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Executive Order On The Danish Medicines Agency's Electronic Registration Of Individual Citizens ' Medication Information

Original Language Title: Bekendtgørelse om Lægemiddelstyrelsens elektroniske registrering af de enkelte borgeres medicinoplysninger

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Table of Contents

Appendix 1

Appendix 2

Appendix 3

Appendix 4

Publication of the computerised form of electronic registration of the individual citizens ' medical information

Purline to section 157, paragraph. 5, 7 and 10, and section 271 (1). 4, in the health code, cf. Law Order no. 913 of 13. July 2010, as amended by law no. 1546 of 21. In December 2010 :

§ 1. The FDA is responsible for the operation of an electronic registration of the individual citizens 'medical information, including the purchase, extradition, intake, dose modification, cessation, health professionals' instructions on the use of medicines, and information related to the medical information of its citizens, cf. Article 157 (3) of the health officer. 1.

Paragraph 2. Information about the medical information of individual citizens, cf. paragraph 1, recorded in the medical board's receptacles, in the Medicines Management Register of Personal Electronic Medicinal Products (Medicine profile) and in the Common Medicine Card (FMK).

Paragraph 3. The medical information of the medicinal product management of the individual citizens contains information on the following types of medicinal products :

1) medicinal products prescribed on prescription,

2) medicinal products issued after prescription at the pharmacy,

3) medicinal products delivered to the hospital or hospital centre ; and

4) medicinal products supplied by general practitioners, practising specialist physician and dentistry, in the institutions of the Department of Corrections, on booffers and corresponding housing units in the municipality, including public housing for people with reduced physical or mental health ; functional capacity and in ambulances, and

5) medicinal products, etc., which are not prescribed on prescription, for which the citizen or an eligible health person with the consent of the citizen has been reported in the medicine cabinet in the person concerned, cf. § 25.

§ 2. The registration of the medicinal products for the medicinal products of the individual citizens shall contain information on persons who :

1) medicinal products prescribed in the last 24 months have been prescribed,

2) in the past 24 months, purchased or received medicinal products after prescription are prescribed in a pharmacy,

3) in the last 24 months, medicinal products have been supplied in a hospital or a hospital centre ;

4) in the case of medicinal products in the last 24 months, medical practitioners or dentistry practitioners have been supplied to medical practitioners of the general practitioner,

5) in the course of the last 24 months, medicinal products in the institutions of the Department of Corrections, housing and similar residence in the municipality, including public housing for persons with reduced physical or mental capacity, and in ambulances, have been supplied ;

6) are covered by a doctor or dentist reporting by the Cave, cf. paragraph 5, or

7) has reported information in his medicine cabinet, cf. § 25.

Paragraph 2. The registration of the medical board of the medicinal product of individual citizens contains information concerning the prescription of medicinal products for doctors and dentists for the medicinal products referred to in paragraph 1. 1, no. 1, including sorting, grouping and compressing the display of prescription prescriptions with a view to displaying an updated image of the patient ' s ongoing medicinal product ordinations.

Paragraph 3. The registration of the medicinal product for the medicinal product of the individual citizens must contain the following information for the dispatch of medicinal products to persons covered by paragraph 1. 1, no. 2 :

1) The parking lot for the parking lot.

2) Dispatch number (applicable to each prescription) and ordination number (applicable to each ordination).

3) Expedition Time, cf. § 17, paragraph 1. 1.

4) The person ' s person number or unique identification number and date of birth, cf. § 3.

5) The special user identification of the expedient.

6) The doctor's or the dentist's exterior number or the hospital department code.

7) Doctor's orthodleid's dental I.D.

8) Item number and quantity of the item number.

9) Name of the medicinal product.

10) A free text relevant to the expedition of the prescription and the delivery of the medicinal product.

11) The dosing code of the Ordinance.

12) The dosing technique of the Ordinality.

13) Ordinationens indication code.

14) Indications of the Ordinality.

15) Expedition type.

16) Withdrawal of expedition.

