Law Amending And Supplementing The Law On Hospitals

Original Language Title: Закон за изменение и допълнение на Закона за лечебните заведения

Read the untranslated law here: http://parliament.bg/bg/laws/ID/15428/

Name of law Law amending and supplementing the law on medical institutions Named Bill a bill amending and supplementing the law of adoption 09/09/2015 number/year Official Gazette 72/2015 Decree No 169

On the grounds of art. 98, paragraph 4 of the Constitution of the Republic of Bulgaria

I DECLARE:

To be published in the Official Gazette the law amending and supplementing the law on medical institutions HLIÌI adopted by the National Assembly on September 9, 2015.

Issued in Sofia on 16 September 2015.

The President of the Republic: Rosen Plevneliev

Stamped with the State seal.

Minister of Justice: Hristo Ivanov

LAW

amending and supplementing the law on medical institutions (official SG. 62 of 1999; amend., SG. 88 and 113 of 1999; Corr. 114/1999; amend., SG. 36, 65 and 108 of 2000; Decision of the Constitutional Court No. 11 of 2001 – issue 51 of 2001; amend., SG. 28 and 62 from 2002. , PC. 83, 102 and 114 from 2003, PCs. 70 by 2004, PCs. 46, 76, 85, 88, and 105 by 2005, issue. 30, 34, 59, 80 and 105, 2006, issue. 31, 53 and 59 since 2007, PCs. 110. Since 2008, PCs. 36, 41, 99 and 101 of 2009, PCs. 38, 59, 98 and 100 by 2010, PC. 45 and 60 by 2011, issue. 54, 60 and 102 by 2012 PCs. 15 and 20 by 2013 and St. 47 by 2014)

§ 1. In art. 2 create al. 4:

(4) medical institutions can provide integrated healthcare-social services pursuant to chapter IV, section I of the Act for health. "

§ 2. In art. 2 a, para. 1 the words "medical schools" shall be replaced by ' schools '.

§ 3. In art. 5 make the following amendments and additions:

1. In paragraph 8. 1, after the word "children" is added "comprehensive service centers for the children with disabilities and chronic diseases" and a comma.

2. in the Al. 5 after the word "activities" a comma and the words "and spent resources and analysis of the activity of medical institutions ' shall be replaced by ' the resources of medical institutions and the analysis of their activity".

§ 4. In art. 6 make the following amendments and additions:

1. In paragraph 8. 1 the words "medical institutions operate" are replaced by "the activity of medical institutions and medical and other professionals who work in them," takes place.

2. paragraph 2 is replaced by the following:

(2) tissue establishments applied technologies and systems for the collection and exchange of information, as well as the zdravnoinformacionni standards established by an Ordinance of the Minister of health. "

3. in the Al. 5 creates the second sentence: "the structure and composition of the information units are determined by the Ordinance under para. 2. "

4. in the Al. 6, after the words "in the Al. 1 "insert" and 2 ".

§ 5. In art. 8, al. 2 creates a second sentence: "diagnostic-consultative centers can detect up to an additional five beds for monitoring and treatment up to 48 hours for the purposes of them carried out by the clinical trials on medicinal products in accordance with the law on medicinal products for human use."

§ 6. In art. 9 the following amendments and supplements shall be made:

1. In paragraph 8. 1:

a) in paragraph 2, the words "and additional" shall be deleted;

b) in paragraph 4, the word "additional" and a comma after it is deleted.

2. in the Al. 3:

and in the text) before item 1 finally added "each of the following areas;

b) in point 1 the words "dental medicine and pharmacy ' shall be replaced by" and/or dentistry and/or pharmacy ";

in) in paragraph 2 the words "in health care, as well as students from all kinds of medical colleges ' shall be replaced by" of students in majors of vocational direction "health care";

d) in point 3, the words "and persons who have completed medical school" shall be deleted.

§ 7. In art. 10 creating item 4 (a):

"4A. comprehensive service center for children with disabilities and chronic diseases."

§ 8. In art. 17, al. 2, the words "with specialists in medical informatics and healthcare management or health economics" are replaced by "with acquired educational and/or science degree, majoring in education or qualification under art. 43 of the law on higher education in the field of health management ".

§ 9. In art. 17 and following amendments and supplements shall be made:

1. In paragraph 8. 1, after the word "that" is added "medical assistants, nurses or" and the word "obstetric" is replaced by "health".

2. in the Al. 3 the word "major" is replaced by "specialties" Medical Assistant "," nurse "or".

§ 10. In art. 18 is hereby amended as follows: 1. Paragraph 1 shall be amended as follows:

"(1) the private medical diagnostic laboratory is a medical facility in which the physician/medical doctors with the help of other specialists carry out prescribed by another doctor or doctor of dental medicine specialized medical research on one or more medical specialties. In her works, at least one doctor specialist at any one of the directions of activity of the laboratory. "

2. in the Al. 2 the words "AIDS" is replaced by "products".

3. in the Al. 3 the words "on account of the laboratory" shall be replaced by "one of the directions of activity of the laboratory".

