Act On Specific Health Services

Original Language Title: zákon o specifických zdravotních službách

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Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=75507&nr=373~2F2011~20Sb.&ft=txt

373/2011 Coll.


LAW
Dated 6 November 2011

On specific medical services

Change: 167/2012 Coll.

Change: 47/2013 Coll.

Change: 82/2015 Coll.

Change: 205/2015 Coll.

Parliament has passed this Act of the Czech Republic:
TITLE
I
GENERAL PROVISIONS

Basic provisions


§ 1
This law


A) regulates the provision of specific health care and related
state administration, rights and responsibilities of patients and providers
health services (hereinafter "Provider") and the rights and obligations
other legal entities and individuals in connection with the provision
specific health services

B) incorporates the relevant regulations of the European Union ^ 1)
down the general principles of radiation protection of individuals in relation to medical exposure mode
implementation of radiological procedures and practices involving medical
exposure and the level of responsibility and healthcare providers
workers in connection with those procedures and activities and provides for measures to ensure
occupational safety and health.

§ 2

(1) Specific health services mean health services
provided under this Act.

(2) The provisions of health services in connection with
providing specific health services apply unless the law provides otherwise
.
TITLE II


HEALTH SERVICES PROVIDED UNDER SPECIAL ARRANGEMENT
Part 1

Assisted reproduction


§ 3

(1) Assisted reproduction means the methods and processes which occur
subscribe germ cells, to manipulate them, to give
human embryo fertilization of egg and sperm outside the woman's body to manipulate with
human embryos, including their storage, for the purpose of artificial insemination of women


A) health reasons when treating their infertility or infertility
man, if

First it is very probable or totally excluded that the woman gets pregnant naturally or
to donosila viable fetus, and

Second Other treatments for the infertility or infertility may not lead
or with high probability it will not lead to pregnancy, or


B) regarding the need for early genetic testing of human embryos
if the health of the future child at risk because of the demonstrable risk
transfer of genetically conditioned diseases or defects, whose bearer is
this woman or a man.

(2) stem cells for the purpose of assisted reproduction means
eggs and sperm.

(3) Artificial insemination of a woman means

A) introduction of sperm into the woman's genital tract, or

B) transfer of a human embryo resulting from fertilization of egg and sperm outside the woman's body
into the woman's genital tract.

(4) For artificial insemination of a woman can use

A) eggs obtained from the woman ^ 2)

B) sperm obtained from male ^ 2), which the woman undergoing treatment for infertility
together

C) the stem cells donated by another person ^ 2), but which is listed in
a) and b), (hereinafter "anonymous donor"); an anonymous donor may be
only woman who has completed 18 years of age and did not exceed the age of 35 years
or a man who has attained the age of 18 years and did not exceed the age of 40.

(5) stem cells and human embryos can be used only for artificial insemination
. This does not apply in the case of unused human embryos for artificial insemination
that can be used for research on human embryonic stem cells
under the conditions and for the purposes set
law governing research on human embryonic stem cells ^ 3) .

§ 4

Treatment methods of assisted reproduction can be performed only provider
has been granted authorization to provide medical services in the field of reproductive medicine
.

§ 5

(1) Methods and techniques of assisted reproduction can be carried out, if they were
requirements prescribed by law on human tissues and cells ^ 2).

(2) Use of the methods and techniques of assisted reproduction is not permitted for the purpose of elections
future child's sex, except in cases where using
methods and techniques of assisted reproduction can prevent serious
genetically conditioned diseases linked to sex.

§ 6

(1) Artificial insemination can be done by a woman in her childbearing, if
her age did not exceed 49 years, on the basis of a written application to women and men

Who this health service intend to take together (hereinafter
"infertile couple"). Request an infertile couple requesting artificial insemination
not be older than 6 months; It is part of the medical records
led by a woman.

(2) Artificial insemination can not make a woman who has a man with whom
submitted a request under paragraph 1, the negative relationship
according to another law marriage.

§ 7

(1) Germ cells can be removed and used for the methods and procedures
assisted reproduction, if the assessed medical fitness

A) persons who are to be germ cells removed, and

B) women should be performed artificial insemination (hereinafter
"recipient").

(2) The recipient must be a person deprived of legal capacity
or a person with limited legal capacity so that it is not eligible
assess the provision of health services, or the consequences of their
provision, or parental responsibility, even partially.
Recipient must also be a person in custody, in a performance
custody, imprisonment or security detention.

(3) An anonymous donor must be a person

A) deprived of legal capacity or with a limited
legal capacity so that it does not consider eligible
provision of health services, or the consequences of their provision,

B) in police custody, in detention, imprisonment or security detention
,

C), which was ordered isolation, quarantine or is serving inpatient
protective treatment or

D) hospitalized without their consent.

§ 8

(1) Before the methods and techniques of assisted reproduction is
provider is obliged to submit infertile couple
information about the nature of the proposed methods and procedures, permanent consequences and potential risks
and how it can be loaded with
redundant human embryos, including the estimated amount of the costs to their
storage and for their storage. Infertile couple may require
when filing information was present witness of his choice.
Record of bringing information signs infertile couple, doctor, or
witness; Record is part of the medical records of the
recipient.

(2) On the basis of the information referred to in paragraph 1 infertile couple
grants written consent to carry out assisted reproduction; Written permission must be granted
repeatedly before each artificial insemination.
Agreement is part of the medical records of the recipient.

(3) Individual performances of assisted reproduction can be done recipient, if
prior to the start they consented.
Consent recorded in the medical records of the recipient
attending physician who signs a record; Record also sign recipient.

§ 9

(1) If at artificial insemination recipient has not used all
human embryos created in favor of an infertile couple, they can be kept and used for further
artificial insemination of the recipient. This does not apply if
infertile couple declares in writing that the embryo does not intend to use for their next
artificial insemination while consenting to their use for Anonymous
another infertile couple or authorizes the use of redundant
embryos for research under the law on research on human embryonic stem cells
or their liquidation. Statement by the infertile couple
withdrawn at any time; It does not apply if the human embryos used for
another infertile couple or in accordance with the declaration liquidated.
Human embryo arising from the recipient egg or sperm from a man
infertile couple can be used for artificial insemination of another recipient, if
been assessed by the medical fitness of an infertile couple
within the range specified for the anonymous donor.

(2) If human embryos are not used or infertile couple has not made a written statement
dispose of them in accordance with paragraph 1 may
provider after 10 years of keeping such embryos
repeatedly proven in writing to the infertile couple to comment on
further storage of these embryos, including consent to their
discarding. If an infertile couple does not respond to repeated demonstrably
sent a written request of the provider, you can not even express an infertile couple
human embryos discarded.


(3) repeated written notice under paragraph 2 shall be its
provable sending by postal services to address
infertile couple, which is known providers, at least
twice with an interval of at least 60 days . The deadline for expressions
infertile couple under the second call is 30 days from its receipt
.

(4) The call is delivered on the day when it assumes the addressee, otherwise
considered delivered the expiry of 10 days from the date of notification of its
deposit with the postal service. If there is a challenge with respect to the change of address
infertile couple undeliverable or rejection of its takeover
, is considered a challenge delivered on the day of its return
providers. The same procedure is an invitation undeliverable
only one person from the infertile couple.

(5) Based on the written declaration under paragraph 1 or written consent
made at the invitation under paragraph 2 provider
ensure disposal of preserved frozen human embryos, for
presence of at least two health workers.
Part of the medical records of the recipient's written statement or a written agreement
or receipt or other document evidencing
provable dispatch of the written invitation infertile couple, and record
annihilation of human embryos; record signed by health workers who were
destruction of human embryos present.

§ 10

(1) A provider who is authorized to perform the methods and procedures
assisted reproduction, is obliged to ensure the maintenance of anonymity
anonymous donor and the infertile couple, and an anonymous donor anonymity and
child born of assisted reproduction.

(2) A provider who performed the assessment of health eligibility
anonymous donor and a woman or man from the infertile couple, is obliged
data about their state of health required for artificial insemination pass
provider who performs artificial insemination ; This provider is obliged
health data anonymous donor to retain for a period of 30 years from the implementation
artificial insemination and upon written request to pass
infertile couple or adult person born of assisted reproduction
health information an anonymous donor.

§ 11

The collection of germ cells arise person that has been taken is entitled
financial or other consideration. Provider of carrying out the sampling, paid
anonymous donors upon their request efficiently, economically and
demonstrably incurred expenses associated with the donation of gametes.
Their compensation may require the recipient to be done
artificial insemination, or providers, which were
germ cells or human embryos for assisted reproduction transmitted.
Provider, who took the stem cells or human embryos for
assisted reproduction, and who paid expenses under sentence
Second, it can reimburse these expenses require the recipient to be done
artificial insemination.
Part 2

Sterilization


§ 12

Sterilization means a medical procedure prevents fertility without removing or damaging
gonads. Sterilization can be done from
health reasons or for other than medical reasons.
Health reasons means that disease or defect, in which there is a high probability
serious threat to health or life
due to pregnancy or childbirth, or the healthy development of the fetus or the health or life
future child.

§ 13

(1) Sterilization of health reasons to carry a patient who
has reached the age of 18 if the sterilization
grants written consent.

(2) patients deprived of legal capacity, patient
limited legal capacity so that it is not capable to assess
provision of health services, or the consequences of their provision
(hereinafter the "patient deprived legal capacity "), or
minor patient can only sterilize medical
reasons on the basis

A) the written consent of their legal guardian (hereinafter referred to as the "legal representative
Patient"); This does not affect the provisions of § 35 of the
health services,

B) positive opinion of the expert committee and

C) approval by a court that is locally relevant providers.

(3) The expert committee constituted by the provider. Members of the jury are


A) 3 doctors with competence in the field of surgery and urology, in the case of sterilization
u man

B), 3 physicians with competence in the field of gynecology and obstetrics, in the case of sterilization for women
,

C) a clinical psychologist and

D) the person designated by the provider, which received higher education in
master's degree program in Law (hereinafter referred to as "lawyer").

(4) At least four members of the expert committee must not be employed by or
similar relationship to the provider, a member of the supervisory body
provider or statutory authority, statutory body or a member
companion providers.

(5) The expert committee meetings may be invited by the attending physician
patient who perform medical procedure recommended, but during an interview
committee members with the patient must be the physician present.

(6) The patient and the patient's legal representative is always invited to the meeting
expert commission; professional conduct committee must be started so that
not to endanger the life or health of the patient. The expert committee shall
patient and his legal representative information about the nature of health
performance, its permanent consequences and potential risks and verifies that
patient and the patient's legal representative that information fully understand. For
into account the patient's intellectual maturity.
Record of filing information signed by the members of the expert committee, the patient and the patient's legal representative
. Part of the record is the view of the patient. If the patient is considering
to their intellectual maturity able to understand the information or record
sign indicating this fact on record. The record is part
medical records of the patient.

(7) The expert committee after discussing the request
draw up a written expert opinion to assess whether all the conditions for
sterilization; also specify the duration of the opinion, while
into account the urgency of medical intervention.
A positive opinion to sterilization needs the approval of all the members of the expert committee
. In the event that the consent of all members
fail to reach an expert committee in its opinion describes the reasons for doing so
. The Provider shall forward a copy of the opinion of the expert commission
legal representative of the patient.

(8) Proposal to consent to sterilization to the court
provider ^ 4). Provider connects to the draft written consent
patient's legal representative, patient statements and expert opinion
Commission. If the patient with respect to their intellectual maturity
able to make observations, provider shall indicate this fact with its
justification in the proposal.

§ 14

Sterilization for other than health reasons can be done by the patient
who has attained 21 years of age, unless prevented its implementation
serious health reasons, and upon written request. The request is part
medical records of the patient.

§ 15

(1) Before the sterilization of medical or non-medical reasons
the attending physician must provide the patient
information on the nature of the medical procedure, its permanent consequences and potential risks
. Information must be submitted before a witness who is
healthcare worker. If the patient requires the presence of another witness
own choosing, it allows the provider.
Record of filing information signs the physician, the patient, a witness, or witnesses;
Record is part of the medical records of the patient. Among
filing information and granting of consent must be reasonable period;
case of sterilization for health reasons, the period must be at least 7 days;
Case of sterilization for other than health reasons
period must be at least 14 days.

(2) Implementation of sterilization can start if the patient or the patient's legal representative
immediately prior to the commencement
gave written consent.

§ 16

Sterilization can not be done in medical facilities of the Prison Service
Czech Republic (hereinafter "the Prison Service").
Part 3


Therapeutic castration, testicular pulpectomy

§ 17

(1) Therapeutic castration or testicular pulpectomy (hereinafter
"castration") means medical procedures removing hormonally active part
gonads in men to suppress his sexuality.

(2) The castration can be done to a patient who has reached the age of 25 years and who

Previously committed violent sexual offense, if for him
professional medical examination revealed the existence of a specific sexual deviance
a high degree of probability that again in the future
commit violent sexual offense, and if u him were successful
other treatment methods.

(3) Castration patient made on the basis

A) written application and

B) positive opinion of the expert commission.

(4) of a patient who is in protective treatment or execution of security
detention, castration is performed only in specially justified cases, and on the basis


A) a written request

B) positive opinion of the expert committee and

C) approval by a court that is locally relevant providers.

§ 18

(1) The expert committee constituted Ministry of Health (hereinafter
"Ministry"). Members of the jury are

A) medical worker who is a state employee assigned to
Ministry

B) the qualifications of the doctor in the field of sexology,

C) the qualifications of the doctor in psychiatry,

D) clinical psychologist

E) Doctor with competence in the field of urology,

F) lawyer with knowledge in the area of ​​health care.

(2) A member of the expert committee must be in employment or similar
relation to the provider, not to be a member of the supervisory body
provider or statutory authority, statutory body or a member
companion providers.

(3) The request shall deliver the patient immediately to the Ministry;
application connects to a favorable opinion of the treating physician
competence in the field of sexology with performing castrations and independent medical opinion
demonstrating a high degree of probability that a patient
in the future commit violent sexual offense.
Part concurring opinion, the diagnosis and description of existing treatments.
The Ministry may request to verify the condition
committing an offense under § 17 para. 2, a copy of criminal records;
Extradition request disclosure of criminal records and a copy of the records
criminal records to be transmitted electronically in a way
remote access.

(4) The patient is always invited to the meeting of an expert commission, which will be held
within 3 months from the date of submission of the patient.
The expert committee shall inform the patient about the nature of the medical procedure, its permanent
consequences and potential risks and verifies whether the patient information
fully understood and that the application reached the patient entirely voluntary.
Patient who is in protective treatment or execution of security
detention, he learns that castration does not constitute a claim for his release.