Paragraph 4. The registration of the medical board of the medicinal product of individual citizens must include the following information reported by hospitals and hospitals on the supply of medicinal products to persons covered by paragraph 1. 1, no. 3 :

1) Leading device ID.

2) Preparation time.

3) Person number or unique identification number of the person.

4) Drug ID.

5) Length of dosage and unit.

6) The time for the start and end of treatment with the relevant drug ID.

Paragraph 5. The registration of the medicinal products for the medicinal products of the individual citizens shall contain the following information, reported by doctors and dentists on the subject of the cave for persons covered by paragraph 1. 1, no. 6 :

1) The identity of the doctor or dentist (authorization ID or person number) of the dentist.

2) People's Social Security Number

3) Drug ID.

4) ATC code level.

5) Free text on the cave.

6) Preparation time.

7) Cave Status (Asset / Inactive) Status.

Paragraph 6. The registration of the medicinal product on the part of the medicinal product of the individual citizens ' electronic medical records may contain the following information reported by the hospital-employed pharmacists and pharmacies on medicinal products for medical reasons or to the following :

1) The identity of the pharmacist or pharmacofinance (Social Security Number).

2) The place of work of the pharmacist or farmhouse.

3) Citizen's Social Security number.

4) Free text relevant to the medical point of order or to the vote.

5) Preparation time.

6) Documentation that the medical care department has authorised the pharmacist or pharmacist to carry out medical and medical reasons for medical reasons or for medicinal purposes.

Paragraph 7. The registration of the medicinal products for the medical board of the individual citizens shall include the following information reported by staff of the institution of the Department of Corrections on the supply of medicines to inmates :

1) The employee ID (Social Security number).

2) The employee's office of employment.

3) Citizen's Social Security number.

4) Free text relevant in relation to the supply of medicines.

5) Preparation time.

Paragraph 8. The registration of the medicinal products for the medicinal products of the individual citizens must include the following information on ambulance processors with special skills handling of medical supplies or the supply of medicinal products :

1) Ambulance handler ID (Social Security number)

2) The position of the ambulance handler.

3) Citizen's Social Security number.

4) Identification of the medicinal product-Drug ID.

5) Length of dosage and unit.

6) Free text relevant in relation to the handling of medical supplies or the supply of medicines.

7) Preparation time.

Niner. 9. The governing board of the individual citizens ' electronic medical information must include the following information about staff on the settlement of housing and corresponding housing in the municipality, including public housing for persons with reduced physical or mental functiveness, which, after delegation from a doctor, extradited medications to citizens with reduced physical or mental capacity :

1) The employee ID (Social Security number).

2) The employee's office of employment.

3) Citizen's Social Security number.

4) Free text relevant in relation to the supply of medicines.

5) Preparation time.

Paragraph 10. The medical information for the medicinal products of the individual citizens must include the following information on the local home-nursing care, including care homes, about the comments made by the Home Health Care Committee on the citizen ' s civil service ; medicinal use :

1) The employee ID (Social Security number).

2) The employee's office of employment.

3) Citizen's Social Security number.

4) Free text relevant to the use of the citizen in relation to the medicinal products of the citizen.

5) Preparation time.

Paragraph 11. The registration of the medicinal products for the medical board of the individual citizens must include the following information on reporting in the medicine cabinet in each citizen, cf. paragraph 1, no. 7, and Section 25 :

1) Citizen's Social Security number.

2) Identification of the medicinal product-Drug-ID/free text.

3) Free text.

4) Preparation time.

5) Preparing.

§ 3. If a person who is covered by the health code does not have a social security number, the person ' s number shall be replaced by a unique identification number that is automatically assigned.

§ 4. The Medieval Management Board shall make a logout of all applications and transfers of the medicinal products covered by this notice.

