This regulation sets detailed rules for licensing and operating private health facilities: it defines facility classes, prescribes technical and staffing standards, fixes application/annual/transfer fees, and requires reporting, record‑keeping and incident notification. It also limits where cosmetic surgery may be performed.
Licensees and practitioners are affected: licensees pay specified fees (ss 7–13, 9), must display licences and submit monthly encounter records (ss 25, 27), notify incidents quickly (s 18) and maintain committees and clinical governance (s 17). The Secretary approves licences and may impose conditions; penalties attach for breaches.
This Regulation updates the regulatory framework governing private health facilities in New South Wales by prescribing classes of facilities, licensing standards, fees, incident reporting and a range of operational requirements. Mechanically it:
Prescribes the services and treatments that count towards the Act’s definition of “private health facility” (Schedule 5; s 4) and defines the discrete classes of facilities (Schedule 1, s 1-19) such as anaesthesia, surgical, chemotherapy, cosmetic surgery, maternity and intensive care.
Establishes licensing standards that apply to all facilities (Schedule 2) and additional, class-specific standards (Schedule 3). The licensee must ensure conduct in accordance with applicable standards; non-compliance attracts a maximum penalty (Schedule 2, s 6(3)).
Sets out the fee schedule for applications, approvals and annual licences (ss 7-13); fees are monetary and tiered (annual licence fees in s 9 by maximum number of licensed patient beds).
Imposes reporting and recordkeeping obligations: patient registers, procedure registers, birth registers, clinical records and monthly encounter record statements to the Secretary (Schedule 2, s 12; Schedule 3 Part 19 s 105; Schedule 10 s 53; s 27).
Prescribes incident-response obligations including the definition of a “reportable incident” (linked to Appendix D of an Incident Management Policy), mandatory notification of the Secretary within set timeframes, and time limits for serious adverse event (SAE) review teams to provide incident reports (s 18).
Regulates disclosure and information exchange in incident reviews and allows certain assessor disclosures for legal, representation and insurance purposes (ss 20-22).
Regulates pecuniary interest definitions and extensive public notice obligations where practitioners have interests in private facilities (ss 23-24), and requires display of the facility’s licence in the foyer (s 25).
Current sections
Direct links to the current provisions in Private Health Facilities Regulation 2024.
The dictionary in Schedule 5 defines words used in this regulation.
Note—
The Act and the Interpretation Act 1987 contain definitions and other provisions that affect the interpretation and application of this regulation.
4
Definition of “private health facility”
4 Definition of “private health facility”
4 Definition of “private health facility”
For the Act, section 4(1), definition of private health facility, the following services or treatments are prescribed, regardless of whether the person provided with the service or treatment is admitted to a facility—
(a) anaesthesia,
(b) cardiac catheterisation,
(c) chemotherapy,
(d) cosmetic surgery,
(e) gastrointestinal endoscopy,
(f) interventional neuroradiology,
(g) (Repealed)
(h) radiotherapy,
(i) rapid opioid detoxification,
(j) renal dialysis,
(k) services or treatments relating to the care of patients injured in accidents, or those suffering from medical or other emergencies, through the provision of the following—
(i) reception,
(ii) resuscitation,
(iii) medical and surgical treatment,
(iv) life support systems,
(l) surgical procedures, other than dental procedures, performed on patients who are administered the following—
(i) general anaesthetic,
(ii) epidural anaesthetic,
(iii) major regional anaesthetic,
(iv) sedation resulting in deeper than conscious sedation.
s 4: Am 2024 (638), Sch 1[1].
Part 2
Licensing of private health facilities
Part 2 Licensing of private health facilities
Part 2 Licensing of private health facilities
Division 1
Classes of private health facilities
Division 1 Classes of private health facilities
Division 1 Classes of private health facilities
5
Classes of private health facilities—the Act, s 10(1)
5 Classes of private health facilities—the Act, s 10(1)
5 Classes of private health facilities—the Act, s 10(1)
Schedule 1 prescribes the classes of private health facilities.
6
Licensing standards—the Act, ss 5 and 65(3)
6 Licensing standards—the Act, ss 5 and 65(3)
6 Licensing standards—the Act, ss 5 and 65(3)
(1) Schedule 2 prescribes licensing standards that apply to all private health facilities.
(2) Schedule 3 prescribes licensing standards that apply to specified classes of private health facilities.
(3) The licensee of a private health facility must ensure the facility is conducted in accordance with the licensing standards that apply to the facility.
Maximum penalty—5 penalty units.
(4) A licensee is not guilty of an offence under subsection (3) if the licensee—
(a) was not aware of the circumstances giving rise to the alleged offence, and
(b) could not reasonably be expected to have been aware of the circumstances.
Division 2
Fees
Division 2 Fees
Division 2 Fees
7
Application for licence—the Act, s 6
7 Application for licence—the Act, s 6
7 Application for licence—the Act, s 6
(1) For the Act, section 6(2)(f), the prescribed fee is $8,454.
(2) For the Act, section 6(2)(f), the following particulars and documents are prescribed—
(a) for a private health facility operated by a corporation, other than a church or religious organisation—the extract of particulars, within the meaning of the Corporations Act 2001 of the Commonwealth, for the current year,
(b) for a private health facility operated by a church or religious organisation—
(i) a certificate of incorporation for the organisation, or
(ii) if the church or organisation is incorporated by an Act—a copy of that Act.
s 7: Am 2024 (598), Sch 2[1]; 2025 (452), Sch 3[1].
8
Request for extension of approval in principle—the Act, s 8
8 Request for extension of approval in principle—the Act, s 8
8 Request for extension of approval in principle—the Act, s 8
For the Act, section 8(4), the prescribed fee is $4,308.
s 8: Am 2024 (598), Sch 2[2]; 2025 (452), Sch 3[2].
9
Annual licence fees—the Act, s 14
9 Annual licence fees—the Act, s 14
9 Annual licence fees—the Act, s 14
For the Act, section 14(1), the prescribed fee is—
(a) for private health facilities of any class that provide for the accommodation of patients admitted for more than 24 hours—the fee determined in accordance with the table to this section, or
(b) for other private health facilities—$7,531.
| Maximum number of patients facility is licensed to accommodate | Fee |
| Fewer than 51 | $7,531 |
| 51–75 | $9,363 |
| 76–100 | $11,194 |
| 101–150 | $14,857 |
| 151–200 | $16,689 |
| More than 200 | $18,520 |
s 9: Am 2024 (598), Sch 2[3] [4]; 2025 (452), Sch 3[3] [4].
10
Transfer of licence—the Act, s 15
10 Transfer of licence—the Act, s 15
10 Transfer of licence—the Act, s 15
For the Act, section 15(3)(b), the prescribed fee is $4,967.
s 10: Am 2024 (598), Sch 2[5]; 2025 (452), Sch 3[5].