(5) Recording of provision of information signed by the members of the expert committee and
patient.

(6) The expert committee after discussing the request
draw up a written expert opinion to assess whether all the conditions for
undergoing castration; also specify the duration of the opinion, while
into account the urgency of medical intervention.
A positive opinion of performing castrations require the consent of all the members of the expert committee
. In the event that the consent of all members
fail to reach an expert committee in its opinion describes the reasons for doing so
. The expert committee shall send the Ministry expert opinion within 3
copies and a copy of the minutes of the meeting.

(7) The expert committee meetings may be invited by the attending physician
patient who perform medical procedure recommended, but during an interview
committee members with the patient must be the physician present.

(8) Part of the medical records of the patient's

A) a written request from the patient

B) copy of the concurring opinion of the treating physician
with competence in the field of sexology,

C) independent medical report pursuant to paragraph 3,

D) the record of the proceedings of an expert commission and

E) the opinion of an expert commission.

(9) The Ministry shall forward

A) a copy of the opinion of the expert committee and a copy of the minutes of the meeting of professional committee
patient

B) 2 copies of the opinions of the expert committee providers for setting up
medical documentation pursuant to paragraph 8 and to trial by
paragraphs 10 and a copy of the minutes of the meeting of an expert commission.

(10) Proposal for granting approval to undergo castration to the court
provider. Provider connects to draft a written request of the patient and

Opinion of the expert commission.

§ 19

Implementation of castration can begin when the patient to immediately
to prior written consent granted.

§ 20

Castration can not be done in medical facilities of the Prison Service and
persons in custody and imprisonment.
Castration also can not perform patient deprived of legal capacity.
Section 4


Changing gender transsexual patients

§ 21

(1) Changing the gender of transsexual patients for the purposes of this Act
means to perform medical procedures designed to perform sex change surgery
while disabling
reproductive function. Transsexual patient is a person, in which the permanent
mismatch between mental and physical sex (hereinafter referred to as "failure
sexual identification").

(2) Surgical interventions aimed at changing the gender can be done
patient

A) which has been clearly defined disorder of sexual identification and
demonstrated ability to live permanently as a person of the opposite sex and

B) which has not concluded a marriage or has entered into a registered partnership or
similar to same-sex unions abroad
or prove that his marriage or registered partnership or similar
volume disappeared.

(3) Surgical interventions aimed at changing the sex was performed
patient who has attained the age of 18 years, on the basis

A) written application and

B) positive opinion of the expert commission.

(4) Surgical interventions aimed at changing the sex was performed
patient deprived of legal capacity, and on the basis

A) written requests for patient's legal representative; This does not affect
§ 35 of the Act on health services,

B) positive opinion of the expert committee and

C) approval by a court that is locally relevant providers.

(5) A change of sex can not be a patient who is in custody,
imprisonment security detention or protective treatment.

§ 22

(1) The expert committee constituted by the Ministry. Members of the jury are

A) medical worker who is a state employee assigned to
Ministry

B) the qualifications of the doctor in the field of sexology,

C) the qualifications of the doctor in psychiatry,

D) clinical psychologist

E) Doctor with competence in the field of diabetology and endocrinology,

F) the qualifications of the physician in urology or gynecology and obstetrics
,

G) lawyer with knowledge in the area of ​​health care.

(2) A member of the expert committee must be in employment or similar
relation to the provider, not to be a member of the supervisory body
provider or statutory authority, statutory body or a member
companion providers.

(3) The request of the patient or the patient's legal representative shall deliver
immediately to the Ministry; the application connects concurring opinion
attending physician with competence in the field of sexology with
performing sex change.

(4) The patient and the patient's legal representative is always invited to the meeting
expert commission, which will be held within 3 months from the date of filing the application
patient or the patient's legal representative. The expert committee shall
patient and the patient's legal representative information about the nature of health
performance, its permanent consequences and potential risks and verifies that
patient and the patient's legal representative that the information is fully understood and that the application
Adult patients and the patient's legal representative
entirely voluntary. In the case of a patient referred to in § 21 para. 4, take into account
his intellectual maturity.

(5) Recording of provision of information signed by the members of the expert commission
patient and patient's legal representative. Part of the record is also the view of the patient
deprived of legal capacity. If the patient with respect to their intellectual maturity
able to express opinion or sign the record
indicate this fact on record.

(6) The expert committee after discussing the request
draw up a written expert opinion to assess whether all the conditions for
perform sex change; also specify the period of validity of the opinions and
while respecting the urgency of medical intervention.
A positive opinion of performing sex change needs the approval of all the members of the expert committee
. In the event that the consent of all members fail

Achieve expert committee in its opinion describes the reasons for doing so
. The expert committee shall send the Ministry expert opinion within 3
copies and a copy of the minutes of the meeting.

(7), the doctor who perform medical intervention
recommended that negotiations may be invited by the expert committee, but during an interview
committee members with the patient must be the physician present.

(8) Part of the medical records of the patient's

A) A written request of the patient or the patient's legal representative,

B) copy of the concurring opinion of the treating physician
with competence in the field of sexology,

C) the record of the proceedings of an expert commission and

D) the opinion of an expert commission.

(9) The Ministry shall forward

A) a copy of the opinion of the expert committee and a copy of the minutes of the meeting of professional committee
patient or legal guardian

B) 2 copies of the opinions of the expert committee providers for setting up
medical documentation pursuant to paragraph 8 and to trial by
paragraphs 10 and a copy of the minutes of the meeting of an expert commission.

(10) Proposal for granting approval to undergo sex change to the court
provider. Provider connects to draft a written request
patient or legal guardian written request of the patient, the patient's statement
deprived of legal capacity and the opinion of the expert committee.
If the patient with respect to their intellectual maturity able to make observations
provider shall indicate this fact with its reasoned
proposal.

§ 23

(1) Implementation of a sex change can begin when a patient
it immediately before it occurred to give a written consent.

(2) The amendments made to gender issues provider of patient confirmation.
Section 5


Psychosurgical performances

§ 24

(1) Psychochirurgickým power means neurosurgical performance that
is done to eliminate or alleviate the symptoms of mental illness in
case where other treatment methods already exhausted and there
high probability that performance will be effective.

(2) psychosurgical exercise is done to a patient who has reached the age of 18 years
based on

A) the written consent of the patient and

B) positive opinion of the expert commission.

(3) A patient who has attained 18 years of age and who is in custody,
imprisonment security detention or protective treatment, the
psychosurgical interventions performed only in specially justified
cases based on

A) the written consent

B) positive opinion of the expert committee and

C) approval by a court that is locally relevant providers.

(4) minor patient or the patient deprived of eligibility to
legal capacity to exercise psychosurgical done only in specially
substantiated cases, on the basis

A) the written consent of the patient's legal representative; This does not affect
§ 35 of the Act on health services,

B) positive opinion of the expert committee and

C) approval by a court that is locally relevant providers.

§ 25

(1) The expert committee constituted by the Ministry. Members of the jury are

A) medical worker who is a state employee assigned to
Ministry

B) the qualifications of the doctor in psychiatry,

C) the qualifications of the doctor in neurology

D) a doctor with competence in the field of neurosurgery,

E) a clinical psychologist

F) lawyer with knowledge in the area of ​​health care.

(2) A member of the expert committee must be in employment or similar
relation to the provider, not to be a member of the supervisory body
provider or statutory authority, statutory body or a member
companion providers.

(3) The consent of the patient or the patient's legal representative
provider immediately forwarded to the Ministry; consent to join
a favorable opinion of the treating physician with qualification in psychiatry with
performing psychochirurgického performance.

(4) The patient and the patient's legal representative is always invited to the meeting
expert commission, which will be held within 3 months from the date of filing the application
patient or the patient's legal representative. The expert committee shall
patient and the patient's legal representative information about the nature of health
performance, its permanent consequences and potential risks and verifies that
patient and the patient's legal representative that the information is fully understood.

Case of a patient referred to in § 24 para. 4, take into account their mental
maturity.

(5) Recording of provision of information signed by the members of the expert commission
patient and patient's legal representative. Part of the record is also the opinion of a minor
patient or a patient deprived of legal capacity. Unless
patient with respect to their intellectual maturity pronounce
able to view or sign the record, this fact shall be on the record.

(6) The expert committee after discussing the request
draw up a written expert opinion to assess whether all the conditions to perform
psychochirurgického performance; also specify the validity period
opinions and while respecting the urgency of medical intervention.
The positive opinion to the execution psychochirurgického performance is
require the consent of all the members of the expert committee. In the event that
consent of all members fail to reach an expert committee in its opinion
description of the reasons that led to this. The expert committee passes
Ministry expert opinion in three copies and a copy of the record of negotiations
.

(7), the doctor who perform medical intervention
recommended that negotiations may be invited by the expert committee, but during an interview
committee members with the patient must be the physician present.

(8) Part of the medical records of the patient's

A) the written consent of the patient or the patient's legal representative,

B) copy of the concurring opinion of the treating physician
with competence in the field of psychiatry,

C) the record of the proceedings of an expert commission and

D) the opinion of an expert commission.

(9) The Ministry shall forward

A) a copy of the opinion of the expert committee and a copy of the minutes of the meeting of professional committee
patient or legal guardian

B) 2 copies of the opinions of the expert committee providers for setting up
medical documentation pursuant to paragraph 8 and to trial by
paragraphs 10 and a copy of the minutes of the meeting of an expert commission.

(10) Proposal on granting consent to the performance psychochirurgického
provider to the court. Provider connects to the draft
written consent from the patient or written parental consent and express
minor patient or a patient deprived of legal capacity
and the opinion of the expert committee. If the patient with respect to their intellectual maturity
able to make a statement, the provider shall indicate this fact with
its justification in the proposal.

§ 26

Implementation psychochirurgického performance can begin, if
to the patient or the patient's legal representative immediately before the commencement
gave written consent.

§ 27

Psychosurgical interventions can not be done in medical facilities
Prison Service.
Part 6

Genetic testing


§ 28

(1) Genetic testing consists of clinical and laboratory testing;
Used to determine the proportion of variants in the human germline genome
development of disease in a patient. Genetic laboratory examination means
laboratory analysis of human embryonic genome or its affiliates.

(2) Genetic laboratory tests can only be performed in laboratories
whose professional competence has been assessed in accordance with the relevant harmonized standards
^ 5) accreditation body ^ 6).

(3) Genetic testing in health care can be offered or performed
purposes only

A) health services, and it

First to preimplantation diagnosis in the context of assisted reproduction,

Second the diagnosis of genetically caused diseases and developmental defects,

Third to determine the degree of predisposition to diseases and developmental defects,

Fourth to establish a symptomless carrier of variants of human embryonic genome
causing illness or developmental defect,

Fifth for targeted screening of newborns to identify
genetically conditioned diseases; targeted screening for needs
genetic testing means detecting share of changes in the human germline genome
develop serious genetically conditioned diseases with risk of early
irreversible damage to the health of newborns

6th to optimize treatment,

B) biomedical research related to health and its disorders.

(4) Genetic testing can be offered to the patient or to perform only

A) following information on its purpose, nature and impact on health, including
health of future generations, and the risks of unexpected findings for

Patient and genetically related individuals and

B) on the basis of a written consent or written consent of the legal representative
patient.

(5) For genetically related person of the patient for the purpose of genetic testing
under this Act shall be construed relatives with
medically significant genetic risk, and lineal

A) direct, which are the grandparents, parents and their children, and

B) indirect, when the level of risk is determined according to the degree of relatedness and
type of genetic diseases.

(6) In the event that the results of genetic testing, diagnostic
clear conclusion that can be expected impact on patient health, including
future generations, or the health of genetically-related persons, advise the patient provider
and the genetically related person
provide genetic counseling by a doctor with specialized qualifications in the field
medical genetics, both before and after the examination.

§ 29

(1) Genetic laboratory tests on biological material taken from the body of the deceased
for educational, scientific and research purposes
can be done only under the assumption that the deceased during his lifetime or persons close to the deceased gave
demonstrable agreement. If the deceased during his life
expressed prohibition of providing information about their health, can not be
this examination is carried out; It does not apply, if necessary
determine or verify the relevant information about changes in human embryonic genome
deceased necessary to safeguard the health of genetically related
people.

(2) For undergoing genetic testing under § 28 par. 3 point. a)
patients should not be offered or receive financial reward or other benefit
. With the rejection of genetic testing must be connected
patient no harm, nor be subjected to psychological pressure
. Results of genetic testing may not be
without the written consent of the patient to third parties.
Sale or donation of the results of genetic tests to third parties without the written consent of the patient
, including the written approval of the genetically related person
is prohibited. Results of genetic testing may not be used for any discrimination
patient and genetically related individuals.

(3) Genetic laboratory examination of the human embryo or fetus, including
determine its sex, can not be carried out for reasons other than
purposes under § 28 par. 3 point. a) paragraphs 1-3 and paragraph 6. Laboratory
genetic testing with a human embryo or fetus can be done for
assumption that a doctor with specialized qualifications in the field of medical genetics
carry out genetic counseling for mothers who are
after completion of laboratory genetic testing for human embryo or fetus
followed by genetic counseling on the proper interpretation of the results.
Laboratory genetic testing with a human embryo or fetus is carried
only after filing the information with the written consent of the mother (§ 28 para. 4).

§ 30

(1) An intervention seeking to modify the human embryonic genome can be performed on patients
only for preventive or therapeutic purposes
serious genetically conditioned diseases while preserving its natural biological
integrity in germ cells. These interventions must be done if
could lead to changes in the genetic material of germ cells.

(2) Every procedure whose purpose is to create a human being who has the same
human genome with other human beings, living or dead, is prohibited
.

(3) It is prohibited to transfer

A) the entire human genome into cells of another species, and vice versa,

B) human embryo into the genitals of another species.


Part 7
Subscriptions human blood and its components, the treatment of blood or its components

§ 31

Subscriptions human blood and its components

(1) Samples of human blood and blood components (hereinafter referred to as "blood") for the manufacture
transfusion products and blood derivatives for use in humans can perform
only authorized provider for this production under the Act on || | Pharmaceuticals.

