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Regulation Of The Ministry Of Social Affairs And Health Of The Patient Records

Original Language Title: Sosiaali- ja terveysministeriön asetus potilasasiakirjoista

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Ministry of Social Affairs and Health

See the copyright notice Conditions of use .

According to the decision of the Ministry of Social Affairs and Health, the law of 17 August 1992 on the status and rights of the patient (785/1992) (2) and of the Law of 9 February 2007 on the electronic processing of customer information in social and health care (159/2007) , as referred to in Law No 653/2000, by virtue of:

General provisions
ARTICLE 1
Scope

This Regulation shall apply to the drawing up of documents used in the organisation and implementation of the patient's care and to the maintenance of their and other treatment-related material. The Regulation shall apply to the (785/1992) The health care and medical care referred to in Article 2 (2) of that Law, as referred to in paragraph 4. The Regulation also applies to healthcare professionals (559/1994) Of the health and medical care referred to above, irrespective of who the professional is or whether he pursues his or her professional autonomy.

ARTICLE 2
Patient documents

Medical records and related medical records or documents, and particulars or documents related to the medical death warrant, as well as other medical records or documents, as well as other related medical records Or any other information and documentation obtained.

On the Law on the electronic processing of customer information on social and health care (159/2007) The national archiving service referred to in paragraph 1 shall be stored in electronic medical records for technical records consisting of one of the same conditions as those relating to the service event referred to in Article 3 (5) of that Law. The markings on the data sheet and have the same retention period. The recording of the patient document may include entries made by different persons involved in the patient's treatment or related tasks.

The electronic medical records to be stored in the archiving service shall constitute a complete set of documents by means of a series of personalised service activities and service codes. When documents are deleted from a service event or a service package, the entry shall remain in the repository.

General principles and requirements
ARTICLE 3
Data integrity and availability

Medical records shall be drawn up and kept by means of instruments and methods, that the integrity and availability of the information contained in the documents can be safeguarded as a storage period.

However, the public authorities' medical file shall be governed by the law on public access to documents (621/1999) Article 18 .

§ 4
Access rights to information contained in the medical file

Patients taking part in the patient's treatment or in related tasks shall only deal with patient documents to the extent that they are required to perform their duties and responsibilities. Access rights to those working in the health care unit shall be defined in detail.

The electronic patient information system shall have a service-rights management system that allows each user to define the access rights to the patient documentation and the different functions of the patient information system. The user of electronic patient information systems shall be identified and identified in such a way as to ensure that the user is explicitly verified.

The daily and summary marks of psychiatry and hereditary medicine should be protected in an electronic patient report under Article 6 (2) of the Law on electronic customer information on social and health care. A confirmatory application for service events or service packages other than those of these specialisms. However, the protection requirement does not apply to any information contained in those data and critical risk data.

§ 5
Acquisition of services

When providing services from another provider of services, a health care unit and a professional health care professional shall agree in writing with this in writing to the The obligations and responsibilities relating to the registration and processing of data and to ensure compliance with the confidentiality and confidentiality provisions of the information contained in the patient documentation.

Medical records arising from the activities referred to in paragraph 1 shall include the manner in which the service is acquired and the subscriber, producer and executor of the service.

Drafting of patient documents
ARTICLE 6
Right to labelling patient documents

In the case of medical records, medical professionals participating in the care of the patient, and in accordance with their instructions, shall also be included in the patient's treatment in so far as they are involved. In accordance with Article 2 (3) of the Law on Healthcare professionals, medical students taking part in the treatment of a patient should be allowed to make notes in the course of their activities. Otherwise, the entries made by a medical student shall be approved by his superior, his director or his authorised person.

Persons other than health professionals participating in the transport of sick persons shall be entitled to make medical records in accordance with the instructions of the healthcare professional responsible for the operation.

The healthcare professional shall be responsible for the identification of the patient documents made on the basis of his/her words.

Furthermore, the labelling of medical records may consist of the labelling necessary for the provision of healthcare equipment.

§ 7
Principles and requirements for the labelling of patient documents

In order to ensure the organisation, design, implementation and monitoring of good care for the patient, the patient documentation shall be accompanied by sufficient information. Labelling must be clear and understandable, and only widely known and accepted concepts and abbreviations must be used. Patient documentation shall be a source of information if the information is not based on the own research findings of a professional or where non-patient information is recorded in the patient documentation.

If, in view of the observation of a patient's life situation or other comparable reasons, it is necessary to record the detailed sensitive information on the person's own life or his/her own life situation, this information shall be recorded in the patient's A separate document forming part of the documentation of the service event, unless it is justified in the light of the whole of the patient marking system to record such information in any other way.