§ 5. The following people shall have access to the recording of electronic medical information for the individual citizens of the Medicinal Mediation Management Board :

1) Doctors, dentists, midwives, nurses, health care professionals, social and health care assistants and nursing home assistants, who have a citizen in treatment,

2) hospital-employed pharmacies or pharmacies which, after the identification of the health care operator of patient and pharmaceutical reasons, are conducting medical reasons or voting,

3) employees of the institutions of the Department of Corrections, who, as part of their professions, deliver medicines to inmates,

4) paramedics with specific competencies, who as part of their professions in an emergency, handle medical supplies or supply medical treatment to patients ;

5) employees of the housing and similar residence in the municipality, including public housing for persons with reduced physical or mental capacity, which, as part of their profession, from the citizen's doctor, extradits medicines to a citizen ;

6) pharmacists and pharmacists, who, as part of the expedition of an ordination, have access to the data recorded ;

7) the registered self and

8) The medical board.

Access to the Register

§ 6. A doctor has access to the section 2, section. 2-7, mentioned information, for patients who are currently in care in treatment when it is necessary to treat each patient. Alintentionally practitioners may also use the register to identify their own patients who are treated inappropriately with medicinal products. In addition, practising specialists may also use the register to identify patients prescribed by the specialist or more medicinal products, which are treated inappropriately with medicinal products. This information must be used solely in order to ensure the quality, safety and efficacy of the medicinal products for medicinal products. The doctor can delegate the access rights to his co-concoder.

Paragraph 2. A doctor shall have electronic access to a list of persons who have access as a help to the person concerned and the actions taken by the help of the medical staff.

Paragraph 3. A doctor can transfer the people in section 2, paragraph 2. 2-11, mentioned information about patients who are currently attending to the local patient record system with a view to updating the patient file. The doctor shall arrange the transfer in such a way that it is ensured that the doctor has access to up-to-date information in the patient file when the information is to be used for the examination of the patient.

Paragraph 4. The medical board can stop the transfer of information after Article 6 (2). 3, if the management board assesses the fact that the receiving systems fail to comply with any applicable data security requirements.

§ 7. A dentist, a midwife, a nurse, a nurse, a health manager, a social and health assistant, and a nursing home assistant, has access to the section 2, paragraph 2. 2-11, mentioned information, for patients, as the dentist, the midwife, the nurse, the health care person, the social and health care services, which are currently in the process of treatment when it is necessary for the treatment of each patient. This information must be used solely in order to ensure the quality, safety and efficacy of the medicinal products for medicinal products. The dentist, the midwife, the nurse, the health care person and the social and health assistant can delegate their access rights to his co-workers.

Paragraph 2. A dentist, a midwife, a nurse, a health care person and a social and health assistant have electronic access to a list of persons who have access to health experts as well as the actions of which they are involved ; help has been carried out.

Paragraph 3. A dentist, a midwife, a nurse, a nurse, a health manager, a social and health assistant, and a nursing home assistant can transfer them in section 2, paragraph 2. 2-11, mentioned information on patients, as the dentist, the midwife, the nurse, the health care manager, the social and health care assistant, and the nursing home assistance is currently in the processing of her local patient record system for the purpose of updating ; Patient records. The transfer must be arranged in such a way as to ensure that the dentist, the midwife, the nurse, health care services, social and health care services have access to up-to-date information in the patient file when the information is available ; shall be used for the processing of the patient.

Paragraph 4. The medical board can stop the transfer of information after Article 7 (2). 3, if the management board assesses the fact that the receiving systems fail to comply with any applicable data security requirements.

§ 8. Pharmacists and apothecary staff shall have access to the section 2 (2) of the section. 2, mentioned information which is registered on ordination when access is necessary for the expedition of an ordination.

Paragraph 2. Pharmacists and apothecary staff shall have access to the section 2 (2) of the section. 3-11, referred to when the medicinal product has given explicit consent, and access is relevant to the instructions for the medicinal product in question. This information must be used solely in order to ensure the quality, safety and efficacy of the medicinal products for medicinal products.

Paragraph 3. By means of explicit consent, any optional, specific and informed will show that the pharmaceutical user agrees that information relating to the person concerned is the subject of treatment. The consent may be withdrawn at any time.