4. Paragraphs 5 and 6 shall be read with the following adaptations:

"(5) the requirements for the implementation of the activities of the laboratories referred to in paragraph 1. 1 and 2 are determined by the relevant medical standards under art. 6, al. 1. (6) activity and the device, the internal order of the laboratories under para. 1 and 2 shall be governed by regulations approved by the head of the laboratory. "

§ 11. In art. 19, para. 1 is hereby amended as follows:

1. Section 5 is repealed.

2. In paragraph 6, the words "medicines and medical equipment" shall be replaced by the words "medicinal products and medical devices".

§ 12. Art is created. 19A:


"Art. 19. In the consultation offices, medical-diagnostic and medico-technical laboratories and wards without beds of the hospitals for hospital care under art. 5, al. 1 may be carried out and the activities under art. 11, para. 1. "

§ 13. In art. the following 20 amendments:

1. In paragraph 8. 1 the words "provide delivery assistance and medical and cosmetic services ' shall be replaced by" proving delivery.

2. in the Al. 2, the words "and additional" shall be deleted.

3. a new paragraph. 3:

"(3) in the hospital for active treatment can provide comprehensive medical care for patients with certain medical conditions and for children with disabilities and chronic diseases."

4. Al are created. 4-6:

"(4) Integrated care under para. 3 can be organized on the functional principle of the structural units of the hospital.

(5) in the cases referred to in para. 4 complex care of patients with psychiatric, dermal-venereal and oncological diseases and for children with disabilities and chronic diseases include activities under art. 26, al. 1, respectively, under art. 26 a, para. 1, art. 26 (b), para. 1 and art. 27, al. 1, and for the sick with other diseases – the necessary activities in their observation and treatment.

(6) the organisation of complex care in the hospital is governed by the regulation on the Organization, operation and internal order of the hospital. "

5. The current paragraph. 3 it al. 7 and after the words "para. 2 "there shall be added" and 3 ".

§ 14. In art. 21, the words "and additional" shall be deleted.

§ 15. In art. 22 and the word "additional" and a comma after it is deleted.

§ 16. In art. 24, after the word "persons" is a comma and add "including".

§ 17. In art. 26 a, para. 3, after the word "practices" a comma and add "compartments".

§ 18. In art. 26 (b) is hereby amended as follows: 1. In para. 1 item 4 shall be amended as follows:

"4. the creation and maintenance of an information database about persons with cancer for the purposes of the national cancer registry and the national medical register;".

2. in the Al. 4 the word "additional" and a comma after it is deleted.

§ 19. Art is created. 26:

"Art. 26. Medical activities in mental health centres, centres for skin-venereal diseases and complex oncologic centres shall be carried out in their structural units, which have levels of competence laid down in accordance with the medical standards established under art. 6, al. 1. "

§ 20. In art. 27, al. 1 after the words, of persons "there shall be added", with the exception of the persons under art. 27.

§ 21. Art is created. 27A:

"Art. 27. (1) the Centre for complex service of children with disabilities and chronic diseases was the establishment, in which medical and other specialists carried out at least one of the following activities:

1. support to families of children with disabilities and chronic diseases for the appointment and conduct of early diagnosis, diagnosis, treatment and medical and psychosocial rehabilitation;

2. long-term treatment and rehabilitation of children with disabilities and severe chronic illness and training for their parents to take care in a family environment;

3. provision of visits by medical professionals for specific care for children with severe disabilities and chronic illnesses, raised in a family environment and in social service resident type;

4. providing specialist palliative care for children.

(2) to ensure the needs of the children of advisory assistance and active treatment, if necessary, the Centre for complex service of children with disabilities and chronic diseases concludes contracts with hospitals for outpatient medical care and general hospitals for active treatment.

(3) Directing the child to comprehensive service center for children with disabilities and chronic diseases is carried out by a doctor following an evaluation of the medical necessity of diagnostics, treatment, rehabilitation and/or palliative care by order, determined by the regulation under paragraph 1. 4.

(4) the drive activity and the internal order of the Center for complex service of children with disabilities and chronic diseases are governed by regulations issued by the Minister of health.

(5) comprehensive service centres for children with disabilities and chronic diseases can provide social services in accordance with the law on social assistance. "

§ 22. In art. 28 and the following modifications are made:

1. In paragraph 8. 1 the words "one or more" shall be deleted.

2. in the Al. 2 the words "Centre for dialysis or hemodialysis Department" shall be replaced by ' Centre, Department or clinic for hemodialysis.

3. in the Al. 3 the words "Minister of health" shall be replaced by the head of the "medical establishment".

§ 23. In art. 29 the following amendments and supplements: 1. Paragraph 1 shall be amended as follows:

(1) the needs of the population of available out-patient and hospital care are determined and plan of territorial principle through a national health card, through the national health policy. "

2. paragraph 2 is replaced by the following:

"(2) the national health card is made on the basis of regional health card."

3. Paragraph 3 is replaced by the following:


"(3) for the development of district health card Health Minister appoints a Committee for each area, which includes the Governor, two representatives of the regional health inspection, two representatives of the regional health insurance fund, two representatives of the Association of the Bulgarian medical association, a representative of the Association of the Bulgarian Dental Association, one representative of the regional association of the Bulgarian Association of health care professionals , a representative of the associations for the protection of the rights of patients recognised by the order of art. 86 of the Health Act, and one representative from each municipality in the area. The Governor is the Chairman of the Commission. "

4. in the Al. 4 the second sentence shall be replaced by the following: "the representative of the associations for the protection of patients ' rights in each of the regional committees shall be elected and shall be exempt from the common representative organisations."

