LAW ON HEALTH RECORDS

CONSOLIDATED TEXT 1

I. GENERAL PROVISIONS
Article 1

This Law shall regulate the records, collections of data and registers in the field of health, the manner
of their collection, procession, storage and keeping of data, publishing data, ensuring data quality and
protection, as well as exercise of rights and obligations related to health records.

Article 2

(1) The terms used in this Law shall have the following meaning:

1. "Statistical research" is preparation, collection, storage and keeping of data and analysis and
publishing of statistical data;

2. "Reporting unit" is holder of collection of data, legal entity and natural person confirmed as data
provider;

3. "Collection of statistical data" is concentration of answers contained in statistical questionnaires,

forms, enquiry documents and information contained in other media with data from the field of health;

4. "Records" is entry of certain basic and specific data, structured group of data as determined by law,
regardless whether it is centralized or divided on functional or geographic basis, as well as regardless
whether it is consisted of individual or collective (aggregate) data;

5. "Individual records" is records of personal and medical data of individuals;

6. "Collective records" is records of collective anonymous data on certain marks;

7. "Health register" is instrument of the health statistics containing basic and specific data on natural
persons or legal entities, based on collected, processed and analyzed individual collections of data and
is used for statistical, research and public health purposes;

8. "Health data" is data referring to the health of the population and include as well medical data;

9. "Medical data" is data referring to the health of an individual as well including the data referring to
anamnesis, diagnosis, prognosis and treatment, as well as data with clear and close relation with the
health;

10. "Collection of data" is registers determined by law and records determined by law based on law,
basis and banks of data kept on the basis of public and other authorizations;

11. "Database" is collection of data sorted by certain rules and standards with prescribed manner of
keeping, updating and time periods for keeping by the holder of the database;
12. "Identification data" are those individual data enabling direct identification of the legal entity or
natural person, and referring to the name and surname, address and personal identification number
kept in accordance with the regulations;

13. "Individual data" are data referring to the legal entity or natural person. Individual data referring
to a natural person shall be considered personal data;

14. "Personal data" is any information referring to an identified natural person or natural person who
can be identified, and person who can be identified is a person whose identity can be directly or
indirectly confirmed, especially on the basis of personal identification number of the citizen or on the
basis of one or more marks specific for his physical, psychological, economic, cultural or social
identity;

15. "Special categories of personal data" are personal data revealing the racial or ethnical background,
political, religious or other belief, membership in a trade union organization and data referring to the
health condition or the sexual life;

16. "Unrevealed data" are data that cannot be directly connected to an individual;

17. "Anonymous data" are personal or unrevealed data that after their special processing can no
longer be directly or indirectly connected to an individual and have no capacity of personal data;

18. "Procession of personal data" is each operation or sum of operations being performed on personal
data in automatic or in any other manner, such as: collecting, recording, organizing, keeping,
adjusting or altering, withdrawing, consulting, using, revealing by transferring, publishing or in any
other manner making them available, leveling, combining, blocking, deleting or destroying; 

19. "Controller" is natural person or legal entity that individually or together with another collects,
processes, analyses and delivers health and medical data;

20. "User" is natural person or legal entity, state body or other body wherefore the data are being
revealed for the purpose of performing regular activities, in accordance with law. The bodies to which
data can be revealed within a special investigation, shall not be considered users in terms of this Law;

21. "Consent of the subject of personal data" is freely and explicitly given statement of the will of the
subject of personal data wherefore he consents the processing of his personal data for previously
determined purposes;

22. Authorized holders of the health statistics are the Institute for Public Health of the Republic of
Macedonia and the institutes for health protection, that when collecting, processing and disseminating
data apply statistical standards and methods;

23. "Health documentary material" is material from its source and reproduced (written, drawn,
printed, photographed, filmed, phonographed, magnetically, optically or otherwise written), received
or created in the work of the healthcare institutions and directly related to the provision of health
protection;

24. "Services of information society" are services provided for compensating distance, via electronic
means and on personal request of the service receiver. “Distance” means that the service is provided
without simultaneous presence of both parties;

25. "Service provider" is any natural person or legal entity providing services of information society by
establishing trade company on indefinite term in the Republic of Macedonia, whereas the presence and
use of technical means and technologies necessary for providing services of information society, are
themselves not considered foundation of the service provider;
26. "Service receiver" is any natural person or legal entity that due to professional or other reasons
uses services of the information society, for the purpose of searching information or making an
information available;

27. "Consumer" is any natural person that uses services of information society for purposes apart
from its trade activity or profession;

28. "Electronic signature" is line of data in electronic form contained or logically related to other data
in electronic form and intended for confirming the authenticity of the data and the identity of the
signature holder;

29. "Infrastructure for managing the health documentary material" is personnel, premises, equipment,
education/training and program equipment intended for enabling complete or partial collecting,
keeping or processing of health, personal or other data and other health documentary material in
digital form and thus related issues;

30. "Bidder (software) of program equipment" is any entity wherefore the health activity providers as
final contracting authorities, enables use of program equipment for managing the health documentary
material;

31. "Information services" are services related to collection, keeping or procession of health
documentary material in digital form, including digitalization of the material, but are inseparable
related with the offer of the program equipment;

32. "Bidder of information services" is any entity performing information services for the health
protection providers as final contracting authorities;

33. "Information of public character" is information in any form created or at disposal of the
information holder, i.e. at disposal only of the information holder, in accordance with his competences;

34. "Information seeker" is any legal entity and natural person without discrimination on any basis, in
a manner and under conditions determined by the Law on Free Access to Information of Public
Character and this Law and

35. "Document" is any entry of information regardless of its physical form or characteristics, written or
printed texts, charts, schemes, photographs, drawings, sketches, working materials, as well as audio,
voice, magnetic or electronic, optical and video recordings in any form, and also transferable
equipment for automatic processing of data with built-in or transferable memories for storing data in
digital form.

