E-Commerce Law Prescription

Original Language Title: Laki sähköisestä lääkemääräyksestä

Read the untranslated law here: https://www.global-regulation.com/law/finland/646760/laki-shkisest-lkemryksest.html

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Get a Day Pass for only USD$49.99.
In accordance with the decision of Parliament: Chapter 1 General provisions article 1 the purpose of This Law the purpose of the Act is to improve the patient-and lääketurvallisuutta, as well as to facilitate and improve the supply of the medicinal product and, by implementing the system, in which the patient's prescriptions can be saved electronically in a national recipe and with the recipe Centre deposited prescriptions can be delivered to the patient at the time of his or her choice at any pharmacy. Recipe Centre with the consent of the patient or her deposited prescriptions will allow taking into account the kokonaislääkityksensä detection and medical treatment. In addition to the recipe and the recipe in the archives of the information can be used to take advantage of the health authorities.

section 2 (28.3.2014/251), the scope of the law this law e-prescription.
Unless otherwise specified in this law, the e-prescription preparation, submission and processing is to be followed, the status and rights of the patient in the rest of the sets, the patient's linguistic rights, the imposition of the medicinal product and, on the processing of personal data, the openness of government activities, and administrative procedures, as well as electronic communications and electronic signatures.

Definitions for the purposes of paragraph 3 of This law: 1) by means of an electronic prescription tietojenkäsittelylaitteella produce a doctor's prescription, which is transferred to the computer networks using the recipe Centre; (28.3.2014/251) 2) drug määrääjällä the doctor to prescribe the medicinal product, dentists and other legitimate health care professional; (May 21, 2010/436), the supplier of the medicinal product at the pharmacy of the medicinal product as a supplier of 3) farmaseuttia and proviisoria;
4) recipe Center database, which is made up of drug määrääjien the provisions of the posting of electronic medicine, pharmacy store on the basis of the criteria stated in article 12 of the medicine and health services providers on the basis of the criteria stated in section 23 of the patients, as well as the provisions of the information released on the delivery of the information attached to the drug; (28.3.2014/251) 5) recipe archive database, where the data is transferred in this recipe the Center by the end of the storage period; (28.3.2014/251) 6) database, a database that contains the information necessary for the delivery of the prescription of a medicinal product and of the medicinal product, its price and the coverage, with each of the eligible pharmaceutical products, vaihtokelpoisista, perusvoiteista and clinical nutrition products, as well as the Ministry of Social Affairs and health regulation of excise duties as defined in other groups; (28.3.2014/251) by means of an electronic signature in electronic form 7) which are attached to or logically associated with other electronic data and which will be used to authenticate the identity of the signer and the integrity of the instrument to ensure the electronic message; (28.3.2014/251) 8) pkv-medicinal product: (a) the medicinal product) which is in the marketing authorisation as a medicinal product as defined in pkv-;
(b)) which is listed as a Centre for the development of the pharmaceutical industry on the list laid down by the security and pkv-lääkeistä; and (c)) that contains mainly in terms of the active substances mentioned in the security and of the Centre for the development of the pharmaceutical sector in the list of those to be laid down by the pharmaceutical substances, which may be exchanged only on medical prescription only and that is to do so, you will find in this list a Z, ZA, P and PA; as well as the (28.3.2014/251) 9) drug drug drug Act (373/2008) article 3, paragraph 1, to the lists of the 1961 Single Convention on narcotic drugs referred to in subparagraph (a) (I), (II) and (IV), as well as those referred to in (b), of the 1971 Convention on psychotropic substances in lists I and II of the substances, as well as drugs under section 3 of the 5 containing the substances referred to in point (e) of the medicines. (28.3.2014/251) (28.3.2014/251) of the patient in fact, that the patient must be given information on the e-prescription and the patient's rights, prior to the establishment of a medical prescription. In addition, the patient will need to provide information on the provision of the national information system, electronic medical services, their general operating principles, as well as the information system services operator, the conditions for the disposal of prescription data, data protection, as well as other aspects relevant to the processing of data of the patient.
The originator must provide the information to health-care services, the patient in person, in writing or orally. The information may also be given to the patient's unique e-service. If the information is provided in a manner other than in writing, the patient has to have the opportunity to get the information in writing. The information provided should make a note of the infringement found in article 16A (a) of the patient's information management service. If the patient has already received the information referred to above, can be from any notification obligations pursuant to depart from the way of the personal data Act (523/1999) provides in article 24.
The adoption of the procedures and content of the information to the Ministry of Social Affairs and health, the provisions of the regulation.
Chapter 2 establishment of the electronic prescription and the contents of the section 5 (28.3.2014/251), the establishment of a Prescription Drug order shall be by electronic means. If the e-prescribing is not due to technical failure possible, prescription can also be made in writing or in telephone medicine regulation. A written or telephone a prescription can also be made at the request of the pharmacy, if a pharmacy is not able to submit an electronic prescription, due to technical failure. In addition, medicine can be drawn up in writing or by telephone, if there is an urgent need for medical care and a prescription because of the exceptional nature of the circumstances may be, or any other special reason to draw up by electronic means.
Abroad for the purchase of the e-commerce of the prescription can be given a copy of the signed written. If the prescription is given a copy of the offshore for the purchase, the supply of the medicinal product in the electronic prescription will be blocked at the same time, technically. For the e-prescription prescriber or of a medicinal product may also refer the patient to a pharmacy in the signed copy, if it is necessary for the patient's foreign trip.
Reasons shall be given for the provision in the written and telephone medicine, why it was not issued by electronic means. The Ministry of Social Affairs and health regulation is necessary in order to provide more detailed provisions on the criteria for the prescription written or telephone and content, the medicinal products prescribed, and for the purchase or offshore on the foreign copy.

