The document is the Healthcare Identifiers Regulations 2010 from Australia. It establishes regulations under the Healthcare Identifiers Act 2010, including defining key terms, specifying classes of healthcare providers, and outlining information that can be requested and rules around disclosing healthcare identifiers. The regulations cover topics such as national registration authorities, classes of individual and organizational healthcare providers, and requirements for maintaining and updating healthcare identifier information.
A pro-life healthcare bill providing universal healthcare by imitating the free market. The Vital Healthcare Act uses a grant process to sponsor hospitals to provide basic government healthcare, with patients voting on the quality of that care so that higher rated hospitals receive more funding and retain grant status. Also included are tort reform solutions which mandate liability sharing of medical lawsuit expenses by hospitals based on hours worked by doctors at the time of malpractice incidents and payment of legal costs by the losing parties in medical lawsuits to discourage frivolous lawsuits. The private sector is left intact apart from the prohibition of discriminating based on pre-existing conditions.
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A pro-life healthcare bill providing universal healthcare by imitating the free market. The Vital Healthcare Act uses a grant process to sponsor hospitals to provide basic government healthcare, with patients voting on the quality of that care so that higher rated hospitals receive more funding and retain grant status. Also included are tort reform solutions which mandate liability sharing of medical lawsuit expenses by hospitals based on hours worked by doctors at the time of malpractice incidents and payment of legal costs by the losing parties in medical lawsuits to discourage frivolous lawsuits. The private sector is left intact apart from the prohibition of discriminating based on pre-existing conditions.
The Medical Council of India regulates uniform standards of higher qualifications in medicine and recognition of medical qualifications in India and abroad. Official registration of doctors with recognized medical qualifications is controlled by the council, and procedures have been laid out under the Indian Medical Council Act 1956 and Indian Medical Degree Act 1916. Although there are no legal constraints specifically dealing with methodology of executing or dispensing medical services in India, various laws including the Drugs and Cosmetics Act, 1940 define negligence; criminal intent; sale, manufacture and distribution of drugs etc., while judicial precedent and case laws determine medical negligence on a case by case basis. The healthcare service provider adopting telemedicine methods of medical practice must ensure that medical consultation, prescriptions, treatment and drugs are dispensed only in accordance with legal provisions and guidelines regulating the medical and healthcare sector in India.
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This is the umbrella legislation which deals with regulation of drugs and medical devices in India. It is from Section 12 of this Act that the Central Government derives the power to make rules and as a result the Drugs and Cosmetics Rules, 1945 were formulated. https://www.rickychopra.co/
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- This Circular provides for the activities relating to production, trading, product declaration, labeling and provision of instructions for use of functional foods such as
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4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
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Final Exposure Draft Regs 12 March 2010
1. Healthcare Identifiers
Regulations 20101
Select Legislative Instrument 2010 No.
I, QUENTIN BRYCE, Governor-General of the Commonwealth
of Australia, acting with the advice of the Federal Executive
Council, make the following Regulations under the Healthcare
Identifiers Act 2010.
Dated 2010
Governor-General
By Her Excellency’s Command
[DRAFT ONLY – NOT FOR SIGNATURE]
Minister for Health and Ageing
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2. Contents
Page
Contents
1 Name of Regulations 2
2 Commencement 2
3 Definitions 2
4 National registration authorities 4
5 Classes of healthcare providers — individuals 4
6 Class of healthcare provider — organisations 5
7 Information that may be requested before
assigning healthcare identifiers 5
8 Identifying information 6
9 Information that may be requested after assigning
healthcare identifiers 7
10 Rules about the disclosure of healthcare identifiers
by the service operator 8
11 Information that may be requested after disclosure
of healthcare identifiers 10
1 Name of Regulations
These Regulations are the Healthcare Identifiers Regulations
2010.
2 Commencement
These Regulations commence on 1 July 2010.