Paragraph 4. Pharmacists and apothecary staff may transfer the in section 2 (2). 2, mentioned information to the pharmacist system in connection with the expedition of a prescription prescribed by a medicinal product.

Paragraph 5. The medical board can stop the transfer of information after Article 8 (3). 4, if the Management Board is to assess the fact that the received systems fail to comply with any applicable data security requirements.

§ 9. Nurses and pharmacies which, after the appointment of the health care department for patient and medical reasons, make medical or vote, have access to the sections 2 (2) of the medical care package. 2-11, when access is necessary for the treatment of the patient. This information must be used solely in order to ensure the quality, safety and efficacy of the medicinal products for medicinal products.

Paragraph 2. A hospital employee pharmacist, or pharmacist, cf. paragraph 1 may transfer the sections in section 2 (2). 2-11, mentioned information about patients who are currently in the processing of her local patient record system with a view to updating the patient file. The transfer must be organised in such a way as to ensure that the person in question has access to up-to-date information in the patient file when the information is to be used for medical use or voting in relation to the individual patient.

Paragraph 3. The medical board can stop the transfer of information after Article 9 (2). 2, if the management board assesses the fact that the received systems do not comply with any applicable data security requirements.

§ 10. In the institutions of the Department of Corrections, who, in the context of their profession, provide medicines to prisoners have access to the sections referred to in section 2 (2). 2-11, when access is necessary for the treatment or care of the person concerned, access is required. This information must be used solely in order to ensure the quality, safety and efficacy of the medicinal products for medicinal products.

Paragraph 2. An employee of the Department of Corrective Services, cf. paragraph 1 may transfer the sections in section 2 (2). 2-11, mentioned information about patients who are currently in the processing of her local patient record system with a view to updating the patient file. The transfer must be arranged in such a way as to ensure that the person concerned has access to up-to-date information in the patient file when the information is to be used for treatment or care for the patient.

Paragraph 3. The medical board can stop the transfer of information after Article 10 (1). 2, if the management board assesses the fact that the received systems do not comply with any applicable data security requirements.

§ 11. Ambulance processors with specific competencies, who, as part of their professions in emergency situations, handle medical supplies or supply medicines to patients, have access to the sections referred to in section 2 (2). 2-11, when access is necessary for the treatment or care of the person concerned, access is required. This information may be used solely in order to ensure the quality, safety and efficacy of the medicinal products for medicinal products in an emergency situation.

Paragraph 2. An ambulance handler with specific skills, cf. paragraph 1 may transfer the sections in section 2 (2). 2-11, mentioned information about patients who are currently in the processing of her local patient record system with a view to updating the patient file.

Paragraph 3. The medical board can stop the transfer of information after Article 11 (1). 2, if the management board assesses the fact that the received systems do not comply with any applicable data security requirements.

§ 12. Arrets in the bolic and similar residence in the municipality, including public housing for persons with reduced physical or mental capacity, which, as part of their profession from the citizen's physician, extradites medicines to a citizen, has access ; to the sections referred to in section 2 (2). 2-11, when access is necessary for the treatment or care of the citizen, access is necessary. This information must be used solely in order to ensure the quality, safety and efficacy of the medicinal products for medicinal products.

Paragraph 2. An employee of a housing offering and similar residence in the municipality, including public housing for people with reduced physical or mental capability, cf. paragraph 1 may transfer the sections in section 2 (2). 2-11, mentioned information about citizens who are currently in the processing of his local patient record system with a view to updating the patient file.

Paragraph 3. The medical board can stop the transfer of information after Article 12 (2). 2, if the management board assesses the fact that the received systems do not comply with any applicable data security requirements.

§ 13. The registered direct electronic access to the sections referred to in paragraph 2 (2). 2-11, the information that has been recorded on the person concerned and to a log of the access of others to the data recorded, cf. § 4.

§ 14. The medical board and a possible operator who, on behalf of the Medicinal Mediation Management Board, will record the registration of the individual citizens ' electronic data on medical information, having access to the data recorded when required by the medicinal products ; operational technical reasons, or a result of the obligations of the Medicinal Management Board, etc. as the data-responsible person. This information may be used only in order to ensure the operation and the data quality of the register, cf. however, paragraph 1 2-4.