36. "National System of Electronic Health Records" is an electronic system where all the medical and
health data on the patients, the data on the healthcare workers and co-workers, the data on the
healthcare institutions, healthcare interventions and services carried out in the healthcare institutions,
the data on the electronic referrals and electronic prescriptions, the data on appointments for
specialist examinations and interventions, and the other data set out by this and another law are
stored and processed.

Article 3

This Law shall apply to:

- the electronic records and the processing of the health and medical data and
- the records in paper form and the manual processing of the health and medical data.

II. BASIC PRINCIPLES

 Article 4

(1) Health records kept on the basis of the principles of quality, efficiency, effectiveness and economy,
whereas the records are proper, relevant and in scope corresponding to the purposes determined by
this Law.

(2) Medical data shall be processed in accordance with the regulations on personal data protection.

(3) Health and medical data shall be collected for particular and clear purposes determined in this Law
and shall be processed in a manner being in line with such purposes.

(4) Personal data, collected for the purposes of the health records, shall be exclusively used for
collection, procession and analysis of health and medical data, in accordance with the regulations on
personal data protection and with this Law.

(5) The access to information prepared on the basis of processed data from collections of data shall be
enabled in accordance with the regulations on free access to information of public character.

(6) Processing of health and medical data for scientific or statistical researches shall be considered in
accordance with the purposes of collecting data, if certain protection measures are undertaken in
accordance with the regulations on personal data protection.

III. RECORDS
Article 5

(1) The Institute for Public Health of the Republic of Macedonia (for the territory of the Republic of
Macedonia) and the institutes for health protection for the areas they have been founded for
(hereinafter: regional centers for public health) shall be authorized holders of the health statistics for
the records kept in the healthcare institutions.

(2) Each healthcare institution, for the activity it performs, shall be obliged to submit collective and
individual records – statistical reports, through the regional centers for public health to the Institute
for Public Health of the Republic of Macedonia.

(3) Records established by this Law shall be kept as individual records (individual data on natural
persons or legal entities) and collective records (aggregate data).

(4) Keeping the records referred to in paragraph (3) of this Article is consisting part of the professional
and medical work in the healthcare institutions and health workers and co-workers.

(5) The records shall serve as source of data for statistical researches in the field of health and shall
be used for following and studying the health condition of the population, for programming and
planning, i.e. undertaking the necessary measures in the field of health protection, for the needs of
the scientific research, for the needs of the local self-government in accordance with the regulations
regulating the competencies of the local self-government, for the needs of the state defense, for
informing the public, for performing international obligations of the state, as well as other official
purposes.

(6) The data contained in the individual records can be used by individual to whom those data refer,
for the purpose of exercising their rights.

Article 6
(1) Healthcare institutions shall be obliged to keep records in the basic medical documentation.

(2) The records shall be kept by entering data in the basic medical documentation (personal health
record, single medical chart, register, medical journal, illness history, and else), on different levels of
health protection.

(3) The basic medical documentation of paragraph (1) of this Article shall contain:
- personal data for the individual (PIN, data of birth, sex, name and surname, name of one of the
parents, belonging to ethnical community, religion, marital status, education, occupation, date of
death, address of permanent place of residence, place, municipality, occupation, employment status
(economic status) and basis for health insurance),
- medical data – data on the health condition (diagnosis, date of visit, planned visits, doctor’s code,
therapy, referral, reason for temporary working disability, reason for death, reason for processing and
social anamnesis of the family) and
- data on medical care and other data related to patient care (nutrition and alike).

(4) The basic medical documentation referred to in paragraph (1) of this Article shall also include the
findings, statements, opinions and other documents related to the health condition and the provided
health protection.

(5) The type, design and contents of the forms for keeping the basic medical documentation referred
to in paragraphs (2) and (4) of this Article shall be prescribed by the Minister of Health.

Article 7

(1) The basic medical documentation referred to in Article 6 of this Law shall be used by health
workers, that is, co-workers in the provision of health protection of an individual, as well as source of
data for the records determined in this Law.

(2) When keeping the basic medical documentation the workers, that is, co-workers shall be obliged to
act in line with this Law, with the regulations on personal data protection and protection of the
patients’ rights.

Article 8

(1) Healthcare institutions, depending on the activity they perform, shall keep the following individual
records for:
1) malign neoplasm;
2) revealing pre-cancerous changes of the cervix;
3) revealing breast cancer;
4) colorectal carcinoma;
5) diabetes;
6) innate disruptions of the metabolism and endocrinopathies;
7) innate anomalies;
8) children with special needs;
9) ischemic heart disease;
10) cerebrovascular diseases;
11) kidney insufficienca;
12) psychosis;
13) drug abusers;
14) alcohol addicts;
15) occupational disease;
16) intoxication;
17) traffic accident trauma;
18) violence;
19) home injuries;
20) stationary treated person;
21) childbirth;
22) in-vitro fertilization;
23) abortion – termination of pregnancy;
24) periodical and permanent absence from work;
25) accident – injury at work;
26) blood donors;
27) transplantation of human body parts;
28) infectious diseases;
29) immunization;
30) HIV/AIDS;
31) tuberculosis;
32) doctor’s report on a deceased person;
33) perinatal death;
34) health workers and co-workers; and
35) units for health protection within the composition of the healthcare institution.

(2) The healthcare institutions shall keep the records referred to in paragraph (1) of this Article
continuously and shall enter each change immediately upon its occurrence.

(3) The design and content of the forms, as well as the deadline and the manner of their filling in,
keeping, processing and storing of the individual records referred to tin paragraph (1) of this Article
shall be prescribed by the Minister of Health.

