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In accordance with the decision of the Parliament:
This law provides for the right to provide private health services to the public.
In addition to what is laid down in this law, the law on health professionals (559/1994) Or elsewhere specified or prescribed for the provision of healthcare services.
For the purpose of this Law By health care services:
1. Laboratory activities;
(2) radiological activities and other methods of imaging and research comparable to it;
(3) studies and measures to identify other health conditions or diseases or to determine the treatment;
(4) physiotherapeutic and other performance-enhancing measures and therapies;
(5) occupational health services;
(6) medical and dental services and other medical and medical care and similar services;
7) massage; and
(8) ambulance services.
The service provider Means an individual or a company, a cooperative, a union or another entity or a foundation which maintains a unit providing healthcare services and a self-employed person providing medical services. The service provider shall not be regarded as any other self-employed or self-employed person who organises himself in the Medical Service (1383/2001) For occupational health services.
Self-employed person Means a healthcare professional within the meaning of Article 2 (1) of the Law on Health professionals who carries out his work independently.
The licensing authorities under this law are the Regional Administrative Agencies and the Office for Social and Health Authorisation and Control. The allocation of powers between the licensing authorities is laid down by a Council regulation.
Health care services must be provided with appropriate facilities and equipment. The provision of hospital transport services shall be accompanied by an appropriate medical transport vehicle. In addition, the service provider must be provided with appropriate training staff.
The activities must be medically appropriate and take account of patient safety.
The service provider shall have authorisation from the licensing authority for the provision of healthcare services. The service sector in accordance with Article 2 of the service provider shall be reflected in the authorisation. In order to ensure patient safety, the conditions necessary to ensure patient safety may be attached to the number of services, staff, premises, medical transport council and equipment, equipment and supplies. (20.11.2009)
The authorisation shall be granted on the basis of a written and signed application to the service provider meeting the conditions laid down in Article 3.
The licence application shall contain the following information concerning the service provider:
(1) business name, business and community identification and contact details;
(2) the services and places of operation of health care and medical care services and their contact details, as well as the number of medical vehicles and their places of employment; (20.11.2009)
(3) the service sector and the content of the healthcare services to be administered on the basis of the authorisation to be applied, as well as their intended scope in each operational unit and location;
(4) the name, personal identification, training and occupation, home address and other contact details of the manager responsible;
(5) the name, training and occupation, telephone number and other contact details of the patient ombudsman;
(6) the number of other staff and training;
7) information on the registration of the ex-ante recovery law; (1118/1996) Within the meaning of the employer register;
(8) the place of retention of patient documentation, a report on the main principles of patient records and the person responsible for keeping records;
(9) where necessary, information on equipment and articles to be used, and any other information necessary to assess the quality, safety and relevance of the services.
In addition, the application for authorisation shall be accompanied by the name and contact details of the applicant's managing director or other person responsible for the business activity.
The Decree of the Ministry of Social Affairs and Health may lay down more detailed provisions on the content and the formula of the application for authorisation and the application for authorisation.
The authorisation of the provision of medical services is justified by the practice of transporting medical services throughout the country, with the exception of the Åland Islands. The authorisation for the provision of hospital transport services shall establish the number of medical vehicles used for the provision of services and their place of employment or place of employment. (20.11.2009)
The service provider shall be the manager responsible for health services approved by the licensing authority. (29.5.2008)
A person who satisfies the requirements laid down in the Regulation shall be accepted as Director-General for the written application of the service provider.
The corresponding Director shall be responsible for ensuring that the operation of the healthcare services complies with the requirements laid down in this Act or by the provisions adopted pursuant to it. The Director responsible for the operation of the services in more than one place of establishment shall draw up a self-control plan covering the activities of the service provider and its separate sites in order to ensure the quality of the activity. The Agency for Social and Health Authorisation and Control may lay down provisions on the content and preparation of the self-control plan. (29.5.2008)
If the responsible director fails to fulfil his supervisory role or otherwise is unable to perform his duties, the approval of the Director responsible may be withdrawn.
The service provider shall provide facilities and equipment for the provision of healthcare services and a medical vehicle and its equipment in order to be inspected by the Board of Health before they are put into service.
