electronic prescription;
(2) the information necessary for the provision of an electronic prescription, including information affecting the sickness insurance allowance; and
(3) any other information at the prescribing centre about the prescriptions of the patient; if the medicinal product is to be retrieved by someone other than the patient or his or her legal representative, the purchaser of the medicinal product shall obtain the consent of the patient or of his or her legal representative.
The pharmacy shall have the right to obtain information on the prescription, even if the patient has made a prohibition under Article 13 (1) or (3) if the buyer of the medicinal product presents a patient instruction or a summary of the patient's instructions given on the order. (28.3.2014/251)
When the medicinal product is supplied on the basis of an electronic prescription, the purchaser must be reliably demonstrated by the purchaser of the medicinal product. If a patient does not have a personal identification code, it is necessary to submit a medical prescription in the pharmacy. (28.3.2014/251)
In the event of the release of the medicinal product, a written explanation of the medicinal product submitted shall be provided to the purchaser of the medicinal product, as well as information on the part not provided by the prescriber, unless the buyer declares that he does not wish to report. The report may, with the consent of the patient, contain information on all medical prescriptions stored in the receptor centre. If a medicinal product is to be retrieved by someone other than the patient or his legal representative, an explanation containing all prescription information shall be provided only if the patient or his/her legal representative has given his consent.
The prescriptions of the prescription are attached to a prescription at the receptor centre. The pharmacy pharmacist can correct incorrect delivery information. Delivery data and their corrections shall be signed by an advanced electronic signature. The electronic signature must be carried out in such a way as to ensure that the supplier's right to supply is validated before the signature. The delivery details of all the prescriptions delivered at the same time may be signed by a single signature function.
Where a prescription has been given in writing or by telephone for a technical failure within the meaning of Article 5 (1), the pharmacy shall record the prescriptions and the related delivery information in the form of a prescription centre or a technical malfunction Prevent immediate recording, as soon as possible. Irrespective of the conditions of treatment, the prescriber of a medicinal product, irrespective of the conditions of treatment, has the right to apply to the prescription centre for information on the prescriptions of the pharmacy to which he is registered. The Ministerial Decree of the Ministry of Social Affairs and Health may provide more specific provisions on the storage of a written or telephone prescription and its supply data to the centre of the prescriptions and of the search function to enable the prescriber of the medicinal product to be informed Storage of prescriptions. (28.3.2014/251)
Information on the prescriptions of the patient, their supply information and requests for renewal may be made available to the health care and social care unit and to the prescriber of the medicinal product in accordance with the prescriptions of the prescriber and the prescriber. If the patient has given his written consent in accordance with Article 14, for the organisation and implementation of medical treatment. The consent shall be valid for the time being and shall include all information contained in the receptive centre and the receptor archive. However, the patient may prohibit the donation of prescriptions to the abovementioned entities and pharmacies. Consent and prohibition may be revoked at any time. The consent and prohibition, and the withdrawal thereof, may be notified to any health or social care unit associated with an electronic prescription or to any other self-employed person The prescriber. The consent and prohibition and the withdrawal thereof shall also be made through the interface referred to in Article 17.
If a full-age patient is unable to decide on his or her care as a result of mental health disorder, disability or any other reason, the consent referred to in paragraph 1 may be given by his or her legal representative, close relatives or other close relatives. The legal representative of the patient, the immediate family or any other person who is close, has no right to withdraw or withdraw the consent.
If a minor is in a position to act in accordance with the (1999) (hereinafter ' the Patient law , within the meaning of Article 7 (1), on the basis of his age and level of development, to decide on its own treatment, he may also decide on the granting of consent and the prohibition referred to in paragraph 1 of this Article. Otherwise, consent may be given by the guardian or legal representative of a minor patient. The legal guardian or the legal representative shall not be entitled to withdraw the authorisation granted and not to issue a waiver. In addition, a minor within the meaning of Article 9 (2) of the Civil Code is entitled to prohibit the disclosure of an electronic prescription to his or her guardian or other legal representative.