Article 9

(1) Healthcare institutions, depending on the activity they perform, shall keep the following collective
records:
1) for following, assessing and planning the work within the framework of the basic (primary) health
protection;
2) for following, assessing and planning the preventive health protection of adults, of child on 0 to 5
years of age, school age children and youth and women;
3) for the work of the health protection workers for the purpose of following, assessing, programming
and planning the health and educational work and research and studying;
4) intended for following the ambulance and hospital physical medicine and rehabilitation of the ill and
injured;
5) for following confirmed illnesses, conditions and injuries and ambulance and policlinic activity;
6) for needs of blood and blood products;
7) intended for following the work of the polyvalent patronage health protection;
8) intended for following the psychological health of children;
9) intended for following the work of the services for lung diseases and tuberculosis;
10) intended for following the work of the specialist and consultative activity;
11) intended for following and assessing the work of the hospital and stationary activity;
12) dental treatment of the individual;
13) for the work of the health protection workers for the purpose of following the scope of the
diagnostics and of assessing the activity of the public health laboratories;
14) for following the work of the clinical biochemical laboratories;
15) for the work of the microbiological laboratory;
16) for following the health properness of the objects for general use and children toys (in the existing
records);
17) for following the quality and health properness of the means for personal hygiene, for care and
beautifying of the face and body from domestic production and from the import;
18) for following the quality and health properness of the means for cleaning in the households from
domestic production and import;
19) for following the quality and health properness of raw materials and scenting compositions used in
the production process in the chemical and pharmaceutical industry;
20) in the field of health ecology;
21) for life styles;
22) for the purpose of following, assessing and planning the work, yet intended for decreasing the
waiting time within the performance of the specialist health protection;
23) for following, assessing and planning the preventive health protection of workers, participants in
the traffic and athletes;
24) intended for following the health protection – care (nursing and obstetric care);
25) for the work of the health protection workers for the purpose of following the work of the urgent
medical assistance service;
26) for the work of the health protection workers with intention to follow the consumption of medicinal
products;
27) for following the ambulant prescription of medicinal products;
28) intended for following the consumption of medicinal product issued without prescription;
29) for the work of the health protection workers for the purpose of providing data on the work of the
pharmacies – for information, staff planning and for financial means;
30) the medicinal products on the market being kept for the purpose of following the consumption of
medicinal products;
31) for following the quality of medicinal products from domestic production and from import;
32) of reproductive health intended for following and assessing the sterilization and in-vitro
fertilization and following the work of the commission of first and second instance for terminating
pregnancy and sterilization;
33) for the patients’ satisfaction;
34) for equipment in healthcare institutions;
35) for revenues and expenditures in the healthcare institutions;
36) for regular following of HFA health indicators;
37) for performed medical procedures;
38) health accounts;
39) for performed medical procedures (DRG);
40) for measuring the effect (individual and institutional);
41) for repeated acceptance for same diagnosis;
42) of number of hospital days per diagnosis;
43) of insured persons, according:
- reporting/cancellation form in the health insurance,
- selected doctor and their deputies and
- change of selected doctor;
44) of issued orthopedic and other devices and the time periods of their validity;
45) of healthcare institutions in agreement with the Health Insurance Fund of Macedonia;
46) of issued health cards / electronic health cards;
47) for treatment abroad;
48) of issued prescriptions per insured persons and per selected doctors;
49) for treatments upon health protection programs;
50) for total revenues of the Health Insurance Fund of Macedonia from incomes from the mandatory
health insurance;
51) for treating uninsured persons;
52) for adverse reactions from the medicinal products and
53) for procedures for biologically assisted fertilization.

(2) The records for adverse reactions from the medicinal products shall be kept in accordance with the
medicinal products regulations.

(3) The center for monitoring adverse reactions from medicinal product shall on annual basis submit a
report to the Institute for Public Health of the Republic of Macedonia for the recorded adverse
reactions from medicinal products.

(4) The records for biologically assisted fertilizations shall be kept in accordance with the regulations
on biologically assisted fertilization.
(5) The healthcare institutions authorized for implementing the procedures for biologically assisted
fertilization shall be obliged to submit collective reports with anonymous data to the Institute for
Public Health of the Republic of Macedonia.

(6) The healthcare institutions shall enter the collective records referred to in paragraph (1) of this
Article in the National System of Electronic Medical Records (hereinafter: National System) every three
months.

(7) Based on the quarterly reports referred to in paragraph (1) of this Article, the centers for public
health shall prepare semi-annual collective reports they submit to the Institute for Public Health of the
Republic of Macedonia every 20th in the ongoing month for the previous six months.

(8) Regional centers for public health shall submit annual reports from the collective records referred
to in paragraph (1) of this Article to the Institute for Public Health of the Republic of Macedonia, at
latest until 31st January for the previous year.

(9) The design and contents of the forms, as well as the manner of filling in, keeping, processing and
storing the collective records referred to in paragraph (1) of this Article shall be prescribed by the
Minister of Health.

Article 10

As an exception to Articles 8 and 9 of this Law, the health workers, that is, co-workers and the
healthcare institutions shall be obliged to submit the data from the records on protection of infectious
diseases within time periods prescribed with the regulations on protection of the population from
infectious diseases.

Article 11

(1) The regional centers for public health shall control and process the data from the individual record
forms.

(2) If the regional center for public health suspects the correctness of the entered data, it shall be
obliged to notify the healthcare institution which have entered the data in order to check the
correctness and in the event of a mistake, to correct the mistake.

