Regulations regarding patient


Date FOR-2000-12-21-1385


Ministry of Health and Care Services


Published In 2000 3107 (Notes)


Commencement 01.01.2001

Edited
FOR-2013-01-17-61

Changes


For
Norway

Legal

LOV-1999-07-02-64-L-40, LOV-1999-07-02-64-L-42, LOV-1999-07-02-64-§43, LAW-1999-07-02- 64-L-45, LOV-1999-07-02-61-3-2, LOV-1983-06-03-54-§1-3a, LOV-1999-07-02-63-§5-1 | ||
Promulgated



Corrected 06.05.2002 (notes added) 10.05.2013 (Notes changed)

Short Title
Regulations on Medical

Chapter Overview:

Main part
Remarks regulation on medical

Adopted by Health and Social Affairs (now the Ministry of Health) 21 December 2000 pursuant to the Act of 2 July 1999 no. 64 relating to health personnel (Health) § 40 subsection § 42 subsection § 43 fourth paragraph and § 45, second paragraph, the Act of 2 July 1999 no. 61 of the specialist health Services (specialized health Services Act) § 3-2 second paragraph, the Act of 3 June 1983 no. 54 on the dental health (dental Act) § 1-3a goodness 2 . July 1999 no. 63 on patient and user rights (patient and user rights Act) § 5-1, sixth paragraph.
Changes: Amended by regulations 20 Dec 2001 no. 1580, 19 Dec. 2002 No.. 1714, February 25, 2003 No.. 232, 2 Dec 2009 No.. 1504, November 9, 2012 no. 1045, January 17, 2013 No.. 61.

§ 1 (Regulations Content) regulations provide further rules concerning:

A)
health professionals' duty of documentation, including the contents of patient records, accounting, rectification, cancellation, storage, transmission, access and destruction of patient records, ref. The Health Chapter 8

B)
businesses responsibility for establishing and organizing the records system, cf. Specialist Health Service Act § 3-2, Dental Health Services Act § 1-3a and Municipal Health Service Act § 1-3a and

C)
right of access to records, ref. Patient and user Rights Act § 5-1.

§ 2 (Exception for pharmacy) Regulation does not apply to personnel in pharmacy health care provider.

§ 3 (Definitions) In these Regulations apply:

A)

Medical / journal: collection or compilation of recorded / registered information about a patient in connection with health care, ref. The Health § 40 subsection

B)

Health care: act contemplated in the Health § 3 subsection and patient and user Rights Act § 1-3 letter c)

C)

Healthcare: personnel as described in the Health § 3 subsection

D)

Patient: person contemplated in patient and user Rights Act § 1-3 letter a) and

E)

Journal Manager: Person who featured in the Health § 39, second paragraph.

§ 4. (Journal System) activities where the provision of health care need to create patient records system. The system must be organized so that it is possible to comply with the requirements established pursuant to law, including rules on:

A)
access to medical records, ref. The Health § 41 and Patient Rights § 5-1

B)
access to and disclosure of medical records, ref. The Health § 25 and § 45 as well as patient and user Rights Act § 5-3

C)
enroll duties and obligations to inform, ref. The Health Chapters 6 and 7,

D)
editing journal, ref. The Health § 39, second paragraph,

E)
rectification and erasure, ref. The Health § 42, § 43 and § 44 and

F)
protection from unauthorized access, ref. The Health Chapter 5, including proper storage, ref. The Health § 21

§ 5. (Creation and organization of journal) There shall be established a record for each patient. As a general rule applied an overall record for the individual patient even though health care is provided by several within the business.
The main rule about an overall record for the individual patient may be waived if the business units both professionally and organizationally clearly emerging as separate agencies.
Where it is not appropriate to aggregate the journal, the Journal can be divided into a main journal and an additional journal. It should then be evident from the main journal that there exists an additional journal and what documentation it contains.
If patient records partly electronic and partly as paper records, it must be clear by both the documentation recorded in the electronic journal and what documentation is recorded as paper records.

§ 6. (Journal Manager) Health institutions shall designate one person who will have the overall responsibility for the individual patient record including to decide what information should be in the patient record, ref. The Health § 39, second paragraph.
In health institution it is the journal responsible to ensure that a record is created.
It must emerge from the records who is responsible for the records.

The journal administrator can not decide that the information shall be excluded from the record if the information is relevant as proof of disagreement between healthcare professionals in professional issues concerning the medical treatment of the patient.

§ 7 (Requirements for record keeping) Patient records shall preferably be written in Norwegian. Danish and Swedish can be used to the extent it is justifiable. In special cases, the Norwegian Board of Health grant permission to use another language.
Records shall ongoing basis. Ongoing is defined that records be made without undue delay after the health care is provided.
The records shall be dated and signed.

§ 8 (Requirements for the Journal's content) Patient records shall contain the following information if they are relevant and necessary: ​​

A)
Sufficient information to identify and contact the patient, including the patient's name, address, municipality of residence, date of birth, telephone number, marital status and occupation.

B)
Information on who the patient's next of kin, ref. Patient Rights § 1-3 letter b and Mental Health Care Act § 1-3, and how competent, if necessary, can be contacted.

C)
If the patient does not have to consent, shall be recorded who consents on behalf of the patient, see. Patient Rights Act Chapter 4.

D)
When and how health care is provided, for example in connection with ordinary consultation, telephone, home visits or in a health institution. Date of admission and discharge.

E)
reason for the health care, information about the patient's medical history and information about ongoing treatment. Description of the patient's condition, including the status at admission and discharge.

F)
Preliminary diagnosis, observations, discoveries, research, diagnosis, treatment, care and other follow-up are implemented and the result of this. Plan or agreement for further action.

G)
Information as mentioned in § 6 fourth paragraph.

H)
Considerations that have led to measures derogating from the applicable guidelines.

I)
If it is given advice and information to patients and their families, and the gist of this, see. Patient Rights § 3-2. Patient any reservation against information.

J)
If the patient has consented to or opposed specified health care. Patient serious conviction or refusal health care, ref. Patient Rights § 4-9. Patient consent or reservation concerning information processing. Patient other reservations, claims or assumptions.

