Source: https://www.global-regulation.com/translation/sweden/2988045/patient-safety-law-%25282010%253a659%2529.html
Timestamp: 2019-12-06 01:35:04
Document Index: 552459355

Matched Legal Cases: ['§ 1', '§ 5', '§ 5', '§ 9', '§ 5', '§ 1', '§ 9', '§ 9', '§ 1', '§ 9', '§ 26', '§ 5', '§ 8', '§ 9', '§ 5', '§ 19', '§ 1', '§ 5', '§ 8', '§ 5', '§ 20', '§ 1', '§ 1', '§ 1', '§ 9', '§ 11', '§8']

Machine Translation of "Patient Safety Law (2010:659)" (Sweden)
Patient Safety Law (2010:659)
Original Language Title: Patientsäkerhetslag (2010:659)
The law's purpose and content
section 1 of this Act is intended to promote high patient safety within
health care and thus comparable activities. In the law
– notification of activities (Chapter 2),
– caregiver's obligation to carry out a systematic
patient safety work (Chapter 3),
– jurisdictional issues (Chapter 4),
– restrictions on the right to health
professionals to take certain health and medical care
measures (Chapter 5),
– obligations for health care professionals and others. (6
Cape.)
— Inspection of nursing and caring supervision (Chapter 7),
-probation and revocation of ID, etc. (Chapter 8),
– Health care disciplinary board (Chapter 9), and
– penalties and appeals, etc. (10 chapters).
General provisions concerning objectives and requirements for health
health care and dental care are provided in health care Act
(1982:763), law on patient rights (2014:821) and dental Act
(1985:125). Law (2014:828).
section 2 of the health care provided for in this law, the activities of
covered by the health care Act (1982:763),
Dental Act (1985:125), the Act (2001:499) about
circumcision of boys as well as the activities of retail trade in
remedies under the Act (2009:366) on trade in drugs.
3 § With caregivers referred to in this law, government agency,
County and municipality in terms of healthcare as
authority, the county or municipality is responsible for and
another legal entity or individual entrepreneur as
engaged in health care.
4 §/expires U: 2016-04-15/
With health-care professionals referred to in this law
1. the identification for a profession in the health and
2. employees who are working at hospitals and other
medical facilities and that
involved in the health care of patients,
3. in other cases at the healthcare of patients
assisting a licensed practitioner,
4. pharmacist who manufactures or dispatching medicines
or provide advice and information;
5. staff of the poison control center that provide advice and
6. staff at the emergency centre and medical advice
relays help or leave advice and information to the
Nursing applicants, and
7. as in other cases in accordance with rules given
in connection with this Act provides services in a
profession in health care during a temporary visit
Sweden without having a Swedish identification card for the profession.
For the purposes of the first subparagraph of paragraph 1 and 3 shall be assimilated
a licensed practitioner according to the particular appointment
has equivalent permissions.
The Government may provide to other groups of
professionals in health care to be covered by the law.
4 section/entry into force: 2016-02-15/
1. the identification for a career in health care,
2. staff working in hospitals and other health care facilities participating in the health care of patients,
3. in other cases at the health care of patients, assisting a licensed practitioner,
4. pharmacist who manufactures or dispatching medicines or provide advice and information;
5. staff of the poison control center that provide advice and information, and
6. staff at the emergency centre and medical advice that imparts help or leave advice and information to health care applicants.
For the purposes of the first subparagraph of paragraph 1 and 3 shall be assimilated to a licensed practitioner according to the particular mandate that has equivalent permissions.
The Government may provide for other groups of professionals in health care to be covered by the law. Law (2016:150).
5 § With care injury referred to in this law, suffering, physical or
mental injury or illness, and deaths that could have been
be avoided if adequate measures had been taken at the patient's
contact with the health care system.
With serious health damage "means damage care
1. are permanent and do not call, or
2. has led to patient a substantially increased
the need for care or died.
section 6, With patient safety as referred to in this law protection against health damage.
Chapter 2. Notification of activities etc.
§ 1 the person who intends to conduct the activities covered by
Inspection for health and social care supervision according to this law
notify the supervision authority not later than one month before the
activities commence. Law (2012:957).
2 § If your business entirely or essentially changing
or is moved, it shall be notified to the supervisory authority for the care and
care within one month after the implementation. If your business is added
down, it should promptly be reported to the inspection. Law (2012:957).
section 3 of the Government or the authority, as the Government determines
Announces rules on how the notification requirement pursuant to 1
and 2 sections to be performed.
section 4 of the Inspectorate for health and social care shall maintain an automated
records of the activities notified in accordance with this chapter.
The register may be used for surveillance and research as well as for
production of statistics.
Inspectorate for health and social care shall also keep a
automated register of health establishments and units
referred to in Chapter 7. 7 §. The register may be used for supervision,
research, the production of statistics and for the placement of
Inspectorate for health and long-term care is responsible for
the processing of personal data in the registry.
Government Announces rules on which authority may have
direct access to the data in the inspection for health and
care records. Law (2012:957).
§ 5 the Government Announces rules on
1. limitations of the data registry under paragraph 4,
contain, and
2. screening of entries in the registry in accordance with section 4.
Chapter 3. Healthcare provider's obligation to carry out a systematic
patient safety work
section 1 of the health care provider to plan, direct and control the activities
in a way that leads to the requirement of good health care in health and
Medical Services Act (1982:763) and dental care Act (1985:125)
section 2 of the health care provider shall take the necessary measures to
prevent that patients suffer health damage. For measures
that cannot be taken immediately to a timetable drawn up.
section 3 of the health care provider should examine the events of the business that has
resulted or could result in a medical injury. The purpose of the
the investigation shall be to
1. as far as possible to clarify the sequence of events and the
factors that have influenced it, and
2. provide input for decisions about actions to be conducted
to prevent similar events from happening again, or to
limit the effects of such events if they don't completely go
The corresponding duty of investigation has the operator
activities referred to in Chapter 7. section 7 for events in the business
that has led, or could have
cause such serious harm referred to in paragraph 6.