3 Definitions
In these Regulations:
Act means the Healthcare Identifiers Act 2010.
healthcare provider organisation means an entity, or part of an
entity, mentioned in paragraph (b) of the definition of
healthcare provider in section 5 of the Act.
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3. Regulation 3
individual healthcare identifier means the type of healthcare
identifier mentioned in paragraph 9 (3) (c) of the Act.
individual healthcare provider means an individual mentioned
in paragraph (a) of the definition of healthcare provider in
section 5 of the Act.
National Law means:
(a) for a State or Territory other than Western Australia —
the Health Practitioner Regulation National Law set out in
the Schedule to the Health Practitioner Regulation
National Law Act 2009 (Qld) as it applies (with or without
modification) as law of the State or Territory;
(b) for Western Australia — the legislation enacted by the
Health Practitioner Regulation National Law (WA)
Act 2010 that corresponds to the Health Practitioner
Regulation National Law.
Note See the Intergovernmental Agreement for a National Registration and
Accreditation Scheme for the Health Professions made on 26 March 2008.
organisation maintenance officer has the meaning given by
paragraph 6 (1) (c).
professional association means an organisation that:
(a) is a separate legal entity under a law of the
Commonwealth or a State or Territory; and
(b) has the following characteristics:
(i) its members practise the same healthcare profession;
(ii) it has enough membership to be considered
representative of the healthcare profession practised
by its members;
(iii) it sets its own admission requirements, including
acceptable qualifications;
(iv) it sets standards of practice and ethical conduct;
(v) it aims to maintain the standing of the healthcare
profession practiced by its members;
(vi) it has written rules, articles of association, by-laws
or codes of conduct for its members;
(vii) it has the ability to impose sanctions on members
who contravene the association’s written rules,
articles of association, by-laws or codes of conduct;
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4. Regulation 4
(viii) it sets requirements to maintain its members’
professional skills and knowledge by continuing
professional development; and
(c) has members who:
(i) may take part in decisions affecting their profession;
and
(ii) have the right to vote at meetings of the association;
and
(iii) have the right to be recognised as being a member of
the professional association.
responsible officer has the meaning given by paragraph
6 (1) (b).
sole practitioner means a person who is both an individual
healthcare provider and a healthcare provider organisation.
4 National registration authorities
For section 8 of the Act, each of the following registration
authorities is a national registration authority:
(a) a National Health Practitioner Board established by the
National Law;
(b) if it is authorised under the National Law to assign
healthcare identifiers to healthcare providers — the
Australian Health Practitioner Regulation Agency
established by the National Law.
Note National Health Practitioner Boards and the Australian Health
Practitioner Regulation Agency are expected to be established by all States
and Territories under the National Law.
5 Classes of healthcare providers — individuals
For paragraph 9 (1) (a) of the Act, each of the following is a
class of healthcare provider:
(a) individual healthcare providers who are registered by a
registration authority as members of a health profession;
(b) individual healthcare providers who are members of a
professional association that:
(i) relates to the healthcare that has been, is, or is to be
provided by the members; and
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5. Regulation 7
(ii) has uniform national membership requirements,
whether or not in legislation.
6 Class of healthcare provider — organisations
(1) For paragraph 9 (1) (a) of the Act, a class of healthcare
providers is healthcare provider organisations each of which
has:
(a) an employee who:
(i) is an identified healthcare provider; and
(ii) provides healthcare as part of his or her duties; and
(b) only 1 employee (a responsible officer) to act on behalf of
the organisation in its dealings with the service operator;
and
(c) an employee (an organisation maintenance officer) to
maintain information about the healthcare provider
organisation that is held by the service operator, and to
provide any further information about the healthcare
provider organisation that is requested by the service
operator.
Note More than 1 employee may be an organisation maintenance officer.
An employee may be the responsible officer and the organisation
maintenance officer for a healthcare provider organisation.
(2) However, a sole practitioner is in the class of healthcare
providers mentioned in subregulation (1) if he or she provides
healthcare and performs the roles of responsible officer and
organisation maintenance officer.