K)
If it is asserted rights as access to medical records and demands for rectification and erasure, the outcome of this, the rejection that the patient is made aware of the right of appeal, and any appeal in such a case.

L)
exchange of information with other health professionals, such as referrals, discharge summaries, admission petitions, results from requisitioned surveys attest copies mm

M)
Patient regular doctor. The health professional who has requested admission or have referred patient.

N)
Individual plan for Specialized Health Services Act § 2-5, the Mental Health Act § 4-1 or the Municipal Health Act § 6-2a.

O)
Sick leave and testimonials.

P)
Statements about the patient, such as expert statements.

Q)
If it is given information to the police, child welfare, health and care services, social services, etc., And if consent is obtained from the patient or the person who is competent to give consent in the case. It shall state the information given.

R)
Involuntary admittance, another use of force, the factual and legal basis for such coercion and any supervisory decisions, ref. The MHA.

S)
A professional begrunnelse1 in those cases the doctor has blocked pharmacy generic bytterett.2

T)
Information on whether the patient with mental illness, drug addiction or serious physical illness or injury have minor children.

U)
Parents who have consequence for the child's treatment situation, including information needed about parental health.

Working documents, the patient's own documentation, radiology images, video and sound recordings, etc. is regarded as part of the record until the required information is recorded properly.
Data other than those mentioned in the first and second paragraph must be included in the register to the extent that they are relevant and necessary.

§ 9. (case summaries) Upon discharge from the health institution shall discharge report (summary of medical records) is sent health personnel who need the information in order to provide the patient with proper monitoring.
The same applies to outpatient care or treatment by a specialist.

The patient should be given the opportunity to state who discharge summaries to be sent. Unless otherwise stated or indicated, sent epicrisis to the admitting / referring healthcare provider and the patient's regular doctor.
Discharge report shall be submitted within the proper time after the health care is completed.

§ 10. (Privacy) Documentation shall be treated in accordance with the provisions of and pursuant to the Personal Data Act. With the limitations imposed by the Health § 21 ff, § 45 and patient and user Rights Act § 5-3 permits healthcare professionals and others given access to a patient record.

§ 11. (Transparency) The patient or a representative of the patient and their families are entitled to access to records under the rules of patient and user Rights Act § 5-1, ref. The Health § 41.
It will be facilitated that Sami language, foreign language and people with disabilities can exercise the right of access, see. patient and user rights Act § 3-5.

§ 12. (A copy or print journal) When the right of access apply for patient and user Rights Act § 5-1, it may by delivery of copy or print journal required payment. The payment shall not exceed an amount equivalent to that provided for printing / copying of medical records in the current tariffs for private practitioner and private practice specialist determined in relation to the Insurance Act § 5-4 on grants to cover expenses for examination and treatment by physician.

§ 13. (Editing, correction and deletion) After an journalnedtegnelse is signed, it can be changed only by the rules on rectification and erasure in the Health § 42, § 43 and § 44. The journal responsible health institution can still edit journal Regarding journal records that are signed. Such editing will take place in consultation with the health professionals who have made records unless it is clearly unnecessary or impracticable.
In health institution decided rectification and erasure by the Health § 42, § 43 and § 44 of the journal responsible. The decision shall where practicable be taken in consultation with the health professionals who have made the record in the journal.
If a demand for correction or deletion is denied, the patient should be informed about the appeal, ref. The Health § 42 subsection, § 43 third paragraph and § 44 second sentence.

§ 14. (Requirements for retention and storage) Patient records must be kept so that they are not going to damage or corruption, and prevent unauthorized access to them.
Records shall be kept for the sake of health assistant character no longer deemed to be needed. Otherwise registry information then be preserved in accordance with the Archives Act or other legislation should be deleted, ref. The Personal Data Act § 28. Transfer or deposit as mentioned in the third and fourth paragraphs should not occur until it is gone for at least 10 years after the last entry in the records.
Records in the public sector subject to the provisions relating to public archives and pursuant to the Archives Act, including provisions on conservation, disposal and transfer to state, county or municipal archival repository.
Records in private business may be delivered to a public archive repository or deposited in another storage institution.

§ 15. (Transfer of records, cessation of operations, etc.) When replacing GP patient may require that patient records are transferred to the new GP. The same applies when changing healthcare professional.
Journal by health transferred to the school health when the child starts school unless the person who has parental responsibility oppose it. The same applies if your child switches schools.
Upon transfer or cessation of activities can the management decide that patient records be transferred to another business. Upon termination of formal working partnership applies regulations on business overall patient for formalized joint ventures. Each patient may oppose such a transfer or demand their records transferred to another specific healthcare or to another particular business. If it is impracticable patients should be made aware of their right under the second sentence.
If the transfer or cessation of business is not appropriate to transfer patient records to a specific healthcare provider or to a particular business, and business are unable to care for them, they can be delivered to the public archive repository, deposited in different storage institution or delivered to the county. Records supplied to the County kept for 10 years and records can then be destroyed after consultation with the Director General or transferred to public archival repository.
For journal in the public sector applies rules on the transfer of stock and delivery of archive Archive Regulations § 3-22, § 3-23 and § 5-3.


§ 16. (Destruction etc.) Destruction of records information and replacement of IT equipment must be carried out so that patient information can not come hands of unauthorized persons.

§ 17. (Commencement) regulations come into force on 1 January 2001.

Remarks regulation on medical

To § 1:

Regulation provides in some areas more detailed rules than the law, and it fills the law also in some areas where the law does not have their own rules, but only authorizes the ministry to issue regulations. Some provisions of these regulations have little independent meaning, but refers to other relevant regulations and are included for clarity.

To § 2:

The definition of health professionals in the Health § 3 first paragraph. 2 includes personnel in the health care service or pharmacy health care provider. To the extent that employees in pharmacies after that is regarded as the healthcare they will initially also be obliged to keep records by health personnel § 39 first paragraph.
The health care provided within the pharmacy as part of pharmacy operations will generally have a different character than health care provided within the health institutions or by authorized health professionals who runs his own business. Health Council in pharmacies will essentially consist of guidance on the use of drugs, in large part to anonymous customers. The provisions of this regulation is not suitable for the type of health care. Personnel in the pharmacy exempt therefore from scope of the regulations.