4 § the caregiver should give patients and their families
the opportunity to participate in patient safety work.
Notification to the Inspectorate for health and social care
§ 5 the caregiver shall to the Inspectorate for health and social care
report events that have resulted or could result in a
serious health damage. The corresponding obligation to have the
carrying out activities referred to in Chapter 7. 2 §. The notification shall
be made as soon as possible after the event has occurred.
The health care provider shall at the same time with notification, or as soon as possible thereafter
to the Inspectorate for health and social care submit the investigation of
the event provided for in paragraph 3 of the first paragraph. Law (2012:957).
section 6 If anyone has suffered or been exposed to risk
of other serious injury than health damage as a result of
security flaws in the operation of a medical facility
or device referred to in Chapter 7. section 7, to the health care provider or
the unit as soon as possible after the event has occurred, notify
this to the Inspectorate for health and social care.
The health care provider or entity shall simultaneously with the notification or
as soon as possible thereafter to the Inspectorate for health and social care submit
the investigation of the incident, as provided for in paragraph 3 of the second paragraph.
Law (2012:957).
paragraph 7 of a health care provider shall promptly notify the Inspectorate for health care
and care if there are reasonable grounds to believe that a
person who has proof of identification for a profession in the health and
health care and who is active or has been active in
caregiver, may pose a risk to patient safety.
Obligation to inform patients about the occurred damage care
section 8 of the health care provider shall promptly inform a patient who has
suffered an injury care
1. that there occurred an event which has brought a health damage,
2. what actions the caregiver intends to take to a
similar incident should not happen again,
3. the ability to report the complaint to the Inspectorate for health care
pursuant to Chapter 7. section 10,
4. the possibility to claim compensation under the patient injury Act
(1996:799) or from drug insurance, and
5. patient RAC activity.
The information to be provided to a related to the patient, if
the patient requests it or cannot take advantage of
The information provided shall be recorded in
the patient record. Law (2012:957).
§ 9 the health care provider must document how the organisational
responsibility for patient safety are distributed within
section 10 of the health care provider shall not later than 1 March of each year, establish a
patient safety report which should include
1. how patient safety has been carried out during the previous
2. the measures taken to increase the
patient safety, and
3. what results have been achieved.
Patient safety report shall be made available to the
wish to take part in
section 11 of the Government or the authority, as the Government determines
may provide for the elements to be included in the
caregiver systematic patient safety work.
section 12 of the Government or the authority, as the Government determines
Announces rules on
1. how the notification requirement pursuant to §§ 5-7 is to be performed, and
2. the information to be included in a
patient safety report according to section 10.
Chapter 4. Jurisdictional issues
section 1 of The program as described in the following
table has completed a university degree or have gone through
training and, where appropriate, fulfilled practical
service shall, on application, receive proof of identification for the profession.
Proof of identity shall be granted if the conditions are such that
papers should have been revoked in accordance with the provisions of
Chapter 8. If the applicant had been licensed.
A licensed psychotherapist, in connection with their
occupation state their basic education.
The Government or the authority, as the Government determines, in
the cases listed in the table, provide for the
training and practical service required to get
Profession/Job Title Education Practical
1. apothecary pharmacy
2. occupational therapist occupational therapy
3. audiology student
4. midwife midwives exam
5. biomedical
Analyst biomedical
analytikerexamen
6. nutritionist dietitian exam
7. fysioterapeutexamen physiotherapist
8. chiropractor in accordance with regulations pursuant to the provisions
9. speech therapy speech therapy degree
10. doctor degree in medicine as prescribed
11. chiropractor in accordance with regulations pursuant to the provisions
12. the optometrist optometry degree
13. the orthopaedic engineer orthopaedic engineering degree
14. psychologist psychology according to regulations
15. psykoterapeut psychotherapist degree
16. prescriptionist receptarieexamen
17. x-ray nurse Radiology nursing
18. medical physicists Medical Physics degree
19. nurse nursing degree
20. dental hygienist tandhygienistexamen
21. dentist DDS
The Government may provide for that other
training than those specified in the table shall give the right to
identification. Team (2013:1149).
section 2 of The otherwise than through such training or
practical service referred to in paragraph 1 has acquired
equivalent competence, may, on application, be granted
identification of the profession.
section 3 of the designation certified may be used only by the
a identification according to § 1 or 2.
The exclusive right to the profession
section 4 authorized to exercise the profession as a pharmacist, midwife, physician,
prescriptionist and dentists are only those who have proper identification
for the profession or as specifically designated to exercise it.
Protected professional title
5 § the specified job title may be used only by the
have identification for the profession or undergo the prescribed practical
' service.
section 6 of the professional activities of the health care area, the
as paragraph 5 of lacking permissions to use a protected
job title does not use a title like
can be confused with such a title.
7 repealed by law (2012:310).
section 8/expires U: 2016-04-15/
A licensed physician or dentist who has gone through the
specific training shall qualify, on application for a certificate of
specialist expertise.
A doctor or dentist may indicate that he or she has
specialist expertise in the specialty of their profession only if
He or she has such expertise.
section 8/shall enter into force in: 2016-02-15/
A licensed physician or dentist who has gone through specific training shall qualify, on application for a certificate of expertise.
Unless otherwise specifically provided, any doctor or dentist specifying that he or she has specialist expertise in the specialty of their profession only if he or she has a certificate of competence as referred to in the first subparagraph.
Law (2016:150).
§ 9/expires U: 2016-04-15/
A nurse may use a title that is matched by a
specialist nursing degree only if he or she has
having passed such an examination.
§ 9/comes into force in: 2016-02-15/
Unless otherwise specifically provided, a nurse use a title that is matched by a specialist nursing degree only if he or she has passed such an examination. Law (2016:150).
section 10 of the National Board of review applications for identification,
special appointment to exercise the profession and evidence about the
specialist expertise. Law (2012:310).
may provide for identification and other privileges
section 12 of the Government may provide for fees for the
examination of the application for identity card and other privileges.