Paragraph 2. The governing board shall have access to the data recorded when necessary for the processing of the type-impact reports, in accordance with the procedure for the management of the management of the management. Article 157 (3) of the health officer. 8, 1. Act.

Paragraph 3. The governing board shall have access to the statistical data on the pharmaceutical consumption of the data recorded in the scope such information is not available through the Medicinal MedieMedieMedieRegister Register Registry, cf. Article 157 (3) of the health officer. 8, 2. Act.

Paragraph 4. The Mediation Board may disclose information on the electronic medical information of individual citizens on prescribed and delivered vaccines for the Danish Vaccine register for the purposes of registering the vaccination status of individual citizens.

Paragraph 5. The Medical Board shall monitor continuously that the data recorded is properly updated with the information that, cf. Article 5 is reported by doctors, dentists, midwives, nurses, health care professionals, social and health care assistants, nursing home assistants, hospital staff, pharmacies, pharmacies, medical professionals, paramedics with special care and special care professionals ; competencies, pharmacies, employees on boilers and similar residence in the municipality, including public housing for persons with reduced physical or mental capacity, medical users and hospitals and outpatient facilities.

Paragraph 6. The governing board shall ensure continuous information that the information is deleted in accordance with section 27.

Paragraph 7. The Pharmaceuticals control that pharmacies, doctors and dentists, including hospitals and hospitals, the municipal home nursing care, including nursing homes, hospitals and pharmacies, staff of the Department of Corrections, EMTs, ambulance processors ; with special competencies as well as staff on housing and equivalent housing in the municipality, including public housing for persons with reduced physical or mental capability, reports in accordance with the rules in section 17-24.

§ 15. The Board of Health shall have access to requisition the sections referred to in section 2 (2). 2-4, referred to by the Medicinal Board of Medicinal Products where necessary for the supervision of the prescriptive of addictive medicinal products and antipsychotics, or if there is a need to see the full ordination image as part of it ; the professional assessment of the appropriateness of an ordination of addictive medicinal products and antipsychotics, and the circumstances may not be adequately covered by the information provided by the Board of Health in the case of the Board of Health, in accordance with the conditions laid down in the Health Agency. Act on pharmacies, section 11 (1). 4.

§ 16. No one in addition to the persons and authorities referred to in section 6 to 15 mentioned shall have access to the information in the medical board's registration of the individual citizens ' electronic medical records.

Reporting to the Register

§ 17. The pharmacy has a duty to report them in section 2, paragraph 1. 3, mentioned information at the time the pharmacy extradits or sends the medicinal product to the pharmaceutical user.

Paragraph 2. The pharmacy has a duty to report them in section 2, paragraph 1. The information referred to in paragraph 2 at the time when the pharmacy expels the prescription provided that the information is given in a paper, telephone or fax prescription.

Paragraph 3. The pharmacy must, at the request of persons who have diagnose information about the person of the medical examiners ' s registration of the individual citizens ' electronic medical records, make the necessary corrections or refer the person to the alert or Medicinal Board of Directions in cases where the pharmacy does not itself have sufficient access to conduct the corrections. The pharmacy alone has the ability to correct information that the pharmacy himself has been reporting.

Paragraph 4. The notification of the Pharmaceuticon of the Medicinal Products for the Medicinal Products for the Medicinal Products shall be carried out in accordance with the technical requirements laid down in Annex 1.

§ 18. A doctor or dentist in a hospital or hospital has a duty to report the items in section 2 (2). 4, mentioned at the latest at the time of the presence of the pharmaceutical user from the hospital or after the end of each hospital visit.