To § 3:

To letter a:
term "patient" includes records carried in all types of businesses where the provision of health care (except for pharmacies, cf. § 2). In such school health and occupational health will recipients of health care often do not have health problems, illness or injury. They are still patients in regulation and patient and user rights Act, cf. The definition of subparagraph d. The regulations used extensively short form "journal" instead of "patient."
A journal will contain records made by health professionals in connection with various types of health care, but can also include some form of documentation, such as including radiographs, photographs and test results. § 8 stated a number of the types of information that will be part of the record if they are relevant to the appropriate patient.
Patient Administrative Systems as many health institutions use in their operations do not fall under the term "journal" which is a compilation of information on a single patient. See also the notes to § 10
To letter b:
term "health care" is defined by reference to the Health and patient and user rights law that have definitions. In patient and user Rights Act § 1-3 letter c "health care" is defined as "actions that have preventive, diagnostic, therapeutic, health-preserving, rehabilitating or nursing and care purposes and conducted by healthcare professionals." The definition in the Health § 3 subsection is very similar, but does not mention nursing and care purposes. It is clear that the concept also in the Health should include care. So shall it also be understood in this regulation.
For letter c:
term "healthcare" is defined by reference to the Health § 3 subsection. As stated there are health professionals not only personnel with an authorization or license health care providers, but also other personnel in the health and care services or pharmacy that perform actions referred to in the definition of "health care", ref. B and notes thereto. Furthermore, pupils and students in connection with health professional training perform such acts, to be regarded as a healthcare professional. Personnel in the pharmacy are exempt from scope of the regulations, cf. § 2 and notes thereto.
For paragraph d:
term "patient" is defined in the Regulation by reference to patient and user Rights Act § 1-3 letter a how patient is defined as "a person who contacts the health and care services with a request for medical assistance, or health services or offering health care as the case "and will thus also include many people who are not sick or injured, but such as receive medical assistance of a preventative nature.
To Letter e:
term "responsible for the records" is not used in the Health or patient and user rights law. The term refers to the person by the Health § 39 second paragraph designated as having overall responsibility for a journal. The requirement for designating responsible for the records do not apply any business where the provision of health care, but only health institutions. Reference is made to § 6 of the Regulations on the registry administrator, and the notes thereto as regards what constitutes a health institution.

To § 4:


For the first paragraph:
activities where the provision of medical care must have records system, ie a system for recording and storing patient records. This applies whether recorded in a journal electronically or on paper, although the system aspect might be more prominent when using electronic medical records systems.
Regulations places no responsibility to maintain records system at any particular part of the business. However, it will be business owner and management which has overall responsibility for the establishment of a records system that meets the requirements. It follows Filing Systems Act (Act 18 May 2001. 24 on health records and processing of health information) § 6, second paragraph that the regional health authorities and health authorities, municipalities and other public or private sector which uses treatment-oriented health registers, the data controller.
Journal system should normally be shared across the enterprise, and will in many cases be used by a large number of health workers from different professions. Health personnel have an independent responsibility to keep records in accordance with legal and regulation requirements, but the company as such is responsible for facilitating this. Reference is made to Specialized Health Services Act § 3-2, first paragraph after health institution covered by this Act shall ensure that the registry and the information systems of the institution is justifiable, and to health and care Act § 3-4 and Dental Health Services Act § 1-3a whereupon respectively the local authority will plan, organize and facilitate the (county) municipality, (dental) health and care services and health care providers can meet requirements prescribed by law or pursuant to law or regulation.
Journal system must make it possible to comply with requirements stipulated in or pursuant to the Health, patient and user Rights Act, the Health Register Act and other relevant laws and regulations, such as the Archives Act (see § 14 of these Regulations and the notes to this) and the Personal Data Act.
In enterprises where several makes records in journals should be developed internal guidelines for the structure and management of records. It is important to have clear guidelines for registry administrator's role.
Filing Systems Act is a special in relation to Personal Data Act (Act 14 April 2000. 31 on the processing of personal data). Personal Data Act and regulations complement Filing Systems Act, cf. Filing Systems Act § 36. Filing Systems Act apply to the processing of health information in health management and health and care services which fully or partly by automatic means and other processing of health data if these are or will be included in a register. An organization's patient records would constitute a treatment directed health registry in health register legal sense. In Filing Systems Act uses the term "treatment" and "data controller" of the processing of health data. It does not require a license from the Data Inspectorate to treat patient / client data by Filing Systems Act § 6, but the data controller for the record system must report to the Inspectorate, ref. Filing Systems Act § 29 and § 30
King may by Filing Systems Act § 16 fourth paragraph make regulations safety when treating health information. The vessel may be further requirements for electronic signatures, communications and long-term storage, for approval (authorization) of software and the use of standards, classification and coding systems, as well as the national or international standard systems to be followed. Moreover, the King pursuant to the Health § 46 subsection issue regulations with further provisions on the use of electronic records, including setting up requirements for training and measures to ensure that outsiders do not gain knowledge of or access to the records. It has not yet issued regulations pursuant to these provisions.
Rules on information security in Personal Data Regulations chapter 2 apply to the processing of health data, until otherwise may be specified explicitly in the Regulations for Filing Systems Act.
Health Directorate provides some recommendations in Circular IS-1/2002 Basic standard for electronic medical records. The circular describes a guiding standard for electronic health records as the Centre for IT in healthcare AS (KITH) completed and published in summer 2001. The standard is entitled "Electronic medical standard, Architecture, archiving and access control" and published on KITH Web site: www.kith.no . The standard provides a proposal or a description of how the electronic patient record systems can be built up, and how the requirements of and pursuant to the Health, Specialist Health Service Act and the Health Register Act can be safeguarded.