7 Information that may be requested before assigning
healthcare identifiers
(1) For subsection 9 (5) of the Act, the service operator or a
national registration authority may ask an individual healthcare
provider for the following information before assigning the
healthcare provider a healthcare identifier:
(a) identifying information about the individual healthcare
provider;
(b) information that shows that the healthcare provider is in a
class of healthcare provider mentioned in regulation 5.
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6. Regulation 8
Note Identifying information is defined in section 7 of the Act.
Regulation 8 prescribes additional identifying information for individual
healthcare providers and healthcare provider organisations.
(2) For subsection 9 (5) of the Act, the service operator may ask a
healthcare provider organisation for the following information:
(a) identifying information about the healthcare provider
organisation;
(b) information that shows that the healthcare provider
organisation is in the class of healthcare provider
mentioned in regulation 6;
(c) information identifying its responsible officer and
organisation maintenance officer, including the person’s
name, work address, work email address, work phone
number or work fax number.
(3) The healthcare provider must give the information in any form
asked for by the service operator or national registration
authority.
Example
A healthcare provider may be asked for original documentation, or for the
information to be given in writing or in a statutory declaration.
(4) If the information given does not satisfy the body that asked for
the information, that body does not have to assign a healthcare
identifier to the healthcare provider.
8 Identifying information
(1) For paragraph 7 (1) (g) of the Act, each of the following is
identifying information:
(a) an e-mail address;
(b) a phone number;
(c) a fax number;
(d) a work address.
(2) For paragraph 7 (2) (e) of the Act, each of the following is
identifying information:
(a) an e-mail address;
(b) a phone number;
(c) a fax number.
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7. Regulation 9
9 Information that may be requested after assigning
healthcare identifiers
(1) This regulation applies to a person:
(a) who is any of the following:
(i) an identified healthcare provider organisation;
(ii) a partner in a partnership that is a healthcare
provider organisation;
(iii) a trustee of a trust that is a healthcare provider
organisation;
(iv) an office holder of an unincorporated association or
body that is a healthcare provider organisation;
(v) an identified individual healthcare provider who is
not regulated under the National Law; and
(b) for whom the entity mentioned in paragraph (a) that
applies to the person is assigned a healthcare identifier by
the service operator.
(2) For section 14 of the Act, the person must tell the service
operator about:
(a) any change of circumstances, including any change to the
identifying information of the healthcare provider, that
removes it from a class of healthcare provider mentioned
in regulation 5 or 6; and
(b) any change to the identifying information of the healthcare
provider other than a change mentioned in paragraph (a).
(3) For subregulation (2), the identified healthcare provider must
tell the service operator of the change of circumstances within
14 days after the healthcare provider becomes aware of the
change of circumstances.
(4) It is an offence for a person not to comply with
paragraph (2) (a).
Penalty: 50 penalty units.
Note A healthcare provider regulated under the National Law must tell the
national registration authority of specified relevant events and changes of
circumstances — see National Law.
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8. Regulation 10
10 Rules about the disclosure of healthcare identifiers
by the service operator
(1) For section 21 of the Act, a healthcare provider or an employee
of a healthcare provider organisation may request the service
operator to disclose an individual healthcare identifier to the
person making the request only if:
(a) the healthcare provider or healthcare provider organisation
is an identified healthcare provider; and
(b) the person making the request provides healthcare or has
duties in relation to its provision; and
(c) the healthcare identifier is to be used or disclosed by the
healthcare provider or healthcare provider organisation to
manage or communicate information supporting the
provision of healthcare.
Note The service operator is authorised to disclose a healthcare identifier
only to an identified healthcare provider or an authorised employee of an
identified healthcare provider — see Act s 17.
(2) It is an offence for a healthcare provider to make a request
under subregulation (1) if paragraphs (1) (a) to (1) (c) do not
apply to the healthcare provider.
Penalty: 50 penalty units.