(3) Based on the submitted individual records referred to in Article 8 of this Law, the Institute for
Public Health of the Republic of Macedonia shall keep the following health registers:
1) Register of cancer – malign neoplasms;
2) Register of organized revealing of pre-cancerous changes of the cervix;
3) Register of organized revealing of breast cancer;
4) Register of colorectal carcinoma;
5) Register of diabetes;
6) Register of innate disruptions of the metabolism and endocrinopathies;
7) Register of innate anomalies;
8) Register of children with special needs;
9)Register of ischemic heart disease;
10) Register of cerebrovascular diseases;
11) Register of kidney insufficienca;
12) Register of psychosis;
13) Register of drug abusers;
14) Register of persons – alcohol abusers;
15) Register of occupational diseases;
16) Register of intoxications;
17) Register of traffic trauma;
18) Register of violence;
19) Register of home injuries;
20) Register of hospital and stationary treated persons;
21) Register of childbirth;
22) Register of monitoring biomedical assisted fertilization;
23) Register of abortions – termination of pregnancy;
24) Register of periodical and permanent absence from work;
25) Register of injuries at work;
26) Register of blood donors;
27) Register of transplantation of parts of the human body;
28) Register of infectious diseases;
29) Register of persons subjected to immunization and implementation of immunization and
appearance of adverse reactions from the immunization;
30) Register of HIV/AIDS;
31) Register of tuberculosis;
32) Register of deceased persons;
33) Register of perinatal death rate;
34) Register of health workers and co-workers; and
35) Register of healthcare institutions.

(4) The form and content, as well as the manner of keeping, processing and storing the registers
referred to in paragraph (1) of this Article shall be determined by the Minister of Health.

Article 12

(1) The records shall be kept by entering data in the basic medical documentation and in the other
documentation prescribed by this Law by this Law. 2

(2) Entry of data shall be done on the basis of the results of the control and documentation of the
healthcare institution, i.e. public and other documents.

(3) If the data cannot be entered in the manner determined in paragraph (2) of this Article, it shall be
entered based on a statement of the person from whom the data entered in the records are being
taken.

(4) The healthcare worker, in the course of carrying out medical check-ups, i.e. other services, shall
be obliged to enter the finding and the results of the check-up, that is, the other services he has
provided in the basic medical documentation.

(5) The healthcare worker shall be obliged to enter data in the individual or collective records referred
to in Articles 8 and 9 of this Law.

Article 13

(1) The health worker shall be obliged to confirm his finding and the results of the check-up, i.e. the
other services he has provided, by putting his signature and seal or his electronic signature.

(2) The health worker shall be obliged to confirm all the data he enters in the individual or collective
records, by putting his signature and seal or his electronic signature.

(3) The health worker performing the entry of the data in the means for keeping records shall be
responsible for the completeness and authenticity of the data entered in the records.

(4) The person giving the statement shall be responsible for the authenticity of the data given in a
statement.
 Article 14

(1) For the purpose of providing single system of statistical research, when keeping the records, single
methodological principles and statistical standards shall be applied (definitions, classifications and
nomenclatures).

(2) Single methodological principles and statistical standards (definitions, classifications and
nomenclatures) shall be determined by the Institute for Public Health of the Republic of Macedonia,
based on previous opinion from the State Statistics Office, as well as based on approval from the
Directorate for Personal Data Protection, in regard to the personal data protection.

(3) The Institute for Public Health of the Republic of Macedonia shall determine the single
methodology for managing health documentary material, upon previous opinion from the State
Archive of the Republic of Macedonia in regard to the harmonization of the regulations wherefore the
protection of the documentary and archive material is regulated.

Article 15

The Minister of Defense, in accordance with this Law, shall prescribe the manner of keeping health
records in military healthcare institutions.

Article 16

Healthcare institutions and health workers, that is, co-workers shall be obliged to protect and keep the
data, regardless of the form they are kept in, in accordance with this Law and with the regulations on
personal data protection.

Article 17

(1) The Ministry of Health shall keep a National System of Electronic Medical Records.

(2) The National System shall provide unity of the health data and of the single information and
communication infrastructure for managing the collections of data and for transferring data and
reports and health documentary material.

(3) Data from the records of healthcare institutions, state bodies, public institutions and other entities
which are entitled to such data in accordance with this Law shall be provided through the National
System.

(4) The healthcare institutions from their health records databases shall deliver the data on each entry
or unit, i.e. alteration or possible deletion to the National System referred to in paragraph (1) of this
Article.

(5) The National System shall in particular include:

- data on the healthcare institution,
- data from the basic medical documentation,
- data from the individual and collective records,
- data on insured persons,
- data on health workers and co-workers,
- data from the electronic list for scheduled check-ups and interventions for using the health services,
- health interventions and services carried out in the healthcare institutions, and
- data from the telephone health consultations done with patients by the healthcare institutions.
(6) The manner of keeping, administering and availability of the data in the National System shall be
determined by the Minister of Health.

(7) The healthcare institutions shall be obliged to submit the data referred to in paragraph (2) of this
Article to the National System with codes and with ensured protection in accordance with the
regulations on protection of the patients’ rights, for personal data protection and with this Law, and in
case of data in electronic form in accordance with the regulations on electronic signature and e-
commerce, as well.

(8) The healthcare institution shall have access to the data from the National System, under the
conditions determined in this Law regarding the processing and protection of personal and medical
data.

Article 18

Every person shall be entitled to protection of health and personal data under the conditions
determined in this Law and in the regulations on personal data protection.

Article 19

Deleted 3

Article 20

The funds for keeping the National System shall be provided from:
- the Budget of the Republic of Macedonia, on the basis of a program adopted by the Government of
the Republic of Macedonia,
- legal entities or natural persons for processing data and for material expenditures for submitting the
data from the records upon their request (Article 35).