In connection with electronic medical records and electronic records system can distinguish between technical standards and content standards. Technical standards will for example be preconditions for cooperating ICT systems (ICT = Information and Communication Technologies) in a national health network. The ongoing standardization work both internationally and nationally and development in IT is fast. Coding systems and classifications are examples of content standards. Classifications are often comprehensive standards that change over time and it is important that access to current versions, while all previous versions of codes and classifications that are used in medical records must be retained. A change in the international classification of diagnoses (ICD) shall not, for example could mean that the importance of already registered diagnostic codes changed in the electronic records.
The use of electronic record, without the "paper-backup", increases their vulnerability and require good procedures etc. to prevent loss or unavailability. Businesses that use only electronic journal must ensure establishing procedures and guidelines. The Ministry will consider whether to grant further guidelines or regulations stipulated requirements about how these matters should or must be safeguarded.
Using electronic records system may sometimes be necessary to read a backup copy of the electronic record. It may be undertaken rectification and deletion of records after backup copy was made. It must be established procedures to ensure that in such cases are made correction / deletion of the restored journal so that it is updated with the lost records.
See notes to § 17 regarding solutions to certain potential transition problems associated with electronic patient record systems in relation to these regulations.

To § 5:

For the first paragraph:
There shall be established journal for each patient receiving health care.
The main rule is that it should be applied one patient for every patient in a business, even though health care provided by many different people and many of them have journaling duty. Journal records or other records material from all healthcare professionals in the business collected one record for each patient, even if the business is divided into several departments. There are some exceptions to the general rule, cf. Second paragraph.
Use of an overall patient can in larger businesses entail challenges with regard to the observance of confidentiality and who will have access to the information in the records. All information in the register shall be accessible to all who use the register unless the patient agrees. Exchange of confidential information between healthcare providers should only happen when it is necessary to provide proper health care, or where they have other legal basis for providing such information, ref. The Health Chapter 5.
For the second paragraph:
Waivers the general rule single unified patient records may be relevant for example in hospitals with both somatic and psychiatric departments. In such cases, both practical considerations and privacy considerations speak for applying separate records. It is natural that it is the management that makes any decision to separate records.
In the third paragraph:
provision specifies that, for practical reasons can share register. There is no question of a split in relation to different people leading journal, but a purely practical subdivision where the journal has become large and unmanageable. Material that is not needed in the current situation can be added in a supplementary journal that does not follow the main journal. This may include test results and x-rays, etc. as a prior health condition, illness or injury that is not particularly relevant in connection with the health care patient now receives. However, it must be stated that there are material in an additional journal and the type of journal material this is, so that it can be easily assessed whether there is a need for it and in that case are forward. Some health institutions practicing such a scheme with the concepts of A-journal and B journal.
For the fourth paragraph:
For healthcare professionals leading electronic record may be necessary to store such discharge summaries and other documents received from other health care professionals as well as photographs, radiographs, etc. in a paper-based records, unless the material is scanned into the electronic journal or received electronically so that it can be stored in the electronic journal. Just as when using the main journal and additional journal after the third paragraph, must make it clear that there is an electronic and paper-based records and the type of documentation contained therein.

To § 6:


According to the Health § 39 second paragraph shall in health institutions designate one person to have overall responsibility for the individual journal, including making decisions relating to what information should be in the records. The requirement for designating responsible for the records do not apply any business where the provision of health care, but only health institutions. In the Health § 3 fourth paragraph is "health institution" is defined as an institution that is Specialized Health Services Act or the Municipal Health Services Act. Typical examples of health institutions are hospitals, nursing homes, rehabilitation institutions and polyclinics. Factors in assessing whether an entity is an institution, will be the company's size, about health care provided by several groups of health professionals and the patients are offered of beds stay. There is of course nothing wrong to appoint responsible for the records also in businesses that are not regarded as a health institution in the legal sense, if the management deems it appropriate.
The Health has no regulations on who should or could be responsible for the records. The organization's management is thus freely by the designation of responsible for the records. Basically it can be designated responsible for the records from any healthcare group, but in practice there will be a limited circle as appropriate to safeguard this coordination responsibility. When choosing the journal responsible should inter alia be taken of their professional qualifications, cf. Acceptability requirements of the Health § 4, the organization of the institution's activities and continuity with respect to the patient.
It may often be appropriate that some of the functions or roles that health law specifies, handled by the same person, so that the journal responsible person is the same that possess one or more of the other features. Health Personnel § 4 third paragraph states that, in collaboration with other staff is doctor and dentist who will be making decisions respectively medical and dental issues regarding examination and treatment of the individual patient. The medical professional / dental professional accountability is not one designated physician / dentist, but will be able to rest with several doctors / dentists in relation to the individual patient. When a patient is admitted to hospital, however, it is often one physician who has primary responsibility for investigation and treatment. Then stipulates the Health § 10 first paragraph, second sentence for health institution that information to patients and their families for patient and user Rights Act shall be granted by the institution designates. It is not established detailed rules about who may be appointed to an information officer. Often it will be natural that a doctor holds the role responsible for the records together with one or more of the other aforementioned features. Privacy considerations may also suggest that you do not spread functions for many people, especially people who are not other reasons need access to patient information, cf. Confidentiality basically also applies to other health professionals at the same institution.
The journal administrator will be responsible for the journal created and that it is recognized and treated in accordance with the laws and regulations specific requirements. The journal managers are given responsibility to decide "what information should be in the register." Journal responsibility will partly involve a coordination responsibility. When several people to make records in the same journal, it may be necessary for structuring and coordination of registry information. The responsibility for structuring the register means that the register must be arranged so that it acts as a tool in accordance with the spirit and as evidence that some health professionals have acted in accordance with the acceptability requirements and other mandatory provisions. Necessary medical records must be readily available for those who will use the information as a basis for decisions about research, diagnosis, treatment and other follow-up of the patient. The journal responsible may on that basis decide that information be taken out because of irrelevance or double entries and edit content. The journal shall if possible consult with the person who has made records before notifying removed unless it is obviously unnecessary, ref. § 13 first paragraph of this regulation. Caution must be exercised with regard to removing information that healthcare professionals believe are important to document proper feasibility of their decisions and actions. Further information about the controversy about treatment etc. could be important in connection with later treatment and possibly by a supervision or compensation case. The journal administrator can not decide that such information should not stand in the register, ref. Subsection.