The holder of the Board of Health shall check the premises and equipment and the vehicle and its equipment and issue an inspection report without delay to the service provider.
The service provider shall make a written declaration to the licensing authority on the initiation of the operation prior to the start of the operation. The notification shall be accompanied by an inspection report, or for a specific reason, a sufficient explanation and a self-control plan referred to in Article 6. The notification is regulated in more detail by a decree of the Government.
Where a provider of services substantially changes or ceases to provide healthcare services, it shall inform the licensing authority in writing.
As a consequence of the notification of the essential change, the authorising authority may, in particular, oblige the service provider to apply for a new authorisation.
The content of the notification may be laid down by a decree of the Council. (20.11.2009)
Before a self-employed person provides health and medical services within the meaning of this Act, he/she must submit a written declaration to the Regional Administrative Agency.
The notification shall contain the following information:
(1) name, personal identification number, telephone number and other contact details, training and name or business name in which the activity is conducted;
(2) health and medical services and a place where services are provided;
(3) information on the registration of the prior authorisation scheme referred to in the law on prior authorisation;
4) the place of storage of patients' documents;
(5) the date of commencement of operations;
(6) Practical experience from a doctor or a dentist.
(08.04.2012)The cessation of activities shall be notified to the regional administrative authority within 30 days of the termination of the service.
The Decree of the Ministry of Social Affairs and Health may provide more detailed provisions concerning the content of the notification, the formula and the conclusion of the notification.
The service provider and the self-employed person shall issue an annual activity report to the licensing authority. The report shall indicate the operational data on health and medical services and changes in staff, premises and activities. (29.5.2008)
The contents of the report, the formula and the adoption of the report are laid down in more detail by a decree from the Ministry of Social Affairs and Health.
Article 11 was repealed by L 17.8.1993/785.
The persons employed by the services and those working in or on the premises of the services producer shall not be allowed to express their status, their duties or their duties as a result of their status, their duties or their duties; On disability or on the measures to be taken against him or any other equivalent. The obligation of professional secrecy shall be maintained after the termination of the duties or duties.
The general guidance and supervision of private health care under this law belongs to the Ministry of Social Affairs and Health.
The management and control of the services provided for in this Act is a matter for the regional administrative authority.
Under the Ministry of Social Affairs and Health, the Ministry of Social Affairs and Health is directing the activities of the Regional Administrative Agencies in order to harmonise their policies, policies and solutions to private health care Under the supervision and control and authorisation procedures. In addition, the authorisation and control agency shall direct and supervise private health care, in particular in the case of:
(1) matters of principle or of general scope;
(2) matters relating to the territory of several territorial authorities or to the country as a whole;
(3) matters relating to the supervision of a healthcare professional in the Office for Social and Health Authorisation and Control; and
4) issues which are accessible to the regional administration.
Where appropriate, a more precise division of labour between the Social and Health Authorisation and Control Agency and the Regional Administrative Agencies will be governed by the Government Decree.
As a supervisory authority, the Law on Public Health Article 6 (6 6/1972) Of a multi-member institution.
The tasks laid down in this law and under this law shall be dealt with by the Regional Administrative Agency in whose territory the services are provided.
Hospital transport services are governed by this law and, by virtue of that, the tasks assigned to the regional administrative authority are dealt with by the regional administrative office in whose territory the place of employment is situated.
The Social and Health Authorisation and Control Agency and the regional management agencies are jointly responsible for the national information system ( Register of private service providers ) The processing of the authorisation and notification cases referred to in this Act and for the purpose of monitoring and statistical activity. The information system includes a register of private healthcare providers and self-employed persons, as well as a register of private social services, provided for in private On social services law (2011) . The functioning of the information system is responsible for the Social and Health Authorisation and Control Agency. (22/2011/933)
The authorisation authorities shall record the information referred to in Article 4 (3) in the register of private service providers. In addition to the register, the licensing authorities shall:
(1) information on changes in the operation;
(2) information on infringements of this law and of any provisions, regulations and prohibitions adopted pursuant to it, and penalties imposed by the Authority, information on the checks carried out by the Authority, their results and other controls; The necessary information; and
(3) other information necessary for the processing and statistical reporting of authorisations and notification, which do not include the identity of the person (523/1999) Article 11 The information referred to.