11
Alterations or extensions to private health facilities—the Act, s 16
11 Alterations or extensions to private health facilities—the Act, s 16
11 Alterations or extensions to private health facilities—the Act, s 16
For the Act, section 16(2)(b), the prescribed fee is $4,967.
s 11: Am 2024 (598), Sch 2[5]; 2025 (452), Sch 3[5].
12
Amendment of licence—the Act, s 17
12 Amendment of licence—the Act, s 17
12 Amendment of licence—the Act, s 17
For the Act, section 17(2)(e), the prescribed fee is $4,967.
s 12: Am 2024 (598), Sch 2[5]; 2025 (452), Sch 3[5].
13
Application for review of Secretary’s decision—the Act, s 24
13 Application for review of Secretary’s decision—the Act, s 24
13 Application for review of Secretary’s decision—the Act, s 24
For the Act, section 24(2)(b), the prescribed fee $4,967.
s 13: Am 2024 (598), Sch 2[5]; 2025 (452), Sch 3[5].
Part 3
Conduct of private health facilities
Part 3 Conduct of private health facilities
Part 3 Conduct of private health facilities
14
Restriction on where cosmetic surgery may be performed—the Act, s 33A
14 Restriction on where cosmetic surgery may be performed—the Act, s 33A
14 Restriction on where cosmetic surgery may be performed—the Act, s 33A
Cosmetic surgery must not be performed at a private health facility unless the private health facility is a cosmetic surgery class private health facility.
15
Qualifications for director of nursing of facility—the Act, s 37
15 Qualifications for director of nursing of facility—the Act, s 37
15 Qualifications for director of nursing of facility—the Act, s 37
For the Act, section 37(2), the minimum necessary qualifications are—
(a) 5 years of post-basic or post-graduate nursing experience, and
(b) 1 year of administrative experience in a position equivalent to, or more senior than, nursing unit manager in a private health facility or public hospital.
16
Register of patients—the Act, s 38
16 Register of patients—the Act, s 38
16 Register of patients—the Act, s 38
For the Act, section 38(4), a staff member of a private health facility must enter the following particulars in the register of patients—
(a) for particulars relating to a patient received at the facility—when the patient is admitted to the facility,
(b) for particulars relating to a patient separated from the facility—when the patient ceases to be a patient of the facility.
17
Medical advisory committee—the Act, s 39
17 Medical advisory committee—the Act, s 39
17 Medical advisory committee—the Act, s 39
(1) For the Act, section 39(1), the licensee of a private health facility must appoint to the medical advisory committee for the facility at least 1 medical practitioner who does not have a pecuniary interest in the facility.
(2) In this section—
pecuniary interest in a private health facility means an interest referred to in section 23(1).
Part 4
Response to incidents
Part 4 Response to incidents
Part 4 Response to incidents
18
Reportable incident—the Act, ss 41 and 49H
18 Reportable incident—the Act, ss 41 and 49H
18 Reportable incident—the Act, ss 41 and 49H
(1) For the Act, section 41, definition of reportable incident, a reportable incident means an incident of a type set out in Appendix D of the Incident Management Policy published in Government Gazette No 292 of 30 October 2020.
(2) If a reportable incident occurs in a private health facility, the licensee must notify the Secretary of the incident no later than 2 business days after the day of the incident.
(3) A serious adverse event review team appointed under the Act, section 46 must provide an incident report in accordance with the Act, section 47 no later than 70 days after the day of the incident.
19
Serious adverse event review—the Act, s 41
19 Serious adverse event review—the Act, s 41
19 Serious adverse event review—the Act, s 41
For the Act, section 41, definition of serious adverse event review, the following types of review are prescribed—
(a) NSW Health Concise Incident Analysis set out in Appendix E of the Incident Management Policy published in Government Gazette No 292 of 30 October 2020,
(b) NSW Health Comprehensive Incident Analysis set out in Appendix F of the Incident Management Policy published in Government Gazette No 292 of 30 October 2020,
(c) Systems Analysis of Clinical Incidents: The London Protocol published in August 2004 by Imperial College London.
20
Disclosure of assessor advice—the Act, s 45
20 Disclosure of assessor advice—the Act, s 45
20 Disclosure of assessor advice—the Act, s 45
For the Act, section 45(1)(e), a licensee may disclose advice or information—
(a) to obtain legal advice, or
(b) to obtain legal representation, or
(c) to notify an insurer of an incident and to provide information in relation to an insurance claim.
21
Disclosure of information by incident reviewers—the Act, s 49D
21 Disclosure of information by incident reviewers—the Act, s 49D
21 Disclosure of information by incident reviewers—the Act, s 49D
(1) For the Act, section 49D(d), the information may be divulged or communicated to a committee for the purposes of research or an investigation that the committee is authorised to conduct under the Health Administration Act 1982, section 23(1).
(2) In this section—
committee means a council, committee or advisory body appointed under the Health Administration Act 1982, section 20 and includes the following—
(a) the Special Committee Investigating Deaths Under Anaesthesia (SCIDUA),
(b) the Collaborating Hospitals Audit of Surgical Mortality (CHASM),
(c) the NSW Maternal and Perinatal Mortality Review Committee.
22
Notification of incidents and exchange of information—the Act, s 49H(g) and (h)
22 Notification of incidents and exchange of information—the Act, s 49H(g) and (h)
22 Notification of incidents and exchange of information—the Act, s 49H(g) and (h)
A licensee of a private health facility (the original licensee) may notify an incident to, or exchange information with, another licensee, or a relevant health services organisation, if, in the opinion of the original licensee, the notification or exchange of information may assist—
(a) the other licensee to exercise a function under the Act, Part 4, or
Pecuniary interests in private health facilities—the Act, s 58
23 Pecuniary interests in private health facilities—the Act, s 58
23 Pecuniary interests in private health facilities—the Act, s 58
(1) For the Act, section 58(4), the following interests are prescribed as pecuniary interests in a private health facility—
(a) an interest as a holder of the licence to conduct the facility,
(b) an interest in a corporation, other than a public company, that is the licensee of the facility,
(c) a holding of 5% or more of the issued share capital of a public company that is the licensee of the facility,
(d) a legal or equitable interest in the premises at which the facility is conducted,
(e) an interest in a corporation, other than a public company, that has a legal or equitable interest in the premises,
(f) a holding of 5% or more of the issued share capital of a public company that has a legal or equitable interest in the premises,
(g) an interest in clinical or administrative services provided to the facility, other than an interest in fees from medical or dental services provided to patients of the facility,
(h) an interest in a corporation, other than a public company, that has an interest in clinical or administrative services provided to the facility,
(i) a holding of 5% or more of the issued share capital of a public company that has an interest in clinical or administrative services provided to the facility.