5. a new paragraph. 6:

(6) the regional health card is made in a form and in accordance with procedures laid down by the methodology approved by the Minister of health. "

6. The current paragraph. 6 it al. 7.7. The current al. 7 it al. 8 and the words "as well as proposals for the restructuring of hospitals for hospital care" shall be deleted.

§ 24. In art. 30 is made the following changes and additions:

1. Create a new para. 2 and 3:

"(2) in the elaboration of regional health district maps Commission under art. 29 carried out an analysis of the relationship between the preliminary calculations by an order determined by the procedure referred to in art. 29, para. 6, total number of beds for hospitalization, including the species that provide the access of population to hospital care in the area, and the existing number of beds on the types and levels of competence of the relevant structures in the area, as well as their distribution in hospitals and in levels of competence of the relevant structures.

(3) after completion of the analysis referred to in paragraph 1. 2 the District Commission applied to the district and health card drawn up opinions on: 1. the specific needs of physicians and dental practitioners in the majors and vocational specialists "health care" to ensure the access of the population to medical care in outpatient medical assistance;

2. the need for a restructuring of hospitals or to take other measures in creating, closing or streamlining of the hospitals in the area, together with any appropriate proposals for the restructuring of hospitals for hospital care as a result of the analysis;

3. the need to create the conditions for the granting of a particular type of care in the field – palliative or other provided for in law. "

2. The current paragraph. 2 it al. 4 and finally, add "and art. 34A ".

3. a para. 5:

"(5) tissue establishments under para. 4 be financed with funds from the State budget or the budget of the national health insurance fund and subject to the provisions of art. 59, para. 1 (a) and 14 of the law on health insurance. "

4. The current paragraph. 3 it al. 6. § 25. In art. 31 is made the following changes and additions:

1. Paragraph 1 shall be amended as follows: (1) Regional health card contains:

1. data on the demographic structure, the incidence in groups by age and disease and hospitaliziranata disease of the population on the territory of the region;

2. the type, number, activity and distribution of existing in the field hospitals;

3. the required minimum number of doctors, dental practitioners and specialists of professional direction "health care" in outpatient care in the specialties;

4. the number of medical practitioners, dental practitioners in the majors and the number of specialists of professional direction "health care" in the outpatient medical care in the field;

5. the number of beds for hospitalization and medical activities have been carried out on the species and their distribution in hospitals and in levels of competence of the relevant structures;           

6. data on the type, number and distribution of activities in the field of high-tech methods of diagnosis and treatment for their application and the available high-tech medical equipment. "

2. paragraph 2 is replaced by the following:

"(2) To the district health card in al. 1 apply a proposal for the distribution of the number of beds and medical types of activities under para. 1, item 5, and of the number of doctors and specialists in al. 1, item 3, determined in accordance with the needs of the population in the area concerned in line with the methodology set out in art. 29, para. 6. "

§ 26. In art. 32 make the following amendments and additions:

1. In paragraph 8. 1 creating the second sentence: "in the composition of the Commission included the Manager of the national health insurance fund, the Director of the National Center of public health and analysis, the Executive Director of the Executive Agency" Medical audit ", the President of the National Association of municipalities in Republic of Bulgaria, two representatives of the Bulgarian medical association, a representative of the Bulgarian Dental Association, one representative of the Bulgarian Association of health care professionals , a representative of the associations for the protection of the rights of patients recognised by the order of art. 86 of the Health Act, and three representatives of the Ministry of health. "

2. paragraph 2 is replaced by the following:

"(2) the national health card contains:


1. the regional health cards;

2. the specific needs of physicians and dental practitioners in the majors and vocational specialists "health care" to ensure the access of the population to medical care in outpatient medical services to all areas;

3. the specific needs of beds for hospitalization and medical activities on the types and levels of competence of the relevant structures for all areas;

4. existing hospitals for hospital care, hospitals under art. 10 and hospitals carrying out high-tech methods of diagnosis and treatment, on the map of the country;

5. analysis of the situation in the regions, including on the necessary doctors and dental practitioners in the majors and vocational specialists "health care" of outpatient medical care in areas;

6. the types of medical activities, planned at the regional level, in accordance with the separate areas of art. 4, al. 3 of the law on regional development;

7. map of the necessary high-tech methods of diagnosis and treatment and their application-related high-tech medical equipment;

8. emergency medical assistance card containing the number and location of centers for emergency care. "

3. a para. 3:

"(3) to the national health map areas are identified by the needs of physicians and dental practitioners in the majors and vocational specialists" health care "in the outpatient medical care, as well as the number of beds for hospitalization and medical types of activities and the levels of competence of the relevant structures, having carried out their planning and planning of hospitals carrying out high-tech methods of diagnosis and treatment. "

§ 27. In art. 34 following amendments and supplements shall be made:

1. In paragraph 8. 2, the second sentence, add "in cases laid down by the procedure of art. 29, para. 6. "

2. Paragraph 3 shall be repealed.

3. Paragraph 4 is replaced by the following:

"(4) the national health card in the Al. 1 is required for the planning of medical activities by type, carried out in tissue establishments, with the exception of establishments under art. 8, al. 1 created by dental practitioners in accordance with this law. "

§ 28. In chapter six is created art. 34A:

"Art. 34. In areas where the number of beds for inpatient treatment exceeds the specific needs of the number of beds by type, as defined by the national health card, the directors of the REGIONAL HEALTH INSURANCE FUND shall conclude contracts with hospitals for hospital care or their associations, selected on criteria and in accordance with procedures laid down by the Decree of the Council of Ministers. "

§ 29. In art. 35 the following modifications are made:

1. In paragraph 8. 1 third sentence is hereby repealed.

2. in the Al. 3, paragraph 1, after the words "psychiatric help" a comma and the words "and homes for medical-social care under medical supervision and specific care for kids" are replaced by "homes for medical-social care under medical supervision and special care for children, and comprehensive service centers for the children with disabilities and chronic diseases".

§ 30. Create art. 37A and 37B:

"Art. 37. (1) before issuing a permit for the carrying out of remedial action under art. 46 for the new hospitals for hospital aid the Commission under art. 32, para. 1 shall carry out an assessment of the needs of the population from medical care on the basis of the national health card.

(2) On completion of the assessment under paragraph 1. 1 shall submit an application to the Ministry of health, to which are applied:

1. information about investment intentions;

2. information on the nature, structure and estimated number of beds for hospitalization and medical activities on the types and levels of competence of the relevant structures;

3. the opinion of the District Council of the Bulgarian medical association or of the Bulgarian Dental Association in the territory of the area in which the medical establishment is created.

(3) the documents referred to in para. 2 shall be examined by the Commission under para. 1, which expresses a reasoned opinion within one month of receipt of the application.

(4) if necessary, additional information and/or documents, the Commission shall inform the applicant in writing within such period as it may specify the relevant documents and information.

(5) the Commission under para. 1 expresses a favourable opinion when there are needs for the beds for hospitalization and medical activities on the types and levels of competence of the relevant structures in the area concerned, laid down in the national health card.

(6) the Commission under para. 1 expressed a negative opinion when the existing number of beds for hospitalization and medical activities on the territory of the region exceeds the specific needs of beds for hospitalization and medical activities on the types and levels of competence of the relevant structures set out in the national health card.

(7) the opinions referred to in paragraph 1. (5) and (6) shall be published on the website of the Ministry of health.

(8) in a negative opinion on the Al. 6 new hospital for hospital care is not included in the national health card and may not conclude a contract with the national health insurance fund to the update of the map by the procedure of art. 34, para. 2.

Art. 37 (b) (1) in accordance with art. 37A is carried out and an assessment of the needs of the population of new medical activities which will be carried out by the hospitals for hospital care.


(2) On completion of the assessment under paragraph 1. 1 the head of the hospital for hospital care shall submit an application to the Ministry of health, to which apply:

1. information about the type of new medical activities;

2. the structures in which the activities referred to in paragraph 1 will be carried out;

3. estimated number of beds for inpatient treatment and levels of competence of the relevant structures;

4. the opinion of the District Council of the Bulgarian medical association or of the Bulgarian Dental Association.

(3) in the case of a negative opinion from the Commission under art. 32, para. 1 for the implementation of the new medical activities are not included in the most recent national health card and the medical establishment may not conclude a contract with the national health insurance fund for the payment of these medical activities to update the map in accordance with art. 34, para. 2. "

§ 31. In art. 39, para. 3 the words "medical school" are replaced by "school".

§ 32. In art. 40 following amendments and supplements shall be made:

1. In paragraph 8. 1:

a) in paragraph 2 the words "Memorandum of the company, according to the cooperative, and ' shall be deleted;

b) sections 6 and 6A shall be repealed.

2. in the Al. 4 figure "14" is replaced by "10".

3. a new paragraph. 5: "(5) on the day of receipt of the application referred to in para. 1 the regional health inspection service sent a request to the time the Bulgarian medical association, according to the Bulgarian Dental Association and the Bulgarian Association of health care professionals, for the issue of certificates of registration in their registers of doctors, dental doctors, medical assistants, nurses or midwives who will guide and/or will work in the hospital, according to the unit under art. 17A. Guild organizations issue certificates within 5 days of receipt of the request. "

4. The current paragraph. 5 it al. 6.

5. The current paragraph. 6 it al. 7 and the number "13" is replaced by "10" and the words "para. 5 ' shall be replaced by "para. 6. "

6. The current paragraph. 7 it al. 8 and everywhere the words "medical school" are replaced by "school".

7. The current paragraph. 8 it al. 9 and the number "7" is replaced by "8" and the number "13" is replaced by "10".

8. The current paragraph. 9 it al. 10 and shall be amended as follows:

(10) within 10 days of the completion of the examination under paragraph 1. 4 and receive certificates under para. (5) and (7) or by removing the limitations under para. 9 the Director of the regional health inspection shall issue a certificate of registration or a certificate of the hospital to perform the healing art activity. 2A. "

§ 33. In art. 41 following amendments and supplements shall be made: 1. In para. 2: a) in paragraph 3 the words "medical school" are replaced by "school";

b) in item 4 the words "art. 40, para. 7, paragraph 2 "shall be replaced by" art. 40, para. 8, item 2. "

2. in the Al. 3, first sentence, after the word "describe" insert "number and type of".