(3) An individual healthcare provider who ceases to be in the class
of healthcare providers mentioned in regulation 5, or to be
registered under the National Law, must not make a request
under subregulation (1).
Penalty: 50 penalty units.
(4) A sole practitioner who ceases to be in the class of healthcare
providers mentioned in regulation 6 must not make a request
under subregulation (1).
Penalty: 50 penalty units.
(5) Subregulations (6), (7) and (9) apply to the following persons:
(a) a healthcare provider organisation;
(b) a partner in a partnership that is a healthcare provider
organisation;
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9. Regulation 10
(c) a trustee of a trust that is a healthcare provider
organisation;
(d) an office holder of an unincorporated association or body
that is a healthcare provider organisation.
(6) A person mentioned in subregulation (5) commits an offence
if:
(a) the healthcare provider organisation is in the class of
healthcare providers mentioned in regulation 6; and
(b) an employee of the healthcare provider organisation
makes a request under subregulation (1); and
(c) the person has not taken reasonable steps to ensure that the
requirements of paragraphs (1) (a) to (c) have been met.
Penalty: 50 penalty units.
(7) A person mentioned in subregulation (5) commits an offence if
the healthcare provider organisation has not taken reasonable
steps to ensure that only authorised employees make requests
under subregulation (1).
Penalty: 50 penalty units.
(8) For section 21 of the Act, a healthcare provider organisation
that asks the service operator to disclose a healthcare identifier
must:
(a) maintain a retrievable record of each person the provider
has authorised to access healthcare identifiers from the
service operator, including each person’s name,
designation and dates of employment with the provider,
for the time the person is authorised and for 7 years
starting on the day after the person ceased to be
authorised; and
(b) ensure that information it exchanges with, or receives
from, the service operator is kept secure so that it is not
accessed, modified or disclosed to or by unauthorised
persons; and
(c) ensure that the service operator always has the current
names and contact details of the provider’s responsible
officer and organisation maintenance officer; and
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10. Regulation 11
(d) ensure its responsible officer, organisation maintenance
officer and any other person authorised to access disclosed
healthcare identifiers, are aware of their obligations under
the Act and these Regulations.
Note 1 A healthcare provider organisation must also comply with
section 27 of the Act in relation to the protection of healthcare identifiers.
All healthcare providers must comply with the Privacy Act 1988 in relation
to the protection of health information as defined in section 6 of that Act,
or with equivalent State or Territory legislation, to the extent that it applies
to them.
Note 2 A breach of the regulations in relation to the healthcare identifier of
an individual is taken to be an interference with the privacy of the
individual for the purposes of the Privacy Act 1988. The act or practice may
be the subject of a complaint to the Privacy Commissioner under section 36
of that Act — see Act s 29 (1).
(9) It is an offence for a person mentioned in subregulation (5) not
to take reasonable steps to ensure that a healthcare provider
organisation complies with subregulation (8).
Penalty: 50 penalty units.
11 Information that may be requested after disclosure of
healthcare identifiers
(1) For section 22 of the Act, a healthcare provider must comply
with a written request by the service operator for information
that is sufficient to identify a person who accessed, from the
service operator, a healthcare identifier for the healthcare
provider.
(2) For subregulation (1):
information includes the name, position and period of time that
the person was authorised by the healthcare provider to access
healthcare identifiers.
(3) Subregulation (4) applies to the following persons:
(a) a person who is the healthcare provider organisation;
(b) a partner in a partnership that is the healthcare provider
organisation;
(c) a trustee of a trust that is the healthcare provider
organisation;
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11. Regulation 11
(d) an office holder of an unincorporated association or body
that is the healthcare provider organisation.
(4) It is an offence for a healthcare provider not to give the
information mentioned in subregulation (1):
(a) in writing if requested by the service operator; and
(b) within 14 days after receiving the request.
Penalty: 50 penalty units.
Note
1. All legislative instruments and compilations are registered on the Federal
Register of Legislative Instruments kept under the Legislative
Instruments Act 2003. See http://www.frli.gov.au.
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