Paragraph 2. A doctor or dentist in a hospital or an EMA must at the request of persons who have diagnotily diagnosing the data of the individual citizens of the Medicinal Management Board of the individual citizens with electronic medical information, do so ; any corrective action or reference of the person to the alert or Medical Board of Medicinal Products in cases where the doctor or dentist at the hospital or the hospital hospital does not have sufficient access to the medical examiner. The doctor or dentist at the hospital or the hospital hospital alone has the possibility of correcting information, as the doctor or the dentist at the hospital or the hospital hospital itself has reported.

Paragraph 3. The report of the doctor or dentist to the recording of the medicinal products for the medical board of the individual citizens shall be carried out in accordance with the technical requirements laid down in Annex 2.

§ 19. A doctor or a dentist shall report the items in section 2 (2). The information provided for in the case of the doctor or dentist is an electronic prescription for the information mentioned.

Paragraph 2. A doctor or a dentist can report them in section 2, paragraph 2. 6, mentioned information (Cave) and changes thereto.

Paragraph 3. A doctor or dentist must at the request of persons who have ascertaining errors in the information about the registration of the individual citizens of the Medicines Management Board of the individual citizens, make the necessary corrections or references ; the person to the reporter or the Medicinal Board of Medicinal Products in cases where the doctor or dentist does not have the required access to conduct the corrections. A doctor or a dentist has the opportunity to correct in information that the doctor or the dentist himself has reported.

Paragraph 4. The report of the doctor or dentist to the recording of the medicinal products for the medical board of the individual citizens shall be carried out in accordance with the information referred to in the Concierge, see it in the case of the medicinal products. Notice no. 155 of 20. February 2007, with subsequent amendments, laid down the requirements for the drafting of electronic prescriptions.

20. The municipal home-nursing care, including care homes, may report to them in section 2 (2). 10, mentioned information and amendments thereto.

Paragraph 2. The local authority home nursing care, including nursing homes, must at the request of persons who have ascertains the error of the data relating to the registration of the individual citizens of the Medicinal Management Board of the individual citizens to carry out the necessary information ; fixes or refer the person to the Medical Agency in cases where the municipal home-nursing care, including the nursing home, does not have sufficient access to make the executions. The municipal nursing care, including nursing homes, has the option of correcting information that the Home Health Care person, including the nursing home, has even reported.

§ 21. Nursing agents and pharmacies which, after the appointment of the health care department for patient and medical reasons, conduct medical or voting, may report to them in section 2 (2). 6, mentioned information, and changes thereto.

Paragraph 2. Nursing agents and pharmacies, cf. paragraph 1, at the request of persons who have ascertaining errors in information about the person of the medicinal products on the medical board of the individual citizens, make the necessary corrections or reference the person to : The medical board in cases where the pharmacist pharmacist and pharmacist does not even have the necessary access to the executions. Nurses and pharmacies alone have the option of correcting information which the person concerned has reported.

§ 22. In the case of the Department of Corrections which, in the context of their professions, handles medical supplies or medical supplies to inmates may report to them in section 2 (2). 7, mentioned information and amendments thereto.

Paragraph 2. Indicated in the Department of Corrective Services, cf. paragraph 1, at the request of persons who have ascertaining errors in information about the person of the medicinal products on the medical board of the individual citizens, make the necessary corrections or reference the person to : The governing board of the medical board in cases where the employee in the Corrective Office does not have the requisite access to the corrections. In the Department of Corrective Services, set out in the Department of Corrective Services alone has the possibility of correcting information which the person concerned himself reported.

-23. Ambulance processors with specific competencies, who, as part of their professions, handle medical information or supply medicine in an emergency, they may report in sections 2 (2). Amendment No 8, as well as changes thereto.

Paragraph 2. Ambulance handlers with special skills, cf. paragraph 1, at the request of persons who have ascertaining errors in information about the person of the medicinal products on the medical board of the individual citizens, make the necessary corrections or reference the person to : The medical board in cases where the ambulance handler does not itself have sufficient access to conduct the executions. Ambulance handlers with special skills have the ability to correct information that the person in question has reported.

§ 24. Recommendation for botenders and corresponding housing units in the municipality, including public housing for persons with reduced physical or mental capacity, which, as part of their profession from the citizen's doctor, extradites medicine to a citizen, may be provided to a citizen ; report the items in section 2 (2). 9, mentioned information and changes thereto.