Chapter 5. Restrictions on the right to health
§ 1 Other than health-care professionals may not
professional look into someone else's health or
treat any other disease or
similar condition by taking or prescribe any of
the following actions in preventive, curative or palliative
1. treat such communicable diseases as referred to in
Act (2004:168) are notifiable diseases,
2. treatment of cancer and other malignant growths, diabetes,
epilepsy or pathological conditions associated with pregnancy
or childbirth,
3. examine or treat someone else under general anesthesia
or under local anesthesia by injection of an anesthetic
or under hypnosis,
4. treat any other radiological practices,
5. without personal examination of the searched him or
her, provide written advice or instructions for treatment,
6. examine or treat children under eight years of age, or
7. try out contact lenses.
Chapter 6. Obligations of health professionals and others.
section 1 of the health workers to perform their work in
conformity with science and proven experience. A
the patient should be given special and careful
health care that meets these requirements. Care, so
far as possible be designed and implemented in consultation with
the patient. The patient should be shown compassion and
section 2 of The belonging to health workers wearing the self
the responsibility for how he or she fulfils its tasks.
The first paragraph does not imply any restriction on the caregiver
responsibilities under this law.
section 3 of The belonging to health practitioners may
delegate a task to someone else, only when it is
consistent with the requirement of a good and safe care.
The delegate a task to someone else, responsible
for that he has the potential to fulfil the task.
4 § health practitioners are obliged to contribute to the
to high patient safety is maintained. The staff in this
a view to healthcare provider report risks to nursing damage and
events that have resulted in or had
been able to bring a medical injury.
Health workers have corresponding
reporting obligations even when
for other damages than health damage as a result of
security flaws in the operation of such
medical facility or device referred to in Chapter 7. 7 §.
paragraph 5 of the health workers, on matters relating to children
who suffer or are at risk of danger, bad interface with
community agencies, organizations and others who
concerned. In the case of disclosure of information concerning the
limits resulting from
12-14 sections and of public access to information and secrecy (2009:400).
Healthcare professionals should take particular account of a child's
needs for information, advice and support if the child's parent or
any other adult baby
permanently lives with
1. have a mental disorder or a mental
2. have a serious physical illness or injury, or
3. is addicted to alcohol or other addictive
The same applies if the child's parent or another adult
as the child permanently lives with unexpectedly dies.
Provisions on the obligation to notify the social welfare board to
a child may need protection board, see Chapter 14. 1 §
the Social Service Act (2001:453).
section 6, It is responsible for the health care of a
patient is to ensure that patients and their relatives are given
information referred to in Chapter 3. patient law (2014:821).
Law (2014:828).
section 7 of The responsible for the health care of a
patient is to help ensure that the patient is given the opportunity to
Select treatment options and assistive technology
persons with disabilities as set out in 7
Cape. 1 and 2 of the law on patient rights (2014:821).
It is responsible for the health care of a patient
to help ensure that the patient receives a new medical assessment
as indicated in Chapter 8. paragraph 1 of the law on patient rights.
This clause does not cover dental services under the dental Act
section 8 if a patient has died, the belonging to health
medical staff carry out their duties with respect for the
the deceased. Related to show respect and consideration.
§ 9 A doctor or dentist who is active in the
publicly run health care is required, in
other obligations of professional misconduct to the extent not
prevent this or that otherwise does not exist special reasons against
it, carry out surveys and issue statements of these on
the request of the County Administrative Board, the courts, public prosecutor's Office,
The police authority or the chief guardian.
A doctor who works in the publicly run health
and health care is at the request of the police officer is obliged to, in the
the extent of the other obligations in professional practice does not hinder
This or that otherwise does not exist special reasons against it,
carry out an investigation that involves body inspection of any
who is suspected of a crime can give prison sentences.
The limitation of the obligation to carry out investigations and provide
advice does not apply to doctors who are active
mainly in open care and, in the case of
survey and opinion on the influence of alcohol, nor
for any other doctor.
In Act (2005:225) of rättsintyg in respect of offences is
the special provisions governing statements in some cases.
Law (2014:888).
10 § whoever in his professional activity in health care
issues a certificate
If someone's health or health care, to design it with
accuracy and care.
Duty of health professionals as
dispatching medicines
section 11 If a licensed professionals prescribing of narcotic
medicines, other specific drugs, alcoholic drug
or denaturation could reasonably be expected to conflict with
Science and proven experience, to the health and
medical staff who dispenses drugs notify
Inspectorate for health and social care.
The Government or the authority that the Government may
provide for what is meant by specific drugs.
Professional secrecy, etc.
section 12 of The who belong or have belonged to the health and
medical staff in the individual health care
must not improperly disclose what he or she is in their
activities have been told about an individual's health or
other personal circumstances. That disclosure is considered
not that anyone performing such obligation arising from
Professional secrecy as applies to a record of a patient's
health condition also applies in relation to the patient himself,
If, having regard to the purpose of the health care system is
of extreme importance that the task cannot be left to the
For the general business terms and
secrecy (2009:400).
paragraph 13 of The who belong or have belonged to the health and
must not improperly disclose information from a
individual about another person's health or other
personal circumstances, if it can be assumed that there is a
risk to anyone who has left the task or any
related to the informant exposed to violence or
other serious but if divulged. That disclosure
is not considered to be any obligation to comply with such that
provided by law or regulation.
section 14 of The who belong or have belonged to the health and
must not improperly disclose or use such
information about a particular product's manufacture or content, as
He or she has become aware of operations which have
left there to be used as a statement or documentation
for treatment or other similar action. As
unauthorised disclosure are considered not to have someone fulfill such
obligation imposed by law or regulation.
section 15 except as otherwise provided by law or a regulation is
health workers required to disclose such
1. apply whether or not someone staying in a hospital facility if the
the data in a particular case is requested by a court,
Public Prosecutor's Office, the police, the security police,
Enforcement authority or Skatteverket,
2. the activities of the person in need of protection of the
Members, the head of State and other members of the Royal House,
Cabinet Minister, Parliamentary Secretary and the Cabinet Secretary, on
the data in a particular case is requested by the security police,
3. need for a forensic investigation,
4. The Board's advice for certain legal, social and
medical questions need for their activities,
5. necessary for the examination of a case for separating a
students from tertiary education or police program,
6. necessary for the examination of a person's suitability to have driving licences,
tractor cards or taxi identification according to
taxi traffic law (2012:211). Law (2014:768).
section 16 of The who, without hearing health
the medical team, due to employment or assignment
or on any other similar basis participates or has participated in
individual's health may not improperly disclose
what he or she learned in that regard for a particular
health or other personal
conditions. That disclosure is not considered that any
to fulfil the obligation imposed by law or regulation.
section 17 of the Government or the authority, as the Government determines
may provide for obligations for health and
medical staff needed to
level of protection of human life, personal safety or health.