(2) For the Act, section 58(5), a practitioner has a pecuniary interest in a private health facility if a relative of the practitioner has an interest of a kind referred to in subsection (1) in relation to the facility.
(3) In this section—
relative, of a practitioner, means a spouse, de facto partner, parent, child or sibling of the practitioner.
24
Notification of pecuniary interests—the Act, s 58
24 Notification of pecuniary interests—the Act, s 58
24 Notification of pecuniary interests—the Act, s 58
(1) For the Act, section 58(2), a practitioner who is required to notify a person of the practitioner’s pecuniary interest in a private health facility must notify the person of the interest—
(a) by a statement made by the practitioner to the person, and
(b) by written notice given by the practitioner to the person, and
(c) by a notice displayed at the private health facility, and
(d) by a notice displayed in each office or other professional premises of the practitioner.
(2) The statement or notice must—
(a) include the full name of the practitioner to whom the notice relates, and
(b) identify the private health facility in which the practitioner has a pecuniary interest, and
(c) specify the nature and extent of the interest.
(3) A notice referred to in subsection (1)(c) or (d) must—
(a) be at least 2,500cm2, and
(b) contain text in plain, bold characters that are—
(i) at least 1cm high, and
(ii) of a colour that contrasts with the colour of the notice’s background, and
(c) for a notice referred to in subsection (1)(c)—be displayed conspicuously in—
(i) the waiting room, or
(ii) every room where the practitioner to whom the notice relates attends to patients or other persons, and
(d) for a notice referred to in subsection (1)(d)—be displayed conspicuously.
25
Display of licence—the Act, s 65(2)(a) and (3)
25 Display of licence—the Act, s 65(2)(a) and (3)
25 Display of licence—the Act, s 65(2)(a) and (3)
The licensee of a private health facility must ensure at least 1 of the following is displayed conspicuously in the entrance foyer of the facility while the facility is conducted—
(a) the facility’s licence,
(b) the front page of the facility’s licence,
(c) a full-sized copy of the facility’s licence.
Maximum penalty—5 penalty units.
26
Notifying Secretary of council orders—the Act, s 65(2)(d) and (3)
26 Notifying Secretary of council orders—the Act, s 65(2)(d) and (3)
26 Notifying Secretary of council orders—the Act, s 65(2)(d) and (3)
(1) This section applies if an order is made in relation to the premises of a private health facility under either of the following—
(2) The licensee of the private health facility must, as soon as practicable after being made aware of the making of the order, ensure the Secretary is notified of the making of the order.
Maximum penalty for subsection (2)—5 penalty units.
27
Information to be provided by licensees—the Act, s 65(2)(d) and (3)
27 Information to be provided by licensees—the Act, s 65(2)(d) and (3)
27 Information to be provided by licensees—the Act, s 65(2)(d) and (3)
(1) The licensee of a private health facility must, for each month, give the Secretary a statement (an encounter record statement) in accordance with this section.
Maximum penalty—5 penalty units.
(2) The encounter record statement must—
(a) be in the form approved by the Secretary, and
(b) contain the information required to complete the statement in the approved form.
(3) The licensee must give the encounter record statement to the Secretary within 14 days after the end of the month to which the statement relates.
(2) An act, matter or thing that, immediately before the repeal of the Private Health Facilities Regulation 2017, had effect under that regulation continues to have effect under this regulation.
29
Transitional provision for cosmetic surgery involving fat transfer and liposuction
29 Transitional provision for cosmetic surgery involving fat transfer and liposuction
29 Transitional provision for cosmetic surgery involving fat transfer and liposuction
A reference to 500mL of lipoaspirate in the following provisions is, until the beginning of 1 March 2025, taken to be a reference to 2.5 litres of lipoaspirate—
(a) Schedule 1, section 5(2), definition of cosmetic surgery, paragraphs (h) and (i),
(b) Schedule 3, section 23(2)(a) and (b).
Schedule 1
Classes of private health facilities
Schedule 1 Classes of private health facilities
Schedule 1 Classes of private health facilities
section 5
sch 1: Am 2024 (638), Sch 1[2].
Schedule 2
Licensing standards for all private health facilities
Schedule 2 Licensing standards for all private health facilities
Schedule 2 Licensing standards for all private health facilities
section 6(1)
Schedule 3
Licensing standards for classes of private health facilities
Schedule 3 Licensing standards for classes of private health facilities
Schedule 3 Licensing standards for classes of private health facilities
section 6(2)
sch 3: Am 2024 (638), Sch 1[3].
Part 6
Emergency class private health facilities
Part 6 Emergency class private health facilities
Part 6 Emergency class private health facilities
30
Clinical records
30 Clinical records
30 Clinical records
(1) A facility must have a clinical record for each patient at the facility.
(2) The clinical record must include the following—
(a) the date and time of the patient’s arrival,
(b) details of the patient’s presenting symptoms and condition,
(c) the triage category allocated when the patient is first assessed,
(d) details of significant clinical, laboratory and radiological findings,
(e) if the patient is treated—details of the treatment,
(f) if the patient is given follow-up directions—details of the directions,
(g) the date and time of the patient’s departure,
(h) the identity and signature of the attending medical officer.
31
Minimum accommodation requirements
31 Minimum accommodation requirements
31 Minimum accommodation requirements
A facility must provide for the accommodation of patients who are admitted for more than 24 hours.
Part 7
Gastrointestinal endoscopy class private health facilities
Part 7 Gastrointestinal endoscopy class private health facilities
Part 7 Gastrointestinal endoscopy class private health facilities
32
Application of part
32 Application of part
32 Application of part
This part applies to a gastrointestinal endoscopy class private health facility.
33
Compliance with guidelines
33 Compliance with guidelines
33 Compliance with guidelines
A facility must comply with the sedation and analgesia guidelines.
34
Disinfection of endoscopes
34 Disinfection of endoscopes
34 Disinfection of endoscopes
Endoscopes used at a facility must be disinfected—
(a) using an automatic endoscope reprocessor or otherwise in accordance with the manufacturer’s instructions, and
(b) in an area that—
(i) has atmospheric extraction facilities, and
(ii) is next to the procedure room where the endoscope will be used.
35
Reprocessing of other equipment
35 Reprocessing of other equipment
35 Reprocessing of other equipment
(1) Instruments and other equipment used at a facility must be decontaminated, cleaned and reprocessed in accordance with—
(a) AS/NZS 4187:2003, Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities, or
(b) AS/NZS 4187:2014, Reprocessing of reusable medical devices in health service organisations.
(2) The decontamination, cleaning and reprocessing of equipment and instruments used in a facility must be carried out by a staff member who has appropriate training and experience.