Journal Responsibility also means to decide on claims for rectification and deletion of records, ref. The Health § 42 - § 44 and § 13 of these Regulations, to decide questions about transparency and disclosure of medical records, and to ensure that journal is terminated in a proper manner.
When transferring journal responsibilities from one person to another, for example by transfer of the patient from one department to another, or when registry administrator ends, it must be stated in the record date on which the journal responsibility went over.

To § 7:

For the first paragraph:
general rule is that records of patient records to be made in Norwegian. Naturally, as well as New Norwegian Bokmål used. It must be assumed that foreign health personnel in Norway providing health care on an independent basis so that they are obliged to keep records, speak Norwegian to such an extent that they can also keep a journal on Norwegian. It is important that the records entered in a language understood by all the health professionals who will use them. According to the Health § 40 first paragraph, second sentence, the journal should be easy to understand for other qualified health. Established terminology can naturally be used.
Most people understand Danish and Swedish to some extent, and these languages ​​can be used in record keeping, to the extent that it is prudent. Special words and phrases that differs significantly from the corresponding Norwegian terms should be avoided, explained or translated so that misunderstandings or uncertainty avoided.
Other languages ​​may be used only with the permission of the State Board of Health. Such permission shall be granted only in exceptional circumstances. An example would be a foreign dentist only to treat the staff at his home country's embassy. There will be practical that they can lead records on home country's language. A factor when considering whether to grant a permit, however, could be the language in question, as journaling in foreign languages ​​will complicate the exercise of oversight. Another factor will be the likelihood that records from businesses may be of significance if patients also come into contact with the ordinary Norwegian health and care services.
There are special rules for the use of Sami in the Sami language that includes the municipalities of Karasjok, Kautokeino, Nesseby, Porsanger, Tana and Kåfjord, ref. Sami Act (Act 12 June 1987 no. 56 on the Sami Parliament and other Sami legal matters) Chapter 3. pursuant to § 3-5 whoever wants to use Sami to safeguard their interests in relation to local and regional public health and social institutions in said management area, the right to be served in Sami. The record shall nevertheless performed in Norwegian. Sami may not be used in record keeping, except possibly after special permission from the State Board of Health under the first paragraph, third sentence. Use of Sami in the register could lead to major problems in relation to co-operating personnel within the same business who do not speak Sami, and the need for medical records when a patient receives medical care elsewhere, for example, upon admission to other health institutions. However, it must be taken to ensure that Sami can exercise the right of access to medical records even if they do not understand Norwegian, cf. § 11, second paragraph.

To § 8:

According to the Health § 40 first paragraph, first sentence, the records kept in accordance with good professional conduct and shall contain relevant and necessary information about the patient and the health care, as well as the information necessary to fulfill the notification or disclosure laid down in or pursuant of law.
Records shall primarily be a tool to ensure that patients receive proper health care, but also has other functions. The journal will include of great evidential significance in connection with any supervision cases and compensation for wrong treatment or the like. In compensation, it is basically the patient who has the burden of health care personnel acted negligently. The Supreme Court, however, in a judgment (reproduced in Rt-1989-674) stated that it should not be set too stringent evidential strength because the facts often not fully possible solve, and the patient often can be difficult to provide evidence . That was the case considered it essential that the operation description in the medical journal did not give details about how the doctor behaved, and what precautions were taken to prevent possible double-harm after it had observed possible damage to the vocal cord nerve on one side during a goiter operation. The evidence clearly thus existed if the operation had been conducted in a fully satisfactory and careful manner, meant that the case was settled in the doctor's disfavor.
For the first paragraph:

Provision contains a long enumeration of information and documentation to be included in the register if they are relevant and necessary. In many patient records, a number of the listed types of information and documentation of course, not be appropriate. On the other hand there may be information and documentation that is not mentioned in the first paragraph but which are relevant and necessary in connection with the individual patient. This must be included in the register, cf. Subsection.
In subsection h:
When implemented treatment measures derogating from existing guidelines, there is a particular need to demonstrate why such treatment is initiated. By Journal is therefore apparent that the measure departs from the guidelines and the considerations which have led to the use of such measures.
To subsection in:
It should inter alia stated in the record that the patient (or his representative) is given the information necessary to give the patient (or representative) a basis of information to consent to or refuse the appropriate examination or treatment, cf. patient and user rights Act § 4-1.
To subsection n:
Regulation of 8 June 2001 no. 676 on individual plans for health care legislation is issued pursuant to the said laws.
For the second paragraph:
In addition to journal records and other written documentation, there may be other types of patient documentation, such as x-rays, photographs, video or audio recording, models of body parts etc. Such documentation may be included in the register in its original form, or the necessary information that can be derived from such media can be recorded in the journal. Until records optionally done in a way that makes it prudent to exclude the original material, the media are to be regarded as part of the record. Using online journal may be necessary to scan in photographs etc. or using digital images. The provision also includes health professionals working documents, such as Kardex. Also included are the patient's own documentation where applicable, for example in the form of a written record of food intake, exercise, symptoms and self-measured blood glucose level.

To § 9:

To the first and second paragraphs:
discharge summaries will enable proper monitoring of patients in primary care after discharge from the healthcare facility. Also at outpatient treatment in a health institution or in private practice specialist will be a need for a feedback to the referring physician / dentist, the regular doctor and / or others who will follow up the patient.
Patient may object to the discharge report is sent, ref. The Health § 45. In some cases, compelling reasons still make it legitimate that the information that is strictly necessary to implement a proper monitoring of the patient disclosed, see the notes to § 10 of Regulations. See also the special motives of Health Personnel § 45 on issues relating to confidentiality and disclosure rights in connection with the discharge report (see excerpt of Health Personnel with annotations).
In the third paragraph:
patient can in many cases also oppose summaries were submitted, cf. Above.
For the fourth paragraph:
It's not set a firm deadline for the discharge report must be sent. There will be variations in how fast monitoring a patient needs. In some cases, this will be immediately after discharge or examination / treatment. Discharge summary must not be submitted later than that required follow-up can be implemented. It must be assessed in each individual situation what is prudent. In any event, should discharge summary is sent within a reasonable time, usually within a week.