IV. COLLECTING AND PROCESSING DATA

Article 21

(1) Healthcare institutions shall, generally, receive medical data directly from the individual they refer
to, and indirectly from medical data of already existing collection of data, if the individual has been
previously introduced and had not opposed thereto.

(2) The healthcare institution can provide its medical data from the doctor, when necessary in order to
protect the individual’s life and health, if they are directly threatened.

(3) Healthcare institutions can obtain medical data referring to racial, national and other background,
political, religious and other beliefs or sexual behavior, directly from the individual for the purpose of
providing health protection to the individual and as source of data for the records determined in this
Law.

Article 22

(1) If there is possibility for direct or indirect connection of the data with the individual, processing of
data shall only be performed if necessary for the purposes of the processing.

(2) Unrevealed data cannot be processed in a manner that will enable their connection to the
individual.
(3) Processing of personal data shall be allowed, if:
1) the individual was previously introduced and did not oppose thereto;
2) processing is necessary for the purpose of protecting the life and health of another person;
3) processing is necessary for the purpose of protecting the population’s health, in accordance with
this Law;
4) processing is necessary for the purpose of protecting public interest, in accordance with law and
5) other cases determined by law.

(4) Processing of unrevealed data can be performed by healthcare institutions only in the cases of
paragraph (1) of this Article.

Article 23

(1) Medical data can be used for the following purposes:

- maintaining and promoting the health and health protection of the individual,
- protection of the population’s health,
- statistical and other research purposes and
- other purposes as prescribed in this Law.

(2) Healthcare institutions, use the medical data referred to in paragraph (1) line 1 of this Article for
the purpose of maintaining, promoting the health of the individual and for all the health related
services to the individual.

(3) The data kept and collected exclusively for statistical or research purposes, must not be used by
state and other bodies, bodies of the local self-government, institutions and enterprises performing
public services and holders of public authorization for the purpose of confirming the rights and
obligations of individuals, of healthcare institutions and other persons to whom the data refer.

(4) The data referred to in paragraph (3) of this Article shall be given by the healthcare institutions
processed in a manner so as not to reveal the personal data of the individual.

Article 24

(1) In the healthcare institutions, the basic medical documentation shall be kept 15 years as of the
last entry of data.

(2) The medical chart and history of disease shall be kept 15 years as of the death of the diseased.

(3) A dental chart shall be kept permanently.

(4) Healthcare institutions shall be obliged to keep and store the basic medical documentation in
electronic form in accordance with this Law.

(5) In the Institute for Public Health of the Republic of Macedonia and in the regional centers for public
health, the processed data along with the analyses and reports shall be kept permanently in electronic
form.

Article 25

(1) Healthcare institutions keeping records and having at their disposal collections of data can
exchange data between separate collections of data for the purpose of providing quality and unity in
the data and for the purposes determined in this Law.
(2) The Ministry of Health, the Institute for Public Health of the Republic of Macedonia and the regional
centers for public health, for the purpose of processing the data from the established screenings, may,
for such purpose, require and connect data from particular collections which are also available to other
bodies and institutions.

(3) Healthcare institutions referred to in paragraph (1) of this Article, keeping records and having at
their disposal collections of data that contain unrevealed data, can exchange data between certain
collections of data in a manner that does not enable connecting of the unrevealed data with the
individual.

(4) The Institute for Public Health of the Republic of Macedonia can, for special needs in regard to the
collections of data, collect and document material in regard to the health protection of individuals, in
accordance with the determined purposes of this Law.

Article 26

(1) The Ministry of Health and the Health Insurance Fund of Macedonia shall have at their disposal and
shall manage the data from the National System.

(2) The Ministry of Health, the Health Insurance Fund of Macedonia, the State Sanitary and Health
Inspectorate, and the Institute for Public Health of the Republic of Macedonia shall be obliged to
exchange data which they have at disposal, as well as to require data from other entities which have
data at disposal.

(3) Access to the National System shall have only the persons who hold a certificate issued in
accordance with the regulations on classified information.

(4) Medical, Pharmaceutical and Dentistry Chamber of Macedonia, the Chamber of health workers with
high school, college and higher vocational degree, the Health Insurance Fund of Macedonia, the State
Statistics Office and other bodies and institutions having data at their disposal, shall be obliged to
exchange primary and other data between separate collections of data for the purpose of providing
quality and unity of the data and for the purpose of ensuring functionality of the records and registers
as introduced by this Law. 

(5) The State Statistics Office shall be obliged, on a request of the Institute for Public Health of the
Republic of Macedonia and the Ministry of Health, to deliver data from the database of deceased
persons and from the register of population on individual level, for the purpose of continuous and
complete functioning of the collections of data and registers as introduced by this Law.

Article 27

Deleted 4

Article 28

Deleted 5

Article 29

(1) Healthcare institutions shall be obliged to provide each individual to be:

1) introduced which health and personal data are collected for him (information on the data collected
and processes, purpose of the processed data, the information security system for those data and
possible exchange of data with other entities) and
2) introduced with his rights in regard to processing his health and personal data and effects of
anonymity of data.

(2) The healthcare institutions shall be obliged, on a request of the individual and on his expense, to
give him a copy of his health and personal records.

(3) The healthcare institutions shall be obliged to provide the individual, in greatest possible scope, to
be included in the decisions on protection, procession and revealing of his health and personal data.

Article 30

(1) The health and personal data of the individual, referring to provision of health protection to the
individual, can be revealed in a scope necessary to provide certain health service and only to the
health workers and co-workers directly included in the treatment process and who have obligation to
protect the data in accordance with law.

(2) It shall be considered that the individual has given his consent, if he is previously introduced that
the data will be revealed for the purpose of his health protection and has not opposed thereto, except
in the cases of Article 31 of this Law.