36
Minimum accommodation requirements
36 Minimum accommodation requirements
36 Minimum accommodation requirements
A facility must provide for the accommodation of 1 or more of the following groups of patients—
(a) patients who are admitted for more than 24 hours,
(b) patients who are not discharged on the same day they are admitted, but are admitted for not more than 24 hours,
(c) patients who are admitted and discharged on the same day.
37
Accommodation standards
37 Accommodation standards
37 Accommodation standards
(1) A facility must comply with the overnight accommodation standards if the facility provides for the accommodation of patients who are admitted for more than 24 hours.
(2) A facility must comply with the extended recovery accommodation standards if the facility provides for the accommodation of patients who are not discharged on the same day they are admitted, but are admitted for not more than 24 hours.
Part 8
Intensive care (level 1 or level 2) class private health facilities
Part 8 Intensive care (level 1 or level 2) class private health facilities
Part 8 Intensive care (level 1 or level 2) class private health facilities
38
Application of part
38 Application of part
38 Application of part
This part applies to an intensive care (level 1 or level 2) class private health facility.
39
Staffing
39 Staffing
39 Staffing
(1) A facility must have—
(a) a medical practitioner appointed as director of the facility who has—
(i) for a level 1 facility—appropriate qualifications, or
(ii) for a level 2 facility—a recognised postgraduate qualification in intensive care, and
(b) for a level 1 facility—a medical practitioner on duty at the facility at all times, with priority for attendance on patients in the facility, and
(c) for a level 2 facility—a medical practitioner with an appropriate level of experience present in the facility at all times, and
(d) sufficient nursing staff on duty at all times, being—
(i) a nursing staff to patient ratio of at least 1:1 for critically ill patients, and
(ii) for a level 2 facility—a nursing staff at least 50% of whom are registered nurses with intensive care certification.
(2) In this section—
level 1 facility means a level I unit within the meaning of the Minimum Standards for Intensive Care Units.
level 2 facility means a level II unit within the meaning of the Minimum Standards for Intensive Care Units.
40
Minimum operating requirements
40 Minimum operating requirements
40 Minimum operating requirements
A facility must comply with the requirements of the Minimum Standards for Intensive Care Units.
41
Minimum accommodation requirements
41 Minimum accommodation requirements
41 Minimum accommodation requirements
A facility must provide for the accommodation of patients who are admitted for more than 24 hours.
42
Accommodation standards
42 Accommodation standards
42 Accommodation standards
A facility must comply with the overnight accommodation standards.
Part 9
Interventional neuroradiology class private health facilities
Part 9 Interventional neuroradiology class private health facilities
Part 9 Interventional neuroradiology class private health facilities
43
Application of part
43 Application of part
43 Application of part
This part applies to an interventional neuroradiology class private health facility.
44
Minimum accommodation requirements
44 Minimum accommodation requirements
44 Minimum accommodation requirements
A facility must provide for the accommodation of 1 or more of the following groups of patients—
(a) patients who are admitted for more than 24 hours,
(b) patients who are not discharged on the same day they are admitted, but are admitted for not more than 24 hours,
(c) patients who are admitted and discharged on the same day.
45
Accommodation standards
45 Accommodation standards
45 Accommodation standards
(1) A facility must comply with the overnight accommodation standards if the facility provides for the accommodation of patients who are admitted for more than 24 hours.
(2) A facility must comply with the extended recovery accommodation standards if the facility provides for the accommodation of patients who are not discharged on the same day they are admitted, but are admitted for not more than 24 hours.
Part 10
Maternity (level 1 or level 2) class private health facilities
Part 10 Maternity (level 1 or level 2) class private health facilities
Part 10 Maternity (level 1 or level 2) class private health facilities
46
Application of part
46 Application of part
46 Application of part
This part applies to a maternity (level 1 or level 2) class private health facility.
47
Definitions
47 Definitions
47 Definitions
In this part—
level 1 facility means a facility licensed to admit patients for maternity class procedures from 37 weeks completed gestation.
level 2 facility means a facility licensed to admit patients for maternity class procedures from 34 weeks completed gestation, subject to section 48(3).
maternity and neonatal service capability guideline means the NSW Health guideline Maternity and Neonatal Service Capability published on 20 May 2022.
48
Term of pregnancy
48 Term of pregnancy
48 Term of pregnancy
(1) A level 1 facility must not admit a patient for maternity class procedures before 37 weeks completed gestation.
(2) A level 2 facility must not admit a patient for maternity class procedures before 34 weeks completed gestation other than under subsection (3).
(3) A level 2 facility may admit a patient for maternity class procedures before 34 weeks completed gestation, but not before 32 weeks completed gestation, if—
(a) the facility is also licensed as a neonatal class private health facility, and
(b) the facility’s licence is subject to a condition to the effect that the facility must have, in the Secretary’s opinion, appropriate support services, infrastructure and staff with clinical expertise to provide maternity class procedures to patients who have completed between 32 and 34 weeks gestation, and
(c) the facility has a written policy, developed having regard to the provisions of the maternity and neonatal service capability guideline, that addresses the following—
(i) clinical governance, including competence and credentialling of staff,
(ii) quality and safety processes,
(iii) service requirements, including consultation, escalation, transfer and education.
49
Normal risk pregnancies
49 Normal risk pregnancies
49 Normal risk pregnancies
(1) A facility must have support services, infrastructure and staff with appropriate clinical expertise to provide care for normal risk pregnancies, including the following—
(a) obstetricians, anaesthetists and a paediatrician on call at all times,
(b) a medical practitioner at the facility at all times,
(c) experienced midwives on duty at all times,
(d) established links with clinical nurse consultants or clinical nurse educators in midwifery and neonatal nursing.
(2) Subsection (1)(b) and (c) do not apply to the Birthing on Country demonstration facility within the meaning of Division 3.
50
Additional risk pregnancies
50 Additional risk pregnancies
50 Additional risk pregnancies
(1) A level 1 facility must not admit a maternity patient with an additional risk pregnancy.
(2) A level 2 facility must not admit a maternity patient with an additional risk pregnancy unless—
(a) the medical advisory committee is satisfied the facility is able to provide appropriate care for the patient, having regard to risk factors relevant to the patient, and
(b) the facility has appropriate support services and infrastructure and staff with clinical expertise relevant to the risk factors of the patient, including—
(i) obstetricians, anaesthetists and a paediatrician on call at all times, and
(ii) a medical practitioner at the facility at all times, and
(iii) experienced midwives on duty at all times, and
(iv) established links with clinical nurse consultants or clinical nurse educators in midwifery and neonatal nursing, and
(v) a special care nursery.
51
Accommodation of neonates
51 Accommodation of neonates
51 Accommodation of neonates
A facility must have appropriate accommodation and procedures to manage healthy neonates and neonates with minimal complications.