To § 10:

After regulation was established, it adopted a law on health records and processing of health data (Law 18 May 2001. 24). Filing Systems Act is a special in relation to Personal Data Act (Act 14 April 2000. 31 on the processing of personal data). Personal Data Act and regulations complement Filing Systems Act, cf. Filing Systems Act § 36. See the notes to § 4 of these Regulations.
The Health has special rules on secrecy in Chapter 5 (§ 21 et seq.).

As a rule, information communicated to other healthcare professionals who need them in order to provide proper health care, ref. The Health § 25 and § 45. In accordance with these provisions and patient and user Rights Act § 5-3 patient may however oppose that records or information from the records provided to other health professionals. According to the patient and user Rights Act § 5-3, third sentence, extradition may still happen if there are weighty reasons for doing so. Similarly follower of Health Personnel § 23 no. 4 after which health professionals' confidentiality in accordance with § 21 is to prevent information from being passed on when weighty private or public interests make it legitimate. This may be situations where disclosure of information deemed necessary to prevent danger to life or serious injury. The considerations that speaks to disclose information against the patient's will, should weigh substantially heavier than the considerations argue against this.
Questions regarding disclosure of medical records should be considered by the journal responsible, who has led the information or other personnel with expertise to assess whether it is permitted to disclose the relevant information to the person requesting it, for example, whether they need them to provide adequate medical assistance, ref. the Health § 45.
Telefax should generally not be used in the transfer of medical records. If it is of great importance for the health care, can fax still used. It should in such cases be made an anonymization or encryption of the data, unless they are very little sensitive. Fax can otherwise be used if the patient agrees.
Record data can be transmitted electronically using systems with security solutions that make it possible to safeguard privacy considerations in accordance with the requirements of the Health Register Act, the Personal Data Act and the Personal Data Regulations. Directorate of Health and KITH (Centre for IT in healthcare AS) under development recommended solutions for electronic messaging, including through referrals, discharge summaries and medical certificates.
Patient Administrative Systems as many health institutions use in their operations do not fall under the term "journal" which is a compilation of information on a single patient. In such systems, however, it is often detected significant amounts of information about patients collected from patient records, including sensitive information such as diagnosis and treatment, possibly in coded form. It follows from the Health § 26 that the health care provider, notwithstanding the confidentiality can provide business patient management such information. Health Personnel rules on confidentiality apply correspondingly to personnel in patient administration, cf. § 26 third paragraph. It is important that the information in the patient administration systems processed so privacy for patients discharged in a similar manner as for the patient records.
Access to patient records in connection with drug trials are subject to regulations on October 30, 2009 No.. 1321 concerning clinical trials of medicines for human use, which are made pursuant to the Medicines Act § 3. See particularly § 4-1 second paragraph letter j, § 4-5 and § 4-6.
See also the notes to § 14 with respect to the processing of patient records to guard against unauthorized access, and the notes to § 17 regarding certain possible solutions for transitional problems using online journal.

To § 11:

For the first paragraph:
records shall primarily be a tool for health professionals to ensure that the patient receives proper health care. The journal has several features, including it should be a source of information for patient understanding of their condition and the research and the treatment the patient is undergoing. The main rule is that patients have access to their own records. This is stipulated in the patient and user Rights Act § 5-1.
Some exceptions to the general rule stated in § 5-1, second paragraph. Patient access may only be restricted where necessary to prevent danger to life or serious damage to the patient or it is clearly inadvisable to disclose the interests of persons close to the patient. The patients themselves must rest on an act of necessity, while the relationship with related parties may rest on the same, but it is not an absolute requirement, even though this exemption clause is narrow. It must be a real danger to the consequences of a certain size for the patient related that access should be denied. It is only the information that is relevant to the specific risk assessment which may be exempt from disclosure. In the Health § 41 provides that healthcare providers are obliged to provide access to medical records for those who are entitled to access for patient and user rights law.

The patient after patient and user Rights Act requirement of transparency in the journal with vouchers. With vouchers refers to radiographs, care plans, Kardex, models and other items not recognized in the Journal, see also § 8 after which such documentation is deemed to form part of the record.
Patients are entitled to a simple and concise explanation of technical terms and the like used in the journal if they ask for it. When a patient asks to see it may in some cases be natural that health offers to go through the Journal's content together with the patient, but the patient must be able to refuse such an offer.
Patients are entitled to a copy of the record if they ask for it. Using online journal is given when normally a paper printout of the record information. See § 12 first paragraph of payment for copy / print.
Carers' right to access to records is restricted unless the patient consents. In patient and user Rights Act § 5-1 fourth paragraph provides that the provisions of § 3-3 and § 3-4 in the other's right to information applies correspondingly for access to medical records.
After patient and user Rights Act § 3-3 the patient's next of kin have information about the patient's health status and the health care rendered if the patient agrees or the circumstances warrant it. Is the patient over 16 years and obviously can not protect their interests because of physical or mental disorders, senile dementia or mental retardation, both the patient and the next of kin's right to information. Who shall be regarded as a patient's next of kin is regulated in patient and user Rights Act § 1-3 letter b.
After patient and user Rights Act § 3-4, both the patient and the parents or others with parental responsibility have information about the patient's health status and the medical care rendered when the patient is a child under 16 years. If the patient is between 12 and 16 the information must not be given to parents / person having parental responsibility when the patient for reasons that should be respected, not wanting it. Information needed to fulfill parental responsibility should be given to parents / person having parental responsibility when the patient is under 18 years.
Whether children have the right to access their own records should take into consideration the rules of patient and user Rights Act § 5-1, § 4-4, § 3-4 and § 3-5. Children over 16 years old are independent right of access to his journal in line with age. Children between 12 and 16 have some degree of independent right of access, but it must be further evaluated based on the child's age and maturity and circumstances what the child should be allowed to study and how. Children under 12 do not have independent access to information.
The next of kin have the right to access a deceased patient's records unless special reasons to the contrary, ref. Patient and user Rights Act § 5-1 fifth paragraph and the Health § 24. Special circumstances may be that the deceased has expressed that he did not want that relatives should have access, or in that of the character of information must assume that the patient would have wanted it.
For the second paragraph:
According to the patient and user Rights Act § 3-5 that the information provided patient and family under chapter 3 be adapted to the recipient's individual abilities such as age, maturity, experience and cultural and linguistic background. It should also to some extent facilitate the recipients with special conditions can benefit from the right to access to medical records. Blind and deaf-blind and persons without adequate knowledge of Norwegian will need assistance in order to exercise the right of access. In some cases there will be a need for an interpreter to convey the content of the journal, or translation of parts of the register.
In the Sámi Administrative (cf. Notes to § 7, first paragraph) will by local and regional public health institutions be natural that it offered an interpreter or partial translation of the journal upon exercise of the right of access if the patient does not speak Norwegian sufficient to understand journal. The cost of this should be covered as part of the ordinary services.