Paragraph 2. Recommendation for botenders and corresponding housing units in the municipality, including public housing for people with reduced physical or mental capability, cf. paragraph 1, at the request of persons who have ascertaining errors in information about the person of the medicinal products on the medical board of the individual citizens, make the necessary corrections or reference the person to : The governing board of the medical board in cases where the staff on the booffer and similar residence in the municipality, including the general housing for persons with reduced physical or mental capacity, do not have the necessary access to the executions. In the case of housing and corresponding housing in the municipality, including public housing for people with reduced physical or mental capacity, only have the possibility of correcting information which the person concerned has reported.

§ 25. The medicinal user or the person concerned may report to them in section 2 (2). 11, mentioned information (medicine cabinet). In medicine, the part of the register in which the individual citizen may make the notification of medical purchases that is not prescribed on a prescription.

Paragraph 2. The pharmaceutical user may, at any time, delete the reported reports.

Cruning, delete, etc.

SECTION 26. Information in the electronic registration of the medicinal products for the medical records of the citizens must not be cooperated with any information in other public or private registers other than those in section 6-15 mentioned patient journals.

§ 27. Information on the person number of the medicinal user will be deleted from the death of 2 years after the medicinal user has been killed.

Paragraph 2. Information recorded in accordance with section 2 (2). 5 (Cave), and section 2 (2). 11 (medicine cabinet) shall be deleted no later than two years after the death of the medicinal user.

Paragraph 3. Information recorded in accordance with section 4 (logging) must be deleted from two years after they have been registered in the Medicinal Board of the Medicinal Products for the electronic recording of the citizens ' electronic medical records.

Paragraph 4. Other information in the electronic registration of the medicinal products for the medicinal products of the medicinal products other than those referred to in paragraph 1. One-point-three, must be deleted from 2 years after registration.

§ 28. Unless higher penalties have been imposed on other legislation, penalties shall be punished :

1) the person who unjustifiable retrieves, discharges or utilise information in the medical examination of the medicinal products for the medical records of the citizens, in accordance with sections 6 to 12 and 14-15,

2) pharmacies which omit to report information to the medical examiner's electronic registration of the citizens ' medical records after Section 17 (3). 1,

3) apothecaries failing to correct incorrect information in the medical records of the medicinal products for the medical records of the medicinal products referred to in Article 17 (3). 3,

4) a physician or dentist in a hospital or an EMA which fails to report any information to the medical information of the medicinal products for the medicinal products in accordance with Article 18 (2). 1,

5) a physician or dentist in a hospital or an outpatient who fails to correct any incorrect information in the medical records of the medicinal products for the medicinal products of the medicinal products in accordance with section 18 (4). 2,

6) a physician or a dentist failing to correct the electronic registration of the medical examiner of the medical examiner of the medical records referred to in paragraph 19 (2). 3, and

7) the municipal nursing care, including a nursing home, which omits to correct incorrect information in the electronic registration of the medical examiner of the citizens ' medical records after paragraph 20 (3). 2.

8) hospital-employed pharmacies and pharmacies, failing to correct any incorrect information in the medical records of the medicinal product of the medical examiner of the citizens in accordance with section 21 (2). 2.

9) employee of the Department of Corrective Services, which omits to correct incorrect information in the medical records of the medical examiner of the citizens in accordance with section 22 (3). 2.

10) paramedics with specific competencies failing to correct incorrect information in the medical records of the medicinal products for the medicinal products of the medicinal products in accordance with section 23 (3). 2.

11) employees of housing and equivalent housing in the municipality, including public housing for persons with reduced physical or mental capacity failing to correct incorrect information in the electronic registration of the medical board of the medicinal products of the medicinal products, medical records referred to in section 24 (2) ; 2.

Paragraph 2. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.

Entry into force

§ 29. The announcement shall enter into force on 16. May 2011.