For self-employed persons, the regional management agencies shall record the information referred to in Article 9a (2). In addition to the register, the licensing authorities shall:
(1) information on changes in the operation;
(2) information on the scale of the activity;
(3) information on infringements of this law and of any provisions, regulations and prohibitions adopted pursuant to it, and penalties imposed by the Authority, information on the checks carried out by the Authority, their results and other controls; The necessary information; and
(4) other information necessary for the processing and statistical reporting of notifications which do not contain the information referred to in Article 11 of the Personal Data Act.
The responsible controller shall be the Agency for the Social and Health Authorisation and Control. The Office and the Regional Administrative Agencies may use the register's data to the extent necessary to carry out their duties. The Office shall be responsible for the information stored in the register and the legality of the transmission of the information under its jurisdiction. The processing of personal data shall, in addition to the provisions of this law, apply to the processing of personal data. More detailed provisions may be adopted by the Government Decree on the basis of Article 2 (2) and (3).
For self-employed persons and for persons referred to in Article 4 (3) (4), (5) and (8), the register shall be deleted from the register five years after the date on which the person entered in the register has ceased his activity As the person responsible, the manager, the patient agent or the person responsible for the register.
Without prejudice to the provisions on the use of secrecy and other information, the Social and Health Inspection and Control Agency and the Regional Administrative Agencies may be transferred from the register of private services by means of a technical service In addition, what other legislation provides for:
(1) For the Social Insurance Institution, when granting sickness insurance, pension and disability benefits, the necessary information on the private health service provider and the self-employed, as well as for determining the rates of sickness insurance, and Information on the activity reports referred to in Article 10 for the development of the compensation system; and
2) For the purposes of statistical reporting, the information necessary for the establishment of a health and welfare institution for the purposes of Article 4 and of the self-employed workers, as referred to in Article 9 (a) and Article 10, Action reports.
(22.12.2009)Before opening a technical service, the requesting authority shall provide a statement that the data protection is adequately protected.
In addition, the Social and Health Authorisation and Control Agency may disclose and disclose, through a public information network, the name or business name of the provider of private health services, the services sector and all The addresses and contact details of the operating units and sites. Non-self-employed persons may also have public information on other business activities in the public information network. However, self-employed persons may prohibit the publication of addresses and contact details.
The transfer of public personal data to non-public information networks shall be governed by the provisions of the law on public access to Article 16 (2) of the ec Treaty Paragraph 3 provides. After the notified operation of the service provider and the self-employed person, it shall be available for publication and release in the public information network for a maximum period of 12 months from the date of the notification to the licensing authority.
The authorisation for the provision of services and the registration of the notification referred to in Article 9a shall be paid. In addition, an annual fee may be charged to the service provider. The fees to be charged by the Office for the Management of the Office are laid down in more detail by a decree of the Ministry of Finance and the fees to be charged by the Ministry of Social Affairs and Health under the Decree of the Ministry of Social Affairs and Health. In the context of the State payment law (150/1992) And fees are provided for. The authorising authority may provide more detailed provisions on the payment of fees.
The regional administrative offices shall carry out the annual contributions under Article 1 (1) to the Office for Social and Health Authorisation and Control, which shall cover the costs of maintaining the register of private service providers. The contribution to the Agency for Social and Health Authorisation and Control will be further adjusted by a decree of the Ministry of Finance.
Law on public authorities' activities (18/09/1999) Notwithstanding the obligation of professional or professional secrecy or of the financial position or of any personal circumstances provided for in this Act, To the Public Prosecutor and the Police Authority to investigate the offence or to any other supervisory authority within the meaning of this Act for the purpose of carrying out this task.
The Social and Health Authorisation and Control Agency and the Regional Administrative Agencies shall have the right, notwithstanding the provisions of confidentiality and free of charge, to obtain the necessary information and reports for the purpose of carrying out their statutory duties, and Self-employed persons.