Chapter 7. Inspectorate for health care oversight
section 1 of the health care system and its staff is under the supervision
of the Inspectorate for health and social care.
For supervision of health services and medical care in the armed forces are
the special provisions. Law (2012:957).
section 2 of The program, but to carry out health care, receive
missions from health services relating to sampling, analysis
or other investigation which forms part of the assessment of a
patient's health condition or treatment, is in this
activities are also under the supervision of the Inspectorate for health and
care. Law (2012:957).
section 3 Supervision according to this law means the examination of the
activities and the staff referred to in paragraphs 1 and 2 meet
requirements and objectives in accordance with the laws and other regulations and decisions
given by virtue of such regulations.
Supervision should focus on the review of the health care provider
comply with their
obligations under Chapter 3.
Notice under sections 20 and 24 and ban pursuant to §§ 26-28
may only be used
When the business does not meet the requirements of the laws,
section 4 of the Inspectorate for health and social care, within the framework of their
1. advise and give guidance,
2. check that the shortcomings and irregularities are remedied,
3. share knowledge and experience gained through
4. inform and advise the public.
§ 5 in the supervision with regard to children's conditions, the child shall be consulted on
It can be assumed that the child does not damage the call. The child
may be heard without the guardian's consent and without
guardian is present.
section 6 of the Inspectorate for health and social care will be systematically
protect patient information boards leaving under
Act (1998:1656) on patientnämndsverksamhet etc.
section 7 of the health and social care Inspectorate supervises
safety in health care facilities where it may be care
under the Act (1991:1128) on involuntary psychiatric or law
(1991:1129) on forensic psychiatric care, as well as at
provide for security customization and
security classification of health care facilities and devices
referred to in the first subparagraph. Law (2012:957).
Reports from health care providers
§ 8 Inspection for health and long-term care to ensure that
events that have been notified to the authority in accordance with Chapter 3. paragraph 5 of the
have been investigated as necessary, as well as to the health care provider has
taken the necessary measures in order to achieve high
The first subparagraph shall apply mutatis mutandis notifications
According to Chapter 3. section 6. Law (2012:957).
§ 9 Inspectorate for health and social care shall disseminate information
to health care providers and relevant authorities about past events
notified to the authority in accordance with Chapter 3. § 5 as well as in
otherwise take the measures notification warrants in order to achieve
high patient safety.
section 10 of the Inspectorate for health and social care, after notification test
complaints against health service and its staff.
section 11 of the Inspectorate for health and social care to do the investigation
necessary to examine the complaint. The authority may
investigate and examine the circumstances that was not raised in the
notification. Law (2012:957).
section 12 of the Inspectorate for health care may refrain from investigating
a complaint about
1. it is clear that the complaint is unfounded, or
2. the complaint has no direct relevance to patient safety and
There is no reason to consider prosecution notification under section 23 or 29.
Inspectorate for health and social care should not investigate events
is more than two years in the past, unless there are
special reasons. Law (2012:957).
section 13, If a complaint relating to defects in the contact between a
the patient and the healthcare provider or any other
similar ratio within activity referred to in paragraph 1 of the law
(1998:1656) on patientnämndsverksamhet etc., the Inspection
for health and social care shall submit the complaint to the relevant
patient Committee for action. It does, however, apply only if
the conditions in section 12 in order not to investigate the complaint is
met. Law (2012:957).
section 14 of the complaint should be notified in writing. In the notification should be provided
1. the health care providers or health professionals as
the complaint is addressed
2. in the event that the complaint relates,
3. the time of the event, as well as
4. name and address of the notifier.
section 15 of the health and social care Inspectorate shall promptly submit
notification and, where appropriate, the documents annexed to
notification to the health care provider or health care professionals
that complaint is directed against or may be considered to be directed against.
The first subparagraph shall not apply if the Inspectorate for health and social care
determines the matter pursuant to section 12. Law (2012:957).
section 16 of the complaint relates, the patient and, if the patient does not
self has been able to report the matter, one related to him or
her, has the right to take part in the case and added
shall, before the case is decided, given the opportunity to take part of and
leave comments on the added matter.
If the complaint relates to healthcare professionals should concern
caregivers can be heard in the matter, unless it is clear
The notification obligation does not apply if the Inspectorate for health care
and care will determine the matter on the basis of section 12.
The right to access information and notification
comes with the limits imposed by 10. paragraph 3 of the
public access to information and secrecy (2009:400). Law (2012:957).
section 17 of the health and social care Inspectorate shall, when it transmits
documents for comment, specify the period within which the opinion shall
come in to the Agency.
It provided the opportunity to be heard shall be informed that the case
may be settled even if no opinion comes in within
the prescribed time limit.
The procedure of Inspection for health and social care are written.
If it seems appropriate from the point of view of investigation,
authority to obtain information orally in a case. Data
obtained orally, and which is of importance for the investigation
shall be documented. Law (2012:957).
section 18 of the health and social care Inspectorate shall decide cases on
complaints under this law by decision.
Inspectorate for health care and social services, in such a decision rule
as to whether an action or omission by health care providers
or health care workers is contrary to the law or other
Regulation or is inappropriate with respect to patient safety.