section 6 of the data content of the Electronic prescription drug order must be: 1) the patient's name and a personal identification number, or the name and date of birth, if he does not have a social security number;
2. in accordance with the data in the database) of the drug, or the drug substance or the composition of the medicinal product to be manufactured in a pharmacy;
the supply of the medicinal product on the market and use of 3) in terms of the necessary information;
4 määrääjä of the medicinal product and of the health care action) of the unit to identify the necessary information;
in order to resolve any health insurance allowance of 5) with the necessary information; as well as 6) identification of a medical prescription.
The drug provision, in addition to the information identified in subparagraph (1) may be more relevant to the information on the use and delivery of the medicinal product.
The detailed content of the e-prescription and ID may be used, where appropriate, to provide the Ministry of Social Affairs and health.

the signing of the order by electronic means, article 7 of the Medical prescription should be the advanced electronic signature of the author of the audit. In addition to the electronic signature should be taken in such a way that the imposition of the author entitled to supply medicinal products to the medical prescription will be certified before the signature. All the prescriptions of the same patient can sign a single signature.
The population register Centre is responsible for the certification of the service, as the social and health care, the law on e-commerce processing of customer data (159/2007) 14. The Ministry of Social Affairs and health Decree gives detailed rules on how the imposition of the author entitled to supply medicinal products to the certification of a medical prescription and certificate service is carried out. Before adopting the regulation, the Ministry of Social Affairs and health will be to hear from the population register Centre, in so far as the matter is the question of the role of the population register Centre referred to in the above. (November 19, 2010/982) section 8 (28.3.2014/251) section 8 is repealed by L:lla 28.3.2014/251.

section 9 (28.3.2014/251) the patient help


E-commerce the prescription must be given to the patient in a separate report (the patient). It is not necessary to give the patient help, if the patient does not have the prescriber as well as the receipt for the prescription of a medicinal product. The patient does not have to provide help, if it is not possible for technical reasons or if the electronic prescription has been prepared by means of a device which does not have a fixed location. The patient should be at least help a patient's name and date of birth, the name of the medicinal product and medical material, as well as its strength and pharmaceutical form, and the quantity of the medicinal product, the dosage, the identification of a medical prescription, the drug prescriber or health care operating unit contact information, the date of the prescription, as well as information relating to the prohibition of section 13, if the patient has made it to the Patient to help the information of all may be entered. the patient at the same time, prescribed medication. In addition, the patient may be given a summary of the provisions of the medical prescription Centre.
The Ministry of Social Affairs and health regulation is necessary in order to provide more detailed provisions on the patient help and a summary of the contents, as well as the reasons on the basis of which the patient instructions need not be given to the patient.