(2) Blood for the needs listed in paragraph 1 can not remove those

A) minors; This does not apply in cases where the collection of blood from minor
replace the collection of blood from a person of full age; In this case
must subscribe to grant written consent of the legal guardian of the minor,
which blood is drawn, and approve it authorized healthcare worker

Providers referred to in paragraph 1

B) placed in police custody on remand, imprisonment or security detention
,

C) located at a school facility for institutional or protective
education or social services facility, if it was ordered
institutional upbringing or protective upbringing

D) in compulsory isolation, quarantine, or in the exercise of inpatient
protective treatment or

E) of the hospitalized without their consent.
The ban on blood donation by letters b) to e) shall not apply to direct
donation between lineal relatives to each other, you can not replace
collecting blood from another person, and subscriptions for the use of health services
person the blood is collected, for example autotransfusion.

(3) Blood for the purposes specified in paragraph 1 may be withdrawn only person who
to that granted its consent. If it is a minor or a person deprived
legal capacity, a written consent granted
her legal representative; This does not affect the provisions of § 35 of the Law on Health
services.

§ 32

Treatment of blood or its components

(1) Treatment of blood means the administration of blood products the patient
transfusions and blood derivatives and other medicines
derived from human blood from a patient in the preventive or curative care
. Before administering a transfusion of blood transfusions is considered
compatible blood product transfusion with blood transfusion recipient
product. For assessing the compatibility of blood transfusion recipient
responsible provider who performs transfusion.
Record of compatibility transfusion of blood of the patient is part
medical records of the patient; signs record
medical worker who transfusion product compatibility with the recipient's blood
verified.

(2) The blood collected for the production of blood derivatives for use in humans
under other legislation and its consumption does not arise person
which blood was collected, qualify for financial or other compensation, with || | except efficiently, economically and demonstrably incurred expenses associated with the collection
her blood, which that person requests and quite
to a maximum of 5% of the minimum wage.

(3) The grantor may cover expenses provided for in paragraph 2
appropriate increase in terms of blood collection
a) to produce a single blood product transfusion

For providing health care to individual patients and which can not be
used blood from another donor

B) requiring special training in the donor or the donor selection by
tissue characteristics and blood group of the recipient.
TITLE III


VERIFICATION PROCEDURES USING NEW METHODS THAT HAVE NOT BEEN IN CLINICAL PRACTICE
live ČLOVĚKU introduction

§ 33

(1) On a live person can perform testing of new techniques in the field
preventive, diagnostic and therapeutic care or biomedical research
associated with health and its disorders using a method that
yet been introduced in clinical practice (hereinafter referred to as "non-phase method")
only under the conditions provided by law.

(2) For non-phase methods are not

) Methods introduced into clinical practice in some states of the European Union
European Economic Area or the Swiss Confederation,

B) modifications to already established methods, the use of which has
adverse effects on the health of the patient.

(3) In case of doubt whether a method pursuant to paragraph 2. b)
decided by the Ministry, and of its own motion or at the request of the provider,
which intends to modify the methods used for the provision of health services.
Appeal lodged against the decision of the Ministry does not have suspensive effect.
Parties to the proceedings are the only providers who intend
modifications of already established methods used in the provision of health services.

(4) non-phase authentication method can only be made provided that

A) a patient to be covered non-phase authentication methods
awarded on the basis of information pursuant to § 34 para. 1 written agreement with the verification
non-phase methods

B) it is expected that non-phase method will bring positive results in favor
patient on which is to be verified, and can reasonably
expected that after successful authentication becomes a new way of prevention, diagnosis or
treatment


C) non-phase authentication methods can not be achieved with comparable efficiency
other way and

D) there is no reasonable risk that the result of the verification phase-
methods will be long-term or serious damage to the health of the patient, the
which is to be non-phase authentication method.

(5) Verification of non-phase method to minors
patient or patient deprived of legal capacity to perform only
the written consent of the legal guardian of the patient after administration
information pursuant to § 34 if

A) the conditions laid down in paragraph 4a. b) to d)

B) verify the non-phase methods of comparable effectiveness can not be performed on patients
capable of giving consent and

C) of these patients with regard to their intellectual maturity or the ability to understand information
awarded to verifying consent; disagreement patients
verification is to be respected, if such verification is only possible
alternative treatments for otherwise incurable diseases;
This does not affect the provisions of § 35 of the Act on health care services.

(6) non-phase authentication methods can not be performed on people exercising
custody, imprisonment or security detention if such
verification is not only possible alternative treatments for otherwise incurable diseases
.

§ 34

(1) Information on non-phase method from the patient or the patient's legal representative
on which it is to be validated method must be
demonstrable and understandable and contains

A) information on the verification of methods, including the purpose for which it is verified,

B) the specific process that will involve the patient

C) the possible benefits of testing of methods for patient

D) the foreseeable risks and possible difficulties or constraints associated with
authentication methods and expected risks associated with premature withdrawal
consent

E) information about other treatment options,

F) data on the method of protecting data acquired by the patient and the method
disclosure of information and data collected in connection with the verification
methods relevant for the evaluation and testing of methods and implementation

G) requirements for cooperation and treatment regimen that the patient; This does not affect
§ 35 of the Act on health care services.

(2) The consent of the patient or the patient's legal representative with the verification
non-phase methods must continue throughout its verification. In the case
withdrawal of consent by the patient or the patient's legal guardian can not be
authentication methods continue.

§ 35

Non-phase authentication methods can be performed provider, which
ministry granted permission to verify the non-phase method.
Application for granting authorization addition to the requirements laid down by the Administrative Code contains

A) a description of non-phase method

B) justification of expediency verification phase-method

C) a report on the results obtained by laboratory research, experiments on animals or other
preclinical research

D) an overview of current knowledge related to authenticated practices
including the lessons learned from abroad

E) a detailed plan for verification of non-phase methods

F) workplace where it should be non-phase authentication methods, stating
name, surname medical personnel who will verify it
, including the designation of those who will manage the authentication and their
qualification

G) environmental health impact assessment, taking into account all available information to the
method that could arise from non-phase
authentication methods

H) for information about the number of patients, for whom should be a non phase
authentication methods

I) binding opinion of the State Office for Nuclear Safety
phase-authentication methods to medical exposure, in which the irradiation
have direct health benefit for the person undergoing it or who is
checked in biomedical research related health and his
disorders.

§ 36

(1) The Ministry shall grant a permit providers to verify the non-phase
method if concludes that

A) subject to verification of non-phase methods are new procedures according to § 33 paragraph
. 1

B) non-phase authentication method is effective and

C) the provider is to verify the non-phase method capable.

(2) The State Office for Nuclear Safety to issue a binding opinion

Non-phase authentication methods to medical exposure, upon written request
provider within 60 days of its receipt.
The application must contain information pursuant to § 35 to the extent necessary to determine the phase-
methods in relation to medical exposure, and radiation protection.

(3) The Ministry shall decide on the application in accordance with § 35 to 90 days from the date of receipt
. If it is a non-phase authentication methods to medical exposure,
Ministry may decide to grant permission only on the basis
binding opinion of the State Office for Nuclear Safety.

(4) The decision to grant permission to phase-authentication methods beside
formalities laid down by the Administrative Code contains

A) the definition of non-phase methods

B) define the conditions under which non-phase method to verify

C) deadline for the submission of reports on individual stages of validation.

(5) The Ministry may permit the non-phase authentication methods withdraw if


A) the provider has violated the conditions laid down for non-phase authentication methods
this Act or permits verification of non-phase method, and
based on the results of its own findings or initiative ethics committee
established provider of non-phase authentication methods (
hereinafter referred to as "ethics committee"), or

B) to revoke the permit given impetus regional authority which granted
providers authorized to provide healthcare services (
"competent administrative authority") and that the audit work found
violation of the conditions for granting health services
under this Act or any other legislation.

(6) A provider who had their licenses revoked for non-phase
authentication methods, authentication is required to immediately terminate and perform operations such
with regard to the completion of the verification is not endangered the health or life of patients
.

(7) The participant in the procedure for granting authorization for non-phase authentication methods
is a provider that submitted an application pursuant to § 35

§ 37

Provider before starting a non-phase authentication methods

A) establish an ethics commission

B) liability insurance for damage to health caused
patients in connection with the verification phase-method, with
insurance company that has been granted permission to carry out insurance activities pursuant
act regulating insurance-7) ;
scope of insurance must correspond to the risks associated with a particular audited
non-phase method.

§ 38

(1) The Ethics Committee is an independent committee whose task is

A) assess ethically phase-authentication methods

B) supervise the progress of non-phase authentication methods
terms of safety and respect for the rights of patients, which is a non-phase method
verified.

(2) The members of the ethics committee are professionals and other persons of
which at least two-thirds must be in employment or similar
relation to the provider, which it set up, a member of the supervisory authority, a statutory body
, a member of the statutory body or member of
provider. The ethics committee must have at least 5 members.
Chairman and members of the ethics committee are appointed and dismissed by the provider.
Members of the ethics committee may only be a person with no personal interest in the verification phase-
methods; member of the ethics commission shall inform the honorable
statement.

(3) If the ethics committee finds in its activities the fact that
suggest that conditions are not respected, under which
non-phase method to verify these facts immediately communicate
providers and ministry.

§ 39

(1) The provider of verifying non-phase method is required

A) report to the Ministry within the deadlines specified in the authorization to verify the non-phase methods
reports on the various stages of verification,

B) immediately suspend or discontinue non-phase authentication methods
if there is reasonable doubt that the non-phase method
not bring the expected result, or that its verification could lead to
long-term or serious damage to the health of the patient, on which
verified; this fact is obliged to immediately notify the Ministry

C) immediately inform the Ministry and the State Office for Nuclear Safety
if issued a favorable binding opinion,
suffered an adverse event; adverse event shall mean an adverse change

Patient's condition arising due to non-phase authentication
methods

D) enable inspection during the verification phase-method
persons authorized by the Ministry, the State Office for Nuclear Safety, if
issued a favorable binding opinion, or members of the ethics committee.

(2) The provider shall, within 30 days after completion of the verification phase-method
Ministry final report on the result of verification, which will examine
phase-in method in terms of its possible uses
in the provision of health services. If you were to grant permission to non-phase authentication methods
given a favorable binding opinion
State Office for Nuclear Safety, submit to the provider within 30 days after completion of the verification
State Office for Nuclear Safety report
during medical irradiation and facts important from the viewpoint
radiation protection.

§ 40

(1) The Ministry, on the basis of the final report on the outcome of phase-
methods, which suggests the possibility of its use in the provision of health services
consider whether non-phase method qualifies for
introduction into clinical practice. When assessing the results of the phase-method
account the benefits of this method for improving the health of patients
.

(2) The Ministry shall issue a decision granting a non-phase method

A) recognize as a standard method if an assessment in accordance with paragraph 1
concludes that the conditions for its introduction into clinical practice
a new standard method
contribute to improving the health of the patients, or

B) does not recognize as a standard method if on the basis of an assessment phase-
methods authority concludes that the conditions for its introduction into clinical practice
.

(3) The parties to proceedings pursuant to paragraph 2 is the only provider that
non-phase method verified.

(4) The Ministry shall publish in the Bulletin of the Ministry of Health and
manner allowing remote access

A) recognized standard method

B) unrecognized non-phase method, including the reasons that led to its failure to recognize
.
TITLE IV


Assessor CARE A medical assessments, occupational medicine SERVICE ASSESSMENT OF OCCUPATIONAL DISEASES

Part 1

Professional review
care and medical opinions

§ 41

Care is part of the Assessment Assessment

A) medical education and during training (
referred to as "training") for schools and school facilities or
physical education and sports or other activities under this Act or other
legislation

B) the medical fitness of need and at the request of the administrative authorities or other bodies
in cases stipulated by other laws,

C) medical upon request by the patient or legal guardian
patient or with their consent, to request a legal entity

D) medical fitness to work or to perform the services under
occupational examinations; part of assessing fitness
to work or to perform the services is particularly
assessing the medical fitness of staff under § 53-58,

E) the state of health in relation to occupational diseases or threats
Occupational Disease (hereinafter referred to as "occupational disease")

F) health condition for the purposes of health insurance and the needs
Labour Office

G) health status of the patient for other purposes.

§ 42

(1) medical opinion on medical or health condition
(hereinafter referred to as "medical opinion") issued by the provider at the request of the patient, which is assessed
person, or other person authorized after
assessment of medical or health condition
considered persons, surveying physician, based on the evaluation

A) the results of medical examinations and other specialized examinations needed
(hereinafter referred to as "physical")

B) an extract from the medical records of the assessed person authorizing its
provider in the field of general practice or
in practical medicine for children and adolescents (hereinafter referred to as "registering
Provider"), je- If the assessed person at such a provider
registered, or in the case of the assessed person whose health condition is
medical documentation in the territory of another state, whether to

The excerpt from the documentation to which it is attached
officially certified translation into Czech; certified translation will not be put to
excerpt from medical records
in Slovak language; excerpt from medical records may require examining physician
through persons assessed

C) health demands on work performance, service, occupation, education,
sport, physical education or other activities (hereinafter referred to as "activity")
for which a person is judged, and the conditions under which it is
activity performed, or claims of activity on the health of the assessed person.

(2) A medical report issued by the registering provider persons assessed
unless this Act or another law provides otherwise. Surveying
is a doctor with competence in the field of general practice in the field
or general practitioner for children and adolescents, unless this Act or other
law provides otherwise.

§ 43

(1) A medical opinion must be issued no later than 10 working days of receipt
or oral application pursuant to § 42 para. 1, in the case
report for recognition of occupational disease within 30 working days, unless
if this law or other legal regulation. The deadline under the first sentence to the last
obtaining the necessary basis for assessing the health
eligibility or health status according to § 42 para. 1 does not run.
Written request under the first sentence or a record of the oral tradition is part
medical records of the assessed person. Record of signs
examining physician and the person who filed a verbal request.

(2) For the purposes of assessing the continuation of medical fitness can
physical persons assessed accomplished first
90 days before the expiry of the current medical opinion, the time validity
does not change if the examining physician does not detect a change in health
condition leading to a medical opinion with a conclusion according to § 44 para. 4 point.
A). Deadline for a medical examination determined
body for protection of public health or other legislation to further
assessing medical fitness assessed person and force
medical opinion by conducting medical examinations in the first sentence unchanged.
This does not affect the possibility of carrying out medical examinations on changing health
eligibility or health or suspicion of such changes.