Such a decision must not be taken without the notifier and the
as the complaint concerns have been given the opportunity to submit observations on
a proposal for a decision on the matter.
Inspection for health and social care decision must be in writing
and contain the grounds on which it is based.
The decision shall be sent to the notifier, the complaint alleges
and interested health care providers. Law (2012:957).
§ 19 Of the Inspectorate for health and long-term care, on their own initiative
initiates an investigation against a health care provider or to the health and
professionals should be concerned by the investigation
the opportunity to submit its observations. The inspection, however,
not hear a patient affected by investigation if it is not
Before a case is decided, the health care provider or health
a healthcare professional who is the subject of an investigation shall be given an opportunity
to be heard, unless it is clearly unnecessary. Otherwise
the second paragraph to section 12, paragraph 17, and, where applicable, section 18
apply. Law (2012:957).
Common provisions on Inspection for health and social care
section 20 of The operating as regulated under
This chapter and health practitioners are obliged to
the Inspectorate for health and social care request leave
documents, samples and other material relating to the activities and
provide the information on the activities that the inspection needs
for their supervision.
Inspectorate for health care may submit to the operator
the business or health care personnel to leave what
is requested. A decision on the injunction may be subject to a penalty.
paragraph 21 of the Inspectorate for health and long-term care, or the like
inspection orders, have the right to inspect the activities of
regulated under this chapter and health
health professionals ' professional activities. The person who performs the inspection
has the right to have access to premises or other facilities
used for the business, but not homes. The performing
the inspection has the right to temporarily dispose of documents;
samples and other material related to the business. The whose
business or professional activities are inspected is obliged to provide
the assistance needed during the inspection. Law (2012:957).
section 22 At such inspection as referred to in section 21, the performing
the inspection has the right to get the help of the police authority
needed for the inspection to be carried out.
Such assistance may be requested only if
1. the particular circumstances give reason to suspect that
the operation cannot be carried out without a police man's special
powers under section 10 of the law on police (1984:387)
2. There are serious reasons.
Law (2014:768).
Actions against health care providers and others.
section 23 Of the Inspectorate for health care becomes aware that
someone has violated a rule which applies to activities that
under supervision, the authority shall take
measures so that the provision is complied with and, if necessary, make
registration for the prosecution. The same applies if someone who does not belong to
health workers have violated any of the
the provisions of Chapter 5. 1 section 1-7. Law (2012:957).
section 24 of the health and social care If the inspection finds that a
health care providers, or device referred to in section 7, does not comply with its
obligations under Chapter 3. and if there is reason to fear that the
failure causes danger to patient safety or
the safety of others, shall submit to the care provider inspection
or the unit to meet its obligations if it is not
clearly unnecessary. A decision on the injunction may be subject
with a penalty. This also applies to the activities referred to in paragraph 2 of
the operation entails danger to patient safety.
section 25 of an injunction under section 24 shall include information on
1. the measures taken by the Inspectorate for health and long-term care believe
necessary for the alleged abuses to
be eliminated, and
2. when the measures at the latest should be performed.
section 26 If a notice under section 24 is not complied with and if the
the abuses are a danger to patient safety or
otherwise is of serious nature, the Inspectorate for health and
care facilities decide to fully or partially prohibit the activity.
section 27 if there is significant danger to patients ' lives, health or
personal security in General, the Inspectorate for health and
care without prior summons may decide to fully or
partially prohibit the activity. Law (2012:957).
section 28 If there is probable cause to business brand
or in part will be prohibited under section 26 or 27 and a
such a decision cannot wait, the Inspectorate for health and
care facilities decide to provisionally prohibit in whole or in part
Such a decision is valid for a maximum of six months. If there is
exceptional circumstances may the period of validity may be extended once
with a further six months. Law (2012:957).
Measures for health professionals
section 29 Of the Inspectorate for health care becomes aware that
health professionals do not fulfil their obligations
According to this law or any other regulation applicable to
health and nursing activities, the Inspectorate take action
to the obligations to be performed.
If health professionals are reasonably suspected of being in
professional practice of having committed an offence for which imprisonment is
prescribed, the Inspectorate for health and social care, if not
subject to the provisions of Chapter 9. section 17, notify the prosecution.
In Chapter 8. the second subparagraph of paragraph 3 of the Act (2006:351) on genetic
integrity etc. are special provisions relating to General
the prosecution of certain offences may be brought only after consent from
The National Board of health and welfare. Law (2012:957).
Action against a licensed health care professional
section 30 Of the Inspectorate for health and long-term care believe there is
reasons for decision on probation, revocation of ID,
withdrawal of other rights to exercise the profession in health
health care or limit prescribing rights under
8. the inspection shall notify the health and
health care's disciplinary board. Law (2012:957).
Chapter 8. Probation and revocation of ID, etc.
§ 1 a trial period of three years shall be decided for the
ID is required to exercise the profession in health care, if the
1. have been inept in the exercise of his profession and
the incompetence likely to be significant for patient safety,
2. in the course of or in connection with the profession has committed
to the offences which are liable to affect the trust in him
3. intentionally or negligently infringed any
Regulation that is essential to the
patient safety, or
4. due to other circumstances give reason to suspect may be inappropriate
to exercise the profession.
Probationary period shall also be decided if it can be expected that a
certified professionals due to illness or any
similar circumstances will not be able to exercise
their profession satisfactorily.
If there are special reasons, decisions on probation be omitted.
paragraph 2 of the decision on probation, it should lay down a plan that the
legitimized should follow if such a trial period plan is expected to be
be important to remedy the ills
that has been the basis for the decision on probation. Proposal for a
trial period plan drawn up by the Inspectorate for health and social care, if
possible in consultation with the registered.
provide for what actions or conditions that may
be included in such a plan. Law (2012:957).