Those opinions and certificates drawn up to be presented to another organisation or body shall be signed by the author of the document. An independent professional health care professional shall sign all other medical records to be stored in the archiving service by means of an electronic signature or By means of an electronic signature by an organisation authorised by the organisation. Other medical records in the National Archives Service referred to in Article 14 (1) of the Act on the electronic processing of customer information in social and health care should be signed by: By means of an electronic signature by an operating unit or an organisation authorised by it.

The structure and labelling of electronic patient documents stored in the archiving service must be used in accordance with Article 14 (2) of the Law on the Electrical Treatment of Customer Information on Health and Welfare of the Department of Health and Welfare To the national code service referred to in the national code service, and to the technical specifications maintained by the National Pensions Office.

§ 8
Deadlines for the labelling of documents and submission of certain documents

The labelling of the patient documents should be made without delay. Labels shall be made no later than 5 days after the patient leaves the reception or the service event ends.

Detergents should be drawn up and delivered without delay. In addition, in an urgent case, the consignment will be sent to an extension post within five days of the need to do so.

A summary of the treatment given to the patient with follow-up instructions should be provided to the patient and to the post or any other place that has been agreed with the patient, in accordance with the patient's consent and without delay. The summary should also be sent within five days of the end of treatment.

Health care services provided by the National Archives Service, as provided for in Article 14 (1) of the Law on the Electrical Treatment of Social and Health Customer Information. The professional person shall establish electronic medical records and record them in the archiving service within the time limit in which the document must be drawn up. The electronic dictation shall be readable to read before entering the archiving service.

The time limits provided for in this Article may be waived only for a specific reason.

§ 9
Patient report

The health care unit and the self-employed health care professional must keep a chronological patient report on each patient in chronological order.

The patient report or parts thereof shall not be rewritten or replaced by a photocopy or any other equivalent.

Significant information on patient documentation
ARTICLE 10
Basic information on patient documentation

The patient report shall contain the following basic information:

1) the patient's name, date of birth, identification number, domicile and contact details;

(2) the name of the health care unit or the professional health care professional;

3) the name, status and date of entry of the author of the label;

(4) for incoming data, the date of arrival and the source;

(5) in the case of a minor, the name and contact details of the guardians or other legal representative and the name and contact details of the legal representative assigned to the adult patient.

Medical records shall also include, where appropriate, the following information:

(1) the name, family relationship and contact details of the family or other contact person reported by the patient;

(2) the patient's mother tongue or contact language;

3) the patient's profession;

(4) the insurance company of the patient's employer in the event of an accident at work or an occupational disease;

(5) the insurance company if the insurance company may be paid by the insurance company;

(6) the consent of the patient for disclosure.

If the technical letter of the marking referred to in paragraph 1 (3) is different from that of the marking, the record shall also include the records of the technical author of the label. In the case of an electronic patient document, this information shall be entered directly on the user information of the patient information system and the time of registration of the marking automatically from the patient information system.

ARTICLE 11
Key management information in the Patient Report

The patient report shall be marked on each patient's service event. Data relating to service events shall, to the extent necessary, reveal the result, pre-data, current status, observations, research results, problems, diagnosis or health risk, conclusions, management planning, implementation and monitoring, disease And the final statement.

ARTICLE 12
Information on the flow of sickness and care

The labelling of the patient documentation shall be sufficient to identify the criteria for the diagnosis, the treatment chosen and the treatment solutions adopted. The choice of methods of research and treatment with different effects and risks shall be made to indicate the basis on which the chosen method was chosen. The criterion for each measure must be clearly defined in patient documentation.

The labelling of the patient documentation shall indicate how the treatment has been carried out, whether there has been any special treatment during the course of treatment and what solutions have been found during the course of treatment. Where appropriate, the participants shall be able to find out.

A surgical or operational report containing a detailed description of the performance of the operation and the observations made during the procedure should be drawn up. The report shall state the reasons for the solutions adopted during the procedure.

Data on permanent implants, implants, dental fillers and other materials should be labelled with the accuracy that they can be identified at a later date.

All the prescriptions issued, medical reports, medical certificates, invalidity certificates and other certificates, and the rehabilitation plan, shall be recorded in the patient's report in accordance with the date of their adoption. In the electronic patient information system, the above indications may be made by linking them to that service event.

If a patient's right to self-determination is limited (1116/1990) , substance maintenance law (1999) , infectious disease (183/1986) Or under any other law, it shall be accompanied by a separate indication in the medical file indicating the cause, nature and duration of the measure and the assessment of its effect on the patient's treatment, as well as the names of the doctor and the supplier who ordered the operation.