(3) The conclusion of the medical report must be made clear whether it is assessed
person for the purpose for which it is judged, physically fit, physically
ineligible or eligible disabled condition, eventually lost
long-term health fitness, or whether her medical condition meets
conditions or requirements that have been assessed.
Part of the medical opinion must be instructed on how to submit pursuant to § 46 para. 1
proposal for its review provider that issued the report. The lesson
will also state the period within which it is possible to file a petition for review, which date from
this period shall be counted and whether or not the proposal to
review under this Act or other laws suspensory || | effect.

(4) A copy of the medical report, is part of the medical records kept
about personality. Assessment of medical or health condition
needs for a medical opinion shall be borne by whoever
asks him if this Act or another law
indicates otherwise. The written copy of the medical report, can be performed
correct obvious misstatements that will not affect his conclusion by
paragraph 2. Repairs performed provider on the initiative of the persons referred to in § 44 paragraph
. 1 or on its own initiative. The repair report
inform the person referred to in § 44 par. 1st

(5) The medical opinion is issued, if the assessed person
refuses to undergo a medical examination or examination that is part of it;
Examining physician that fact is recorded in medical records
kept about this person. If the assessment of medical fitness
assessed person asking another person authorized to do so, she
provider announces issuance of evidence, including the reason for its issuance.

(6) If the medical report was not issued because
referred to in paragraph 5, or if the assessed person not undergone a medical examination for
to further assess medical eligibility for another reason,

Seen the assessment of persons for the activity for which should be
health assessed as medically unfit or as a person
whose medical condition does not meet the prerequisites or requirements to which
was assessed.

§ 44

(1) A provider medical report issued immediately provide its proven transmission


A) the person assessed and

B) a person who has a medical assessment considered persons for the purpose of issuing an opinion
legitimately ask if it is not considered persons.

(2) demonstrable passing a medical opinion under paragraph 1
mean his takeover

A) the person referred to in paragraph 1 of this person a signed, with
stating the date of receipt, and in the case of a person referred to in paragraph 1. b)
or a person authorized by that person shall also
identity card number or other proof of identity and the reason for issuing an opinion;
acknowledgment of receipt of the medical report is part of the medical records kept
about personality,

B) delivery postal operator;
service must be documented receipt, or

C) based on an electronic receipt signed by renowned
electronic signature to the clipboard above the assessed person and the person who
assessment of medical fitness asked.

Medical opinion is also considered demonstrably passed if
person authorized to accept the report refuses to report or take its takeover
confirm signing; that fact is recorded examining physician
into the medical records of the person assessed; signs record
examining physician and other medical staff present takeover
report. In case of refusal to take the medical opinion
notified via postal service shall apply mutatis mutandis
§ 9 para. 4th

(3) A person who is not a person referred to in paragraph 1. b) which
applying medical opinion gives rise to rights or obligations passed
report assessed person, unless this Act or any other legislation
provides otherwise.

(4) The legal effects of the medical opinion

A) the conclusion of incapacitation, long-term disposal of medical eligibility
considered persons or medical condition
occur to a person who has been handed the day of its demonstrable
handover

B), concluding on the fitness assessed person
occur to a person that has passed, the date of expiry of the previous
opinion, but not before the date of expiry of the deadline for filing a motion for the review or the day
demonstrable delivery of the decision on the confirmation report
administrative authority, which granted permission to the provider
provision of health services,

C) of health occur for a person that has passed,
day of the deadline for filing a petition for review or the day
demonstrable delivery of the decision on the confirmation report administrative office
providers who granted permission to provision of health services.

(5) A medical opinion can be applied for the purposes for which it was issued within 90
days from the date of issuance, unless it or other legislation
shorter deadlines. If the administrative authority that providers
granted authorization to provide health services under medical
Opinion under § 47 para. 2 point. a) confirm the report to the authorized person
used for the purposes for which it was issued within 10 working days of
demonstrable delivery of the confirmed opinion.

(6) A medical opinion shall lapse

A) the expiration of the period for which it was issued

B) the date when it should have under other legislation or decision
public health authorities or medical examiner or to any other person authorized
a medical examination for new medical assessment
persons assessed

C) the day, which was the effective date medical report issued
for the same purpose and under the same conditions as the previous report, when the
this Act or any other law stipulates otherwise

D) termination of employment or service relationship, if it is a critique
according to § 41 point. d); this does not apply if within 3 months from the date of termination of the employment relationship
with the same performance work again closed with
same employer, if at the time of his termination did not change

Development or health status of the individual.

(7) If the medical report invalid, it shall be assessed
person for the purpose for which they should be medically examined for health
ineligible, or the person whose health condition does not qualify
or requirements which was assessed.

§ 45

(1) The medical examiner, who found that the assessed person is no longer
physically fit to perform the activity or exercise activities
condition or that his state of health does not qualify or
requirements to which was assessed, it shall notify the person
assessed and promptly, also persons applying to medical opinion
create rights or obligations, if he is the person known.
Person is assessed for this activity deemed medically unfit or eligible
health condition, or a person whose state of health
meets the prerequisites or requirements to which was being considered, until
arise legal effects of a new medical opinion.

(2) A doctor who has a reasonable suspicion that a change in the health condition of the patient
changing the medical fitness activity or to perform actions
condition or the patient's medical condition does not meet the prerequisites or requirements
, which was assessed, it is required for this
notify the patient and the provider responsible for issuing
medical opinion if he or provider know if his patient had
address. Part of the information, health data
patient, which led to the suspicion that there has been a change in health
capacity or state of health.

(3) In order to establish medical or health condition and
a medical opinion on the basis of the information referred to in paragraph 2
assessed person is required to attend at the invitation of providers
competent to issue a medical opinion or the other
person authorized to do so within the specified time for a medical exam.

§ 46

(1) If a person or assessed by applying the medical report
create rights or obligations for that medical opinion it is wrong
may, within 10 working days of its demonstrable
handover to submit a proposal on its review of providers who report
issued. The person who created the application appraisal rights or obligations and that
report was forwarded to the assessed person may petition for review
medical opinion submitted within 10 working days of its submission, and it
providers mentioned in the first sentence.

(2) If a petition for review of a medical report filed after the deadline
under paragraph 1, a provider of the proposal aside.
This fact in writing to the person who petition for review of a medical report
filed, and the person you are applying to medical opinion arise
rights or obligations, if he is known and assessed person, unless
a person who submitted the petition. When revealing the reasons for which the assessed
person or any other person authorized to file a petition for review
objectively prevented the submission of the proposal within the prescribed period, the provider
missed the deadline for filing a petition pardons. Forgiveness missed deadlines
not affect the deadlines set for the application of medical opinion.

(3) Proposal on the review of the medical report does not have suspensive effect
if his conclusion is that the person is assessed for the purpose for which it was assessed
, physically unfit, physically fit with a condition or
lost its long-term health condition.

(4) Should the provider of the application for review to the full extent
under medical opinion immediately canceled and the findings
facts or new assessment of medical fitness, issued a new report
. Proof of cancellation report is part
medical records of the patient.

(5) If the provider of a proposal to review medical opinion
does not comply in full, in advance within 10 working days of its receipt
if a medical certificate of competence, in other cases
within 30 days, file with the proposal for review, including
documentation required for the review of the medical opinion and his
opinion, the competent administrative authority.

(6) The Provider shall immediately notify in writing the fact that he was
proposal to review the medical report filed, the person to whom the application

Medical opinion gives rise to rights or obligations, if he is known and assessed
person, unless the person who submitted the petition. Similarly
progresses, compliance with a proposal to review the medical report, in full
extent or forward the proposal to review the relevant administrative body
. If the provider complies with the proposal to review the report in full
range will present a communication under the first sentence of the fact that it led to
.

§ 47

(1) The competent authority when reviewing the medical opinion
determines whether

A) was assessed for medical fitness or health
assessed person carried a medical report issued by a legitimate
provider

B) were carried out medical examinations, which provides
legislation or which indicate the examining physician,

C) the health status of the individual for the purposes of medical assessment
detected and completely

D) conclusion of the assessment of medical fitness or health
corresponds to the currently ascertained state of health of the person examined;
when reviewing the medical opinion based on documents supplied by
provider.

(2) The competent authority within 30 working days of receipt of the file
proposal for reviewing the medical opinion

A) reject this proposal and infected medical opinion confirming or

B) under medical report be canceled and return the matter to the provider for release
new medical opinion, or

C) under medical report canceled.
Deadline under the first sentence, the administrative authority in
particularly justified cases, be extended by another 15 working days.

(3) The competent authority may, to the extent necessary for the examination
medical opinion under Paragraph 1

A) invite providers to supplement his statements and documents while
specify the time within which the supplier is obliged to submit documents;
Provider is obliged to provide necessary assistance,

B) require expert opinion from a competent person in accordance
other legislation if it is necessary for a proper assessment
procedure for issuing a medical report to the medical or health condition
considered persons; In these cases, the period referred to in paragraph 2
interrupted.

(4) For the examination report by the competent administrative authority applies
unless stipulated otherwise, the fourth part of the Administrative Procedure analogy.

(5) Another petition for review of a medical opinion confirmed by
paragraph 2. a) or canceled pursuant to paragraph 2. b) or c)
competent administrative authority can not be filed. If the competent administrative authority confirms
medical opinion, you can make a new assessment of the health
competence or health of the person assessed only in the case
if a medical examination obvious that the assessment of its
medical or health state
likely to lead to a different conclusion than is listed in the current medical opinion.

§ 48

(1) When assessing health eligibility and issuing a medical opinion
according to § 46 and 47 shall proceed accordingly with the fact that if the provider

A) Prison Service, petition for review of a medical report forwarded
examining physician Director of the organizational units of the Prison Service, where
are provided health services, which according to § 46 medical report
examine; if the director of the organizational units of the Prison Service of the proposal to review
does not comply in full, forward it to the General Directorate of the Prison Service
which proceeds according to § 47

B) Security Information Service, petition for review of a medical report
according to § 46 shall examine the examining physician; if the proposal fails
review in full, forward it to the Director
Security Information Service, which shall proceed in accordance with § 47

C) The Office for Foreign Relations and Information, petition for review
medical opinion according to § 46 shall examine the examining physician;
if the proposal fails to review in full, forward it to the Director of the Office for
Foreign Relations and Information, acting in accordance with § 47

D) The General Directorate of Customs, petition for review of a medical opinion
according to § 46 shall examine the examining physician; if a proposal to review
does not comply in full, forward it to the Director General of the General Directorate of Customs
, acting in accordance with § 47


E) The Ministry of the Interior, the petition for review of a medical report forwarded
examining physician designated health professional in a medical facility
within the jurisdiction of the Ministry of Interior, or organizational units of the state
it established, in which health services are provided , which
according to § 46 shall examine the medical report; if the designated medical officer
proposal for the review does not comply in full, it passes
Interior Ministry, which shall proceed in accordance with § 47

F) Ministry of Defence, petition for review of a medical report forwarded to the Director
examining physician or healthcare professional manager
providers of health services in the Ministry of Defence, which
according to § 46 shall examine the medical report; if the proposal fails
review in full, forward it to the Ministry of Defence, which
proceed according to § 47

(2) If a review of the medical opinion on the fitness of aviation personnel
proceed in accordance with the Civil Aviation Act.

Common provisions for the care and diagnostic opinions medical opinions

§ 49

(1) When assessing health status for the purposes of health insurance
the provisions of § 41-48, by analogy with the fact that

A) evidence of demonstrable handover decisions in matters of temporary incapacity
assessment of persons and matters necessary treatment and care
person who requested the assessment of health status, the record in
medical records, which assessed person signs, or
if sent by post marking
delivery on the receipt; if an electronic communication
proof of despatch of decisions regarding the temporary incapacity
assessed person also proof of sending data through
mailbox or record stored on your computer in electronic form in the format specified
legislation with
function to verify the authenticity of the stored data and time stamp obtained through a state-recognized
authority

B) the period for filing a petition for review in accordance with § 46 para. 1
is 3 working days; This proposal does not have suspensive effect,

C) deadline for forwarding the proposal to review under § 46 par. 5
amounts to 5 working days

D) proceedings for a review of the decision is the provider that issued the decision
, a person whose state of health is assessed;
proposal for review of the decision may be filed this person or that decisions are made by applying
rights or obligations.

(2) If the patient with regard to their health status or
refuses to sign if the patient record pursuant to paragraph 1. a) sign
healthcare worker this fact recorded in the medical documentation
while the reasons that hinder the patient signing;
Record signs the health care worker and witness.

(3) Legislation health assessment for purposes of pension
insurance, sickness insurance, state social support, assistance in
material need and benefits for persons with disabilities
not affect the provisions of this Act.

(4) The provisions on the duty of confidentiality under another
legislation in matters Assessment of care and medical reports
applied so as not to shorten procedural rights
assessed person and the persons to whom the assertion of rights arising and obligations.
This is without prejudice to any other legislation which lays down an obligation to disclose certain facts
or obligation to keep certain facts
confidentiality.

§ 50

When deciding authority, the health insurance of health
for purposes of health insurance under another legal regulation 8)
provisions of § 41-48 apply.

§ 51

Assessing medical fitness to education, physical education and sport


(1) Medical fitness training to assess a medical report on medical issues
registering provider. Surveying
is a doctor with competence in the field of general practitioner for children and adolescents
or in the field of general practice, unless this Act or another
law provides otherwise. In the case of applicants for
education in schools and school facilities established by the Ministry of Defence
medical fitness to assess education and medical opinion

Medical fitness issued by the medical service provider, which
Defense Ministry granted permission to provide health
services in health facilities established by it;
examining physician is a doctor with competence in the field of general practice.

(2) If the practical education or practical training takes place

A) at workplaces natural or legal persons, issued
medical certificate of medical fitness of the person preparing the profession before
her first assignment practical education or practical training
and during this service provider of occupational persons

B) workplace natural person who is self-employed,
issued a medical report on the health of a person preparing
to profession before its first inclusion on practical education or practical training
and during
registering the provider of this person, and if that person is authorizing the provider of occupational services provider
school

C) only in the school or school facility issues a medical opinion on medical
persons preparing for occupation before its first assignment
practical education or practical training, and in the course of registering their
provider of this person and if the person registering the provider does
provider of occupational
school services,

D) at workplaces of persons referred to in subparagraph a) or b) and
school or school facility issues a medical opinion on medical fitness
persons preparing for occupation before its first assignment
practical training or practical training and during,
launches if practical education or practical training

First school, service provider referred to in subparagraph c)

Second workplaces natural or legal persons provider
described in subparagraph a) or b);

Examining physician under point a) is a doctor with competence in the field
general practice or in occupational medicine,
surveying physician referred to in subparagraphs b) to d) is a doctor with competence in the field of general practice
Medicine, in practical medicine for children and adolescents
or in occupational medicine.