3. a para. 5:

"(5) in this Ordinance under para. 4 is determined and the order in which registered by the procedure of art. 40 establishment can register a second or subsequent address of business in the territory of the regional health inspection other than the regional health inspection at initial registration. "

§ 34. In art. 44, para. 1 make the following amendments and additions:

1. In paragraph 1 the figure "8" is replaced by "9".

2. In paragraph 5, after the words "dentistry" a comma and add "medical assistants, nurses".

§ 35. In art. 45, para. 2 all over the words "medical school" are replaced by "school".

§ 36. In art. 46, para. the words "under art. 20, para. 2 "shall be replaced by the words" and the provision of activities under art. 20, para. 2 and 3 ".

§ 37. In art. 47 make the following amendments and supplements: 1. Al. 1:

a) in paragraph 3, the words "for specialists in medical informatics and health changes or džm″nt of Economics of health" are replaced by "of educational and/or degree, majoring in education or qualification under art. 43 of the law on higher education in the field of healthcare management;

b) point 7 is repealed;

c) in item 8, the words "para. 4 "shall be replaced by" para. 5 "and the words" under para. 6 ' shall be replaced by "under para. 7. "

2. in the Al. 4 the number "30" is replaced by "20".

3. a new paragraph. 5: "(5) on the day of receipt of the application referred to in para. 2 the regional health inspection service sent a request to the time the Bulgarian medical association, according to the Bulgarian Dental Association, for the issuance of certificates of registration in their registers of members of the Executive and the supervisory authorities of the medical establishment, who are medical doctors or doctors of dental medicine. Professional organizations issue certificates within 5 days of receipt of the request. "

4. The current paragraph. 5 it al. 6.5. The current al. 6 it al. 7 and the number "30" is replaced by "20" and the words "para. 5 ' shall be replaced by "para. 6. "

6. The current paragraph. 7 it al. 8 and in her words "para. 4 and 6 "shall be replaced by" para. 4 and 7 "and the words" para. 1, 2, 4 and 6 "shall be replaced by" para. 1, 2, 4, 5 and 7 ".

7. The current paragraph. 8 it al. 9 and the number "30" is replaced by "20".

8. The current paragraph. 9 it al. 10.

9. The current paragraph. 10 it al. 11 and shall be amended as follows:

"(11) where necessary, the Minister of health may request verification regarding compliance with the requirements under paragraph 1. 4 of Executive Agency "Medical audit". "

10. Al are created. 12 and 13:

(12) in 20 days from the receipt of the request under paragraph 1. 11 the Executive Agency "Medical audit" sent to the Ministry of health and the regional health inspection finding from the checks carried out.


(13) the regional health inspection in accordance with the findings of the examination under paragraph 1. 12 issued a new certificate of compliance with the requirements under paragraph 1. 4, and in the established nonconformities gives instructions and shall set a deadline for their removal. "

§ 38. In art. 48 the following modifications are made: 1. In para. 1:

(a)) in the text before paragraph 1 the word "three" is replaced by "75-day";

b) in paragraph 3 the words "para. 2 "are replaced by" para. 2 and 3 ".

2. in the Al. 2:

a) in paragraph 1 the figure "8" is replaced by "9";

(b)) in item 5, the words "and/or" shall be deleted.

§ 39. In art. 49 following amendments and supplements shall be made: 1. a new paragraph. 2: "(2) the register referred to in para. 1 fit and tissue establishments authorised by the Minister of Health appointed by him or by the Deputy Minister to carry out assisted reproduction, as well as for the provision, use and storage of human ova, sperm and zygotes in the Health Act. Suspension and termination of the activities of assisted reproduction, provision, use and storage of human ova, sperm and zygotes, as commenced and the suspension of stopping are subject to entry in the register. "

2. The current paragraph. 2 it al. 3.

3. The current paragraph. 3 it al. 4 and, after the word "describe" insert "number and type of".

4. The current paragraph. 4 it al. 5.

5. The current paragraph. 5 it al. 6 and the number "4" is replaced by "5".

§ 40. In art. 50 the following endorsements are added: 1. Al. 2 creates a second sentence: "the only documents concerning the alteration and whose term of validity has expired, accompanied by a declaration of the absence of change in all other documents and circumstances."

2. a para. 4:

"(4) the entry of changes in the circumstances of the registration of the establishments under art. 49, para. 2 is subject to the procedures for the issuance of a permit under the law on health, as well as to al. 2, second sentence. "

§ 41. In art. 51, para. 3 the words "item 4" shall be replaced by "3 and 4" and after the words "the infringement of" insert "chapter III, sections I-III and chapter IV, sections III and IV of the Health Act or".

§ 42. In art. 52 the following modifications are made:

1. In paragraph 8. 1 the second sentence shall be deleted.

2. in the Al. 2 the second sentence shall be deleted.