section 10 (28.3.2014/251), cancellation and renewal of a prescription If the prescription is incorrect prescription Centre, can the person in charge of the medicinal product followed by the määrääjä of the prescription drug provision of the necessary corrections made. Reliever pharmacist Act in order and may, in addition, to make the necessary technical adjustments at the time of delivery. If a prescription is unclear or incomplete, is the prescriber as well as the consent of the medicinal product, the repair must be oral.
Patient handling määrääjä of the medicinal product and the supplier of the medicinal product may, in agreement with the patient to void recipe Center to be an undeliverable or partially delivered a prescription. The author of a medical prescription, and section 12 of the saving referred to in subsection 4 of the prescription or pharmacists ' Association in order to be able to make the cancellation done without the patient's consent, if the prescription is prepared on the basis of incorrect information provided by the patient deliberately or by forcing. In addition, the prescription of the death of the person to whom the order is voided.
Electronic prescription is renewed through a new prescription on the basis of a medical prescription the prescription Centre. At the request of the patient or the patient's pharmacy of a request for renewal of the prescription of a medicinal product can be made määrääjälle, and health care operations. You can, however, to prescribe the medicinal product entitled to prevent the reform of the medical prescription prescription Center on the grounds of the saved, and when the prescription is drawn up on the basis of incorrect information provided by the patient deliberately or by forcing.
When the provision of medicinal products as referred to in subparagraph 1 to 3, the cancellation or prevent the renewal of a provision attached to the measure is medicine. Prescription for renewal, cancellation and blocking has to be signed by electronic means.
The Commission of any cancellation of the e-prescription, reform and its prevention, as well as the related provisions of the labelling to the Ministry of Social Affairs and health.
Chapter 3, section 11 of the Electronic transmission of prescription to the pharmacy access to the patient, or a person acting on his behalf (the drug buyer) be accredited by the oral request shall have the right to get the recipe for the center of the patient: 1 to identify the e-prescription necessary) dead-letter or part of the information on the submitted electronic prescriptions;
2. the information necessary for the provision of e-prescription), including information on the impact of the health insurance expenses; as well as the other recipe Center 3) data from a patient's medicine; If the drug picked up by someone other than the patient or his legal representative in this case, the buyer of the medicinal product, shall be signed by the patient or his legal representative's consent.
The supply of the medicinal product, shall be entitled to be accredited by the information on the prescription even if the patient is made by section 13 of the prohibition referred to in paragraph 1 or 3, if the drug buyer to present an overview of the order on the patient help or printed. (28.3.2014/251) section 12 of the electronic transmission of a prescription When the drug is delivered on the basis of a medicinal product in the Member State of an electronic prescription for the buyer to show confidence, that he is entitled to receive the medicine. If the patient does not have a personal account, the supply of the medicinal product requires that the pharmacy will be presented to the patient. (28.3.2014/251)
In the context of the transfer of the medicinal product, the medicinal product shall be sold with a written report for the medicinal product, as well as the part of your prescription delivered, unless the buyer to notify me that he does not want to. With the consent of the patient's oral statement can be stored in the data of all the provisions of the patient's drug prescription Centre. If the drug picked up by someone other than the patient himself or his legal representative, may be all the prescription that contains the data you report only if the patient or his legal representative has given his consent, signed it.
The delivery of the prescription drug order data is appended to a recipe in the Centre. The drug supplied by the pharmacy can correct an incorrect delivery information. Shipping information and the corrections shall be signed by an advanced electronic signature. The electronic signature must be made in such a way that the right of delivery of the supplier of the medicinal product will be certified before the signature. All the information to be provided in the same time, you can sign up to the delivery of medical prescriptions in one of the signature function.
If the prescription has been issued as referred to in subparagraph (1) of section 5 of the technical due to the failure in writing or by telephone, you must save your prescription to the Pharmacy and its associated delivery information to the recipe Centre prescription on delivery or technical failure prevents the immediate recording, as soon as it is possible. The drug provision of the relationship, regardless of the määrääjällä of the medicinal product in question is the right to apply for a recipe for saving the provisions of the pharmacy's Medical Center, which he has labeled a drug määrääjäksi. The Ministry of Social Affairs and health regulation, the provisions of a written or telephone can be used to provide more accurate prescription and its delivery on the retention of data for the recipe and the search function, which you can get information on the medicinal product määrääjä pharmacy saving medicine. (28.3.2014/251) Chapter 4 the recipe's disclosure of information and the patient's right of access under section 13 (28.3.2014/251) the patient's right to control the transfer of data from the archives of the information centre and the recipe Recipe of the patient's medical information, the provisions of the delivery and renewal requests shall be made available, health and social care policy and drug määrääjälle the patient's health and medical care and, if the patient has given written consent to it in accordance with article 14. The consent is valid for an indefinite period and it includes all of the recipe in the archives of the information centre and the recipe. The patient, however, can deny the yksilöimiensä of prescriptions for the transfer referred to above and to pharmacies. Consent and the ban may be revoked at any time. The ban and the withdrawal of consent and may indicate any of the e-medicine health care or social care provision, assuming it operations unit, or to the määrääjälle of the medicinal product, assuming it as a self-employed person. The ban and the withdrawal of consent and shall not make the use referred to in article 17.
If the age of the patient is not in a position to decide their treatment by a mental health disorder, development disability or for any other reason, the consent referred to in paragraph 1, can give his legal representative, the immediate family or other close. The patient's legal representative, lähiomaisella or any other nearby does not have the right to withdraw consent and not to make a donation.
If the status and rights of the patient is a minor, the patient is able to Act (785/1992), hereinafter referred to as the patient Act, section 7 (1), on the basis of the meaning of age and maturity to decide their treatment, he may decide to include this paragraph 1 referred to in subsection consent has been given and the conclusion of the ban. Otherwise, the consent of the patient's legal guardian of the minor or to give a legal representative. The person having custody of the minor, or the legal representative does not have the right to withdraw consent and not to make a donation. The patient of the law within the meaning of article 9 (2) of the minor also has the right to prohibit the disclosure of the information of the e-prescription for huoltajalleen or other legal representative.
Notwithstanding the provisions of paragraph 1, may be supplied: 1) the information referred to in sub-section 1, the, if the information or the right to be eligible for any of the information is expressly provided for by law;
2) pkv and drug-drug for the district data from all patients prescribed medicines and drugs and pkv in delivery of the information;