(3) An assessment of the health of a person preparing for a performance
profession before its inclusion on practical education or practical training
is not performed

A) if in the context of practical training or practical instruction
carried on under conditions similar work included
into the first category and not a part of this work activity for which that health conditions are
eligibility determined by another legal regulation
^ 21)

B) if such training or teaching begins in less than 12
calendar months from the date of issue of the medical report pursuant to paragraph 1
and if not during this time to change the state of health;
medical assessment in this case made no later than 12
calendar months from the date a person on practical education or practical training
or

C) if no other legislation governing the system of education branches in
secondary and higher vocational education does the health conditions
eligibility for education.

(4) Medical fitness to

A) physical education in educational programs and to sport for all
^ 9) and the conditions for release from teaching in the subject
physical education for one semester of the school year or school year, assesses and medical
report issued by registering a provider

B) výkonnostnímu sport in organized sports competitions judged
a medical report issued by the registering provider
in the field of sports medicine,

C) senior sport to sport representation of the state and its preparation
considered a medical report issued by the provider in the field of sports medicine
; top sport for the purposes of this Act means the area
sport, which includes the national teams and prepare
talented athletes to this representation, which are members of the departmental sports centers
^ 9) or youth sport centers and
similar facilities for the preparation of athletes,

D) education in schools focusing on sports and physical education and in

During the course assesses a medical report issued
provider in the field of sports medicine.

(5) If a medical report issued by the authorizing provider
examining physician is a doctor with competence in the field of practical
medicine for children and adolescents or general practice.
In the event of a medical report issued by the provider in the field of sports medicine
examining physician is a doctor with competence in the field
Sports Medicine.

(6) legal persons performing activities of a school or school facility
where education is provided, which includes practical lessons
or practical training pays assessing medical students
high school students or colleges including medical examinations
.

§ 52

Implementing regulation provides

A) procedures for ensuring medical checkups, types, frequency and content
medical examinations necessary for obtaining the health
assessed person and assessing fitness
including the scope of examinations

B) a list of diseases, conditions or defects that prevent or restrict eligibility for health
training or during training, sport, physical education
or other activities

C) particulars of medical opinion in relation to the activity under consideration.
Part 2


Occupational medicine services and assessing fitness
person applying for a job
The occupational
Services

§ 53

(1) the occupational health services are preventative services, which
part of the impact assessment work, the working environment and working conditions
health, preventative checks, and
health assessment for the purpose of assessing fitness
to work, counseling focused on health at work and protection
of occupational accidents, occupational diseases and related diseases
work, training in first aid and regular supervision
workplaces and over performance work or services (hereinafter referred to as "work").

(2) occupational medicine services for employees and people applying for jobs provide
employer under the conditions laid down in this
Act and other legislation.

§ 54

(1) The provider of occupational services

A) provider in the field of general practice or

B) provider in the field of occupational medicine.

(2) The employer to perform work at their workplaces, unless further
otherwise stated,

A) shall, in the case of works which are included under the Act on Public Health Protection
^ 10) in the category of first-second, risky
third or fourth, or is part of a work activity, for the exercise are
conditions imposed by other laws, enter into a written contract for the provision of occupational
service provider referred to in paragraph
1

B) may, in the case of work assigned only to the first category
under the Act on Public Health Protection and does not form part of this work activity for
whose performance conditions are set by other legislation, || | ensure the implementation of occupational inspections and assessments
fitness for work on the basis of a written request by
provider referred to in paragraph 1. a) who is the authorizing
provider employees or jobseekers;
other occupational services according to § 53 par. 1 employer provides
Provider referred to in paragraph 1, which concluded
written contract

C) shall, if there is a change in the classification of work into a category higher than
first category under the law on the protection of public health or change
activities for the exercise of the conditions laid down by other legal provisions
conclude new or supplement existing written contract with
provider under paragraph 1 of the occupational services that
so far not requested, not later than three months from the date when this
change.

(3) Assessment of occupational and medical examinations for
works that are or will be carried out in a trial by
another law, the employer provides the provider
according to paragraph 2. a) or b), based on the results of the risk assessment

By another law or measurement results, if it was for the purpose
consent to put into trial operation carried out.

§ 55

(1) The employer shall

A) to allow authorized employees of the provider of occupational
service entrance to each of your workplace and give them the information needed to
risk assessment and prevention of possible danger to life or health
workplace, including the results of measurements of factors working conditions
submit their technical documentation of machinery and equipment, tell them
information relevant to the protection of health at work; in the case of workplaces that are subject
due to the state or other legally protected secrets
special regime, entering the workplace only determine
employees of occupational providers of services who are in this case
obliged to respect the special scheme,

B) the assignment of employees to work to follow the conclusions
medical reports about their medical fitness

C) when sending employees to occupational
inspection under this Act or any other legislation to equip them with the applications
containing information about the type of work mode and working conditions to which the employee
assessment required | ||
D) send employees to an extraordinary examination of occupational if
by the employee asked.

(2) The employer has the right to send employees to an extraordinary examination of occupational
if it has doubts about the medical
employee to work.

§ 56

Employee is obliged

A) submit to pracovnělékařským services provider
of occupational services, with whom the employer concluded a written agreement
or pracovnělékařským inspection and assessment of health eligibility
provider of occupational services pursuant to § 54 para. 2
point. b); He is also obliged to undergo medical services
indicated provider of occupational services to assess
health; providers of other health services staff determine
provider of occupational services;
other health services are part of occupational services

B) submit to pracovnělékařským services ordered by another
legislation

C) inform the provider of occupational services name and address of the registrant
providers, and other providers who accept him into
care

D) to inform providers of occupational services at its request or on its own initiative
all known or suspected
facts relating to health protection at work.

§ 57

(1) The provider of occupational services is required

A) to inform employees about the possible influence of factors of working conditions at its
health, knowledge development of his state of health,

B) inform employers about the possible influence of factors
working conditions on the health of its employees

C) carry out regular supervision of the employer's workplaces and in work over
employees

D) cooperate with the employer, employee, representative for the area
occupational safety and health as competent persons under the law regulating
securing other conditions for safety and
health at work ^ 11), union organizations and enforcement authorities
safety and health at work ^ 12)

E) promptly notify the employer or detection of serious
recurring factors adversely affecting safety and health at work
,

F) file a motion control authorities in the field of safety and health at work
^ 12) to remedy the observance of obligations
occupational safety and health ^ 13) if it finds that | || employer is not in compliance with medical reports or through
repeated warnings fulfills the obligations of health and safety at work
set by other legislation

G) keep documentation of occupational services performed for
employer that does not relate to a specific employee
separately from the medical records of the specific
employees; Documentation of occupational services means
records on the implementation of supervision in the workplace of the employer, including results

Analyzes of the advice given by employers and other similar
records on the activities undertaken in the framework of occupational services

H) to keep separate medical records of the patient from
medical records of the employees in the provision of occupational
services if the authorizing provider
patient and also a provider of occupational services.

(2) The provider of occupational services is entitled to require the employer to ensure
measurement or expertise, in order
analysis of working conditions, working environment and the response of the organism
employees, including the results of categorization of health risks,
if it suspects that there has been a change in working conditions that negatively
affects or could affect the health of employees. The employer is obliged
measurement provider or expertise required by the first sentence
secure. If the requirement to provide such measurements or
expertise disagree, request the opinion of the competent authority
protection of public health under the law on the protection of public health or
The State Office for Nuclear Safety, in the case of work in an environment of ionizing | || radiation ^ 14). The application was opposed by providing measurements or examinations as required
service provider of occupational reasons.

(3) The competent public health protection authority under the Act on the Protection
public health or the State Office for Nuclear Safety
examine the reason for the request and employers communicate their views in writing within 15 days of receiving the request
employers.

§ 58

Employer pays occupational services provided under this Act
, with the exception of the assessment of occupational diseases, and monitoring developments
health condition during preventive medical examinations for occupational diseases
development and health condition in medical preventive || | inspection after the hazardous work covered in the Act on the protection
public health.

§ 58a
Provision of occupational
Services
employer under employment or similar relationship

(1) An employer who has been authorized to provide health services
by law on health services in the field according to § 54 par. 1
point. a) or b) can do the job in their workplaces provide occupational medicine services through


A) a doctor with specialized qualifications in occupational medicine
or specialized qualifications in the field of general practice medicine and


B) other health care professionals involved in the provision of occupational
services, with whom the labor
or similar relationship. The employer is obliged to ensure the professional independence
employees mentioned in subparagraphs a) and b).

(2) The provision of occupational services referred to in paragraph 1

A) means authorized staff according to § 55 paragraph. 1 point. a)
healthcare worker referred to in paragraph 1

B) the employee is obliged to submit to pracovnělékařským services at
doctor referred to in paragraph 1 point. and); facts according to § 56 point. c)
d) communicates the doctors

C) medical report pursuant to § 46 may be examined only by an employee who is
doctor referred to in paragraph 1. a)

D) the employer is obliged

First fulfill the obligations according to § 57 through
medical personnel referred to in paragraph 1

Second ensure the fulfillment of other duties and responsibilities that are
this Act or other legislation established health providers
services only through health workers referred to in paragraph 1


§ 59

Assessment of the health of a person applying for a job

(1) If a person applying for a job, proceed at
assessment of its fitness for work similarly to the
assessing the medical fitness of employees within
of occupational services that | ||
A) initial medical examination is carried provider of occupational
service provider with whom the employer has entered into a written contract
, or by registering the provider, which sent
employer person seeking employment, unless
other legislation ^ 20) and otherwise in the case of work referred to in § 54 par. 2 point.
B) ,,


B) the employer medical examination always ensure before closing


First employment

Second contract for work or contracts for work if it is to be
person applying for a job assigned to the job, which according
law on the protection of public health or hazardous work is part of this work
activity for whose performance conditions are medical
set by other legislation;
entrance employer may also require a medical examination if it has doubts about the health
eligibility of persons applying for a job that does not work and risk
to be performed under the contract for work or agreement
for work or

Third pracovněprávnímu relationship like relationship.

Persons seeking employment is deemed medically unfit
to work, to which should be included unless subjected to input
medical examination in accordance with point 1, 2 or 3.

(2) Initial medical examination shall be borne by the person applying for a job.
The employer pays medical examination if closes with
job seeker employment or similar relationship, unless
another legal regulation. First and second sentence shall not apply if
person applying for employment with any employer or
employee and employer agree otherwise or if a legal prescription
otherwise.

§ 60

Implementing regulation, unless another law ^ 15) otherwise provides


A) procedures for ensuring medical checkups, types, frequency and content
medical examinations necessary for obtaining the health
assessed person and assessing fitness
including the scope of examinations

B) organization, content and scope of occupational services and content
documentation of occupational services performed for
employer

C) the risk factors of the working environment and diseases, conditions and defects that
upon the occurrence of these factors exclude or limit medical fitness
work or service

D) requirements for applications to perform inspections and occupational
assessment of fitness for work,

E) particulars of medical opinion in relation to the activity under consideration.
Part 3



Occupational Diseases Section 1


Assessment and recognition of occupational diseases

§ 61

(1) The health status of people in connection with occupational diseases to detect and assess
providers of occupational services.

(2) Occupational diseases assess, recognize and development
health status of persons with recognized occupational illnesses watch providers in the field of occupational medicine
who have obtained authorization from the Ministry for recognition of occupational diseases
if further otherwise stated; for these purposes may also perform
, where appropriate, tests to determine the health status
.

§ 62

(1) The provider stated in § 61 paragraph. 2 occupational diseases recognized on the basis


A) obtaining the health provider listed in § 61 paragraph. 1 and
including obtaining the health before the onset of the disease and the results
it requested expert examinations and opinions

B) the results of other professional examinations, if it is justified,
requested or performed provider referred to in § 61 paragraph. 2 and

C) verification of the conditions occurrence of occupational diseases in accordance with paragraph 3

(2) The provider referred to in § 61 paragraph. 1 for the purpose of assessment and recognition
occupational diseases transmitted providers mentioned in § 61 paragraph. 2
copy of the medical records to the extent necessary to assess the disease.
The same procedure is failing illness considered persons continue
conditions for the duration of occupational diseases specified in the implementing legal regulation
.

(3) Verification of conditions occurrence of occupational diseases ^ 16) performs

A) the competent public health authorities under the Act on the Protection
public health

B) The State Office for Nuclear Safety, in the case of suspected occurrence
occupational diseases in relation to work in conditions of ionizing radiation
,

C) a provider of occupational services referred to in § 61 paragraph. 2
case of suspected occurrence of occupational disease while working in
abroad, to which the employee was sent by an employer based in
Czech Republic, on the basis of a communication under consideration and a person

Detailed written statement about the sending employer
conditions under which the work was performed abroad or
Other findings from the place of work; results verify the conditions of formation
illnesses are providers examining occupational disease
binding.

(4) In the case of persons permanently living abroad, the assessment and
recognition of occupational diseases based on a medical report issued by the country of residence
persons assessed and certified to the competent authority of the country where the
announced international treaties by which the Czech Republic is bound
otherwise requires; a medical report must be accompanied by an officially
certified translation into Czech; translation is not required in the case of
medical report in the Slovak language.

(5) The conclusion of the medical report must be made clear whether the disease
assessed person recognizes or does not recognize as an occupational disease, or whether
disease assessed person no longer meets the conditions for recognition of occupational diseases from
set by the implementing legislation.
Provider referred to in § 61 paragraph. 2, which issued the medical report shall provide its proven transmission
persons pursuant to § 44 para. 1 and other persons to whom
applying medical opinion arise rights or obligations, whose | || circuit is defined by an implementing regulation.

§ 63

(1) The physician is obligated to send to the provider mentioned in §
61 paragraph. 1 or 2 entity which is based on an expert examination arose
reasonable suspicion of occupational disease, or the providers listed in | || § 61 paragraph. 2, if it is suspected that the disease no longer meets the conditions
for recognition of occupational diseases. Required to send employees to
providers mentioned in § 61 paragraph. 1 and 2 also has an employer
if it has reasonable grounds to suspect the emergence of occupational diseases, or
providers mentioned in § 61 paragraph. 2, if suspected that the disease has
longer fulfills the conditions for the recognition of occupational diseases.

(2) In the event that the provider specified in § 61 paragraph. 2 finds that
based its assessment of occupational disease on incorrect data, performs
own initiative a new assessment of the health status of the individual;
Based on the new assessment will issue a new medical report. In this case
inform this fact considered persons and persons who
in connection with the application of medical opinion gives rise to rights and obligations
if these people had known.