52
Patient transfer
52 Patient transfer
52 Patient transfer
(1) A facility must have procedures in place to transfer patients requiring a higher level of care than the facility provides, including procedures—
(a) for the transfer of patients in premature labour, and
(b) for the resuscitation and stabilisation of neonates before their transfer.
(2) The procedures must be—
(a) reviewed at least once every 3 years, and
(b) submitted to the medical advisory committee for approval.
(3) In this section—
patient in premature labour means a patient who is in labour but who has not completed the number of weeks gestation required for admission to the facility.
53
Birth register
53 Birth register
53 Birth register
(1) A facility must keep a birth register.
(2) The birth register must contain details of every child born at the facility, including the following—
(a) the mother’s full name and clinical record number,
(b) the date and time of the child’s birth,
(c) the sex of the child,
(d) whether the child was born alive,
(e) the method of delivery,
(f) the names of midwives and medical practitioners present at the birth.
(3) The details of a child’s birth must be kept in the birth register for at least 25 years after the child’s birth.
54
Minimum accommodation requirements
54 Minimum accommodation requirements
54 Minimum accommodation requirements
A facility must provide for the accommodation of patients who are admitted for more than 24 hours.
55
Accommodation standards
55 Accommodation standards
55 Accommodation standards
A facility must comply with the overnight accommodation standards.
Division 3
Birthing on Country demonstration facility
Division 3 Birthing on Country demonstration facility
Division 3 Birthing on Country demonstration facility
56
Definition
56 Definition
56 Definition
In this division—
Birthing on Country demonstration facility means the level 1 facility that has an agreement with the Illawarra Shoalhaven Local Health District for—
(a) support for the delivery of maternity care within the facility, and
(b) the transfer and admission of patients to a hospital operated by the local health district.
57
One Birthing on Country demonstration facility
57 One Birthing on Country demonstration facility
57 One Birthing on Country demonstration facility
(1) The Birthing on Country demonstration facility must be located only in the area served by the Illawarra Shoalhaven Local Health District.
(2) There must not be more than 1 Birthing on Country demonstration facility at any time.
58
Additional requirements for Birthing on Country demonstration facility
58 Additional requirements for Birthing on Country demonstration facility
58 Additional requirements for Birthing on Country demonstration facility
(1) The Birthing on Country demonstration facility must—
(a) have an endorsed midwife on duty at the facility at all times while a patient is admitted to the facility for maternity care, and
(b) have at least 1 additional endorsed midwife on call at all times, and
(c) have a written policy for the delivery of a Birthing on Country model of maternity care, and
(d) have a written policy, developed having regard to the provisions of the maternity and neonatal service capability guideline, that address the following—
(i) clinical governance, including competence and credentialling of staff,
(ii) quality and safety processes,
(iii) service requirements, including consultation, escalation, transfer and education, and
(e) comply with the National Midwifery Guidelines for Consultation and Referral, 4th edition, published by the Australian College of Midwives, and
(f) ensure all midwives providing services at the facility have skills and experience in the following—
(i) the repair of perineal tears, other than third and fourth degree perineal tears,
(ii) the management of obstetric emergencies and neonatal emergencies.
perineal tear and third and fourth degree perineal tear have the same meanings as in the Third and Fourth Degree Perineal Tears Clinical Care Standard published by the Australian Commission on Safety and Quality in Health Care in April 2021.
59
Modification of Schedule 2 for Birthing on Country demonstration facility
59 Modification of Schedule 2 for Birthing on Country demonstration facility
59 Modification of Schedule 2 for Birthing on Country demonstration facility
For the Birthing on Country demonstration facility—
(a) a reference in Schedule 2, section 11 to nursing staff must be read as a reference to midwifery staff, and
(b) a reference in Schedule 2, section 18 to a registered nurse must be read as a reference to a midwife practising at the Birthing on Country demonstration facility.
Part 11
Medical class private health facilities
Part 11 Medical class private health facilities
Part 11 Medical class private health facilities
60
Application of part
60 Application of part
60 Application of part
This part applies to a medical class private health facility.
61
Minimum accommodation requirements
61 Minimum accommodation requirements
61 Minimum accommodation requirements
A facility must provide for the accommodation of patients who are admitted for more than 24 hours.
62
Accommodation standards
62 Accommodation standards
62 Accommodation standards
A facility must comply with the overnight accommodation standards.
Part 12
Mental health class private health facilities
Part 12 Mental health class private health facilities
Part 12 Mental health class private health facilities
63
Application of part
63 Application of part
63 Application of part
This part applies to a mental health class private health facility.
64
Design and construction
64 Design and construction
64 Design and construction
A part of a facility used to provide mental health care must be designed to meet the needs of mentally ill and mentally disordered persons, within the meaning of the Mental Health Act 2007, including—
(a) appropriate arrangements for patient safety and protection, and
(b) areas for observation of patients, and
(c) accommodation providing personal privacy, consistent with the care being provided.
65
Electro convulsive therapy
65 Electro convulsive therapy
65 Electro convulsive therapy
A facility at which electro convulsive therapy is administered must—
(a) have treatment and recovery areas set aside for that purpose, and
(b) also be licensed as an anaesthesia class private health facility, and
(c) have procedures in place to ensure compliance with—
(ii) Electroconvulsive Therapy: ECT Minimum Standard of Practice in NSW published by the Ministry of Health in January 2011.
66
66
66 (Repealed)
67
Conduct of facilities
67 Conduct of facilities
67 Conduct of facilities
(1) A facility must have—
(a) a written policy on providing psychiatric services, including a statement of the facility’s philosophy of service, which must be consistent with the principles specified in the Mental Health Act 2007, section 68 for the care and treatment of people with a mental illness or mental disorder, and
(b) written policies and procedures for—
(i) supporting the functions of the Mental Health Review Tribunal constituted under the Mental Health Act 2007, and
(ii) supporting the functions of official visitors and authorised officers, and
official visitor means an official visitor appointed under the Mental Health Act 2007, Chapter 5, Part 3.
68
Telephone access
68 Telephone access
68 Telephone access
A facility must have on each floor used to provide mental health care at least 1 telephone that patients and their next of kin may use for incoming and outgoing calls.
69
Visiting hours
69 Visiting hours
69 Visiting hours
(1) Patients in a facility must be allowed to receive visitors at a reasonable time.
(2) However, if necessary for the care of a patient, a medical practitioner or the senior nurse on duty may—
(a) restrict the hours for visiting the patient and, if necessary, other patients in the same ward, and
(b) restrict the number of persons who may visit the patient at one time.
70
Minimum accommodation requirements
70 Minimum accommodation requirements
70 Minimum accommodation requirements
A facility must provide for the accommodation of patients who are admitted for more than 24 hours.