ARTICLE 13
Labelling of risks, harmful effects of treatment and suspected damage

The patient report shall be marked on the known patient's allergy to medicinal product, material allergy, hypersensitivity and other relevant treatment.

Information on health hazards arising from the work of the worker must be included or attached to the occupational health records of the occupational health service.

The report shall contain information on the adverse effects of the research and management measures found and on the inefficiency of treatment.

For suspected cases of patient, equipment and medical damage, details of the patient's report shall be made with details of the description of the damage, an explanation of the healthcare professionals involved and the medical and medical damage. Description of the injury suspected. Identification of the medicinal products and equipment must be identified. Labels shall be made immediately after the injury suspicion has occurred.

ARTICLE 14
Information on parttime care

A patient's patient report should be made available in chronological order, in chronological order, on changes in his condition, the studies performed and the treatment administered to him. In addition, the patient is being treated as part of a patient report on a daily basis, on a daily basis, on account of his/her condition, treatment and related matters.

At least every three months after the start of the treatment period, the doctor should make a follow-up summary of the patient documentation of the patient in hospital treatment, regardless of whether the patient has undergone any substantial changes.

§ 15
Labelling of consultation and management negotiations

A health care professional who is in charge of medical treatment shall report to the patient on a telephone conference of the patient's diagnosis or treatment as well as other similar consultations and treatment. Such labelling shall indicate the date of consultation or negotiation, the parties involved and the treatment solutions and their implementation.

If the consultation is carried out in such a way that the patient can be identified, the consultant shall also, in the circumstances referred to in paragraph 1, make the information on the consultation which he has provided on the patient file or otherwise remain The reply.

ARTICLE 16
Information on first treatment and medical transport

Medical records shall be made the necessary particulars of the treatment and supervision of the patient, as well as medical care. If a doctor takes part in first treatment or medical care in person or on the basis of consultation, this should be reflected in patient documentation.

§ 17
Final statement of treatment

A final opinion shall be drawn up for each section of the compartment or institution. The final opinion of the treatment should accordingly be drawn up in a policline treatment cycle, after the end of which the treatment ends or the healthcare provider moves to another health care unit or a healthcare professional independently. To a professional, unless there is a particular reason for this derogation.

In addition to the summaries of treatment, the final opinion should include clear and detailed guidance for the implementation of patient monitoring and follow-up therapy. The final opinion should further describe any abnormalities in post-patient recovery and patient status at the end of the service event.

ARTICLE 18
Information on the patient's access to information and treatment statements

If the patient in the situation referred to in Article 4 (1) of the law on the status of the patient and the rights of the patient has to wait for access to treatment, the patient documentation must be labelled for the reason of the delay, the patient's time of access and, Have been reported to the patient. The patient documentation shall also include information on the patient's guidance to the rest of the treatment. In the event of a change in time of treatment, the patient documentation shall indicate the new date, the reason for the change and the fact that the patient has been informed of the change.

Patient documents must be labelled with a view to reporting on matters relating to the treatment of the patient referred to in Article 5 of the Law on the status and rights of the patient. If the report has not been given, it should be included in the patient's file.

If a patient refuses a study or treatment, the refusal shall be made in a reliable manner in the case of medical records.

If the patient wishes to express his firm commitment to the future, this should be made clear, the patient's self-certification mark, or a separate document expressing the will of the patient. In addition, the patient documentation shall be accompanied by an indication that the patient has been given an adequate explanation of the effects of compliance. The marking of the will to change and remission shall be subject to the provisions of Article 20 of the correction of the error in the patient documentation.

If the patient is receiving information pursuant to Article 13 (3) (3) of the Law on the Status of the patient and the rights of the patient, the transfer of data should be reported to the patient if the patient's unconsciousness or other The comparable reason ends. The notification shall include the information disclosed, the basis for the donation and the date of delivery. Information on the notification to the patient should be recorded in the patient's file.

§ 19
Labelling for participation in treatment in specific situations

If a minor is treated in the context of the situation referred to in Article 7 (1) of the Law on the Status of the patient and the Rights of the Child, in agreement with him, this should be made in the case of medical records. It must also be made clear whether the underage patient allows for the provision of information on his or her medical condition or the provision of such care to her guardian or other legal representative, or whether she is in accordance with Article 9 (2) of the Law on the status and rights of the patient , prohibited the provision of information.

If the adult patient is treated in the circumstances referred to in Article 6 (2) and (3) of the Law on the Status and Rights of the patient, in agreement with his/her legal representative, next of kin or other close relatives, this should be made: Patient documentation.