Withdrawal of identity card
paragraph 3 of the identification card to exercise a profession in health care
shall be withdrawn if it legitimized
1. have been grossly inept in the exercise of their profession,
2. in or outside of the profession has been guilty of
a serious offence which is liable to affect the confidence in the
him or her, or
3. otherwise has proved manifestly inappropriate to exercise
If there are special reasons in the cases referred to in the first subparagraph
2 get the recall be omitted.
4 § Papers shall also be revoked if the registered
1. due to illness or any similar circumstance does not
can exercise the profession
2. given probationary period according to article 1, first paragraph, under
the probation period on new
proven unfit to practise,
3. given probation with a trial period plan and failed
to follow the plan, or
4. Requests that the papers should be withdrawn and there are no
barriers against withdrawal from the public point of view.
2 or 3, the withdrawal be omitted. If the recall
during the song's get probation decided
§ 5/expire U:2016-04-15 by law (2016:150)./
Papers should be revoked if a person, who got his
identification in Sweden on the basis of authorisation in another
State of the European economic area (EEA) or in
Switzerland, have lost their authorisation.
section 6, If there is probable cause for withdrawal of a case
under section 3(1) or paragraph 4(1) 2 or 3,
should papers be withdrawn until
until the issue of withdrawal have been tried. This
applies, however, only if it is necessary to ensure
patient safety or it is otherwise necessary
from a general point of view.
A decision as referred to in the first subparagraph applies for a maximum of six months.
If there are special reasons, the period of validity of the decision
may be extended once by no more than six months.
section 7 If there is reasonable cause to believe that the authentication
shall be withdrawn in accordance with paragraph 4(1) 1, the
registered practitioner to allow itself to be investigated
of the physician health disciplinary board
If a medical examination has been decided to
the authentication is revoked until the question of
the recall has been tried. This
patient safety or it is otherwise necessary from public
It has legitimized the practitioner has not followed an injunction
If a medical examination within one year from the time he or she
got part of the injunction, the papers recalled.
Withdrawal of other privileges
§ 8 other privileges to practise a profession in the health and
the health care system than
identification card issued pursuant to Chapter 4, should be withdrawn if the
1. have been inept in the exercise of their profession,
offences liable to affect confidence in his or
her, or
3. otherwise have proved unsuitable to exercise the profession.
The withdrawal should also be done if the permission is not
satisfactory due to illness or any similar
section 9 If there is reasonable cause to believe that permission
to be revoked under section 8, the permission is revoked until
Limitation of prescribing the right
section 10 If a doctor or dentist has abused its
authority to prescribe narcotic drugs, other
specific drugs, alcoholic product or technical
spirits, this permission is withdrawn or restricted.
Jurisdiction shall also be suspended or restricted if the doctor
or dentist direct. Law (2014:828).
section 11 If there is probable cause for suspecting such a
abuse of prescription rights referred to in section 10 shall
permission is withdrawn or limited front
until the issue of the withdrawal or restriction of
permission has been tried. However, this applies only if the
It is necessary to ensure patient safety or otherwise
is necessary from the point of view of the public.
If there are special reasons, the validity may be extended
once by no more than six months.
New ID, etc.
section 12 Has an identity card withdrawn or a permission
to prescribe narcotic drugs, other special
medicines, alcoholic product or technological liquor
been suspended or limited, a new ID
each jurisdiction will be notified after application if the requirements of
Chapter 4. are met. Law (2011:1190).
13 § health care disciplinary board hearing matters under
Chapter 9. Health care disciplinary board
Composition and quorum, etc.
section 1 On notification of the Inspectorate for health care hearing
Health care disciplinary board issues referred to in Chapter 8.
1-11 sections.
At the request of the professionals concerned, try
Disciplinary Board issues referred to in Chapter 8. section 1, paragraph 4 of the first
paragraph 4 and paragraphs 10 and 12.
Provisions on the right of the parliamentary ombudsmen and of
The Attorney General to make notification in cases referred to in the first
the paragraph is in the third paragraph of section 6 of the Act (1986:765)
instruction for the parliamentary ombudsmen and in section 6, first paragraph
Act (1975:1339) if the Attorney General's oversight.
Article 2 of the Disciplinary Board consists of a Chairman and eight other
members. They are appointed by the Government for three years. The Chairperson shall
have been regular judges. Other
Members shall have special insight into health care.
The Chairman shall be appointed for the same time one or more
Deputy. Such a representative should be or have
been ordinary judges. For each other
Member, there shall be a sufficient number of Deputies
shall be appointed for the same time as the Member.
section 3 Disciplinary Board is quorate with the President and at least six
other members. To the meeting of the Board shall each
Members are called. If a Member
report impediments, a replacement is called.
The President may alone decide
1. which do not include the final judgement on the merits, however, does not
decision on the injunction to undergo a medical examination in accordance with 8
Cape. paragraph 7 of the first paragraph, or if the temporary withdrawal of
ID or permission in accordance with Chapter 8.
section 6, second paragraph, section 7, section 9 or section 11,
2. If the withdrawal of its request ID or
jurisdiction in cases when there is no obstacle to the withdrawal,
3. If the withdrawal of identification in accordance with Chapter 8. paragraph 7 of the third
the paragraph when it legitimized not followed procedure if
Cases that have been decided in accordance with the first subparagraph shall be notified by the
1. which do not include the final judgement on the merits, but not decision on injunction to undergo a medical examination in accordance with Chapter 8. paragraph 7 of the first paragraph, or if the temporary withdrawal of identification or eligibility in accordance with Chapter 8. section 6, second paragraph, section 7, section 9 or section 11,
2. If the withdrawal of identification at his own request or permission in cases when there is no obstacle to the withdrawal,
3. If the withdrawal of identification in accordance with Chapter 8. the third subparagraph of paragraph 7 as it legitimized not followed procedure for medical examination, or
4. If a notification under section 18.
Cases that have been decided under the first subparagraph shall be reported at the next meeting of the Board. Law (2016:150).
§ 5 in the case of conflict of interest against dealing with matters in
Disciplinary Board, the provisions of Chapter 4. the code of judicial procedure if
conflict of interest against judges shall apply.