71
Accommodation standards
71 Accommodation standards
71 Accommodation standards
A facility must comply with the overnight accommodation standards.
Part 13
Neonatal class private health facilities
Part 13 Neonatal class private health facilities
Part 13 Neonatal class private health facilities
72
Application of part
72 Application of part
72 Application of part
This part applies to a neonatal class private health facility.
73
Accommodation of neonates
73 Accommodation of neonates
73 Accommodation of neonates
A facility must have appropriate accommodation and procedures to manage healthy neonates, neonates with minimal complications and recovering neonates, including a neonatal intensive care unit.
74
Transfer of neonates
74 Transfer of neonates
74 Transfer of neonates
(1) A facility must have written procedures for the transfer of neonates requiring a higher level of care than the facility provides.
(2) The procedures must provide for the resuscitation and stabilisation of neonates before their transfer.
(3) The procedures must be—
(a) reviewed at least once every 3 years, and
(b) submitted to the medical advisory committee for approval.
75
Minimum accommodation requirements
75 Minimum accommodation requirements
75 Minimum accommodation requirements
A facility must provide for the accommodation of patients who are admitted for more than 24 hours.
76
Accommodation standards
76 Accommodation standards
76 Accommodation standards
A facility must comply with the overnight accommodation standards.
Part 14
Paediatric class private health facilities
Part 14 Paediatric class private health facilities
Part 14 Paediatric class private health facilities
77
Application of part
77 Application of part
77 Application of part
This part applies to a paediatric class private health facility.
78
Admission policy
78 Admission policy
78 Admission policy
(1) A facility must have a written policy for determining whether a paediatric patient may be admitted to the facility.
(2) The policy must provide for the following—
(a) the age of paediatric patients who may be admitted to the facility,
(b) the types of procedures that may be performed on, and treatments that may be given to, paediatric patients,
(c) the maximum period for which a paediatric patient may be admitted,
(d) the maximum number of paediatric patients who may be admitted to the facility at one time,
(e) the facilities that are available for the care and treatment of paediatric patients.
(3) The policy must be—
(a) reviewed at least once every 3 years, and
(b) submitted to the medical advisory committee for approval.
79
Visitor policy
79 Visitor policy
79 Visitor policy
A facility must have a written visitor policy that—
(a) allows a person who has the care of a paediatric patient to access the patient at all times, except while the patient is undergoing surgery, and
(b) allows a person who has the care of a paediatric patient to access a patient undergoing surgery while the patient is in pre-anaesthesia or recovery unless, in the opinion of the medical practitioner responsible for the patient’s treatment, it would not be in the patient’s best interests, and
(c) ensures resources are made available to allow a person who has the care of a paediatric patient to remain at the facility during the patient’s stay at the facility.
80
Patient transfer
80 Patient transfer
80 Patient transfer
(1) A facility must have procedures in place that provide for the transfer of patients who require care or treatment not provided by the facility.
(2) The procedures must be—
(a) reviewed at least once every 3 years, and
(b) submitted to the medical advisory committee for approval.
81
Minimum operating requirements
81 Minimum operating requirements
81 Minimum operating requirements
While a paediatric patient is admitted to a facility, the facility must have—
(a) a paediatric physician available for consultation, and
(b) a registered nurse on duty who has appropriate paediatric experience or qualifications, and
(c) for a paediatric patient less than 12 months of age—microchemistry available for analysis of capillary blood specimens.
82
Minimum accommodation requirements
82 Minimum accommodation requirements
82 Minimum accommodation requirements
A facility must provide for the accommodation of 1 or more of the following groups of patients—
(a) patients who are admitted for more than 24 hours,
(b) patients who are not discharged on the same day they are admitted, but are admitted for not more than 24 hours,
(c) patients who are admitted and discharged on the same day.
83
Accommodation standards
83 Accommodation standards
83 Accommodation standards
(1) A facility must comply with the overnight accommodation standards if the facility provides for the accommodation of patients who are admitted for more than 24 hours.
(2) A facility must comply with the extended recovery accommodation standards if the facility provides for the accommodation of patients who are not discharged on the same day they are admitted, but are admitted for not more than 24 hours.
Part 15
Radiotherapy class private health facilities
Part 15 Radiotherapy class private health facilities
Part 15 Radiotherapy class private health facilities
84
Application of part
84 Application of part
84 Application of part
This part applies to a radiotherapy class private health facility.
85
Conduct of facilities
85 Conduct of facilities
85 Conduct of facilities
A facility must—
(a) maintain the facility’s radiotherapy equipment in good working order, and
(b) maintain a system for independent dosimetry auditing of linear accelerators, and
(c) have a written policy on providing radiotherapy services as part of a multidisciplinary approach to patient care, including specific provisions about—
(i) consultation, and
(ii) referral, and
(iii) links to other relevant services for the patient, including medical oncology, surgical services, clinical haematology, palliative care and clinical support services, and
(d) have sufficient appropriate practitioners for the services provided, including radiation therapists, radiation oncologists, medical physicists and other relevant specialists for consultation.
86
Minimum accommodation requirements
86 Minimum accommodation requirements
86 Minimum accommodation requirements
A facility must provide for the accommodation of 1 or more of the following groups of patients—
(a) patients who are admitted for more than 24 hours,
(b) patients who are not discharged on the same day they are admitted, but are admitted for not more than 24 hours,
(c) patients who are admitted and discharged on the same day.
87
Accommodation standards
87 Accommodation standards
87 Accommodation standards
(1) A facility must comply with the overnight accommodation standards if the facility provides for the accommodation of patients who are admitted for more than 24 hours.
(2) A facility must comply with the extended recovery accommodation standards if the facility provides for the accommodation of patients who are not discharged on the same day they are admitted, but are admitted for not more than 24 hours.
Part 16
Rapid opioid detoxification class private health facilities
Part 16 Rapid opioid detoxification class private health facilities
Part 16 Rapid opioid detoxification class private health facilities
88
Application of part
88 Application of part
88 Application of part
This part applies to a rapid opioid detoxification class private health facility.
89
Compliance with guidelines
89 Compliance with guidelines
89 Compliance with guidelines
A facility must comply with the NSW Clinical Guidelines: Treatment of Opioid Dependence—2018 published by the Ministry of Health in September 2018.
90
Patient transfer
90 Patient transfer
90 Patient transfer
(1) A facility must have access to an intensive care (level 1 or level 2) class private health facility or a public hospital to which a patient may be transferred for intensive care in less than 30 minutes.
(2) A facility that is not also licensed as an intensive care (level 1 or level 2) class private health facility must have—
(a) written procedures in place that provide for the transfer of a patient in less than 30 minutes to an intensive care (level 1 or level 2) class private health facility or a public hospital if the patient requires a higher level of care than the facility provides, and
(b) an appropriately equipped vehicle, that is available while rapid opioid detoxification is carried out, to transfer a patient to an intensive care (level 1 or level 2) class private health facility.