To § 12:

For the first paragraph:
There will be variations in the costs and the use of resources that will be associated with providing a patient copy or print journal. A journal can be very extensive.
It is reasonable that business gets some compensation for expenses and work by giving patients copy or print journal. However, it is important that the cost for the individual patient is not so great that it limits patient practical possibility to request copy / print.

The second sentence provides that payment shall not exceed an amount equal to the rate for printing / copying of medical records in the current tariffs for private practitioner and private practice specialist determined in relation to the Insurance Act § 5-4 on grants to cover the costs of examinations and treatment by a doctor. Fare applies directly only to physicians who are obliged to follow the fares, but the provision of these Regulations makes tariff applicable to all healthcare professionals. The maximum amount that may be required for copy / print journal is thus the same for all healthcare professionals, whether their business justifies grants to cover expenditure under the National Insurance Act. For practical reasons, the maximum amount related to the aforementioned tariff rounded up regularly. Pr. 1 April 2002 valuation 70 million. There is of course nothing wrong with taking a lower amount or provide copy / print gratuitously, for example where the journal is little bulky.
In connection with the fulfillment of the reporting and disclosure requirements may healthcare demand payment for disclosure of medical records where payment is authorized by statute or regulation or agreed with the state, county or municipality.

To § 13:

For the first paragraph:
refer to the notes to § 6 of the Regulations on the registry administrator's duties. One of the tasks will be to edit and clean record in order to avoid double entries, etc. so that the Journal is clearly an excellent tool. If the journal administrators believe records should be removed, this must as far as possible be done in dialogue with the person who made the recordings. Caution must be exercised with regard to removing information that healthcare professionals believe are important to document proper feasibility of their decisions and actions. In case of disagreement about the information should be in the register or removed, the records are not destroyed, but can optionally be stored in an additional journal. Disagreement on treatment etc. must be indicated in the register and will be important in later treatment and possibly by a supervision or compensation case. See also § 6 fourth paragraph.
It must be assumed that the journal controller editing takes place within a reasonable time after the records are made. When the journal administrator has edited journal records, the journal responsible dating and signing, so it appears that the record has changed. Later changes are only made pursuant to the provisions of rectification and erasure in the Health § 42 - § 44. After discharge of the patient should change only according to provisions of the Health § 42 - § 44
In an electronic patient should the original version of the information changed or removed as part of the journal controller editing, not permanently deleted, but hidden so that they can be made available to those who have registered information, the journal managers and supervisors when necessary.
For the second paragraph:
In operations where there is no designated journal responsible decided rectification and erasure by the Health § 42, § 43 and § 44 of the health professionals who have made the record in the register, or the health professionals who have been transferred to the register itself, cf. this regulation § 15.
in the third paragraph:
Refusal of a request for correction or deletion may be appealed to the county medical. Fylkeslegen shall obtain the opinion of the Data Inspectorate. It should be stated in the record that a demand for correction or deletion is made, the outcome of this, the rejection that the patient is made aware of the right of appeal, and any appeal, ref. § 8 subsection k.

To § 14:

According to the first paragraph must be established adequate measures to protect patient data against damage and unauthorized access. This applies when using both electronic journal paper-based records and where paper based journaled by electronic means. It will be partly different measures necessary. The measures must be partly physical protection against fire, water damage, burglary, etc. Furthermore, the records are kept so that they are not accessible to anyone other than those who are entitled to access. One must also ensure that computer monitors, printers and the like are positioned so that unauthorized knowledge of patient information. Cables for electronic aids must not be readily available for tapping.
According to the second paragraph must be kept journals until no longer believed to be needed. This can for circumstance involve long periods. A business can therefore have significant amounts of records that are not in active use, but (currently) can not be deleted. When it is been ten years since the last administration in the journal, the Journal can be stored outside the establishment, cf. Subsections.