3) on the reform of the medical prescription for health care or social welfare activities to the unit or the drug määrääjälle the patient's prescription for information requested by the renewal;
4 määrääjälle of the medicinal product in terms of continuing treatment information) his recipe for the Center and the tallentamistaan medical data as well as the treatment of the relationship, regardless of the pharmacy on the basis of the third paragraph of article 12 of the recipe for saving the provisions of, the Centre is marked by the pharmaceutical drug määrääjäksi, as well as the provisions related to the delivery of the data for these medicinal products;
5) health care or social welfare activities for the unit or health care professional about recipe Center saved the medicine and the delivery of information to the patient in the referred to in article 8 of the law in urgent situations; If a prescription is prohibited, in accordance with paragraph 1, information shall be made available only if the patient has separately announced that they may, however, be disclosed in one of the situations referred to above; as well as the activities of the e-6) prescription for health-care services, the giver, the social insurance institution of Finland or your system vendor for technical personnel employed by the information about the disorder and error conditions to the extent necessary for an investigation.
The Ministry of Social Affairs and health regulation is necessary in order to provide more detailed provisions on the consent referred to in articles 1 to 3, and the ban on the procedure, as well as of the implementation of the right of access referred to in paragraph 6 and the technical staff of how to determine which of the rights.

Article 14 of the Agreement (28.3.2014/251) and the ban on the transmission of the document on the consent of the recipe for the Centre and shall draw up a document signed by the patient. The consent document must contain the information referred to in article 4 of the agreement and of the e-commerce, as well as the importance of the ban on the prescription. The ban on the paper should be a statement that the adoption of health-and medical care is not to be able to use the information on the subject of the prohibition in force, even if they are relevant to the subject of the treatment of the ban reversed, or ban is not exempted under section 8 of the patient in the event referred to. The social insurance institution shall draw up models of consent and a ban on the document. Consent and a ban on the consignee is to inform the document, a copy of the consent to or prohibition. The patient gives consent, or when a ban on the use of the referred to in article 17 of the connection must correspond to the data through the user interface. If the consent given in section 13 of the situation referred to in paragraph 2 or 3, other than the patient himself, the consent of the person providing the consent is the document to be signed.
Consent and withdrawal of the ban or the recipient shall maintain signed the document on behalf of the social insurance institution of Finland or to be saved to the original document into a copy of the national information system. For the storage of documents, shall apply to the patient under section 12 of the 1990 law provides for the retention of patient documents. The Ministry of Social Affairs and health, the provisions of the regulation to the technical method by which a copy of the referred to above shall be taken and stored in the national information system.

Article 15 of the communication of data to public authorities and for scientific research (28.3.2014/251) Salassapitosäännösten and without prejudice to the other provisions on the use of data in the social insurance institution may be a Registrar to dispose of the recipe and the recipe archive, on request, technical user, in addition to what the rest of the law provides: 1) in the field of Social Affairs and health, the Agency and the authorisation and supervision of medicinal products for the Regional Office of health professionals the information necessary for the medicinal product under the supervision of the establishment and the provision of medicinal määrääjien; (22 December 2009/1567) 2) for security and development in the pharmaceutical sector the medicine Act (395/1987) referred to in article 21 (f) special permit application in the safe and appropriate prescriptions, the use of medicines under the guidance of the information required in accordance with the law and the law on Narcotics, as well as the supervision of the medical information necessary for medicine and providing them. (28.3.2014/251)
(2009/781) Before the opening of the technical information about the use of the connection in which the applicant authority is situated shall be described by a statement of the fact that the protection of the information is disposed of in a proper manner. The information must be handed over to the authorities referred to in subparagraph (1) free of charge.
The social insurance institution of Finland the right to get the recipe in the archives of the information centre and the recipe is determined by the Health Insurance Act (1224/2004) on the basis of article 1 of chapter 19. The social insurance institution are also not allowed to provide information on the law or other obligation to provide data laid down in the communication on the basis of the right.
The social insurance institution may not disclose the recipe in the archives of the information centre and a recipe for scientific research Act on the openness of government activities (621/1999), in accordance with section 28. However, the transfer shall be subject to the health and well-being of the area. (28.3.2014/251)
The social insurance institution is permitted to establish and to release summaries of the recipe in the archives of the information centre and the recipe, which may play a role in drug safety as well as the benefits and costs of medical care.