Article 31

(1) If processing of health and personal data is necessary for protection of the life and health of the
individual and of other persons and consent cannot be obtained from the individual, the healthcare
institution shall be obliged to process the data in a necessary scope.

(2) The institution referred to in paragraph (1) of this Article shall be obliged in a period of three days
as of the day of the completed data processing, to introduce the individual with the content of the
processed health and personal data, the scope of the processing and the urgent reasons thereof.

Article 32

(1) The healthcare institution shall be obliged to provide protection of health and personal data even
after the death of the individual to whom the data refer.

(2) If a person with capacity to contract has given written statement before his death, requesting
protection or revealing of health and personal data, the healthcare institutions shall be obliged to
respect such decision even after his death.

Article 33

(1) The healthcare institution shall be obliged to reveal the health and personal data of the individual
for the purpose of providing health protection to other persons, if it is necessary for protecting
people’s life and health, in the necessary scope and only to health workers and co-workers directly
included in the treatment process and who have obligation to protect those data in accordance with
law.

(2) Processing of health and personal data for preventive health protection, medical diagnostics and
other health protection, as well as performing health activity can be performed in accordance with this
Law.

Article 34
(1) The Institute for Public Health of the Republic of Macedonia shall process the health and personal
data for statistical and research purposes:
- from existing collections of data being kept by it or by other legal entities,
- by connecting existing collections of data kept by it or by other legal entities in the health or other
sector,
- from the National System,
- by making surveys it performs or is performed for it by healthcare institutions, and
- directly from the healthcare institutions.

(2) The Institute for Public Health of the Republic of Macedonia can, for the purposes of paragraph (1)
of this Article, request data prescribed in this Law from legal entities being holders of such data.

(3) The Institute for Public Health of the Republic of Macedonia can process the unrevealed data for
statistical and research purposes only in a manner that does not enable connection of the data with
the individual.

(4) The Institute for Public Health of the Republic of Macedonia can collect the data, for statistical and
research purposes, in collections of data prescribed by this Law, from the healthcare institutions, from
the register of the population, the register of business entities, as well as from other collections of
data.

(5) The Institute for Public Health of the Republic of Macedonia can, when necessary, appoint
healthcare institutions or number of individuals for collecting data (method of samples).

(6) Collections of data for statistical and research purposes shall be of permanent significance.

Article 35

(1) On a request of legal entity or natural person, the Ministry of Health can give data from the
records they keep in accordance with this Law and with the regulations on personal data protection
and for the information of public character.

(2) The persons referred to in paragraph (1) of this Article shall pay compensation for the costs for
processing the data and for the material costs in accordance with the expenditure list determined by
the Minister of Health.

Article 36

(1) The healthcare institutions shall be obliged, on a request of the Ministry of Health, to deliver data
from the collections of data they keep, free of charge.

(2) The data referred to in paragraph (1) of this Article shall be delivered by the healthcare institutions
in anonymous form.

(3) As an exception to paragraph (2) of this Article, healthcare institutions can deliver personal data to
the Ministry of Health, if with the use of anonymous data the purposes determined in this Law cannot
be achieved.

(4) The healthcare institutions shall deliver unrevealed data in form that does not enable connection
with the individual.

Article 37
(1) The Ministry of Health, from among the experts in law, medicine, information technologies and
statistics, shall form a commission for monitoring and promoting the health records, which shall
perform the following tasks:
- give opinions and directions for processing the data prescribed in this Law,
- prepares and publishes annual report regarding the conditions in terms of health records.

(2) The manner of work of the commission referred to in paragraph (1) of this Article shall be
regulated with a Rulebook.

V. SECURITY SYSTEM
Article 38

(1) The healthcare institutions shall implement and maintain security system that includes security
measures for securing the health and personal data they possess, in accordance with this Law and
with the regulations on personal data protection, in regard to:
- the personnel, students and external cooperators or other legal entities and natural persons,
- communication infrastructure and
- procedures for processing health personal data, i.e. health material.

VI. INTERNATIONAL STATISTICAL COOPERATION

Article 39

(1) When fulfilling the international obligations, the Institute for Public Health of the Republic of
Macedonia, in cooperation with the authorized holders in the field of statistics, shall cooperate,
mediate and exchange data with other countries that have implemented proper data protection and
with international organizations.

(2) Copy of the data that the Institute for Public Health of the Republic of Macedonia delivers within
the framework of the statistical cooperation, shall be as well delivered to the Ministry of Health.

(3) When performing the obligations from paragraph (1) of this Article, the Institute for Public Health
of the Republic of Macedonia shall cooperate with the ministry competent for external issues, and if
necessary with other state administration bodies. 

Article 40

(1) For the purpose of performing its tasks, upon prior approval from the Government of the Republic
of Macedonia, the Institute for Public Health of the Republic of Macedonia can become member in
international organizations and cooperate thereof.

Article 41

International statistical cooperation shall be realized through:

- preparation of statistical data in accordance with international and interstate agreements concluded
and accepted by the Republic of Macedonia,
- membership and cooperation with international and regional organizations and associations,
- participation in preparation of international publications,
- participation in realization of international projects,
- cooperation with statistical bodies of other countries in the field of statistics and
- preparation and giving for use statistical data on a request of users from abroad.
 Article 42

The provisions of this Law and the regulations on personal data protection shall be applied in regard to
data protection during international statistical processing.

VII. SUPERVISION
Article 43

(1) The Ministry of Health shall perform supervision over the implementation of the provisions of this
Law.

Article 44

(1) The State Sanitary and Health Inspectorate and the Bureau for Medicaments shall conduct
inspection over the entry of data and keeping of medical documentation and health records by the
healthcare institutions in accordance with law.