6 § in the case of voting in Board of accountability, the provisions
in chapter 29. the code of judicial procedure concerning the vote in court with only
Members-in-training is applied. The President says his opinion
The proceedings of the disciplinary board
section 7 of the notification to the disciplinary board shall be made in writing and
1. who in question and details of his occupation, address and
2. What is demanded in the case, and
3. the circumstances relied upon in support of the notification.
The notifier shall also submit the investigation undertaken in
If a party is represented by an agent, power of attorney be submitted.
section 8 application to the disciplinary board shall be made in writing and
be personally
signed and include information on
1. applicant's name, social security number and mailing address,
3. the circumstances invoked in support of the application.
section 9 Is a notification or application so incomplete that it does not
can be used as a basis for a substance, the
Disciplinary Board shall submit to the notifier, or
applicant within a certain period of time to submit additional
tasks. In order to demonstrate that the matter otherwise
not be admissible.
section 10 of the procedure is written. Hearing may, however,
occur, when it is likely to be beneficial to the investigation.
section 11 Notification and, where appropriate, supporting documents should
as soon as handed over to the one in question. The receiver should
be required to respond within a certain period of time.
Surrender and injunctive relief pursuant to the first subparagraph needed
not if it is clear that the notification cannot be accepted or
that notice is unnecessary.
section 12 of The submitted that answer should do so in writing,
If not Disciplinary Board decide that the answer may be provided at a
The response should indicate if the respondent accepts or
oppose what the notifier calls on the matter. If the defendant
oppose the claim, he or she
give reasons for their position and the circumstances
relied upon and, if appropriate, submit the documents
be invoked in the case.
section 13, If a matter requires specific expertise,
Disciplinary Board obtain the opinion
from the authorities and others with such specific expertise.
As regards the special case of 40 Cape. 2-7 and 12 §§
the code of judicial procedure, mutatis mutandis.
Those who are obliged to leave the opinion has the right to compensation
for its statement only if it is legally required.
Other experts entitled to a refund of public funds
for its mission. The Board may grant advances on such
section 14 if the Disciplinary Board finds that a witness or
special needs be heard under oath or a party be heard during
affidavit or that someone needs
be required to provide a written document or a
items as evidence, the Board may request this in the District Court
in whose territory the person allowed to be consulted or at
otherwise concerned by the measure.
If there are no obstacles to the right to prepare to hold hearings
or notify the injunction. In the case of such measures should in
apply the provisions of evidence
in the trial, but a hearing.
section 15 To an oral hearing, the Parties shall be called. A
individual participant may be required to appear in person. In
the notice shall state that it does not obstruct the
further prosecution if he or she fails to materialize.
A single party, which has set itself to the oral
negotiation, of the disciplinary board are granted fair compensation
of public funds for travel and subsistence expenses.
The Board may grant an advance on the compensation.
The Government announces the details of compensation and
section 16 of the provisions of §§ 20 and 21 of the administrative procedure act
(1986:223) shall also apply to decisions taken under Chapter 8. 6 §
first subparagraph, first and second subparagraphs of paragraph 7,
section 9 and paragraph 11.
Registration for the prosecution
section 17 of the disciplinary board Finds in a case that there is
conditions for registration for prosecution under Chapter 7. section 29 other
subparagraph, the Board to make such notification, if not
Inspectorate for health care already has reported the matter to the
prosecution. Law (2012:957).
/Rubriken entry into force: 2016-02-15/
the entry into force of section 18/in: 2016-02-15/
If the disciplinary board or a general administrative court, in accordance with Chapter 8. decides on withdrawal of legitimation, probation or suspension or limitation of the right prescriptions, the disciplinary board may decide to inform the competent authorities of other States within the European economic area (EEA) and Switzerland on the decision or judgment. Authorities shall be notified not later than three days after the date of the decision or judgment. If this decision or that judgment later expires, the disciplinary board shall, without delay, inform the competent authorities of other States in the EEA and Switzerland.
Notifications as referred to in the first subparagraph shall be done via the internal market information system (IMI).
10 Cape. Penalties and appeals, etc.
§ 1 the person willfully or negligently starting, moving
or significantly modify an activity falling within the scope of supervision
According to this law without having made prior to written notification pursuant to
Chapter 2. 1 or 2 § is sentenced to a fine. Team (2013:276).
section 2 of The who, either intentionally or negligently, continues to
conducting an activity in contravention of a prohibition under Chapter 7. 26, 27
or section 28 shall be liable to a fine or imprisonment of up to six months.
section 3 of A doctor whose identification card has been revoked or whose
permission otherwise has ceased or been reduced and that
improperly exercising the medical profession and for consideration, is sentenced to
fines or imprisonment of up to six months.
4 § the unauthorized and against compensation exercises the profession of dental practitioner
shall be liable to a fine or imprisonment of up to six months.
As the unauthorized practice of dentistry is not considered to be the
professional activity exercised by the ID
dental hygienist or who have the required skills
dental hygienist or dental assistant.
5 § the contravenes any of the provisions of Chapter 4. 3, 5
or section 6, shall be liable to a fine.
section 6 to a fine or imprisonment not exceeding one year are judged on that
1. violates any of the provisions of Chapter 5. 1 § 1-7;
2. in the exercise of activities as stated in Chapter 5. 1 §
intentionally or negligently:
a) adds the examined or treated an injury that does not
is calling, or
b) develops danger to such harm.
First paragraph 2 applies regardless of whether the injury or danger is caused
by inappropriate treatment or by interruption of or delay
with medical care.
The fact that the perpetrator because of lack of
education and experience were not able to understand the nature
or predict the damage or danger releases him or her no
If the Act is subject to a punishment pursuant to section 3 or 4 shall in
rather than incur liability under these provisions.
section 7 liability under any of the provisions of paragraphs 3 to 6 shall
not be sentenced, if the Act is punishable by stricter penalties in
Imposition of fines, etc.
section 8 has anyone guilty of crimes referred to in paragraph 6, the
Inspectorate for health care and social services decide on the ban for him
or her to during the certain period of time or forever wield
activities referred to in Chapter 5. § 1. Such a decision may
combined with a penalty.