section 16 of the patient's right of access to information on the patient's right to inspect the data concerning him prescription Center, is in effect what the personal data Act, section 26 to 28. The verification request can be made for the social insurance institution of Finland, to the pharmacy, or health care operations. The recipe for the information may be checked on the same basis as the information in the information relating to the prescription Centre inspection request has, however, always for the social insurance institution of Finland. The inspection request has to be signed for.
The recipe in the archives of the Centre for the repair of the incorrect information and the recipe is applied, in addition to the above, section 10 of the personal data provided for in article 29 of the law, what the law provides. If the patient or his legal representative requires bug fixes of the personal data Act article 29 based on invalid data is based on the medicinal product, the prescriber or and the supplier of the medicinal product to do the marking, there is a requirement to show an incorrect entry in the person who lodges the repair or for the Organization, which employs an error made by a person is not an error.
The patient is entitled to obtain, on request and on the basis of the information in the log which are dealt with and looked at him in the archives of the Centre for the recipe, recipe, or the patient's information management service. The patient does not have the right to get a log to the log, if the donor is aware that the log information might pose a serious risk to the health or care of the customer, or someone else's rights. Not two years old log information does not have the right to obtain, unless there are special reasons for this. You may not use or disclose the information obtained in the log data for any other purpose. The social insurance institution shall provide the information without delay. The provision of information shall not charge a fee. If the patient requests the same information, is he entitled to the same log information based on data only if there is a valid reason for his interest, or for the implementation of their rights. The social insurance institution is permitted to charge again for a fee, which shall not exceed the cost of providing the information. (28.3.2014/251)
If the patient feels that his information is used or released without sufficient grounds, will be the social insurance institution, the health care of the activities of an entity or a pharmacy, as well as information about the used, or at the request of the person to whom the data refer the patient to a statement of the reasons for the use of the information.

16 (a) of section (28.3.2014/251) of the patient's information management service of social and health care, the law on the processing of customer data, e-14, as referred to in (a) of the patient's information management service is stored in the data of the patient consents to the adoption and to do with prohibitions and the patient the information given. In addition to the data management service can be used to display information in the archives of the Centre and of the medicinal recipe and the recipe for the delivery of information to the extent required by section 13 of this Act. Information may be used, as well as the organisation and implementation of the medicinal product, for the assessment to the patient, the patient's health and medical care.

section 17 (28.3.2014/251), the patient is given a national user interface the user interface of the citizen with the information his recipe and the recipe in the archives of the recorded provisions, as well as the repair connected to medicine and the delivery of the information consents and the labelling of the supply, the prohibitions, as well as log information, except for the transferee, as well as the transfer of personal data to the log information that the patient is not under the third paragraph of article 16, have the right to get one.
The patient may also, through the user interface: 1) to receive the information referred to in article 4;
2) give and cancel the agreement referred to in article 13, as well as make and cancel the prohibition referred to in the said article; as well as 3) to make a request for renewal provided for in article 10.
The user interface in addition to the activities listed in paragraph 1 may be accompanied by other patient's access to information, as well as the implementation and monitoring of activities that provide medical care.

Citizen interface must be implemented in such a way that the patient's privacy is not compromised. The minor patient information shall be made available, in addition to the user interface through the patient's legal representative or the rest of his huoltajalleen. In this case, be taken into account in the transfer of information is what the patient's status and rights in law, section 9 of the Act provides for the right to prohibit a minor patient's State of health for the patient's parent/guardian or other legal representative. Access to data by using the user interface does not affect the patient's right of inspection pursuant to the personal data Act.
The Ministry of Social Affairs and health regulation is necessary in order to provide more detailed provisions on the activities referred to in paragraph 2, as well as how the information will be provided through the user interface of the citizen and the legal representative of the patient's parent or guardian of the minor, or how the right of access to information.
Chapter 5 miscellaneous provisions in section 18 of the controller, the social insurance institution is the recipe and the recipe archive. The Institute is responsible for the recipe in the archives of the availability of the data center and the recipe and integrity ensures that the data on the retention of data, as well as the content and the destruction of the.
The drug määrääjä is responsible for the accuracy of the data center to save prescription prescription and medicinal products supplied by the pharmacy to the accuracy of the data that can be stored in the Centre supply a recipe.