§ 43. In art. 55 al. 1 is repealed.

§ 44. In art. 62, para. 2 the words "medical school" are replaced by "school".

§ 45. In art. 63 the following modifications are made:

1. In paragraph 8. 1, the words "with specialists in medical informatics and healthcare management or health economics" are replaced by "with acquired educational and/or science degree, majoring in education or qualification under art. 43 of the law on higher education in the field of health management ".

2. in the Al. 3 after the word "help" a comma and the words "and centers – the sole commercial companies" shall be replaced by the words "diagnostic-consultative centers – sole trade companies, and hospitals under art. 10 – sole trade companies ".

§ 46. In art. 64, para. 2 make the following amendments and additions:

1. In paragraph 2, the words "damages" are replaced by "the deterioration of financial performance or damages incurred which are for".

2. paragraph 4 shall be inserted:

"4. in the event of economic indicators set out in the award of contracts for management or control."

§ 47. In art. 65, para. 3, after the words "psychiatric help" a comma and the words "and the home for medical and social care, in which medical surveillance and special care for children" are replaced by "the home for medical and social care, in which medical surveillance and special care for children, and a comprehensive service center for children with disabilities and chronic diseases", and the words ' every three years ' shall be replaced by "annually".

§ 48. In art. 68, para. 5 in the first and second sentences, the words "in higher medical schools" shall be replaced by "in medical faculties and the faculties of dental medicine of universities".

§ 49. In art. 69, para. 2 make the following amendments and additions:

1. In paragraph 3 the words "medical school" are replaced by "school".

2. point 4 shall be replaced by the following:

4. monitor the financial position of the hospital and are responsible for its financial stability; ".

3. In paragraph 6, the words "the implementation of the financial and medical devices" are replaced by "controlling the financial situation".

4. In paragraph 8, the words "spent resources" shall be replaced by "resources".

5. an item 11:

11. perform other activities assigned to them by the treaties. "

§ 50. In art. 71, item 5, the words "of higher medical schools" shall be replaced by ' of the medical faculties and the faculties of dental medicine of universities ".

§ 51. In art. 73, the words "medical school" are replaced by "school".

§ 52. In art. 80 is made the following changes and additions:

1. In paragraph 8. 1:

a) a new paragraph 3:

"3. the graduate by the order of the Ordinance under art. 181, para. 1 of the Health Act; "

(b)) the current paragraph 3 becomes paragraph 4.

2. in the Al. 2 the words "medical school" are replaced by "school".

3. in the Al. 3 Finally, the comma and added "as well as posts for graduate students".

§ 53. In art. 80 and the following modifications are made:

1. In paragraph 8. 1, the words "of higher medical school" are replaced by "the high school".

2. in the Al. 2, the words "of higher medical schools" shall be replaced by ' of the medical faculties and the faculties of dental medicine of universities ".

§ 54. In art. 81 Al are created. 3 and 4:

"(3) the evaluation of failure under para. 1, item 1 and al. 2 is carried out depending on the needs of medical care under the national health card.


(4) in the cases referred to in para. 1, item 1 and al. 2 the Director of the regional health inspection determines the minimum number of hours, but no less than 10 hours a week, in which physicians and dental practitioners should work in hospitals under para. 1, paragraphs 1 and 3.

§ 55. In section III of chapter eight article is created. 81 (a):

"Art. 81. Workers in the hospitals, for which reduced working hours has been established according to art. 137 of the codec of labor can work in shifts, such as the maximum length of the work shift when totalizing the calculation of working time can be up to 12 hours regardless of the length of the reduced working time. "

§ 56. In art. 86, para. 1, after the words "medical and social care" is added "comprehensive service centers for the children with disabilities and chronic diseases".

§ 57. In chapter nine is created art. 89 (b):

"Art. 89 (b) (1) in the Ministry of health is leading a public register of tissue establishments, received accreditation evaluation. In the register shall be entered:

1. the number and date of the order for accreditation;

2. the designation of accredited medical facility;

3. the information referred to in art. 89 a, para. 2 and 3.

(2) the register referred to in para. 1 dedicating a separate section, the order in which shall be entered the persons applied for accreditation, and describe the number and type of attached to the application documents. This section notes and file movement formed in the application.

(3) the conditions and procedures for the keeping of the register shall be determined by the Ordinance under art. 87, para. 1. "§ 58. In art. 90 following amendments and supplements shall be made:

1. In paragraph 8. 1:

a) in paragraph 2 the words "in health care, as well as students from all kinds of medical colleges ' shall be replaced by" of students in majors of vocational direction "health care";

b) in paragraph 3 the words "and persons who have completed medical school" shall be deleted.