(3) In case of any illness or suspected illness that
no longer meets the conditions for recognition of occupational disease is assessed
obliged to undergo specialist examination the indicated
provider referred to in § 61 paragraph. 1 and 2, the provider, his
which the provider determines. Provider referred to in § 61 paragraph. 1 or 2
Designated Provider shall communicate the facts which led to the suspicion
first sentence. Designated Provider is obliged to carry
an examination by the date agreed with the assessment of persons, the longest
within 30 days from the date of communication of occupational service provider.

(4) If the assessed person refuses to undergo specialist examination
looks at her as a person who does not suffer from occupational diseases.
This fact provider must disclose in a demonstrable manner
person liable for damages to health, if he is known.
Medical opinion is issued.

§ 64

The employer is obliged to allow authorized employees of the provider
referred to in § 61 paragraph. 1 or 2 to enter the workplace, where
employee or former employee works or worked under conditions which influence
assessed occupational disease originated and this in order to determine
other facts or conduct of a clinical test, or remove
sample material acquisition or audiovisual recording
required for the assessment of occupational disease. The employer is also obliged to ensure
objectivity of the investigation and verification of conditions of occupational disease occurrence
allow entry to the workplace former employee.

§ 65

Implementing regulation provides

A) detailed requirements for the procedure for the assessment and recognition of occupational diseases
,

B) detailed requirements for the procedure for the assessment of occupational diseases in
where the disease continues to fulfill the conditions of occupational disease,

C) the class of persons which the service providers mentioned in § 61 paragraph. 2 transmit

Medical report on occupational diseases,

D) the conditions under which the disease can not continue to be recognized as an occupational disease,

E) particulars of medical opinion, recognizing an occupational disease
illness or who are not recognized as an occupational disease.
Section 2


Permission for recognition of occupational diseases

§ 66

(1) The Ministry shall grant permission for recognition of occupational diseases
providers in occupational medicine, at his request, which includes


A) identifying information providers,

B) a copy of the authorization to provide medical services in the field of occupational medicine
,

C) the scope and volume of health services, which is able to provide, and their
minimum staffing,

D) for the provision of occupational services, which must last at least 5 years
,

E) technical and material equipment of medical devices

F) cost for medical services not covered by public health insurance
, for which he intends to provide health services,

G) the number of individual professional examinations and
number of persons examined in relation to occupational diseases for the past three years
before submitting the application, if the activity is exercised in the past.

(2) The provider may submit a request on the basis of calls published
Ministry. Call Ministries contains

A) the place where the applications are submitted,

B) the deadline for submission of applications,

C) the territories to be health services are provided

D) requirements for the scope and volume of required health services.

(3) The Ministry after assessing the documents in applications from individual applicants and
facts contained therein exclude providers who
not meet the conditions set out in the call, and the other will determine the order in
relation to the territory for which they have health services to be provided.
The criteria for ranking applicants are qualifying assumption
duration and scope of practice and the range of services that are offered.
Permit for recognition of occupational diseases can grant the providers in the order specified
first sentence. Permission is granted for 10 years.

(4) The Ministry shall grant authorization only provider with which
assessment and recognition of occupational diseases carried out at least two physicians
specialized qualifications in occupational medicine and occupational medicine if
provides services for at least 5 years.

(5) Permission for recognition of occupational diseases contains

A) the information under paragraph 1. a)

B) defining the territory to be health services are provided

C) the scope and volume of provided health services.

(6) The Ministry will publish a list of providers who granted permission
for recognition of occupational diseases, in a manner allowing remote access.

(7) In the event that for a given area within a specified time
not register any provider or not the condition assessment of occupational diseases
least two doctors with specialized qualifications in the field of occupational medicine
ensure recognition occupational diseases Department
so that it decides ex officio that the assessment of occupational diseases
will perform one of the authorized suppliers. Ministry
according to the first sentence may appoint only provider with whom
assessment and recognition of occupational diseases carried out at least two physicians
specialized qualifications in occupational medicine and occupational medicine if
provides services for at least 5 years.

§ 67

Provider is required to notify the Ministry of any changes in the data
and the conditions under which the authorization for recognition of occupational diseases
granted within 15 days of their occurrence.

§ 68

(1) Permission for recognition of occupational diseases expires

A) the date of termination of the authorization to provide health services in the field of occupational medicine
,

B) removing the authorization of the Ministry.

(2) The Ministry permit for recognition of occupational diseases

A) revoke the provider asks about it or does not
health service for the territory specified in the authorization

B) may be withdrawn if the provider has ceased to meet any of the conditions
according to § 66 para. 1 point. e), or paragraph. 5 point. C).

(3) In the case of a provider, which after the end of the period for which he was
issued a permit for the recognition of occupational diseases has not been granted in accordance with § 66

New authorization for recognition of occupational diseases, shall be used for the management of medical documentation
mutatis mutandis law on health services
governing the handling of medical records upon termination
provider that medical documentation until its
over to the new provider responsible for recognition of occupational diseases
takes over the ministry.
Section 4


Common provisions for assessing fitness to work, occupational
services and the assessment and recognition of occupational diseases at
members of security and armed forces and prisoners

§ 69

(1) The employer shall also mean

A) security body which carries out the rights and obligations under other legislation
against an individual who in the security corps
performs a service (hereinafter referred to as "a member of the security forces")

B) the armed forces of the Czech Republic, which shall exercise the rights and obligations
according to another law against member in the service of
which they carry out service

C) prisons and institutions for security detention in the case of persons
imprisonment, detention or preventive detention.

(2) If the Prison Service employer provides occupational
service employees and persons in custody
sentence of imprisonment or preventive detention assigned to work in their
medical facilities.

(3) Employees shall also mean a member of the security forces or
member of the armed forces of the Czech Republic in service by
another law. Employee also means a person exercising
custody, imprisonment or security detention if
included in the work.

(4) The place of employment shall also mean the place stipulated by a legal regulation
.

(5) If other statutory assessment of health eligibility
member to perform services in a security ward or
Armed Forces of the Czech Republic or a citizen who seeks
recruitment to security corps, or candidates for
call to service in the armed forces otherwise, proceed
according to another law.

(6) Permission for recognition of occupational diseases among employees
Ministry of Defense and Armed Forces of the Czech Republic, students of military schools and other employees
budgetary and subsidized organizations, whose founder is
Ministry of Defence, is awarded to providers
in the field of occupational medicine at the Ministry of Defence; § 66 through 69
apply.
TITLE V


Medical exposure and clinical audit
Part 1

Medical exposure


§ 70

(1) medical exposure means exposure of individuals under another
legislation.

(2) clinical responsibility for medical exposure means
responsibility for individual medical exposures, including in particular
justification of medical exposure, including the assessment of the aims of medical radiation, its
optimization, clinical evaluation, practical cooperation with
attending other health professionals, or obtaining information about previous
provision of health services, provision of information or records
conducted medical exposure to other physicians or prescribers
practitioners and at their request and provide information about
the risk of ionizing radiation irradiated persons.
Bearer clinical responsibility of a practitioner is the extent of their competence to perform
profession.

(3) indicating the doctor means any doctor or dentist
doctor who recommended his written statement
patient for medical exposure to a practitioner.
Indicating doctor is obliged to assess all the information about the patient's condition
important for medical exposure, which are known to him, so as to avoid unnecessary exposure of the patient
.

(4) Practitioner means a medical doctor, dentist or other health professional
authorized to perform the activities of medical radiation
under other legislation, and which is empowered to take responsibility for individual medical exposures
clinical responsibility.

(5) National radiological standards means procedures

Provision of health services, which include medical exposure
according to current knowledge of science and clinical medicine (hereinafter
"national radiological standards").
National Radiological Standards issued by the Ministry; publishes them, including their updates, the Ministry of Health Bulletin
and
manner allowing remote access.

§ 71

(1) Provider of providing health services, which include
medical exposure is required

A) perform medical exposure only if it can demonstrate its
net benefit, weighing the total potential diagnostic or therapeutic benefit
including the direct health benefits to an individual and the benefits to society in comparison to the harm
that the exposure might cause;
justification process must be involved indicating the physician and practitioner;
indication criteria for justification of medical exposure publish and update
Ministry in the Bulletin of the Ministry of Health and
manner enabling remote access,

B) develop local radiological standards and ensure their compliance
; when drawing up local radiological standards based on
national radiological standards, specific workplace conditions
medical equipment and scope of health services,

C) conduct an internal clinical audit, and if it finds on the basis of its results
deficiencies, implement measures to eliminate them,

D) have an external clinical audit by authorized persons
; if an external clinical audit found shortcomings
provider performs actions in order to eliminate them; if
external clinical audit found shortcomings
undetected internal clinical audit provider will investigate the reasons for this
undetected and take appropriate measures; external clinical audit is not performed on
radiological departments of health facilities equipped only
dental radiographs or bone densitometers,

E) ensure compliance with the rules of radiation protection in search
examinations using ionizing radiation during irradiation
for medico-legal purposes, in the verification phase-method with medical
irradiation, for which no binding opinion issued by the State
Office for nuclear safety in accordance with § 36, and in patients, which could be used or
were irradiated during pregnancy and lactation.

(2) The provider is also obliged to ensure that

A) the local radiological standards available to all healthcare
staff performing medical exposure

B) the provision of medical services, which include medical
bombardment, except to provide these services to radiological
departments of health facilities equipped only with dental X-rays
or bone densitometers, relevant activities related to medical || | irradiation performed by a healthcare professional, which is a radiological physicist
with specialized qualifications, radiological physicist
radiological technician, radiology assistant with specialized qualifications or
radiology assistant, and that the healthcare professional in the workplace available
provider; way of ensuring the availability of
medical worker and the extent and method of securing it
activities performed during medical irradiation in the implementing legislation,

C) in the provision of health services, which include medical
irradiation was performed optimization of radiation protection

D) follow-up was carried out theoretical and practical training
healthcare professionals involved in the medical exposure, taking into account
new findings in the field of radiation protection

E) steps are taken to prevent accidents or unplanned application
patient dose.

(3) The registered provider the patient is obliged, on request
provider of healthcare services, which include
medical exposure, submit written information about the patient's condition
important for medical exposure. This does not affect the obligation under the Act
of health services to provide information needed to ensure continuity
health services.

§ 72

(1) Medical exposure of patients as part of medico-legal procedures by

Other laws and the verification of the non-phase method with
medical exposure, for which no binding opinion issued
State Office for Nuclear Safety in accordance with § 36, can be performed only in particularly justified cases
and using appropriate techniques, to be used only
procedures consistent with national radiological standards.
Medico-legal purposes are the procedures performed for insurance
or legal purposes without a medical indication.

(2) Provisions for non-phase authentication methods apply mutatis mutandis to
exposure of healthy individuals or patients voluntarily participating in
biomedical research program, including those exposures that do not have
direct health benefit for people undergoing irradiation.

(3) The implementing regulation lays down

A) rules and procedures for radiation protection of persons within their
medical diagnosis or treatment, indicating the contents of the activities of a doctor
practitioner and other staff who are involved in
medical exposure,

B) rules and procedures for radiation protection of persons irradiated for
medico-legal procedures without a medical indication

C) rules and procedures for radiation protection in the context of occupational
services and preventive health care

D) rules and procedures for radiation protection of persons within the voluntary participation
healthy individuals or patients for medical verification phase-
methods associated with medical exposure,

E) rules and procedures for radiation protection of patients irradiated during
pregnancy and lactation,

F) rules and procedures for the evaluation of local radiological
standards and their compliance with national radiological standards

G) the minimum requirements for staffing external clinical
audit

H) the extent and method of optimization of radiation protection in medical exposure
.

§ 73

National Radiological Standards contain mainly

A) training requirements, specific training and specialized
competence of health professionals

B) technical parameters of radiological equipment on which they performed
medical exposure, minimum equipment for their checking and adjustment,

C) the method of determining the load of patients; requirements documents necessary for
estimate the dose, the manner of their evaluation and their registration,

D) radiological procedures

E) requirements for patient preparation for examinations and course
own methods.
Part 2

Clinical audits


§ 74

(1) The internal clinical audit is to verify and assess whether
health services, which include medical exposures, are performed
in accordance with local radiological standards and whether the system followed
quality of medical radiation .

(2) Internal clinical audit is conducted once a year, and it
through people who have a labor provider or
similar relationship and are competent in the area in which the audit is to be conducted
.

(3) The provider maintains records of internal clinical audit
which records the date of the audit, the findings of his
basis in relation to the objective set out in paragraph 1 and the name or names
surname persons who carry out internal clinical audit, and their relationship with the
.

§ 75

(1) The external clinical audit is to verify and assess the radiological
compliance with local standards in providing
health services, which include medical exposures.
Results are compared with national standards, radiological, and if desired,
these activities are modified or, if necessary, are established
new standards. External clinical audit is conducted at least once every 5 years
.

(2) External clinical audit can perform a legal entity that has been
ministry granted permission for such activities on the basis of a
binding opinion of the State Office for Nuclear Safety;
Ministry will require a binding opinion before deciding on
authorization to conduct an external clinical audit.
Permission to conduct an external clinical audit can not be converted
nor passed on to another legal entity.

(3) The Ministry shall grant legal entity authorized to conduct an external audit of clinical
upon written request if


A) is not the provider or member of a legal person that is
provider

B) a statutory body or its member or member of its supervisory body
is not currently a statutory body or its member or member
supervisory body of another provider nor the provider

C) has drawn up rules for the evaluation process of local radiological
standards and their compliance with national radiological standards (
"the rule evaluation process") for each field of medical
exposure; medical exposure means

First radiology, including interventional radiology and cardiology,

Second radiotherapy,

Third Nuclear Medicine and

D) security personnel to conduct an external audit of clinical
the extent to which the requested authorization.

§ 76

(1) An application for authorization to conduct an external audit of clinical
addition to the requirements laid down by administrative rules must also contain

A) business name or name and registered address of the applicant

B) identification number, if assigned,

C) the name or names, surnames, nationality, address of the place
permanent residence in the Czech Republic or in the case
persons without permanent residence in the Czech Republic, address of residence outside the Czech Republic and
or place of registered residence on the territory of the Czech Republic
and date of birth of persons that are statutory bodies
applicant or its members or acting on behalf of the legal person
entered in the commercial or similar register prior to its creation,

D) the date on which it intends to carry out an external clinical audit,

E) medical exposure for which the authorization to be granted.