section 19 of the retention of Electronic prescriptions and they kept the recipe Centre for 30 months. Healthcare services and pharmacy from the obligation to keep information about a medicine specifically provided for in the provisions.
The recipe for the information is transferred to the first paragraph of the Centre after the time limit laid down in a separate recipe in the archives. The notification provided for in article 11, the right of access does not apply to the recipe in the archives. The recipe for the data will be kept for 20 years. (28.3.2014/251) of section 20 of the E-prescription computer implementation of the electronic prescription must be implemented in such a way that: 1) to the recipe of viewing information, storage, and other treatment requires the processor to a unique strong authentication method and system to manage permissions to the site;
information relating to the medicinal product are the same 2) the medicine with the data in a database;
3) only this law and in accordance with the provisions adopted in the implementation of the prescription and the associated delivery information will be transferred to recipe Center;
4) electronic transfer of information on a medical prescription and the prescription or from there to the rest of it is encrypted and signed by electronic means so that bystanders will not be able to find out the encrypted message, and that the data do not change the transfer;
5) recipe Center is turned on, without interruption, and it has the necessary backup systems to malfunction and emergency;
6) recipe Center is stored separately for each prescription information (logs) about who is viewed, changed, or otherwise dealt with, or been withdrawn about a prescription, as well as the timing of the measure; and 7) draw up and submit to this law and it is possible for all, in accordance with the provisions adopted on the basis of the CFR and the technical meeting the requirements of software and hardware.
In addition to the social insurance institution will implement the user interface, which allows for the preparation and processing of electronic prescriptions over the Internet, as well as telephone and data communications networks that use a system of sliding devices. (28.3.2014/251)
The Ministry of Social Affairs and health regulation is necessary in order to provide more detailed provisions on the e-prescription, recipe, recipe of the archive and medicine, on the technical execution of the database.

section 21 of the medical prescription and delivery of software to be used for the provision of an electronic prescription and information systems, and they are supported by the software must be made in such a way that the information is based on information on medicinal products database and the software used are driven by the choice of rational drug therapy medicinal product.
The systems referred to in subparagraph (1) above, and the software must also be worded in such a way that the prescriber as well as is in the order of the statements or be added to the drug and the entries, which the Ministry of Social Affairs and health regulation in a regulation or decision of the social insurance institution of Finland provides for a person write to or significant.
The Ministry of Social Affairs and health, the provisions of the regulation may be used, where appropriate, to provide more accurate updating of information systems and software, pharmaceuticals, food products and clinical trials to be reimbursed for the emollients and rational drug therapy medicinal product in accordance with the selection criteria.

section 22 of the social insurance institution of Finland Medical database to maintain the drug database. Centre for the development of the pharmaceutical sector of security and should be delivered to the social insurance institution of Finland in the particulars necessary for identification of the unequivocal identification of the medicinal product authorised garages and of registered pharmaceutical products, as well as the pharmaceutical law of referred to in article 21 (e) and (f) in accordance with article 21 of the patient or the population of the erityisluvallisista referred to in pharmaceutical products. In addition, the holder of the marketing authorisation, the manufacturer or importer shall inform the perusvoiteiden of which may be reimbursed and the clinical trials of medicinal products, the price of food products, information for the social insurance institution of Finland. (2009/781)
Medicine database, you can also include other than those mentioned in paragraph 1 above by means of an electronic prescription of the product type (s) of information. (28.3.2014/251)
More detailed information on the content of the database of medicinal, pharmaceutical preparation that you can add to any of the groups in the database and data reporting for the social insurance institution may, where appropriate, lay down more detailed provisions in the regulation, the Ministry of Social Affairs and health. (28.3.2014/251), section 22 (a) (28.3.2014/251), the approval and introduction of information systems and software for the preparation and submission of an electronic prescription information systems to be used, and they are supported by the software, as well as in the recipe and the introduction of a database on medicinal products, to be verified or evaluated prior to their medical records in order to ensure the confidentiality, security, and interoperability as social and health care, the law on e-commerce processing of customer data, 3, 19, 20 (a) (a) to (g) 19-20 (h) and section 22 of the provides.

Article 22 (b) (28.3.2014/251) self control electronic prescription services of operating units, pharmacies and the self-employed, as well as of the social insurance institution and the customer data service shall be drawn up in omavalvontasuunnitelma, in order to ensure the confidentiality and security of patient information, to monitor the activity and indicate the deviations as social and health care, the law on the processing of customer data, e-19 (h) and article 19 (i).

section 23 (28.3.2014/251) to be transmitted to the social or health care medicines are social or health care information relating to the medicinal products given to the patient, operating unit can store the recipe. These medicines to save information on recipe Center shall apply mutatis mutandis, the provisions of this act otherwise provides, an electronic prescription.
The Ministry of Social Affairs and health, the provisions of regulation is necessary in order to give more specific social or health care to the patient for medicinal products supplied on the retention of data for the recipe.