The Social and Health Authorisation and Control Agency and the Regional Administrative Agency shall be able to verify the activities of the service provider and the self-employed person, as well as the operating units and premises used for the organisation of the activities. Where there is a valid reason for carrying out the inspection. In addition, the Agency for Social Affairs and Health may, for a reasoned reason, instruct the Regional Administrative Agency to carry out an inspection. The inspection may be carried out unannounced. (22.12.2009)
The inspector shall be admitted to all premises of the establishment. The inspection shall, notwithstanding the provisions of confidentiality, present all documents requested by the inspector necessary for the purpose of carrying out the inspection. In addition, without prejudice to the provisions of confidentiality, the inspector shall be provided free of charge with copies of the documents necessary for the inspection of the inspection. The inspector also has the right to take photographs during the inspection. The inspector may be assisted by the experts necessary for carrying out the audit.
The inspection shall be maintained.
In particular, the examination of the matters to be taken into account and the precise content of the verification procedure, as well as the Protocol to be kept and its retention and storage period, may be laid down by a decree of the Government.
The Board of Health shall inform the relevant regional administrative authority of any shortcomings or maladministration in its information.
The police shall be obliged to provide the supervisory authority with assistance in carrying out the supervisory function referred to in Articles 16 and 17 and in implementing the suspension and prohibition of use referred to in Article 21.
Where, in the organisation or implementation of healthcare services, there are deficiencies or other irregularities which jeopardise patient safety, or otherwise acts contrary to this Act, the Social and Health Authorisation and Control Agency, or The Agency may issue an order for the remedying of deficiencies or omissions. When the order is adopted, a time limit shall be set for the adoption of the necessary measures. In the case of patient safety, the operation may be ordered to be suspended or the operation of the functional unit, or part thereof, of the vehicle or its equipment or device may be prohibited immediately.
The Social and Health Authorisation and Control Agency or the Regional Administrative Agency may oblige the producer of the services concerned and the self-employed person to comply with the provision referred to in paragraph 1, at the risk of the fine or at the risk of: Shall be suspended, or that the operation of the unit or part thereof, the transport vehicle or its equipment, or the device shall be prohibited.
The decision to suspend the activities of the Agency for Social and Health and the Agency and the Regional Administrative Agency, or the prohibition of the operation of a vehicle or its part, of a medical vehicle or its equipment or equipment shall be complied with. In spite of the appeal, unless otherwise specified by the appeal authority.
What is laid down in this Article does not apply to the medicines law (185/1987) , which is responsible for monitoring the safety and development of the pharmaceutical industry. If, under its control, the Social and Health Authorisation and Control Agency or the Agency has detected deficiencies or other shortcomings in the field of pharmacovigilance, they shall be notified to the Agency for Safety and Development.
Article 21 has been repealed by L 29.12.2005/1258 .
The authorisation authority may withdraw its authorisation for the provision of healthcare services if there is serious breach of this law or any provisions or regulations adopted pursuant to it.
Where, in the context of the supervision or control of a private health service, it is established that the service provider has failed to act or failed to fulfil its obligations under this law, or failed to fulfil its obligations, Other measures, the Social and Health Authorisation and Control Agency or the Regional Administrative Agency may provide the service provider or the responsible director with a comment to the contrary, or draw attention to the proper functioning of the Organisation and good governance.
The observations and observations made by the Social and Health Authorization and Control Agency or the Regional Administrative Agency referred to in this Article shall not be subject to appeal.
Article 22b has been repealed by L 12.12.2014/11 .
The penalty for breach of the obligation of professional secrecy laid down in Article 12 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.
Punishment for the provision of healthcare services privately without authorisation Article 44 (3) of the Penal Code -In. (24.5.2002)
Every intention or carelessness
(1) fails to comply with an application, notification or obligation to grant recognition under this law, or
(2) infringes the prohibition or order issued by the Authority under this law;
Shall be condemned unless there is a heavier penalty provided for in the law elsewhere, On violation of the provisions on private health care Fine.
Paragraph 3 has been repealed by L 24.5.2002/412 .
An appeal against the decision of the Regional Administrative Agency and the Office for Social and Health Protection under this Act shall be appealed to the Administrative Court, as referred to in the Administrative Law Act. (18/06/1996) Provides.
An appeal shall not be lodged against the decision referred to in Article 9 (2).
The withdrawal of the approval, suspension of operation and withdrawal of authorisation as well as the decision on the prohibition of the operation of the operating unit, of the vehicle or of the vehicle or its equipment, as well as the use of the device may be suspended Regardless of the appeal, if it is necessary for patient safety.