2. paragraph 2 is replaced by the following:

"(2) the Council of Ministers shall, on a proposal from the Minister of health determines which tissue establishments or their clinics or wards, received" very good "or" excellent "accreditation rating for the activities referred to in para. 1 acquire the rights of university hospitals/clinics or wards for the duration of the accreditation evaluation. The proposal of the Minister of health shall be made on the basis of a reasoned request from the Rector of the higher school, in consultation with the head of the hospital. "

3. a new paragraph. 3:

"(3) in accordance with para. 2 the Council of Ministers can take away the rights of University hospital/clinic or ward before the expiry of the accreditation assessment of hospital/clinic or ward. "

4. The current paragraph. 3 it al. 4 and, after the word "hospital" is added "/clinics or wards.

5. The current paragraph. 4 it al. 5 and in her words "medical school" are replaced by "school".

6. The current paragraph. 5 it al. 6.

§ 59. Article 93 is amended as follows:

"Art. 93. the conditions and the way of financing of training, as well as the criteria to be met by hospitals under art. 91 and 92, respectively, shall be determined by regulations under art. 181 of the Health Act and in art. 87, para. 1. "

§ 60. In art. 100 make the following amendments and supplements: 1. Al. 2 section 2 is amended as follows:

"2. the overhaul or repair, associated with the redevelopment of the hospital;".

2. in the Al. 4, first sentence, the words "the services provided by budget" shall be replaced by the words "the services provided by the State or municipal budget," and in the second sentence, after the words "such as" State "is added and the municipalities" and the word "record" shall be replaced by "record".

3. in the Al. 7, the words "the services provided by budget" shall be replaced by the words "the services provided by the State or municipal budget," and in the second sentence, after the words "such as" State "is added and the municipalities" and the word "record" shall be replaced by "record".

§ 61. In art. 101 the following modifications are made:

1. In paragraph 8. 1 the words "top medical schools" are replaced by "high schools".

2. in the Al. 3 the words "art. 49, para. 4 "shall be replaced by" art. 49, para. 5. "

3. in the Al. 4, the words "higher medical schools" are replaced by "high schools".

§ 62. In art. 116 (a), the words "500 to 2000" shall be replaced by ' 2000 to 5000.

§ 63. Create art. 116 (b) and 116 in:

"Art. 116. (1) (b) Which violates the provisions of this law or the normative acts for its implementation in the conduct of activities in the medical establishment under art. 10, is punishable by a fine from 1500 to 3000 BGN.

(2) medical establishment under art. 10, who carries out the activity in violation of this law or the normative acts for its implementation, shall be punished with a penalty ranging from 2500 to 5000 EUR

Art. 116. (1) the medical establishment, which operates in violation of the provisions of the approved zdravnoinformacionni standards, is punishable by a fine of 500 to 1000 EUR

(2) when the offence under para. 1 was carried out by the medical establishment – sole trader or legal entity having a proprietary sanction from 500 to 1000 EUR "

§ 64. In art. 117 the words "art. 115-116 (a) ' shall be replaced by "art. 115-116.

§ 65. In § 1 of the additional provisions are made the following amendments and additions:

1. In paragraph 8, after the word "assistance" a comma and the words "and its capacity" are replaced by "Center for mental health, the Center for skin-venereal diseases and complex Oncology Center and their capacity".

2. point 10 shall be replaced by the following:

"10." high-tech methods of diagnosis and treatment "are defined as high-tech methods in the procedure under art. 29, para. 6. "

3. an item 11:


"11." new medical activities "are medical specialties, activities in which the hospital is not carried out, as well as on medical specialties, activities in which the medical establishment operates, but is changing its volume (a new structure for the same specialty or raise the level of competence of the existing structure of the medical establishment), including high-tech methods of diagnosis and treatment and their application-related high-tech medical equipment."

Transitional and final provisions

§ 66. In the Health Act (promulgated, SG. 70 by 2004; amend., SG. 46, 76, 85, 88, 94 and 103 by 2005, issue 18, 30, 34, 59, 71, 75, 81, 95 and 102 in 2006, issue 31, 41, 46, 59, 82 and 95 (2007), no. 13, 102, and 110 in 2008, issue 36, 41, 74, 82 , 93, 99 and 101 of 2009, PCs. 41, 42, 50, 59, 62, 98 and 100 by 2010, PC. 8, 9, 45 and 60 by 2011, issue. 38, 40, 54, 60, 82, 101, and 102 from 2012, PCs. 15, 30, 66, 68, 99, 104 and 106 by 2013, PCs. 1, 98 and 107 by 2014 and PCs. 9 by 2015.) in chapter IV, section Ia is created with art. 125b-125 (d):

Section Ia

Integrated health-social services

Art. 125. (1) (b) the integrated health and social services are activities that medical professionals and specialists in the field of social services providing health care and medical supervision and carry out social work, including in the home environment, in support of children, pregnant women, people with disabilities and chronic diseases and the elderly who need assistance in the performance of daily activities.

(2) the services under para. 1 may be provided by municipalities, hospitals and by the persons under art. 18, al. 2 of the Act on social assistance.

(3) the municipalities and the persons under art. 18, al. 2 of the law on social assistance can provide the services under para. 1 after notification pursuant to art. 36 of the regional health inspection in the territory of which the services are carried out.

(4) medical institutions can provide the services under para. 1 subject to the provisions of art. 18, al. 2 and 3 of the Act on social assistance.

(5) the services under para. 1 for children shall be provided in compliance with the requirements of the law for the protection of the child.

Art. 125. (1) the Integrated Health and social services under art. 125 (b), para. 1 may be financed by:

1. the State budget;

2. municipal budgets;

3. national and international programmes;

4. the persons under art. 18, al. 2 of the law on social assistance;

5. other sources.