Paragraph 2. Publication no. 990 of 2. In October 2006, the register of the Medicinal Medicine Management Registry (PEM) is hereby repealed.

Homeland Security, the 11th. May 2011

Bertel Haarder

-Dorthe Eberhardt Søndergaard


Appendix 1

Field overview : Pharmaceutical reporting to the Medicine profile

No!
Description
Type / Length
Typical value quantities /
Validation / Remarks
1.
Social Security Number
Text string of 10 characters
Social Security Number
2.
Identification number
Text string of 10 characters
Unique identification number of persons with no social security number.
3.
Date of birth if identification number
Date
YYYY-MM-DD
4.
Expedition Issue P Number
10 integer between 0 and 9
5.
Dispatch Number
Numeric value
0 to 999999999999
6.
Ordino Number
N2
Numeric value
0 to 999999999999999
7.
Pharmacist stamp
N14
Date and Time
Date and time of delivery expressed on the form
YYYY-MM-DDTTT:MM:SS
For example :
1999-05-31T13:20:00
read : 31. May 1999 13.20
8.
Dispatch ' s user identification
AN8
1-10 characters text string
To be filled with user identification on the person performing the operation that causes the transaction to report.
9.
Outer number or Medicato Level Code
Text string of 1-17 characters
This field can be filled in different ways with a second number, substitution code, or hospital / department code.
10.
Authorization-
identifiers
1-8 characters text bar
The approval number of the doctor and the dentist
11.
Item Number
Numeric value
Item number of the item sold item = Item Number for the Heat of the Medicinal Products.
Between 1 and 999999
12.
Number of packages
Integer, Minimum 1
If the alert relates to dose dispensation, the number of units shall be filled in with the number of units.
13.
Free text relevant for the expedition of the prescription and the delivery of the medicinal product
Text string of maximum 245 characters
14.
Dosing Code
1-8 characters text string
This field is populated with code for dosage, when this is stated in the prescription.
15.
Text of dosing from electronic prescription
1-70 characters text string
16.
Indication code
Text string of 1-17 characters
This field is populated with code for Indication when this is stated in the prescription.
17.
Electronic Prescription Indications Text
1-70 characters text string
18.
Expedition Type
2 characters text string
To be filled with the type of dispatch corresponding to the type of dispatch to which the pharmacy is reporting to the medicinal statistics

Appendix 2

Field overview : Medical and Medical Students Reporting for Medicine

No!
Description
Type / Length
N = Numeric
AN = Alphanumeric
Typical value quantities /
Validation / Remarks
1.
Social Security Number
N10
The person number on the person reporting relates.
Set without hyphen.
2.
SKS Code for Reporting Entity
AN20
Code for the hospital-department report strains.
3.
ExtreeTime
N14
The time information is calculated in the EPJ system.
YYYYMMDDHMMSS
4.
Directed from ID
A change to an existing report shall state the ID of the alert to be corrected.
Otherwise empty.
5.
Grapher ID
N11
Identification of the medicinal product reporting is concerned.
6.
Total quantity of quantity
N20
Quantity of the medicinal product patient has received.
7.
Dosis Device
AN10
The unit as the total dose quantity is specified in.
8.
Process Start
N14
The start time of the processing.
YYYYMMDDHMMSS
9.
Process end
N14
The end time of the processing
YYYYMMDDHMMSS
10.
Identification number
N10
Identification number in which the report was previously reported.
xLLLnnnnnn, where x is 4, LLL a country code and nnnnn a serial number. The identification number is modulus-11 correctly.
11.
SKS Code for Reporting Entity
AN20
Code for the infirmary who wishes to modify the identification number of a social security number.

Appendix 3

Viewing information about the capped

No!
Description
1.
Preparing name and organization
2.
Date of reporting
3.
Medicinal Medium
4.
ATC Code and text for medicinal product
5.
Reaction
6.
Description
7.
Delete Date
8.
Name and Organization Deleted

Appendix 4

Viewing information in the citizen's medicine cabinet

No!
Description
1.
Date
2.
Present name, form and strength
3.
Notice