§ 20
Correction of medical records

For the purpose of correcting the information in the case file, the Personal Data Act shall apply (523/1999) Article 29 .

The correction of the statistical documents shall be made in such a way that the original and corrected entry is later legible. The name of the repair person, the service station, the date of correction and the criterion of the correction must be entered in the medical file.

If patient documentation is deleted from the point of view of the patient's care, the patient file shall be marked with it, the author and the date of removal.

ARTICLE 21
Labelling of data transmission

The release of the information contained in the patient documentation referred to in Article 13 (2) and (3) of the Law on the status and rights of the patient should be entered in the patient file. The labelling shall indicate when and what information has been disclosed to whom the information has been disclosed, who has given up the information and whether the donation has been based on the consent or the law of the patient's written, oral or factual context. The patient's declaration of intent by which he has prohibited his/her information shall also be entered in the patient documentation.

However, Article 5 and Article 14 (1) of the Law on the processing of electronic customer information in the field of electronic medical records shall apply to the labelling of electronic patient documents.

Preservation of patient documents
§ 22
Responsibility for conservation

The maintenance of patient documents and other material related to the treatment is carried out by the health care unit or by the professional health care professional who has been born, unless social and The law on the electronic processing of customer information in the healthcare sector. If the patient document is of such a nature that the patient's health or health care is adversely affected by the labelling separately in each unit of action, the patient document may be treated as a patient's response to another healthcare However, with the consent of the patient or of his or her legal representative, the operational unit shall be transferred to the activity unit indicated in the original. The healthcare unit shall be informed of where the original documents have been transferred.

ARTICLE 23
Storage and disposal of patient documents and other material related to management

Medical records and samples and organ models containing biological material arising from research and treatment shall be kept for at least the time referred to in the Annex to this Regulation. The retention of patient documents, samples and models at the end of the retention period shall be laid down in Article 12 (2) of the law on the status and rights of the patient.

Where the retention period referred to in the Annex to this Regulation is completed, or where the patient documentation, samples and organ models retained after that date are no longer necessary for the organisation or implementation of the patient's care, there is a need for The responsible health care unit and the professional health care professional acting independently, shall ensure that patient documents and any other material referred to above is immediately disposed of and in such a way that the Information is available.

For its part, the Social Insurance Institution shall ensure the technical disposal of documents stored in the archiving service on the medical file of a health care unit or a professional health care professional At the end of the retention period. Prior to disposal, the National Pensions Office shall inform the above entities.

§ 24
Preservation of log data

The log data referred to in Article 5 of the Law on the Electrical Treatment of Social and Health Customer Data relating to the use and disposal of electronic patient information shall be kept intact and unchanged for at least 12 years The birth.

For its part, the Social Insurance Institution shall ensure the technical disposal of the log data stored in the archiving service by a health care unit or a professional health professional At the end of the retention period. Prior to disposal, the National Pensions Office shall inform the above entities.

ARTICLE 25
Implementation of the viewing connection

If patient information is provided through the national archiving service by means of an electronic view, the patient should be identified in a reliable manner. When the healthcare provider informs the patient in accordance with Article 17 of the Law on the Electrical Treatment of Customer Information on Healthcare, the patient should at the same time be informed about the possibility of using an electronic view The identification procedures required for use.

Entry into force
§ 26
Entry into force and transitional provisions

This Regulation shall enter into force on 1 August 2009.

This Regulation repeals the Ministry of Social Affairs and Health of the Ministry of Social Affairs and Health of 19 January 2001 on the establishment of patient documents and the preservation of their and other medical material (2001) .

Article 2 (2) and (3), Article 4 (2) and (3), Article 7 (3) and (4), Article 8 (4), Article 10 (3), Article 21 (2), Article 23 (3), Article 23 (3) and Articles 24 and 25 Shall, however, only apply from 1 April 2011, unless documents are processed by means of the national information system services referred to in Article 14 of the Law on the electronic processing of customer information on social and health care.

The retention periods referred to in the Annex to this Regulation shall apply to medical records drawn up or received on or after 1 May 1999. However, if the period of custody of the document is calculated on the basis of the death of the patient, the retention periods shall apply to documents relating to the person who died on or after 1 May 1999.

Medical records drawn up or received before 1 May 1999, or if the period of custody of the document is calculated on the basis of the death of a patient prior to 1 May 1999, As well as the retention periods laid down in the Decision of 14 April 1989 on the disposal of municipal documents in the medical records of the Corrections Service. In addition, the archives of the State Archives and the Archives have been applied separately for the preservation of documents.