The breach of such an injunction may not be sentenced to
criminal penalty for acts covered by the ban.
The appeal of the Committee's responsibilities in health care decisions
§ 9 liability of healthcare Board decision under this
law may be appealed to the administrative court.
paragraph 10 of the Decision of the disciplinary board, which does not mean that a case
determined, may be appealed only in connection with the appeal by the
final decision on the matter.
A decision is not final, however, may be appealed against, in particular,
When the Board
1. dismissed an objection of conflict of interest against a member of the Board
or an objection that there are obstacles to examination,
2. rejected an agent or an attorney,
3. ordered the matter pending the completion of the case is decided,
4. submitted someone to undergo a medical examination in accordance with Chapter 8.
paragraph 7 of the first paragraph, or
5. ordered compensation to anyone involved in the case.
§ 11 Liability the Board's final decision may only be appealed by
1. the inspection for health and social care in order to protect the public
2. the professionals that the decision is aimed at.
The Attorney General to appeal the decision on probation or in
permission question, see paragraph 7 of the Act (1986:765) with instruction
for the parliamentary ombudsmen and in section 7 of the Act (1975:1339) om
Attorney General's supervision. Law (2012:957).
12 §/expires U: 2016-04-15/
Decisions on matters referred to in Chapter 8. effective immediately, if the
unless otherwise specified in the decision.
the entry into force of section 12/in: 2016-02-15/
Decisions on matters referred to in Chapter 8. and Chapter 9. section 18 applies immediately, unless otherwise specified in the decision.
The appeal of the Inspectorate for health and social care and Social
decision, etc.
paragraph 13 of the Inspectorate for health care decisions may be appealed
to the General Administrative Court, if the decision concerns
1. notice under Chapter 7. section 20, second paragraph to leave
information, documents or other materials,
2. notice under Chapter 7. section 24 to take corrective action,
3. the prohibition referred to in Chapter 7. 26, 27 or 28 § to carry on business,
4. the prohibition to exercise the activities referred to in paragraph 8.
Other decisions by the Inspectorate for health and social care under this
law may not be appealed.
13 a of the Board's decision on the identity card or other
jurisdiction under Chapter 4. may be appealed to the General
Other decisions of the Board under this Act shall not
paragraph 14 of the decision taken by the Inspectorate for health and social care and
Social Board under this Act shall be effective immediately, if the
unless otherwise specified in the decision. Law (2012:957).
Handling of general administrative courts, etc.
section 15 of the Inspectorate for health and social care is a counterpart to the
professionals who appealed the Board's responsibility or court
final decisions in accordance with Chapter 8. 1-12 sections. However, this does
be subject to the second subparagraph of paragraph 7 the law
(1975:1339) if the Attorney General's oversight or section 7 other
law (1986:765) with instruction for the Swedish Parliament
Ombudsmen. Law (2014:62).
section 16 Is the enforcement of a decision on probationary period abrogated
or suppressed as a result of the decision by the Court after
appeal, but decided then nevertheless probation, should be
the time during which the trial has been going on included in the probation period.
section 17 of the Decision as a general administrative court notifies the according to
This law applies immediately, unless otherwise specified in the decision.
2010:659
1. this law shall enter into force on 1 January 2011, when the Act
(1998:531) if the professional activities of the health care area
shall be repealed.
2. a dental examination pursuant to the provisions
applied before 1 July 1994 shall carry out practical service
According to the rules in force at that time to get
identification as a dentist.
3. For matters relating to probation, revocation of ID and
other privileges or restriction of prescribing the right that
brought in health care before the disciplinary board
January 1, 2011 still apply the provisions of the repealed
4. If the trial period has been decided on the basis of the repealed Act
is still in Chapter 5. 7 section 4 of the Act.
5. Health care disciplinary board, to National Board
submit documents in cases where the disciplinary sanction that has
begun in Committee before 1 January 2011 and which have not yet
has been adjudicated. At the Board's handling of these cases
concerning Chapter 7. 10-18 of the new law.
6. The repealed Act shall continue to apply in assessing the
the question of the disciplinary sanction in court after appeal
or in health care disciplinary board after
referral from the Court.
2011:1190
This law shall enter into force on 1 January 2012 but applied
for the period from 1 January 2011.
2012:957
1. this law shall enter into force on 1 June 2013.
2. for the purposes of 7 a of the administrative judicial procedure Act (1971:291) shall
Inspectorate for health and social care to be the individual's counterpart, if
inspection after the entry into force is competent to deal with the type of
3. For the offences referred to in Chapter 10. paragraphs 1 and 2 and which have
committed before the entry into force applies Chapter 2. paragraphs 1 and 2 and 7
Cape. 26-28 of its older version. Team (2013:276).
2013:1149
1. This law shall enter into force on January 1, 2014.
2. applications for identification as a physiotherapist who has come
in to the National Board before January 1, 2014, but not yet
has been adjudicated to be valid as applications for identification
3. When applying for identification as a physiotherapist,
physical therapist degree deemed equivalent to fysioterapeutexamen.
4. Older provisions still apply for registered
physical therapists and physical therapist for the professional title.
2014:62
1. this law shall enter into force on 1 January 2014.
2. It shall also apply to decisions delivered before
the entry into force.
2002 Law (2002:297) Om Biobanks In Health Care, Etc.
2015 §8.01-581.17. Privileged communications of certain committees and entities
2013 The Health Services (Cross-Border Health Care) Regulations (Northern Ireland) 2013
2016 Law Law Of Duties And Rights Of Patients And Health Providers.
Organisation Of The Market In Health Care Law
2000 Law On Health Personnel, Etc. (Helsepersonelloven)
2015 Notice Of The Publication Of Decisions, Etc. In Appeal Proceedings In The Field Of Health
2015 62J.54 Identification And Implementation Of Unique Identifiers
2016 Health Services Organisation Act
2017 Health Services Organisation Act