(2) The Health Insurance Fund of Macedonia shall control the entry of data and keeping of medical
documentation and health records by the healthcare institutions which is kept in accordance with the
regulations on health insurance and this Law.

Article 45

(1) In the course of conducting inspection, that is, control referred to in Article 44 of this Law, the
competent inspector, that is, controller shall be obliged to inspect, that is, control the entry of the data
and the keeping of the medical documentation and the health records by the healthcare institutions.

(2) The inspector, who when performing inspection supervision acknowledges personal data, shall be
obliged to keep them as classified information in accordance with the regulations on classified
information.

Article 46

(1) The inspector referred to in Article 45 of this Law, shall be obliged, by a decision, to:
1) order undertaking of measures for removing the flaws he shall confirm in regard to the
implementation of this Law and 6

(2) An appeal can be filed against the decision referred to in paragraph (1) of this Article in a period of
eight days as of the day of serving the decision.

(3) The appeal shall be filed to the State Commission for Decision-making in Administrative Procedure
and Labor Relations Procedures in Second Instance. 7

Article 46-a

(Education procedure)

(1) If in the course of conducting the inspection supervision the inspector establishes that for the first
time there has been an action contrary to Article 48 paragraph (1) of this Law, he/she shall be obliged
to prepare minutes in which he/she shall define the irregularity and indicate that the established
irregularity should be eliminated in a time period of eight days and shall at the same time hand over
an invitation for education to the person or entity where such irregularity has been established during
the inspection supervision.

(2) The form and content of the invitation for education, as well as the manner of delivery of the
education shall be prescribed by the Minister.

(3) The education shall be organized and delivered by the State Sanitary and Health Inspectorate, in a
period not longer than eight days as of the day of conducting the inspection supervision.

(4) The education may be delivered for several identical, or of the same kind, established
irregularities, for one or more entities.

(5) The education shall be considered delivered if the person or the entity to be educated does not
show at the scheduled time for education.

(6) If the person or entity to be educated shows at the scheduled time for education and completes
the education, it shall be considered educated in regard to the established irregularity.

(7) If in the course of conducting the control supervision, the inspector determines that the
established irregularities referred to in paragraph (1) of this Article have been eliminated, he/she shall
adopt a conclusion to stop the procedure for inspection supervision.

(8) If in the course of conducting the control supervision, the state sanitary and health inspector
determines that the established irregularities referred to in paragraph (1) of this Article have not been
eliminated, he/she shall file a motion for initiation of a misdemeanor procedure with a competent
court.

(9) The State Sanitary and Health Inspectorate shall keep records for the delivered education in a
manner prescribed by the Minister of Health.

Article 46-b

The Ministry of Health shall prepare quarterly reports for the completed controls and delivered
educations and shall publish them on the web site of the Ministry of Health, in a unified quarterly
chart.

Article 47

Deleted 8

VIII. MISDEMEANOR PROVISIONS

Article 48

(1) Fine in the amount of Euro 2.000 in Denar counter-value shall be imposed for a misdemeanor on a
legal entity if:
1) it does not keep records in accordance with the principles of quality, efficiency, effectiveness and
economy, whereas the same are proper, relevant and in a scope corresponding to the purposes
determined by this Law (Article 4 paragraph (1));
2) it does not submit collective and individual records - statistical reports, through the regional center
for public health to the Institute for Public Health of the Republic of Macedonia (Article 5 paragraph
(1));
3) it does not enter the collective records in the National System every three months (Article 9
paragraph (6));
4) it engages in international cooperation contrary to Article 41 of this Law.

(2) Fine in the amount of 30% of the determined fine for the legal entity shall be also imposed on the
responsible person in the legal entity for the misdemeanors of paragraph 1 of this Article.

(3) Fine in the amount of Euro 200 to 300 in Denar counter-value shall be imposed on the health
worker and/or co-workers in the healthcare institution for the misdemeanor from paragraph (1) of this
Article.

Article 48-a

(1) Fine in the amount of Euro 2.500 in Denar counter-value shall be imposed on the legal entity for a
misdemeanor if it:
1) does not keep records in basic medical documentation (Article 6 paragraph (1));
2) does not keep records in accordance with Article 6 paragraphs (2), (3) and (4) of this Law;
3) does not keep the records in accordance with the activity it performs as referred to in Articles 8
paragraph (1) and 9 paragraph (1) of this Law;
4) does not keep the records continuously and does not enter any change immediately upon its
occurrence (Article 8 paragraph (2));
5) does not prepare six-months (semi-annual) collective reports based on the quarterly reports and
does not submit them to the Institute for Public Health of the Republic of Macedonia every 20th in the
month for the previous six months (Article 9 paragraph (7));
6) does not submit annual report from the collective records to the Institute for Public Health of the
Republic of Macedonia at latest until 31st January for the previous year (Article 9 paragraph (8));
7) does not submit data from the records for protection from infectious diseases in accordance with
Article 10 of this Law;
8) does not keep the registers referred to in Article 11 paragraph (4) of this Law;
9) does not keep the records in a manner determined in Articles 12 and 14 paragraph (1) of this Law;
10) does not confirm the single methodological principles and statistical standards (definitions,
classifications and nomenclatures) (Article 14 paragraph (2));
11) does not submit data in regard to every entry or unit, i.e. change or possible deletion in the
National System (Article 17 paragraph (4));
12) does not store the medical documentation in a manner and within the time periods referred to in
Article 24 of this Law;
13) performs exchange of data against Article 25 of this Law or does not perform exchange of data
(Article 26);
14) does not submit data to the Ministry of Health in accordance with Article 36 of this Law.

(2) Fine in the amount of 30% of the determined fine for the legal entity shall be also imposed on the
responsible person in the legal entity for the misdemeanors referred to in paragraph (1) of this Article.