(2) An applicant for authorization requests to conduct an external audit of clinical
joins

A) a statement that is not a provider or partner
legal entity which is a provider

B) a statement of the statutory body or its members or
control authority that are not currently a statutory body or its
members or members of the supervisory body of another provider, nor any other
provider

C) proof that the legal person has been constituted or established if
will be entered into the commercial or similar register or registration
not been done yet, or proof that the legal person is registered || | the commercial or similar register; if the applicant is a legal entity
located outside the territory of the Czech Republic, joins extract from the commercial or similar register
conducted in the State of residence and proof that
legal person or an organizational component of the enterprise legal person || | the Czech Republic were entered into the commercial register if
registration has already been made; proof of entry in the commercial or similar
Register or excerpt from these registers must not be older than 3 months,

D) list of persons, by means of the external clinical audit
carried out, indicating the name, surname;
among health workers also indicate their expertise or specialized competence
for the medical profession and other persons of their education
with the study program and the field in which it was obtained,

E) rules evaluation process for each area of ​​medical
exposure.

§ 77

(1) The decision on granting permission to conduct an external audit of clinical
addition to the requirements laid down by the Administrative Code also contains

A) the date from which such external clinical audit performed,

B) medical exposure for which the authorization is granted.

(2) The Ministry shall forward a copy of the written decision to
authorization to conduct an external clinical audit within 30 days from the day
decision comes into force the local tax
carrying out the administration of income tax, locally relevant district administration
social security and the State Office for nuclear safety.

(3) The Ministry shall publish a list of persons authorized to carry
external clinical audit, including the data referred to in paragraph 1
manner allowing remote access.

§ 78

(1) A legal entity that has been granted permission to conduct an external audit of clinical
is obliged to publish the rule evaluation process
manner allowing remote access.


(2) A legal entity that has been granted permission to conduct an external
clinical audit is required to notify the Ministry of any
changes regarding the information contained in the decision on granting permission, in
application for authorization and in the documents submitted with this application
and document these changes relevant documents. Changes to the data in the first sentence
must be notified within 15 days of the date on which they occurred.

(3) If a change of data, which is not mentioned in the decision to grant
permission to conduct an external clinical audit, and if they continue
conditions laid down for the evaluation, the Ministry performs
about the change recorded in the file; in other cases decided by the Ministry
by circumstances to change permissions or its
withdrawal.

§ 79

(1) Permission to conduct an external audit of clinical expires

A) the termination of a legal person who has this privilege

B) the deletion of legal entities established outside the territory of the Czech Republic
Commercial Register

C) the decision of the Ministry to revoke the license.

(2) The Ministry shall withdraw the authorization to conduct an external audit of clinical
if a legal entity that has been granted

A) ceases to meet any of the conditions set out in § 75 para. 3, or


B) a withdrawal of authorization requested.

(3) The Ministry may withdraw permission to conduct an external audit of clinical
if the legal person or seriously
repeatedly violated any of the obligations set out in § 78 para. 1 or 2
or § 81 paragraph . 2 or external clinical audit conducted by a person
excluded from the clinical conduct of the external audit
according to § 81 paragraph. 3rd

§ 80

Ministry will send a copy of the written decision to change
or withdrawal of authorization to conduct an external audit of clinical
within 30 days of the date of the ruling authorities referred to in § 77 par.
Second

§ 81

(1) A legal entity that has been granted permission to conduct an external audit
clinical assessments are carried out under an agreement between the provider and
this person. External clinical audit must be performed
within 12 months from the date of conclusion of the contract.

(2) A legal person performing external clinical audit is the implementation
ratings obliged

A) act impartially,

B) comply with the rules of the evaluation process.

(3) conduct an external clinical audit is excluded person who
in employment or similar relationship to the provider, on which he has
be audited, or for that provider performs the function
professional representative or is a partner of the provider, his
statutory body or member of a statutory body or a member of his
supervisory authority.

§ 82

(1) Legal person who carried out an external clinical audit, issued
providers report on the implementation of the external clinical audit (hereinafter
"Report").

(2) The report contains

A) information on the legal entity that conducted external clinical audit, and it
business name or name and registered address and identification number, if
assigned

B) identification of the provider, which are

First in the case of a natural person, the name or names, surname and address
place of permanent residence in the Czech Republic or in the case of a natural
persons without permanent residence in the Czech Republic address
residence outside the Czech Republic and possibly place of registered residence in the Czech Republic
identification number, if assigned, and date of birth

Second in the case of a legal entity or company name, business address and
identification number, if assigned,

C) medical exposure for which the external clinical audit
executed and place or places of provision of health services,

D) a description of the course and the clinical findings of the external audit with regard to
objectives set out in § 75 para. 1

E) the date of the report.

(3) A legal person who carried out an external clinical audit, issued
providers upon request confirmation of the clinical
external audit. Confirmation contain the information specified in paragraph 2. a) to c) and e
).

(4) A legal person performing external audit of clinical records
leading providers where by an external clinical audit.
TITLE VI

Protective treatment


§ 83


(1) Compulsory treatment is performed on the basis of a final court decision
imposing protective treatment (hereinafter "the decision of the court") as
protective medical treatment performed as inpatient care or treatment performed
protective form outpatient care.

(2) Protective treatment imposed by the court can also perform during the performance
imprisonment in medical facilities of the Prison Service, and it
protective medical treatment carried out in the form of day care and protection
treatment performed either outpatient care.
Conditions under protective treatment must not affect the conditions of imprisonment.

(3) In the exercise of protective treatment is only to such limitations
Human Rights, which lays down the law, and to the extent that is necessary to achieve the purpose
protective treatment if this aim can not be achieved
otherwise.

§ 84

(1) Providers are obliged, unless stipulated otherwise
provide protective treatment outside imprisonment if
authorized to provide health services in the field to the contents of these activities include
.

(2) A provider providing protective treatment outside prison punishment
liberty as inpatient or outpatient care in addition to the rights set
law on health services is entitled to refuse admission to the hospital
protective treatment, if the patient adoption
been exceeded acceptable workload.

(3) Compulsory treatment in addition to imprisonment carries
provider in medical facilities of the Prison Service, where
for the provision of medical services met the conditions set by the
health services. Medical Equipment Prison Service is part
prison.

§ 85

(1) Provider of providing protective treatment outside prison punishment
freedom as inpatient care may

A) exceptionally prohibit

First visit a particular patient

Second using the phone the patient or

Third forwarding correspondence patient
if there is a reasonable suspicion that would seriously disrupt
individual medical procedure; For this reason it may also monitor packets
patient; the reasons for the ban or to check the packages led
recorded in the medical records of the patient;
patient can not prohibit visits by his lawyer or representative organizations
providing advice to patients and the use of the telephone and correspondence
when communicating with these representatives

B) to refuse to allow the patient leaving short-term health care facility

C) require accompaniment by the Police of the Czech Republic, in the case of
patient whose attendance at court and provider ensures that
could be dangerous to themselves or nearby, or if there is danger of his escape
.

(2) Restrictions on correspondence or check correspondence between patient and
court appointed guardian, between patient and
legal representative or representative organization providing counseling to patients
between the patient and the public authorities, the Ombudsman or
diplomatic mission or consular office of a foreign country, or between patient and
international organization, which according to international conventions to which
Czech Republic is bound, it is appropriate to deal with complaints
relating to the protection of human rights, inadmissible.
This correspondence was sent to the addressee and delivers patient immediately.

(3) Service Provider providing protective treatment outside power custodial
liberty must ensure that the patient upon admission to guard
treatment demonstrably acquainted with their rights and obligations associated with
provision of health services in healthcare device while performing
protective treatment with an expected duration of treatment and the possibility of changing forms
health care according to § 83 paragraph. 1, in which the protective treatment is performed,
further with individual therapeutic procedure, with the internal rules of the medical | || inpatient care facilities (the "internal Rules"), if the submission of such information shall not preclude
his health. The record of familiarization with
patient's rights and responsibilities is part of the medical records of the patient
. Record of signs the patient, health professional and a witness who was present
filing information.
Obligation to submit information to the patient about his health and proposed medical services

According to the law on health services is not the procedure in the first sentence
affected. Medical documentation is also recorded
any disagreement with the proposed individual patient therapeutic procedure.

(4) The provisions of paragraphs 1 to 3 shall also apply to compulsory treatment
provided in addition to imprisonment, unless other legislation
stipulates otherwise.

§ 86

(1) Provider of providing protective treatment outside prison punishment
freedom as inpatient care the patient at his request
allow short-term abandonment of medical devices, after examining
patient's medical condition; for this purpose he will issue a pass.

(2) pass form can be issued if the patient's condition stabilized
and if it can be reasonably assumed that during a short leave
medical device does not change it, which would lead to failure
behavior in relation to which it was ordered protective treatment.
Permit short-term abandonment of medical devices must not be contrary to the purpose
protective treatment and should not distort individual treatment.

(3) An application under paragraph 1 patient the reasons for short
leave the medical facility, the period for which authorization is sought, and
address to which the patient will linger.
Pass includes the name and surname of the patient, date of birth, time
to which it is exposed, and the address to which the patient will linger.
A written request or a record of the oral submissions and copies of the culverts is
included medical records of the patient.
If a provider refuses to expose the culvert is part of the medical record documentation
rejection, which shall state the reasons for the refusal.

(4) If a provider refuses to issue a pass, a patient can submit a new application
earlier than 7 days from the date of rejection of the original application.

§ 87

(1) Provider of providing protective treatment outside power custodial sentence could
if it violates If the patient is seriously
individual therapeutic approach of protective treatment, to petition the court, which
protective treatment ordered to draft change in the way of his performance. If
protective treatment is provided in addition to imprisonment, the court served
proposal to change the way of protective treatment
director of the organizational units of the Prison Service.

(2) A provider providing protective treatment outside power custodial
freedom is obliged to inform the court that ordered protective treatment that

A) can not ensure the patient's admission to the protective treatment due
referred to in § 84 par. 2; part of this announcement is the justification
refusal to accept the patient and the expected date of its communication
possible adoption,

B) patient, who was ordered protective treatment is performed by means

First inpatient or outpatient care, the deadline set by the court
did not start to perform protective treatment

Second inpatient care, the svémocně of medical devices withdrew

Third Outpatient care is not only delivered to medical examinations within the specified deadline
,

C) the patient was based on sudden changes in health status which
unrelated to protective treatment exercised as inpatient care,
transferred to another workplace provider executing protective treatment or medical facility
another provider; If the patient
court appointed guardian, a provider of him that is also
notified.

(3) The provider makes a notification under paragraph 2 within 24 hours
when the circumstances referred to in paragraph 2 occurred.

§ 88

(1) The patient is in addition to the obligations stipulated by the health services in
protective treatment obliged

A) undergo individual therapeutic procedure established for
protective treatment, including all medical procedures that are part
individual medical procedure; This does not affect the patient's right to choose
possible alternative treatment or the right to consent under
law on health services for individual medical procedures that
not directly related to the fulfillment of the purpose of protective treatment

B) to submit a reasoned request to the attending physician
personal inspection in the interest of ensuring internal rules and the exclusion of

To carry not thing disturbing the individual medical procedure;
Tour performing same-sex

C) allow employees to provider-specific control of their personal
things

D) announce a momentary abandonment of medical equipment
address that will linger, and the place of residence met; if
refuses to disclose this fact, the provider fails to issue a pass.

(2) The procedure under paragraph 1. b) or c)
and any subsequent measures taken by the provider to record
medical records of the patient.

§ 89

(1) Expenses related to the performance protective treatment for people who
not participants of public health insurance in the Czech Republic
paid by the state from the state budget chapter Ministry.

(2) The bill referred to in paragraph 1 shall be sent to the Ministry
provider no later than the fifteenth day of the calendar month following
calendar quarter in which the healthcare services were provided.

(3) The state is entitled to recover from patient costs reimbursed according
paragraph 1 or portion thereof, through the Ministry.
TITLE VII



ADMINISTRATIVE OFFENCES
§ 90

(1) The provider commits an administrative offense by

A) fails to ensure that before sterilization the patient was informed
according to § 15 para. 2

B) establish an expert committee whose composition and the relationship of its members to
providers is inconsistent with § 13 par. 3 and 4, in the case of sterilization

C) carry

First contrary to § 14 without the written consent of the patient
sterilization of medical reasons

Second without the patient's written request pursuant to § 17 para. 3 point. a) or
positive opinion of the expert commission according to § 17 par. 3 point. b)
or without the patient's written request pursuant to § 17 para. 4 point. a)
or positive opinion of the expert commission according to § 17 para. 4 point. b)
consent or court under § 17 para. 4 point. c) castration according to § 17 para. 2

Third without the patient's written request pursuant to § 21 par. 3 point. a) or
positive opinion of the expert commission according to § 21 par. 3 point. b) change
sex transsexual patient according to § 21 para. 2, or

Fourth without the written consent of the patient according to § 24 par. 2 point. a) or
positive opinion of the expert commission according to § 24 par. 2 point. b)
or without the written consent of the patient according to § 24 par. 3 point. a) or
positive opinion of the expert commission according to § 24 par. 3 point. b)
consent or court under § 24 par. 3 point. c) psychosurgical performance
according to § 24 para. 1

D) carry

First without the written consent of the legal guardian in accordance with § 13 para. 2 point.
A) positive opinion of the expert commission according to § 13 para. 2 point. b)
consent or court under § 13 para. 2 point. c)
sterilization for health reasons

Second without a written application by the legal representative under § 21 para. 4 point. a)
or positive opinion of the expert commission according to § 21 para. 4 point. b)
or court approval pursuant to § 21 para. 4 point. c) gender reassignment
transsexual patients according to § 21 para. 2, or

Third without the written consent of the legal guardian in accordance with § 24 para. 4 point.
) Or positive opinion of the expert commission according to § 24 para. 4 point. b)
or court approval pursuant to § 24 para. 4 point. c) psychosurgical
performance

E) perform sterilization, castration or psychosurgical
performance of other reasons or a person other than specified in § 13 para. 1 or 2 in the case
sterilization, or § 17 para. 2, 3 or 4, in the case of castration, or
§ 21 paragraph. 2, 3, 4 or 5, in the case of transsexual sex reassignment
patient or § 24 para. 2, 3 or 4, in the case of psychosurgical
performance

F) provides, sells or donates inconsistent with § 29 par. 2
results of genetic examination of the patient to third parties

G) allows intervene in the human genome for reasons other than
specified in § 30 paragraph. 1, or creates conditions for the implementation of such
intervention

H) contrary to § 30 paragraph. 2 allows performing procedures designed to
create a human being, or create the conditions for carrying out such
processes or enable the creation of new human beings,

I) allow practices contrary to § 30 paragraph. 3 or
create conditions for the implementation of such procedures

J) blood was taken in contravention of § 31 para. 2

K) issues a medical opinion, the issue is not authorized under § 42 para.
2

L) does not issue an opinion within the period specified in § 43 para. 1


M) has advanced a proposal for the review of medical opinion within
specified in § 46 para. 5

N) in contravention of § 47 para. 3 point. a) does not submit to the competent administrative authority
based on his call additional documentation or perform a specified
deadline

A) recognize the occupational disease, although not entitled to occupational diseases under
§ 61 paragraph. 2 recognize, or

P) does not dispatch according to § 63 para. 1 entity which is based on an expert examination
created a reasonable suspicion of occupational disease, or if
suspected that the disease no longer fulfills the conditions for the recognition of disease
profession, to the appropriate provider.