Notwithstanding the provisions of paragraph 1, the following shall be given:
(1) the information referred to in paragraph 1 if the provision of information or the right to information is expressly provided for by law;
(2) information on the pkv and the drug-related drug for all patients with pkv and drug-related drugs and their supply data;
(3) the medical or social care unit responsible for the renewal of the prescription or the prescribing of a medical prescription to be renewed by the prescriber;
(4) In the course of the continuation of the treatment relationship with the prescriber, information on the prescriptions and the delivery details of the prescriptions to be stored in the centre of treatment of the medicinal product, regardless of the medical prescription and the conditions of the treatment, on the basis of Article 12 (3) of the pharmacy; The prescriptions to which he is registered as the prescriber of the medicinal product and the supply information related to these prescriptions;
(5) health care or social care services, or healthcare professionals, information on the prescriptions stored at the centre and their supply information in the case of urgent situations referred to in Article 8 of the Patient Code; The release of prescriptions shall be prohibited in accordance with paragraph 1; information may be disclosed only if the patient has expressly stated that they may be disclosed in the situation referred to above; and
(6) information for technical personnel in the service of the health service provider, the National Pensions Office or the provider of an information system for the provider of the electronic prescription; To the extent required.
The Ministerial Decree of the Ministry of Social Affairs and Health may provide for more detailed provisions on the procedure for the consent and prohibition of the information referred to in paragraphs 1 to 3 and of the right to information referred to in paragraph 4 (6) and the rights of technical staff To find out.
A document signed by the patient shall be drawn up on the consent and prohibition of the release of the information in the Resource Centre. The consent document shall contain the information referred to in Article 4 on the electronic prescriptions and the importance of consent and prohibition. The prohibition document shall contain a statement that health and medical care may not be used for the purposes of the prohibition in force, even if it is relevant to the treatment, unless the prohibition or prohibition is not A derogation in respect of the situation referred to in Article 8 of the patient law. The Social Insurance Institution draws up the models for the consent and prohibition document. The consignee and the consignee shall provide a copy of the document to the consent or prohibition. When the patient gives his or her consent or through the interface referred to in Article 17, the patient must be provided with the corresponding information via the user interface. Where consent is given in the circumstances referred to in Article 13 (2) or (3), other than the patient itself, the consent document shall be signed by the authorising officer.
The consignee or the consignee of the prohibition or their revocation shall keep a signed document on behalf of the National Pensions Office or record a copy of the original document to the national information system service. The storage of documents shall be governed by the provisions of Article 12 (2) of the Patient Law on the retention of patient documents. The Decree of the Ministry of Social Affairs and Health may provide more detailed provisions on the technical method for taking and storing a copy of the above copy for the national information system service.
Notwithstanding the provisions on the use of secrecy and other information, the National Pensions Office may, as a controller, extradite the Centre and the Record Archives on request, including by means of a technical service, in addition to: The legislation provides:
(1) Information required by the Social and Health Authorisation and Control Agency and the Regional Administrative Agency for the supervision of healthcare professionals for prescribing and providing prescribers of a medicinal product; (22.12.2009)
2) Pharmaceutical Safety and Development Centre Article 21f of Regulation (395/1987) , the information necessary for the application of the prescription, the safe and appropriate use of medicinal products, as well as the information necessary for the control of medicinal products under the drugs law and the Narcotic Drugs Act, and Delivery. (28.3.2014/251)
(16/10/2009)Before opening a technical service, the requesting authority shall provide a statement that the data protection is adequately protected. The information shall be disclosed to the authorities referred to in paragraph 1 free of charge.
The entitlement of a public pension institution to receive information at the Centre and in the Record Office shall be determined by the sickness insurance institution Article 19 (1) of Chapter 19 Based on. Furthermore, the Social Insurance Institution may not continue to provide information on the basis of the disclosure requirements laid down in any other law or the right of communication.
The Social Insurance Institution may disclose information in the prescriptions centre and the prescriptions to scientific research in accordance with the law of the Article 28 of the ec Treaty In accordance with However, extradition will always require the permission of the health and welfare establishment. (28.3.2014/251)
The Social Insurance Institution may draw up and release summaries of the information available at the receptor centre and in the Record Archives, which may be relevant for the purpose of pharmacovigilance, as well as the benefits and costs of medical treatment.
The patient's right to check the information on him at the prescribing centre is in force, as provided for in Articles 26 to 28 of the Personal Data Act. The request for verification may be made to the National Pensions Office, the pharmacies or the health care unit. However, the information in the repository shall be checked on the same basis as the information contained in the prescriptions, the request for verification of the information must always be made to the People's Pension Fund. The request for verification shall be signed.