91
Staffing
91 Staffing
91 Staffing
(1) A facility must have—
(a) a medical practitioner who has experience in opioid treatment and managing detoxification, including severe withdrawal management, on staff or on call at all times, and
(b) a medical practitioner on duty for 4 hours after an induction procedure is carried out on a patient, and
(c) a medical practitioner on duty or on call between 4 hours and 48 hours after an induction procedure is carried out on a patient.
(2) A facility must have sufficient nursing staff on duty at all times, including—
(a) a nursing staff to patient ratio of at least 1:2 for 8 hours after an induction procedure is carried out on a patient, and
(b) a nursing staff to patient ratio of at least 1:4 between 8 hours and 24 hours after an induction procedure is carried out on a patient.
92
Minimum accommodation requirements
92 Minimum accommodation requirements
92 Minimum accommodation requirements
A facility must provide for the accommodation of patients who are admitted for more than 24 hours.
93
Accommodation standards
93 Accommodation standards
93 Accommodation standards
A facility must comply with the overnight accommodation standards.
Part 17
Rehabilitation class private health facilities
Part 17 Rehabilitation class private health facilities
Part 17 Rehabilitation class private health facilities
94
Application of part
94 Application of part
94 Application of part
This part applies to a rehabilitation class private health facility.
95
Conduct of facilities
95 Conduct of facilities
95 Conduct of facilities
A facility must—
(a) have a written policy on providing rehabilitation services, including—
(i) a statement of the facility’s philosophy of service, and
(ii) details of links with community-based services to ensure continuity and coordination of patient care, and
(b) have clear written criteria and assessment procedures for admitting inpatients and outpatients to rehabilitation programs, and
(c) have a written rehabilitation plan for each patient that—
(i) is based on an assessment of the patient, and
(ii) states the needs and limitations of the patient and the goals of the rehabilitation plan, and
(iii) is prepared by a multidisciplinary team with the active participation of the patient’s family, and
(iv) provides for the patient’s discharge, continuing care and review, and
(d) have procedures for regularly evaluating the progress of a patient against the patient’s rehabilitation plan, and
(e) have a formal and planned discharge procedure, and
(f) provide for regular case management meetings involving the treating medical practitioner and appropriate therapists to review individual rehabilitation plans, and
(g) have specialists for consultation, and
(h) have sufficient appropriate therapists for the services provided, and
(i) have sufficient registered nurses with appropriate rehabilitation qualifications or experience on duty at all times, and
(j) if a patient with brain impairment is being treated—have access to the services of a neuropsychologist, and
(k) if a patient with chronic pain is being treated—have access to the services of a clinical psychologist.
96
Clinical records
96 Clinical records
96 Clinical records
The clinical record of a patient in a facility must include the following—
(a) a clear statement by the treating medical practitioner—
(i) explaining why the patient is receiving rehabilitation, and
(ii) that is consistent with the policies, procedures and plans referred to in this schedule, section 94,
(b) a rehabilitation plan based on the assessment of the patient,
(c) a record of each evaluation of the patient’s progress,
(d) a discharge plan.
97
Minimum accommodation requirements
97 Minimum accommodation requirements
97 Minimum accommodation requirements
A facility must provide for the accommodation of patients who are admitted for more than 24 hours.
98
Accommodation standards
98 Accommodation standards
98 Accommodation standards
A facility must comply with the overnight accommodation standards.
Part 18
Renal dialysis class private health facilities
Part 18 Renal dialysis class private health facilities
Part 18 Renal dialysis class private health facilities
99
Application of part
99 Application of part
99 Application of part
This part applies to a renal dialysis class private health facility.
100
Design and construction
100 Design and construction
100 Design and construction
A part of a building used for a facility must comply with the requirements for class 5 buildings in the Building Code of Australia, as in force—
(a) on the issue of the licence for the facility, or
(b) if a later date is specified in the licence—on the later date.
101
Minimum accommodation requirements
101 Minimum accommodation requirements
101 Minimum accommodation requirements
A facility must provide for the accommodation of 1 or more of the following groups of patients—
(a) patients who are admitted for more than 24 hours,
(b) patients who are not discharged on the same day they are admitted, but are admitted for not more than 24 hours,
(c) patients who are admitted and discharged on the same day.
102
Accommodation standards
102 Accommodation standards
102 Accommodation standards
(1) A facility must comply with the overnight accommodation standards if the facility provides for the accommodation of patients who are admitted for more than 24 hours.
(2) A facility must comply with the extended recovery accommodation standards if the facility provides for the accommodation of patients who are not discharged on the same day they are admitted, but are admitted for not more than 24 hours.
Part 19
Surgical class private health facilities
Part 19 Surgical class private health facilities
Part 19 Surgical class private health facilities
103
Application of part
103 Application of part
103 Application of part
This part applies to a surgical class private health facility.
104
Concurrent licensing
104 Concurrent licensing
104 Concurrent licensing
A facility must also be licensed as an anaesthesia class private health facility.
105
Procedure register
105 Procedure register
105 Procedure register
(1) A facility must keep a procedure register.
(2) The procedure register must contain details of every surgical procedure carried out at the facility, including the following—
(a) the patient’s full name and medical record number,
(b) the name of the procedure,
(c) the names of surgeons, surgical assistants, anaesthetists and scrub nurses involved in the procedure,
(d) the anaesthetic administered,
(e) the date, time and place of the procedure.
106
Clinical records
106 Clinical records
106 Clinical records
(1) A facility must have a clinical record for each patient at the facility on whom a surgical class procedure is carried out.
(2) The clinical record must include the following—
(a) if anaesthesia is administered—the anaesthetic record, which must comply with the PG06(A) Guideline on the anaesthesia record published by the Australian and New Zealand College of Anaesthetists in 2020,
(b) the procedural report for the surgical procedure carried out on the patient, including pre-procedural and post-procedural diagnoses, and a description of the findings, technique used and tissue removed or altered,
(c) if the patient’s tissue or body fluid is removed—a pathological report on the tissue or body fluid,
(d) a record of the swab, sponge and instrument count,
(e) the post-procedural recovery record.
107
Specialist equipment
107 Specialist equipment
107 Specialist equipment
A facility must have the following equipment available in each room in which a surgical class procedure is carried out—
(a) adequate equipment and instruments for elective use,
(b) sterile instrument sets available for emergency procedures.
108
Minimum accommodation requirements
108 Minimum accommodation requirements
108 Minimum accommodation requirements
A facility must provide for the accommodation of 1 or more of the following groups of patients—
(a) patients who are admitted for more than 24 hours,
(b) patients who are not discharged on the same day they are admitted, but are admitted for not more than 24 hours,
(c) patients who are admitted and discharged on the same day.