(3) Fine in the amount of Euro 250 to 370 in Denar counter-value shall be imposed on a health worker
and/or co-worker in a healthcare institution for the misdemeanor referred to in paragraph (1) of this
Article.

Article 48-b

(1) Fine in the amount of Euro 3.000 in Denar counter-value shall be imposed for misdemeanor to a
legal entity, if it:
1) does not process the medical data in accordance with the personal data protection regulations
(Article 4 paragraph (2));
2) uses the personal data, gathered for the purposes of the health records, contrary to Article 4
paragraph (3) of this Law;
3) does not submit a collective report with anonymous data in regard to the implementation of the
procedures for biologically assisted insemination to the Institute for Public Health of the Republic of
Macedonia (Article 9 paragraph (5));
4) does not protect and store the data, regardless of the form they are kept in, in accordance with this
Law and the regulations on personal data protection (Article 16);
5) provides data contrary to Article 21 of this Law;
6) performs data processing contrary to Article 22 of this Law;
7) uses medical data contrary to Article 23 of this Law;
8) acts contrary to Article 29 of this Law;
9) reveals health and personal data of the individual contrary to Article 30 of this Law;
10) does not act in accordance with Articles 31, 32, 33 of this Law;
11) processes data and acts against Article 34 of this Law and
12) does not implement and maintain a security system in accordance with Article 38 of this Law.

(2) Fine in the amount of 30% of the determined fine for the legal entity shall be also imposed for the
misdemeanors referred to in paragraph 1 of this Article on the responsible person in the legal entity
who shall be terminated the duty - director of the institution for the misdemeanor referred to in
paragraph (1) of this Article.

(3) Fine in the amount of Euro 300 to 450 in Denar counter-value shall be also imposed on a health
worker and/or co-worker in a healthcare institution for the misdemeanor referred to in paragraph (1)
of this Article.

Article 49

Fine in the amount of Euro 500 to 800 in Denar counter-value shall be imposed for misdemeanor on a
health worker and/or co-worker if:
1) they use basic medical documentation against Article 7 paragraph (1) of this Law or do not act in
accordance with Article 7 paragraph (3) of this Law;
2) do not act in accordance with Article 13 of this Law;
3) do not protect and store the data regardless of the form they are kept in, in line with Article 16 of
this Law and
4) do not act in a manner determined in Article 27 paragraph (2) of this Law.

Article 49-a

(1) With regard to the misdemeanors determined in Articles 48, 48-a, 48-b and 49 of this Law, the
competent inspector shall be obliged to issue a misdemeanor payment order to the perpetrator of the
misdemeanor, in accordance with the Law on Misdemeanors.

(2) The competent inspector shall be obliged to keep records of the issued misdemeanor payment
orders and of the outcome of the initiated procedures.

(3) The following data shall be gathered, processed and kept in the records referred to in paragraph
(2) of this Article: name and surname, that is, name of the perpetrator, permanent, that is, temporary
residence, head office, type of misdemeanor, number of the misdemeanor payment order which is
issued, and outcome of the procedure.

(4) The personal data referred to in paragraph (3) of this Article shall be kept for five years as of the
day of entry in the records.

(5) The Minister of Health shall prescribe the form and the contents of the misdemeanor payment
order.

Article 49-b
The amount of the fine for the legal entity shall be determined in accordance with the Law on
Misdemeanors.

Article 50

(1) The misdemeanor procedure for the misdemeanors anticipated in this Law shall be conducted and
misdemeanor sanctions shall be imposed by the competent court.

IX. TRANSITIONAL AND FINAL PROVISIONS

Article 51

Until the adoption of by-laws and methodologies, as referred to in this Law, the existing by-laws,
methodological principles and standards shall be applied, unless they are contrary to this Law.

Article 52

The single methodology shall be prescribed by the Institute for Public Health of the Republic of
Macedonia in a period of 18 months as of the day this Law enters into force.

Article 53

Healthcare institutions shall be obliged to harmonize their work with the provisions of this Law and
with the methodologies adopted thereon, in a period of two years as of adopting the single
methodology referred to in Article 52 of this Law.

Article 54

As of the day this Law enters into force, the Law on Health Records (“Official Gazette of SFRY” number
22/78, 18/88 and “Official Gazette of the Republic of Macedonia” number 15/95) shall cease to be
applied and the Law on Health Records (“Official Gazette of SRM” number 37/79 and “Official Gazette
of the Republic of Macedonia” number 15/95) shall cease to be valid.

Article 55

This Law shall enter into force on the eight day as of its publication in the “Official Gazette of the
Republic of Macedonia”, and the provision of Article 3 paragraph (1) line 1 of this Law shall be applied
as of 1st January, 2013.

PROVISIONS OF OTHER LAWS:

Law Amending the Law on Health Records ("Official Gazette of the Republic of Macedonia" no.
53/2011):
Article 6
The bylaws anticipated by this Law shall be adopted in a period of 15 days as of the day this
Law enters into force.

Law Amending the Law on Health Records ("Official Gazette of the Republic of Macedonia" no.
164/2013):
Article 37
This Law shall enter into force on the eight day as of the day of its publication in the "Official
Gazette of the Republic of Macedonia" and Article 31 shall start to apply as of 1 May 2014.
Law Amending the Law on Health Records ("Official Gazette of the Republic of Macedonia" no.
150/2015):
Article 6
The bylaw determined by this Law shall be adopted within a period of 30 days as of the day of
entry into force of this Law.

Law Amending the Law on Health Records ("Official Gazette of the Republic of Macedonia" no.
150/2015):
Article 7
This Law shall enter into force on the day of its publication in the "Official Gazette of the
Republic of Macedonia".