In addition to the incorrect information contained in the prescriptions centre and in the Record Archives, the provisions of Article 29 of the Personal Data Act shall apply to the correction of incorrect data. Where the patient or his/her legal representative requires the correction of a defect on the basis of Article 29 of the Personal Data Act and the incorrect information is based on the indication of the prescriber or the supplier of the medicinal product, the correction requirement shall be demonstrated. The person who made the mark or the organisation whose service was made by the person who made the mistake.
The patient shall be entitled, upon request, to be informed on the basis of the log data about who has processed and watched the information contained in the prescription centre, the receptor archive or the patient's data management service. However, the patient does not have the right to log data if the log data donor is aware that the provision of log data could constitute a serious risk to the health or treatment of the client or to any other rights. In addition, there is no right of access to data from two years of age, unless there is a particular reason for it. The customer may not use or dispose of the log data he has received for any other purpose. The Social Insurance Institution shall provide information without delay. No payment shall be made for the provision of information. If the patient asks for the same information, he/she shall have the right to receive information based on the same log data only if there is a reasonable cause for his or her interests or rights. The National Pensions Office may collect a fee for repayable information which shall not exceed the cost of providing information. (28.3.2014/251)
If the patient considers that his or her data has been or has been released without sufficient grounds, the patient will be given to the patient by the National Pensions Office, the relevant health care unit or the pharmacy, as well as the person who has used or informed the patient. An explanation of the reasons for using the data.
The patient's information-management service, as referred to in Article 14a of the Act on the electronic processing of customer information in the field of social and health care, is stored on the patient's consent and the prohibitions and the Information. In addition, the information management service can provide information on prescriptions at the receptor centre and on prescriptions and their delivery information to the extent provided for in Article 13 of this Act. The information may be used when prescripto the patient and the patient's health and medical care.
The patient is provided with a citizen's user interface with information on the prescriptions stored in his receptive centre and the Record repository and on the associated repair and delivery markings, information on consent and prohibitions, and The release log data, with the exception of the personal data of the transferee, as well as the data on the release log which the patient is not entitled to receive under Article 16 (3).
In addition, the patient may use the interface:
(1) receive the information referred to in Article 4;
(2) to issue and withdraw the consent referred to in Article 13 and to suspend and withdraw the prohibition referred to in that Article; and
3. Make a request for renewal referred to in Article 10.
In addition to the activities referred to in paragraph 1, the user interface may be accompanied by other patients' access to information as well as activities to be carried out and to monitor medicinal products.
The user interface should be implemented in such a way that the patient's privacy is not compromised. In addition to the patient, the patient may be extradited to the patient in addition to his/her guardian or other legal representative. The transfer of information must take into account the provisions of Article 9 (2) of the Law on the Status of the Patients' Rights and Rights of the Child on the right of a patient to refuse access to his/her medical condition to the patient's guardian or other To the legal representative. Access to information via the user interface does not affect the right to check the patient's personal data law.
The Regulation of the Ministry of Social Affairs and Health may provide for more detailed provisions on the activities referred to in paragraph 2, as well as the way in which the information is provided through a citizen's user interface and the manner in which the guardian or legal representative of the The right to be informed.
The Social Insurance Institution is the controller of the receptor centre and the receptor archive. The Social Insurance Institute shall be responsible for the availability and integrity of the information contained in the prescriptions centre and in the Record Archives, the lack of information content and the storage and disposal of data.
The prescriber is responsible for the accuracy of the information contained in the prescription to be stored in the receptor centre and provided by the pharmacy to the accuracy of the delivery data stored at the receptor centre.
The electronic prescriptions and the information on them will be stored at the prescription centre for 30 months. The obligation of health care units and pharmacies to keep data on prescriptions is laid down separately.