(2) the integrated health and social services are provided in return for payment by the persons under art. 125 (b), para. 1.

(3) Integrated health services, which are financed from the State budget and are provided free of charge to the persons under art. 125 (b), para. 1 shall be determined by decision of the Council of Ministers.

Art. 125. (1) the type of services under art. 125 (b), para. 1 the terms and conditions of their provision, criteria and standards for their quality and rules for the control of compliance with them shall be governed by an Ordinance adopted by the Council of Ministers, on a proposal from the Minister of health and Minister of labour and social policy.

(2) the checks on compliance with the criteria and standards of quality of services under art. 125 (b), para. 1 is carried out jointly by the authorities under art. 31, para. 2 and 3 of the law on social assistance and regional health inspections. "

§ 67. In the law on health insurance (official SG. 70 of 1998; amend., SG. 93 and 153 of 1998, no. 62, 65, 67, 69, 110 and 113 in 1999, issue 1 and 64 in 2000, 41/2001, no. 1, 54, 74, 107, 112, 119 and 120 of 2002, no. 8, 50, 107 and 114 from 2003. , PC. 28, 38, 49, 70, 85 and 111 in 2004, PCs. 39, 45, 76, 99, 102, 103 and 105 of 2005, St. 17, 18, 30, 33, 34, 59, 80, 95 and 105, 2006, issue. 11 of 2007; Decision of the Constitutional Court No. 3 of 2007 – PCs. 26 of 2007; amend., SG. 31, 46, 53, 59, 97, 100 and 113 of 2007, PC. 37, 110 and 71 of 2008, PCs. 35, 41, 42, 93, 99 and 101 of 2009, PCs. 19, 26, 43, 49, 58, 59, 62, 96, 97, 98 and 100 by 2010, PC. 9, 60, 99 and 100 by 2011, issue. 38, 60, 94, 101 and 102 of the 2012 issue. 4, 15, 20, 23 and 106 by 2013, PCs. 1, 18, 35, 53, and 54 107 by 2014 and PCs. 12, 48, 54 and 61 by 2015.) make the following changes and additions:

1. In art. 58 the words "medical institutions" shall be replaced by "medical institutions or their associations.

2. In art. 59:

and Al is created). 1a:

"(1A) Contracts under para. 1 cannot be concluded with new hospitals for hospital or medical help for new activities carried out by the hospitals for hospital care under art. 37 and, accordingly, under art. 37 (b) of the law on medical institutions, for which the Commission under art. 32, para. 1 of the law on medical institutions has expressed a negative opinion. ";

(b)) is hereby set up al. 14:

(14) For diseases for which the basic package of art. 45, para. 2 provided for providing complex treatment (provision of each single part of the overall treatment process), the Director of the REGIONAL HEALTH INSURANCE FUND shall conclude contracts only with hospitals or their associations, which have provided a complex treatment of these diseases. "

§ 68. (1) within 6 months from the entry into force of this law the Commission under art. 32, al. 1 on the basis of the analysis undertaken under art. 30, para. 2 carry out judgment and expresses an opinion on the options for providing complex treatment (provision of each single part of the overall treatment process) of the patient in the existing mental health centres, centres for skin-venereal diseases and complex Oncology centers.

(2) the Commission referred to in paragraph 1. 1 shall notify its opinion the Minister of health, as well as the Director of the Centre for mental health, the Centre for skin-venereal diseases or of integrated Oncology Center, or the respective owner of the Centre, you can take appropriate action in accordance with this law to carry out complex treatment of the patients.


§ 69. (1) establishments which do not meet the requirements of art. 9, para. 1, art. 19, para. 1, art. 20, para. 1 and 2, art. 21 and 22 a, shall comply with the requirements, as entered in the commercial register, change and submit documents for the change of permits issued for curing to the Minister of health within three months of the entry into force of this law.

(2) State fees for registration of changes in the Al. 1 not due.

§ 70. (1) the Minister of health sets the appropriate medical standards under art. 6, al. 1 in accordance with the requirements for levels of jurisdiction under art. 26 in within one month from the entry into force of this law.

(2) mental health centres, centres for skin-venereal diseases and complex Oncology centers shall bring their activities into line with the requirements of art. 26 in and submit documents for the change of permits issued for curing to the Minister of health within one month from the entry into force of the medical standard in al. 1.

(3) State fees for registration of changes in the Al. 2 not due.

§ 71. (1) the procedure under art. 29, para. 6 shall be approved within one month from the entry into force of this law.

(2) Regional health cards are made and the national health card is accepted in accordance with this Act within two months from the validation of the methodology referred to in paragraph 1. 1.

(3) in the event that in the appointment of committees for the development of regional health cards are not certain representatives of the municipalities, pursuant to the law on local self-government and local administration within 15 days of receipt of a request for their determination, for representatives of the municipalities are considered to be the mayor or authorized by them.

§ 72. Paragraph 24, item 3 and § 67, item 2 shall enter into force from 1 January 2016.

The law was passed by the National Assembly-43 on September 9, 2015 and is stamped with the official seal of the National Assembly.

President of the National Assembly Tsetska Tsacheva:

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