23 (a) section (28.3.2014/251) cross-border e-prescription Elsewhere than in Finland, drawn up in the electronic prescription can be approved and delivered in Finland in the pharmacy, even if the prescription does not meet all the requirements laid down in this law for the purpose of electronic medicine. In order to be accepted, however, that it complies with the approved in the European Union or of the European Union and the Member States of the European economic area between the agreed requirements and prescription are transmitted to the Finnish pharmacist on the authenticity of the prescription to ensure foreign and Finnish national focal point. In accordance with this law, an electronic prescription for supply to the rest of the patient's consent to dispose of than in Finland. A prerequisite for a prescription abroad is that supply takes place through the national contact point for the host country and Finland.
The Institute works in Finland, the national contact point for the prescription, pharmacies and foreign national contact point. The Institute is the national contact point of information you want to store the data controller.
The Ministry of Social Affairs and health regulation is necessary in order to give more specific provisions: 1) in the rest of Finland, the minimum content of the medical prescriptions drawn up for the electronic transmission of prescription to the Pharmacy;
2) e-prescription for the disposition of another State concerning the disposal of the national contact point and the patient's consent; as well as 3) related to the handling of cross-border electronic prescriptions, saving and processing of the log data.

section 24 in the control, tracking and control


The electronic prescription and in the organisation of national information system services referred to in the law and the implementation of the overall design, control, and carried out by the Ministry of Social Affairs and health. Social and health care, the law on e-commerce customer data processing referred to in article 14 of the population register Centre's certificate services operated by the General command and control include, however, the Ministry of Social Affairs and health and the Ministry of finance. (November 19, 2010/982)
The National Institute for health and welfare is responsible for the e-prescription and in access to and use of the services national information system referred to in the law and planning and control. (21 December 2010/12)
The data protection officer, Centre for the development of the pharmaceutical industry, security and Social Affairs and the Office for the authorisation and supervision of the health sector, as well as the regional government agency in the territory of the powers provided for in the Guide and monitor them in accordance with this law. (22 December 2009/1567)
Recipe Center, the controller has to be monitored and supervised, that it provide service related to your protection as provided for in this Act, the personal data Act and the rest of the legislation. In addition, the health care, social care, the operating unit operating unit and pharmacy, for its part, monitor and verify that the recipe for the information centre can view and work with only the legitimate and that according to this law the data viewing and processing takes place on the grounds set out in this law. The data controller, of the activities of an entity and a pharmacist must, on their own initiative, take the necessary measures, if someone is illegally held, used or otherwise disposed of by the recipe Centre. In order to implement the monitoring of, and control of health-care policy unit, social welfare activities, and be accredited by the social insurance institution has the right to log the information in so far as the relevant operating unit and the Pharmacy staff is watched and dealt with the recipe Centre. (28.3.2014/251)
The data controller, the health care and social care, operating unit operating unit Director as well as the apothecary will give written instructions from the customer data and the procedures to be followed, as well as to ensure the adequate expertise and skills of the staff of the patient information. In addition, the controller, the operating unit of health care, social welfare policy, and must be accredited by the monitoring and control functions for the named data protection officer. (28.3.2014/251), section 25 (28.3.2014/251) Payments the E-prescription and its delivery on the retention of data, as referred to in this act as well as the certification of the recipe, the recipe archive and medicine information in the database can be used at an amount equal to the payment of the costs of the provision of the service. The payment will be in addition to ensure the liquidity of the Fund of the social insurance institution of service. Payment of levy, the social insurance institution. Municipal health care fees and charges shall be levied for sairaanhoitopiireittäin available from the Hospital District Board. The social insurance institution of Finland provides the basis of payment of the State Fees Act (150/1992), notwithstanding the provisions of article 10 of the Decree of the Ministry of Social Affairs and health in such a way that they correspond to the amount of the costs of the management of the services. Social and health care, the law on e-commerce customer data processing referred to in article 14 of the civil registry Agency provided the basis for payment of the State fees provided for in the law and in accordance with it.
The social insurance institution and the population register Centre must submit an annual report to the Ministry of Social Affairs and health costs and the cost of the factors of the previous year, as well as an estimate of the total cost of the next year, on the basis of the charges.

a reference to the provisions of section 26 of the Penalty and That intentional or grossly negligent violation of this law, section 11, 13 or 14 of the right of access to information, or the provisions on the processing of information and thus endanger the patient or his or her rights, the protection of privacy is to be condemned, as provided by law, unless a more severe penalty in other parts of the Act, an electronic prescription to a fine for infringement of the law.
The penalty for breach of the criminal law provides for the computer (39/1889) section 38, Chapter 8: crime and punishment in the penal system in section 38, Chapter 9. The penalty for violation of professional secrecy, are sentenced to the Penal Code, chapter 38, section 1 and 2, unless the Act is not punishable under the Penal Code, chapter 40, section 5 of the Act on provision of a heavier penalty, or elsewhere.
Chapter 6 transitional provisions article 27 entry into force and the date of entry into force of this law shall enter into force on 1 April 2007.
Before the entry into force of the law can be used to take the measures needed to implement it.