The information in the Resource Centre shall be transferred after the deadline provided for in paragraph 1 to a separate medical prescription file. The right of access provided for in Article 11 shall not apply to information contained in the Record Archives. The information in the Receptor Archives will be kept for 20 years. (28.3.2014/251)
The electronic prescription shall be carried out in such a way that:
(1) viewing, depositing and other treatment of information at the receptor centre requires a strong identification process, as well as the management of access rights relating to the system;
(2) the information on the medicinal product is consistent with the information on the medicinal product database;
(3) only the prescriptions and related supply data in accordance with this Act and the provisions adopted pursuant thereto may be transferred to the receptor centre;
(4) the transfer of an electronic prescription and its information to or from the receptor centre has been encrypted and electronically signed so that bystanders cannot find out the secret message and that the information does not change in the transfer;
(5) the receptor centre is used without interruption and has the necessary back-door systems in case of malfunctioning and exceptional circumstances;
(6) separate data from each prescription centre is stored in the receptor centre ( Log data ) The persons who have considered, altered or otherwise processed the particulars of the prescription or annulled the prescription and the date of the measure; and
(7) the establishment and transmission of prescriptions shall be possible for all software and equipment that complies with this law and with the provisions adopted pursuant to it.
In addition, the Social Insurance Institution shall carry out a user-interface service which enables the production and processing of electronic prescriptions by means of the Internet and mobile devices using mobile telephone and communication networks. (28.3.2014/251)
The Regulation of the Ministry of Social Affairs and Health may provide for more detailed provisions on the technical implementation of the electronic prescriptions, the receptor, the prescriptions and the medical database.
Information systems and supporting software for the preparation and transmission of an electronic prescription shall be carried out in such a way that the information on medicinal products is based on the pharmacovigilance database and that the software used is guided by Selection for rational medical treatment.
The systems and software referred to in paragraph 1 shall, in addition, be drawn up in such a way that the prescriber of a medicinal product must himself write or add to the prescription such statements and particulars that are made by a decree of the Ministry of Social Affairs and Health or The decision of the Social Insurance Institution shall be made personally to be written or significant.
The Regulation of the Ministry of Social Affairs and Health may, where appropriate, provide more detailed provisions on the updating of information systems and software, medicinal products, replacement basic creams and clinical nutritional information, as well as rational The criteria for the selection of a medicinal product.
The Social Insurance Institute maintains a pharmacovigilance database. The Centre for the Safety and Development of Medicinal Products shall provide the National Pensions Office with the information necessary for its unambiguous identification of the medicinal products and registered medicinal products, as referred to in Article 21e of the Pharmaceutical Code. And the special authorised medicinal products for the population or for the general population under Article 21f. In addition, the marketing authorisation holder, the manufacturer or importer shall notify the information on the price of the medicinal products, the primary lubricants and the clinical food products to the People's Pension Fund. (16/10/2009)
The medicinal product database may also include information from product groups other than those referred to in paragraph 1 above. (28.3.2014/251)
Where appropriate, further detailed provisions may be provided by the Ministry of Social Affairs and Health by means of a regulation by the Ministry of Social Affairs and Health. (28.3.2014/251)
Information systems for the preparation and transmission of an electronic prescription and supporting software, as well as a receptor centre and a medicinal database shall, before their introduction, be subject to an examination or assessment of the confidentiality of patient information, information security In order to ensure interoperability, as provided for in Articles 3, 19 to 19g, 20a-20 h and 22 of Law No 3, Articles 20 a and 20 h and 22 of the Law on the Electrical Treatment of Customer Information on Social and Health Information.
The providers of electronic prescriptions, pharmacists and self-employed persons, as well as the National Pensions Office and customer information providers shall establish a self-control plan for the confidentiality of patient information and information security. In order to ensure, monitor and report deviations, as provided for in Articles 19h and 19i of the Act on the electronic processing of customer information in social and health care.
Information on medicinal products administered by a social or health care unit may be stored in a receptor centre. The storage of information on these medicinal products at the receptor centre shall apply mutatis mutandis, which is otherwise provided for in this Act for an electronic prescription.
A regulation of the Ministry of Social Affairs and Health may provide for more detailed provisions on the storage of information on medicinal products supplied to the patient in social or health care.
An electronic prescriptions issued in Finland, other than in Finland, may be approved and delivered in a pharmacy operating in Finland, even though the prescription does not meet all the requirements laid down in this law for an electronic prescription. However, the approval shall be subject to compliance with the requirements agreed in the European Union or agreed between the European Union and the Member States of the European Economic Area, and the prescription shall be passed on to the Finnish pharmacy To ensure the accuracy of the foreign and Finnish national contact point. Similarly, the electronic prescription in accordance with this law may be released, with the consent of the patient, to be delivered elsewhere than in Finland. The requirement for a prescription abroad is that the transfer takes place through the national contact point in Finland and the country of destination.