The provisions must be seen in connection with the rules laid down in and pursuant to the Archives Act (Act of 4 December 1992 No.. 126 on stock).
Patient records in a business is an archive of the Archives Act, cf. Act § 2 letter b. As also stated in the third paragraph, patient records in the public sector are treated in accordance with the rules laid down in and pursuant to the Archives Act, cfr. Act Chapter II on public records and regulations of 11 December 1998. 1193 on public records (archives regulations). Archives Regulation provides more detailed rules on public archives, ie archives created by state, county and municipal bodies. Archives Regulation including detailed rules on requirements for archive premises (Chapter IV) and delivery of archive to public archival repository (§ 5.1). It is also stipulated requirements for procedures and quality assurance using microfilm to replace paper-based archival material.
According to the Archives Regulations § 5-2 rule, the archival material must be returned when it is about 25-30 years old. The Director General may determine other delivery deadlines for state archive material. Counties and municipalities may impose equivalent of county / municipal archival material. For some health care facilities may be relevant even longer delivery deadlines, as may be required to keep records longer in some institutions.
When it can no longer be assumed to be used for records should be deleted unless they are to be preserved in accordance with the Archives Act or other legislation, ref. The Personal Data Act § 28.
The general rule for public records is that they can not be deleted without the rules established pursuant to the archives Act, cfr. law § 9 letter c, first sentence. After third sentence could nevertheless person registry or parts of personregister deleted pursuant to the Personal Data Act. An organization's patient records is a personal register. Before deleting must consent is obtained from the Director General, ref., Fourth sentence. It refers in this regard also to the Archives Regulations § 3-18 to § 3-21 and Regulation of 1 December 1999 no. 1566 on supplementary technical and archival provisions regarding the handling of public records. It will collaborate with the National Archivist be compiled disposal regulations for patient records.
For private archives, there are no similar rules for public records. Archives Act Chapter III on private archives dealing primarily listed private archives. Although Archives Regulations do not apply to private archives, can provide guidance in a number of conditions concerning the treatment of records, such as how they should be stored to meet the requirements of the first paragraph, and on procedures using microfilm.
Private business can enter into an agreement with a public archive repository for delivery there or may deposit old archive material from another storage institution. This may be private companies that offer storage of archives. Using private storage institution should declarant ensure that storage is justifiable including considering the privacy of patients and it should be required to submit a declaration of confidentiality. When it can no longer be assumed to be used for records in a private business, cf. Second paragraph should be deleted if they are not protected by the Archives Act or be preserved in accordance with other rules.
Health professionals activities deemed private even though healthcare has RGP contract or other agreement with the public, but not public service employees.
See also the notes to § 17 of solution of transition problems associated with delivery by electronic journal.

To § 15:

For the first paragraph:
doctor scheme was introduced on 1 June 2001. journal can be transferred in original or copy.
For the second paragraph:
Such transfers shall take place automatically unless the parents object to the transfer. If the child is over 16 years old is the child himself who may oppose the transfer.
In the third paragraph:
It's not uncommon that health transfers activities to other health and in the context transfer medical records to the buyer or upon closure of the business transfer journal archive to other health care professionals who want patient basis. Those patients practicable to reach, should then be informed of the transfer / termination and that their records will be transferred unless they oppose it. It shall also state that the patient may require the journal instead transferred to another health care provider. The third paragraph is therefore required no explicit consent for the transfer, but the patient has the right to oppose the transfer and shall, if possible, be notified.
By structural reorganizations, for example in the public health and care services, it will not be necessary to warn patients about the transfer of records.

For public records appear to archive Regulations § 3-22 and § 3-23 on the transfer of stock, cf. § 5-3.
For the fourth paragraph:
Patient records must initially retained for the sake of health assistant character no longer deemed to be needed, see § 14, second paragraph and notes to § 14. In unforeseen termination as the death or acute serious disease that makes health workers unable to discontinue operations have relatives or possibly the estate / probate ensure that records are transferred to another company or being delivered to the public archival repositories or deposited with other storage institution, or delivered to the county medical storage. The same applies to the trustee if the business goes bankrupt. The scheme for safekeeping by the county medical officer for 10 years continued from previous regulation of 17 March 1989 no. 277 on physician and health institution journal patient. When county doctor has kept records for 10 years records after consultation with the Director General either destroyed or transferred to public archival repository for further storage. Ministry aims to establish a different scheme for the storage of records after the termination of health personnel.
See also the notes to § 17 of solution of transition problems associated with delivery by electronic journal.

To § 16:

Destruction of both paper-based records that electronic records or portions of records must be made so that patient information does not go astray or be traceable. The same applies when replacing IT equipment, both by electronic records system and using computer equipment associated with paper-based journal.

To § 17:

Regulations came into force at the same time as the Health, 1 January 2001.
Health care facilities, doctors, dentists and midwives have had the obligation to keep records also by previous legislation. Existing records can of course continue, but must from 1 January 2001 satisfy the requirements imposed by the Health and Regulations. If you choose not to continue the journals, but creating new, it must be of the new journal stated that there exists an earlier journal, so that this can easily be retrieved if there is need for it.
For companies already record system in use pr. 1 January 2001 will pursuant to § 4 to create and organize the records system, consist in ensuring that the system is so organized that it is possible to comply with the requirements established pursuant to law. The Ministry has contacted providers of electronic patient record systems to assess whether the requirements of the Health and Regulations causes problems for users of existing electronic records systems. The Ministry has concluded that there is no need for transitional rules. Some problems and possible solutions are:

-
Regarding the Health § 45 first paragraph, second sentence: If it can not log who is given access to the records, the requirement for a transitional period addressed by notes in the journal.

-
Concerning Regulations § 10: If a patient is entitled or reservations regarding use of the journal information that can not be realized in the health record must be kept paper records for the patient.

-
Regarding the Health § 43: If the information will only be hidden and not be completely removed from the register, the enterprise must establish internal procedures and rules that restrict access to hidden information.

-
Concerning Regulations § 14 and § 15: If the Journal fails to be delivered in a standardized electronic format in accordance with provisions pursuant to the Archives Act, the transfer effected by paper printing. Referring to provisions on electronic records being transferred or transferred as a deposit to the Archives set out in Part VIII of the Regulation of 1 December 1999 no. 1566 on supplementary technical and archival provisions regarding the handling of public records, cfr. § 5-8, cf. . archives Act § 10 and § 12

Existing health facilities will have a number of records that are not in active use, but still must be stored because it may be needed later, ref. § 14. It is not necessary to designate journal responsible for all records that are maintained. It is sufficient that there be appointed journal responsible for records that are in active use or created after 1 January 2001. Records that are not in active use at this time, can be reactivated later either in connection with the new health care or the exercise of the right of access, demand for correction or deletion or the like. It shall then be appointed responsible for the records of the journal if it is not already done.

May be required correction and deletion in accordance with the Health § 42, § 43 and § 44 also in the journal writings from the period before 1 January 2001. This also applies if earlier demand for correction / deletion of the same registry information is rejected by the then regulations.