Article 28 transitional provision Article 5 obligation to draw up in accordance with the prescriptions by electronic means, shall enter into force on the private healthcare units and their atmospheres for the self-employed, as from 1 January 2015. In addition, in the province of the Åland Islands, as well as social welfare services providers, and other non-Article 23, as referred to in sub-section 1 of doctors and dentists in a self-employed capacity, as well as of private services providers, which will draw up to a maximum of 5 000 prescription a year, prescriptions may be drawn up in writing, by phone and fax-order by 1 January 2017. By way of derogation from article 5 of the Act, the patient has the right to receive an electronic prescription, if they so wish, instead of written, telephone or telefax prescription until 1 January 2017. The right does not, however, apply to 1 January 2015, including prescription, which applies to section 3 of the 8 and 9 medicinal products referred to in paragraph pkv and drugs. (28.3.2014/251)
In accordance with article 25 of the law fees are starting to charge pharmacies as well as from 1 January 2012, municipal and State health departments from 1 January 2013 and private healthcare services with effect from 1 January 2014. The population register Centre may, however, charge for social and health care e-commerce processing customer data in accordance with article 14 of the law on money for the costs of the provision of services for the provision of social and health fees to be charged corresponding to the authorisation and supervision of medicinal products for the Agency until such time as health-care services, donors will take to carry out the population register Centre in accordance with article 25 of this law. (21 December 2010/12)
The experiment on the electronic prescription for the Ministry of Social Affairs and health regulation (771/2003) for the recipe in the database will be disabled on 31 December 2007. In accordance with the regulation of the recipe in the database that have not been delivered and partly delivered prescriptions lapse. In whole or in part, the provisions concerning the delivery of information is to be transmitted to the drug store pharmacy, from which the drug is delivered, as the delivery of information to the Security Council for the maintenance of a special provision.
THEY'RE 250/2006, Shub 43/2006, EV 216/2006 acts entry into force and application in time: 2009/781: this law shall enter into force on 1 November 2009.
Before the entry into force of the law can be used to take the measures needed to implement the law.
THEY'RE 166/2009 28/2009, Shub, 22 December 2009/122/2009 EV 1567: this law shall enter into force on 1 January 2010.
Before the entry into force of this law may be to take the measures needed to implement the law.
THEY 161/2009, HaVM 18/2009 on 21 May 2010, EV 205/2009/436: this law shall enter into force on 1 July 2010.
Before the entry into force of this law may be to take the measures needed to implement the law.
THEY 283/2009, Shub 2/2010 EV/2010 November 19, 2010/982: this law shall enter into force on 1 December 2010.
Before the entry into force of the law can be used to take the measures needed to implement the law.
THEY 155/2010, Shub 24/2010 2010-21 December 2010/158, EV 12: this law shall enter into force on 1 January 2011.
Before the entry into force of this law may be to take the necessary steps in the implementation of the law.
THEY'RE 176/2010 30/2010, EV, Shub 195/2010 28.3.2014/251: this law shall enter into force on 1 April 2014.
Before the entry into force of the law can be taken in the implementation of the law.
This law provided for in article 4 (2) by way of derogation from the information given to the patient must make a note of the data management service instead of the patient, the patient's report to be drawn up, by 1 January 2017.
The amendments referred to in article 10 of the law of electronic prescription renewal, cancellation and will be implemented by 1 January 2015.
Article 12 of the law, by way of derogation from article 4, be accredited by has no obligation to store written, telephone or telefax-prescription prescription Center before 1 January 2017.
Under section 13 of the Act in accordance with the patient's right will enable information technology implementations must be implemented in such a way that the patient can make the ban referred to in article 17, through the user interface, no later than 1 January 2015. The ban is to be able to make a person providing health-care services through an information system that is used by no later than 1 January 2017.
The social insurance institution under section 20 of the interface of the service referred to in paragraph 2 until 1 January 2017.

Before the entry into force of the law on information systems and software, which will be used for the development and for the e-prescription, there will be 22 this Act (a) to conform to the provisions referred to in section no later than 1 January 2015. Before the date referred to in the information system, which is not accompanied by a certificate of conformity, can be attached to the decision of the center of the social insurance institution of Finland up to a recipe for a period of two years. If your system is connected to the recipe Center prior to the entry into force of this law, the information system used by a certificate of conformity may be in the context of the accession to the number of recorded time without end.
THEY 219/1/2014, 2013, Shub EV 10/2014

Related Laws