The Social Insurance Institution operates in Finland as a national contact point between a receptor centre, pharmacies and a foreign national contact point. The Social Insurance Institution shall be the controller of the data to be stored at the national contact point.
The Decree of the Ministry of Social Affairs and Health may lay down more precise provisions:
(1) the minimum content of electronic prescriptions drawn up outside Finland and the transmission of a prescription to the pharmacy;
(2) the surrender of an electronic prescription to the national contact point of the other State and the consent of the patient requiring the release; and
3) the storage and processing of data relating to the processing of cross-border electronic prescriptions.
General planning, control and control of the organisation and implementation of the electronic prescriptions and the national information system services provided for in this Act shall be part of the Ministry of Social Affairs and Health. However, the general guidance and supervision of the certification service, as referred to in Article 14 of the Law on Electrical Processing of Client Data for Social and Health Care, however, is a matter for the Ministry of Social Affairs and Health; and The Ministry of Finance jointly. (19/11/98)
The health and welfare institution shall be responsible for planning and directing the use and implementation of the electronic prescriptions and the national information system services provided for in this Act. (21.12.2010/1229)
The Data Protection Supervisor, the Agency for the Safety and Development of the Medicinal Products, the Agency for Social Affairs and Health, and the Regional Administrative Agency in its territory, shall guide and supervise compliance with this law in accordance with the delegated powers. (22.12.2009)
The controller of the Centre shall, for its part, monitor and supervise the implementation of the data protection related to the service as provided for in this Act, the Personal Data Act and elsewhere in law. In addition, the health care unit, the social services unit and the apteek shall, for their part, monitor and ensure that the information provided by the Centre can only be viewed and processed under this law by: The viewing and processing of data shall take place on the basis of the criteria laid down in this Act. The controller, the operating unit and the pharmacy must take the necessary measures on their own initiative if, contrary to the law, the information at the centre of origin has been used or disposed of by someone. For the purposes of monitoring and surveillance, the health care unit, the social service activity unit and the pharmacies shall have access to the log data from the National Pensions Office in so far as the staff of the relevant activity unit and apteek are: Watched and processed information at the receptor centre. (28.3.2014/251)
The controller, the head of the health service and the head of the social care unit, as well as the pharmacist, shall issue written instructions on the handling and procedures to be followed, as well as the staff Adequate expertise and competence in handling patient information. In addition, the controller, the health service unit, the social service activity unit and the pharmacies must have a data protection officer appointed for the purposes of monitoring and control. (28.3.2014/251)
The storage of an electronic prescription and its supply data, the certification referred to in this law, and the use of the information centre, the receptor archive and the medical database are charged with the cost of providing the service. The corresponding fee. In addition, the payment must be made to secure the liquidity of the National Pensions Office. The fee shall be levied by the Social Insurance Institute. Charges for municipal health care are collected by nurses from the local community centre. The fees charged by the People's Pension Fund shall be governed by the (150/1992) Notwithstanding the provisions of the Ministry of Social Affairs and Health, they are responsible for the cost of providing services. The fees to be charged by the Centre for the Centre for the Electrical Disposal Act, as referred to in Article 14 of the Act on the electronic processing of customer data, are laid down in the State payment law and on the basis of it.
The National Pensions Office and the Population Register Centre shall report annually to the Ministry of Social Affairs and Health on the factors contributing to the costs and costs of the preceding year, together with an estimate of the underlying Total costs.
Any breach of the provisions of Articles 11, 13 or 14 of this Act, or provisions relating to the processing of information, and thereby jeopardising the protection of the privacy of the patient or of his or her rights, shall be condemned, if not, by any of the provisions of Articles 11, 13 or 14 of this Act, or The rest of the law provides for a more severe penalty, On the violation of the law on the electronic prescription Fine.
Penalty report is punishable under criminal law (39/1889) in Chapter 38, And the punishment for the offence of identity registration Article 9 of Chapter 38 of the Penal Code . Punishment for breach of the obligation of professional secrecy Chapter 38 of the Criminal Code 1 or 2, if the act is not punishable Article 5 of Chapter 40 of the Penal Code Or otherwise, the law provides for a heavier penalty.