(2) Service Provider performing assisted reproduction methods
commits an administrative offense by

A) carry out the destruction of human embryos in conflict with § 9

B) contrary to § 10 paragraph. 1 fails to maintain mutual anonymity
anonymous donor and the infertile couple, and an anonymous donor anonymity and
child born of assisted reproduction,

C) contrary to § 10 paragraph. 2 does not keep data on health status
anonymous donor for 30 years from the implementation of artificial insemination.

(3) Service methods to verify the non-phase commits an administrative offense
that

A) phase-out the verification method, although it towards its implementation
been granted by the Ministry,

B) phase-performs authentication methods in conflict with § 33 para. 4 or 5

C) have completed phase-authentication methods if he was under § 36 paragraph
. 5 licenses revoked for verifying

D) contrary to § 37 point. a) never faded ethics committee or establish it in
composition that is inconsistent with § 38 par. 2

E) inconsistent with § 37 point. b) conclude an insurance contract

F) contrary to § 39 par. 1 point. a) no notice of phase-step verification
methods

G) in conflict with § 39 par. 1 point. b) immediately interrupt or stop
non-phase authentication methods,

H) comply with the notification obligation pursuant to § 39 par. 1 point. c)

I) in contravention of § 39 par. 1 point. d) to allow persons authorized
Ministry, State Institute for Nuclear Safety and
members of the ethics committee of the scrutiny, or

J) inconsistent with § 39 par. 2 fails to submit a final report on the outcome
non-phase authentication method.

(4) The provider of occupational services commits an administrative offense
that

A) comply with the notification obligation pursuant to § 57 par. 1 point. e) or

B) fails to file according to § 57 par. 1 point. f) stimulus
control authorities in the field of occupational safety and health.

(5) Provider of providing health services, which include
medical exposure, commits an administrative offense by

A) contrary to § 71 para. 1 point. b) fails to ensure compliance with local
radiological standards

B) contrary to § 71 para. 1 point. c) fails to internal clinical audit
according to § 74 para. 2

C) contrary to § 71 para. 1 point. d) failing to carry out an external
clinical audit in accordance with § 75

D) contrary to § 71 para. 1 point. c) and d) implement measures to correct the shortcomings
,

E) contrary to § 71 para. 2 point. a) fails to ensure that local
radiological standards available to all healthcare professionals
performing medical exposure, or

F) contrary to § 71 para. 2 point. c) fails to optimize radiation protection
.

(6) Service Provider providing protective treatment has committed an administrative offense
that

A) does not provide protective treatment outside imprisonment, although
conditions are fulfilled according to § 84 par. 1 and unless the procedure pursuant to § 84 paragraph
. 2

B) contrary to § 85 para. 1 point. a)
recorded in the medical records of the patient the reasons that led to the ban or to check
packages

C) failure of administration to the patient information according to § 85 para. 3, or

D) comply with the notification obligation pursuant to § 87 para. 2nd

(7) An administrative offense shall be fined up

A) 1,000,000 CZK, for an administrative offense under paragraph 1. g), h) or i
)

B) 500,000 CZK, for an administrative offense under paragraph 1. f) or
a), paragraph 2. a) or paragraph 3 letter. a), c), e) or g)

C) 300,000 CZK, for an administrative offense under paragraph 1. a), c)
d), e), k) or p), para 3. b)

D) or j), paragraph 5. a), b) or c) of paragraph 6 point. a)


D) CZK 200,000 in the case of an administrative offense under paragraph 1. b) j)
l), m) or n), para 3. f), h) or i) to paragraph 4. a)
or b) paragraph 5. d) or paragraph 6 point. d) or

E) 100 000 CZK, for an administrative offense pursuant to paragraph 2. b) or
c) paragraph 5. e) and f), or paragraph 6 point. b) or c).

§ 91

(1) The legal person commits an administrative offense that carries out
external clinical audit, even if it has to implement it granted permission
according to § 75 para. 2nd

(2) A legal entity that has the authority to conduct an external audit of clinical
, commits an administrative offense by

A) contrary to § 78 para. 1 publish rules evaluation process

B) comply with the notification obligation pursuant to § 78 para. 2

C) contrary to § 81 paragraph. 2 point. b) the implementation of the external audit of clinical
not comply with the rules of the evaluation process, or

D) contrary to § 81 paragraph. 3, the external clinical audit
person excluded from this assessment.

(3) An administrative offense is saved

A) a fine up to 1 million CZK in the case of an administrative offense under paragraph 1

B) a fine up to 300,000 CZK, for an administrative offense pursuant to paragraph 2.
A), b) or c), or

C) a fine up to 200,000 CZK, for an administrative offense pursuant to paragraph 2.
D).

§ 92

(1) A legal person for an administrative delict if it proves that
made every effort that could be required to breach
legal obligations prevented.

(2) In determining the amount of the fine legal person takes into account the seriousness
administrative offense, especially the manner of its commission, its consequences and
circumstances under which it was committed.

(3) The liability of a legal person for an administrative tort shall expire if
administrative authority has initiated proceedings within 1 year of the date when it became
but no later than 3 years after the date on which it was committed .

(4) Administrative offenses under this Act in the first instance

A) the competent administrative authority in the case of administrative offenses pursuant to § 90 par.
1, 2, 4-6,

B) the Ministry, in the case of administrative offenses pursuant to § 90 par. 3 and § 91

C) The State Office for Nuclear Safety, in the case of administrative offenses pursuant
§ 90 paragraph. 5th

(5) The liability for conduct that occurred in the business of a natural person
^ 17) or in direct connection therewith, shall be subject to the provisions of this
Act on liability and sanctions to legal persons.
TITLE VIII


COMMON, TRANSITIONAL AND FINAL PROVISIONS
Common provisions


§ 93

Jurisdiction imposed by this Act to regional authorities
the exercise of delegated powers.

§ 94

Activities of the members of expert committees established under this Act is another
act in the public interest ^ 18), during which they are entitled to compensation of salary or wages
. Members of expert panels who are not in employment or
similar working relationship, but they are gainfully employed,
be compensated for lost earnings for the period during which participated in the initiative, in their
proven amount but not exceeding the average wage in the national economy
announced and published by the Ministry of Labour and social Affairs
in the Official Gazette for employment ^ 19).
Members of the expert committees are also in replacement of proven travel expenses.
Enabling provisions


§ 95

(1) The Ministry will issue a decree to implement § 52. a) and c) and § 60.

(2) The Ministry shall, in agreement with the Ministry of Education, Youth and Sports
decree to implement § 52. b).

(3) The Ministry shall, in agreement with the Ministry of Labour and Social Affairs
decree to implement § 65.

(4) The Ministry shall, in agreement with the State Office for Nuclear Safety
decree to implement § 71 para. 2 point. b) and § 72 para. 3rd
Transitional provisions


§ 96

(1) If prior to the effective date of this Act, submitted
request for medical intervention, which is regulated by this law,
complete the consideration of this application under the existing legislation.
If it was before the effective date of this Act has already begun to
health performance, which is regulated by this law, the procedure
date of entry into force of this Act under this Act, if it is in favor
patient.

(2) Providers of verifying non-phase method according to existing

Laws are required to request for consent to the verification phase-
methods under this Act submit to the Ministry within 3 months of
entry into force of this Act. Non-phase method, providers can verify
until a decision on the request.

(3) Service may be subject to a procedure pursuant to § 9. 2
ensure the destruction of frozen human embryos created before the effective date
force of this Act, if the deadline has passed for at least 10 years after their creation
.

§ 97

(1) The Ministry shall publish a national radiological standards according to § 70 paragraph
. 5-6 months after the effective date of this Act.

(2) A provider providing health services, which include
medical exposure is required

A) local radiological standards pursuant to § 71 para. 1 point. b) Develop
within 1 year from the date of publication of the national radiological standards

B) perform the first internal clinical audit in accordance with § 74 para. 2-2 years from the date of publication
national radiological standards

C) enter into an agreement pursuant to § 81 paragraph. 1 to carry out an external audit of clinical
at all its workplaces providing medical exposure to
1 year from the date of publication of the list according to § 77 paragraph. 3rd

§ 98

(1) The occupational medicine services can be provided under the existing legal
regulations governing the provision of preventive care
for a maximum period of 1 year from the effective date of this Act. This does not affect
obligation of employers to pay for preventive care within the range specified for occupational
services under this Act, from the date
effective date of this Act.

(2) If before the effective date of this Act has been requested
medical opinion and has not yet been issued, the procedure when
issuance under this Act.

(3) Medical reports issued before the effective date of this Act
be reviewed under existing legislation.

§ 99

(1) The Ministry will publish the first call for applications for issuance
permit for the recognition of occupational disease within 3 months from the date of entry into force of this Act
.

(2) Assessment of occupational diseases, starting before issuing a permit to
recognition of occupational diseases under this Act shall be completed pursuant
existing legislation.

(3) providers of occupational services, which are listed in Annex
to Decree no. 342/1997 Coll., Laying down the procedure for
recognition of occupational diseases and publishes a list of medical devices that
They recognize such diseases, as amended effective on the effective date of this Act
, recognize such diseases to the publication of the list according to § 66 paragraph
. 6. The Ministry of them date of publication of the list communicate
least 30 days before the publication of the list pursuant to § 66 para. 6th

(4) Providers referred to in paragraph 3 completes the recognition of occupational diseases
cases, which started before the date of notification under paragraph 3
Efficiency


§ 100

This Act shall take effect on the first day of the fourth month
following the date of its publication.
Nemcova vr

Klaus vr

Nečas


1) Council Directive 97/43 / Euratom of 30 June 1997 on health protection
individuals against the dangers of ionizing radiation in relation to medical exposure
and repealing Directive 84/466 / Euratom.

Council Directive 89/391 / EEC of 12 June 1989 on the introduction of measures to
improving the safety and health of workers at work.

2) Act no. 296/2008 Coll., On ensuring quality and safety of human
tissues and cells intended for human use and amending related laws
(Act on human tissues and cells), as amended
regulations.

3) Act no. 227/2006 Coll., On research on human embryonic stem cells and related
activities and amending certain related
Acts, as amended.

4) § 179 of the Civil Procedure Code.

5) EN ISO 15189.2007 Medical laboratories - Particular requirements
for quality and competence.

6) Act no. 22/1997 Coll., On technical requirements for products and amending
and supplementing certain acts, as amended.

7) Act no. 277/2009 Coll., On Insurance, as amended
regulations.

8) Act no. 187/2006 Coll., On Sickness Insurance, as amended

Regulations.

9) Act no. 115/2001 Coll., On the promotion of sports, as amended
regulations.

10) Act no. 258/2000 Coll., On protection of public health and amending
some related laws, as amended.

11) Act no. 309/2006 Coll., Stipulating further requirements
occupational safety and health in labor relations and
ensure the safety and health activities or providing service outside labor
relations (Act on securing other conditions
occupational safety and health), as amended.

12) For example Act no. 251/2005 Coll., On labor inspection, as amended
amended, Act no. 258/2000 Coll., As amended
regulations, Law no. 18/1997 Coll., on peaceful use of nuclear energy and
ionizing radiation (atomic Act) and amending and supplementing certain acts
, as amended, Act no. 61/1988 Coll., on mining
, explosives and state mining administration, as amended
regulations.

13) For example Act no. 262/2006 Coll., The Labour Code, as amended
regulations, the Act no. 309/2006 Coll., As amended, Regulation
no. 361/2007 Coll., laying down the conditions
health at work, as amended Government Regulation no. 68/2010 Coll.

14) Act no. 18/1997 Coll., As amended.

15) Act no. 361/2003 Coll., On the service of members of security forces
, as amended.

Decree no. 393/2006 Coll., On fitness, as amended by Decree No.
. 407/2008 Coll.

Act no. 221/1999 Coll., On Professional Soldiers, as amended
regulations.

Act no. 585/2004 Coll., On conscription and its provision (
Conscription Act), as amended.

Decree no. 103/2005 Coll., On fitness for active military service
.

16) Decree no. 290/1995 Coll., Which publishes the list of occupational diseases
, as amended Government Regulation no. 114/2011 Coll.

17) § 2 para. 2 of the Commercial Code.

18) § 200 et seq. Labour Code.

19) Act no. 435/2004 Coll., On employment, as amended
regulations.

20) For example, § 247 of the Labor Code.

21) For example Act no. 49/1997 Coll., On civil aviation and amending and supplementing
Act no. 455/1991 Coll., On business
(Trade Act), as amended,
as amended, Act no. 219/1999 Coll., on the armed forces of the Czech Republic,
amended, Act no. 221/1999 Coll., soldiers
profession, as amended, Act no. 361/2000 Coll., on
road traffic and on amendments to some laws (Act on road traffic
), as amended, Act no. 361/2003 Coll
. on the service of members of security forces, as
amended, Act no. 585/2004 Coll., on conscription and its
assurance (conscription Act), as amended, Regulation No. governments
. 211/2010 Coll., on fields of studies in basic, secondary and higher
vocational education, as amended, Decree no.
101/1995 Coll., issuing the rules for the health and professional competence | || persons in the rail operation and rail transport, as amended
, Decree no. 493/2002 Coll., on the assessment of medical fitness
to issue or validity arms license and the content of first-aid
operator shooting as amended by Decree no. 254/2007 Coll., and
Decree no. 352/2003 Coll., on assessment of medical staff
fire rescue units and enterprises
members of volunteer fire brigades units or enterprises municipalities .