Where an appeal has been lodged, the appeal authority may prohibit the execution of the decision or order it to be suspended.
This Act shall enter into force on 1 January 1991.
This law repeals the Law of 24 July 1964 on private medical and research institutions (196/64) With its subsequent modifications.
The service provider of the services referred to in Article 2 (2), who performs this law upon entry into force of this Act by virtue of the law on the private medical and research institutions, or the law on the action of the self-medicator and the miller Shall be notified of the continued operation to the provincial government concerned within one year of the entry into force of this Act.
Upon receipt of the notification, the provincial government may oblige the service provider to apply for the authorisation referred to in this Act or the approval of the equivalent director by the deadline set by the Board of Directors. The decision on the authorisation or approval shall be taken within six months of receipt of the notification to the provincial government.
Where no declaration of continued operation has been made by the deadline referred to in paragraph 1, the provincial government shall withdraw the authorisation for the exercise of the activity.
More detailed provisions on the implementation of this law shall be adopted by the Regulation.
Before the entry into force of this Act, measures may be taken to implement it.
HE 46/89, tv miet. 15/89, svk.M. 243/89This Act shall enter into force on 1 March 1991.
HE 233/90, sosvkms. 44/90, svk.Met. 227/90
HE 185/91 StVM 15/92
This Act shall enter into force on 1 December 1992.
The provisions and guidelines issued by the Social and Health Government at the time of entry into force of this Act shall remain in force until the Ministry of Social Affairs and Health annuls them.
THEY 264/92 , StVM 38/92
This Act shall enter into force on 1 September 1995.
THEY 94/93 , LaVM 22/94, SuVM 10/94
This Act shall enter into force on 1 December 1999.
30/1998 , Case 31/1998, EV 303/1998
This Act shall enter into force on 1 September 2002.
THEY 17/2001 , LaVM 5/2002, No 35/2002
This Act shall enter into force on 1 January 2006.
Before the law enters into force, measures may be taken to implement the law.
The records of the service providers applying for new authorisation may be entered in the register of the private service providers prior to the entry into force of this Act.
At the time of entry into force of this Act, the county governments shall transfer the information on the providers of services referred to in Article 4 to the register of private service providers within 12 months of the entry into force of this Act.
At the time of entry into force of this Act, the Health Care Centre shall transfer from the central register of healthcare professionals a register of self-employed persons from the central register of healthcare professionals to the register 12 Within one month of the entry into force of this Act.
THEY 34/2005 , StVM 6/2005,
This Act shall enter into force on 1 October 2005.
The decision of the Administrative Authority issued before the entry into force of this Act shall be subject to the provisions in force at the time of entry into force of this Act.
THEY 112/2004 , THEY 5/2005 , HaVM 13/2005, EV 91/2005
This Act shall enter into force on 1 September 2006.
Before the law enters into force, measures may be taken to implement the law.
THEY 154/2005 , StVM 19/2005, EV 129/2005
This Act shall enter into force on 1 September 2009.
Applications for authorisation before the entry into force of this Act shall be processed in accordance with the provisions in force when the law enters into force. Authorisations issued prior to the entry into force of this Act shall remain valid until the end of the period. However, a provider of services operating in the territory of several counties may apply to the licensing authority to replace separate licences with a single permit. Where the conditions under this law for the replacement of authorisations by a single permit exist, a new authorisation shall be issued by the licensing authority which shall replace the previous separate authorisations.
Before the law enters into force, measures may be taken to implement the law.
THEY 10/2009 , StVM 6/2009, EV 23/2009
This 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 3 December 2009.
Applications for authorisation before the entry into force shall be processed in accordance with the provisions in force at the date of entry into force of the law.
Before the law enters into force, measures may be taken to implement the law.
THEY 191/2009 , StVM 36/2009, EV 151/2009
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 May 2011.
THEY 326/2010 , StVM 54/2010, EV 319/2010
This Act shall enter into force on 1 October 2011.
THEY 302/2010 , StVM 56/2010, EV 342/2010
This Act shall enter into force on 1 January 2015.
THEY 185/2014 , StVM 15/2014, EV 154/2014