This Act shall enter into force on 1 April 2007.
Before the law enters into force, measures may be taken to implement it.
The obligation to make prescriptions by electronic means, in accordance with Article 5 of the Act, shall enter into force on 1 January 2015 for private health care units and self-employed persons acting on their premises. In addition, in the Province of Åland, as well as self-employed doctors and dentists and other providers of private services other than those referred to in Article 23 (1) of the Up to 5 000 prescriptions per year, prescriptions may be drawn up in writing, by telephone and by telefax until 1 January 2017. By way of derogation from the provisions of Article 5, the patient is entitled to receive a written, telephone or telefax prescription instead of an electronic prescription until 1 January 2017. However, the right shall not apply from 1 January 2015 to the prescription for medicinal products referred to in Article 3 (8) and (9). (28.3.2014/251)
As from 1 January 2012, from 1 January 2012, including from 1 January 2013, from 1 January 2013 and from 1 January 2014, the payments under Article 25 of the Law shall begin to be charged to the pharmacies of pharmacies; Including. However, the Population Register Centre may charge fees corresponding to the costs of the production of services provided by Article 14 of the Law on the electronic processing of customer information in the social and health care sector. From the Health Authorisation and Control Agency until such time as healthcare providers take charge of the fees payable under Article 25 of this Act to the Population Register Centre. (21.12.2010/1229)
The Ministry of Social Affairs and Health Regulation of the Ministry of Social Affairs and Health (771/2003) Shall be withdrawn from use on 31 December 2007. The non-supplied and partially supplied prescriptions in the Regulation database shall lapse. The supply information for all or part of the prescriptions supplied shall be stored in the pharmacy for which the medicinal product has been supplied, as provided for by the storage of the supply data.
THEY 250/2006 , StVM 43/2006, EV 216/2006This Act shall enter into force on 1 November 2009.
Before the law enters into force, measures may be taken to implement the law.
THEY 166/2009 , StVM 28/2009, EV 122/2009
This Act shall enter into force on 1 January 2010.
Before the entry into force of this Act, measures may be taken to implement the law.
THEY 161/2009 , HVM 18/2009, EV 205/2009
This Act shall enter into force on 1 July 2010.
Before the entry into force of this Act, measures may be taken to implement the law.
THEY 283/2009 , StVM 2/2010, EV 32/2010
This Act shall enter into force on 1 December 2010.
Before the law enters into force, measures may be taken to implement the law.
THEY 155/2010 , StVM 24/2010, EV 158/2010
This Act shall enter into force on 1 January 2011.
Before the entry into force of this Act, measures may be taken to implement the law.
THEY 176/2010 , StVM 30/2010, EV 195/2010
This Act shall enter into force on 1 April 2014.
Before the law enters into force, action can be taken to enforce the law.
By way of derogation from the provisions of Article 4 (2) of this Law, the information given to the patient should be entered in the patient's patient report instead of the information management service until 1 January 2017.
The amendments referred to in Article 10 of the Act concerning the repair, cancellation and renewal of an electronic prescription shall be implemented by 1 January 2015.
By way of derogation from Article 12 (4), pharmacies are not obliged to store written, telephone or telefax prescriptions at the receptor centre before 1 January 2017.
The provision of information enabling a patient under Article 13 (1) of the Law to make it possible must be carried out in such a way as to allow the patient to make a ban by 1 January 2015 at the latest on the user interface referred to in Article 17. The prohibition shall be made available through the information system used by the healthcare provider at the latest by 1 January 2017.
By 1 January 2017, the Social Insurance Institution shall carry out the service-related service referred to in Article 20 (2).
Information systems and software used before the entry into force of the law to produce and supply an electronic prescription shall comply with the provisions referred to in Article 22a of this Act by 1 January 2015. Before that date, an information system without a certificate of conformity may be attached to a receptor centre by a decision of the National Pensions Office for a maximum period of two years. If the information system is connected to a receptor centre before the entry into force of this Act, the information system shall be used without a certificate of conformity until the end of the period established for accession.
THEY 219/2013 , StVM 1/2014, EV 10/2014