109
Accommodation standards
109 Accommodation standards
109 Accommodation standards
(1) A facility must comply with the overnight accommodation standards if the facility provides for the accommodation of patients who are admitted for more than 24 hours.
(2) A facility must comply with the extended recovery accommodation standards if the facility provides for the accommodation of patients who are not discharged on the same day they are admitted, but are admitted for not more than 24 hours.
Schedule 4
Accommodation standards
Schedule 4 Accommodation standards
Schedule 4 Accommodation standards
Schedule 5
Schedule 5
Dictionary
Schedule 5 Dictionary
Schedule 5 Dictionary
section 3
anaesthesia means the administration of general, epidural or major regional anaesthetic or sedation resulting in deeper than conscious sedation, other than—
(a) sedation provided in connection with dental procedures, or
(b) anaesthetic or sedation administered—
(i) in diagnostic imaging premises, within the meaning of the Health Insurance Act 1973 of the Commonwealth, on the premises of a licensed anaesthesia class private health facility, and
(ii) to a patient of the private health facility, and
(iii) by a registered medical practitioner who is a member of staff of, or accredited to provide health services at, the private health facility.
Australasian Health Facility Guidelines means the Australasian Health Facility Guidelines endorsed by the Australasian Health Infrastructure Alliance in Australia and New Zealand that commenced on 23 November 2007.
cardiac catheterisation means the passing of a catheter or other instrument through a major blood vessel and into the heart for a diagnostic or therapeutic purpose.
chemotherapy means intravenous treatments using 1 or more cytotoxic agents.
class of procedures, in relation to a private health facility, means the services or treatments for which the facility is licensed.
Examples—
Rapid opioid detoxification class procedures are the services or treatments for which a rapid opioid detoxification class private health facility is licensed—see Schedule 1, section 16.
Surgical class procedures are the services or treatments for which a surgical class private health facility is licensed—see Schedule1, section 19.
cosmetic surgery—see Schedule 1, section 5(2).
extended recovery accommodation standards means the standards set out in Schedule 4, Part 1.
gastrointestinal endoscopy means the use of a flexible endoscope with an internal lumen for the passage of an instrument to examine the upper or lower gastrointestinal tract.
interventional neuroradiology means the use of techniques to guide catheters or other instruments around the arteries or veins in the head, neck or spine to diagnose and treat diseases of the central nervous system, head, neck or spine.
medical advisory committee, for a private health facility, means the medical advisory committee appointed for the facility under the Act, section 39.
minimum standards for intensive care units means the Minimum Standards for Intensive Care Units published by the College of Intensive Care Medicine of Australia and New Zealand and last reviewed in 2016.
overnight accommodation standards means the standards set out in Schedule 4, Part 2.
sedation and analgesia guidelines means the Guideline on procedural sedation published by the Australian and New Zealand College of Anaesthetists in 2023.
This regulation is the Private Health Facilities Regulation 2024.
2 Commencement
2 Commencement
2 Commencement
This regulation commences on the day on which it is published on the NSW legislation website.
Note—
This regulation repeals and replaces the Private Health Facilities Regulation 2017, which would otherwise be repealed on 1 September 2024 by the Subordinate Legislation Act 1989, section 10(2).
3 Definitions
3 Definitions
3 Definitions
The dictionary in Schedule 5 defines words used in this regulation.
Note—
The Act and the Interpretation Act 1987 contain definitions and other provisions that affect the interpretation and application of this regulation.
4 Definition of “private health facility”
4 Definition of “private health facility”
4 Definition of “private health facility”
For the Act, section 4(1), definition of private health facility, the following services or treatments are prescribed, regardless of whether the person provided with the service or treatment is admitted to a facility—
(a) anaesthesia,
(b) cardiac catheterisation,
(c) chemotherapy,
(d) cosmetic surgery,
(e) gastrointestinal endoscopy,
(f) interventional neuroradiology,
(g) (Repealed)
(h) radiotherapy,
(i) rapid opioid detoxification,
(j) renal dialysis,
(k) services or treatments relating to the care of patients injured in accidents, or those suffering from medical or other emergencies, through the provision of the following—
Repeals and replaces the 2017 Regulation and contains transitional rules including for cosmetic surgery involving fat transfer and liposuction (s 28-29).
The instrument does not itself set the monetary value of a penalty unit; it expresses sanctions in penalty units and otherwise prescribes specified fees (ss 6(3); 7-13). The Regulation cross‑references external standards and guidelines (Australasian Health Facility Guidelines, Building Code of Australia, ANZCA position statements and various professional guidelines), and often ties compliance to the version “as in force” on the issue of the licence or on a later date specified in the licence (Schedule 2, s 1; s 2).
The Government’s stated purpose is to provide class‑specific safety and quality standards and to modernise the 2017 regulation (see s 2 and s 28). The measures translate into concrete compliance obligations, explicit fee costs and administrative reporting flows for licensees. Implementation will require licensees to align premises, staffing, equipment, policies and incident-management systems with both the Regulation and the external standards it incorporates by reference.
Main concepts
The Regulation organises the regulatory regime around several recurring legal and operational concepts. Each concept sets a mechanical rule and, in many cases, references an external standard or procedure to be followed.
Classes of facility and scope: Schedule 1 prescribes distinct classes (anaesthesia, cardiac catheterisation, cardiac surgery, chemotherapy, cosmetic surgery, emergency, endoscopy, intensive care levels 1 and 2, interventional neuroradiology, maternity levels 1 and 2, medical, mental health, neonatal, paediatric, radiotherapy, rapid opioid detoxification, rehabilitation, renal dialysis and surgical). The definition of “private health facility” in s 4 prescribes specific services and treatments that, if provided, bring a location under the Act’s definition of a private health facility regardless of admission status (s 4).
Licensing standards: Two layers of standards apply. Schedule 2 prescribes standards applicable to all private health facilities (environmental, clinical care, quality improvement, incident management). Schedule 3 prescribes additional standards tailored to particular classes (for example Anaesthesia Part 1, Chemotherapy Part 4, Surgical Part 19). The licensee is legally required to ensure the facility is conducted in accordance with the applicable licensing standards (Schedule 2, s 6(3)).
Prescriptive cross‑references: The Regulation repeatedly requires compliance with recognised external codes and guidelines, with the operative wording “as in force … on the issue of the licence” or on a later licence‑specified date (Schedule 2, s 1; s 2). That mechanism makes the licensing standard dynamically referential to bodies such as the Australasian Health Facility Guidelines, Building Code of Australia, ANZCA position statements and various clinical society guidelines (see multiple Schedule 3 parts).
Fees and payment points: The Regulation prescribes fees for initial licence application ($8,454, s 7(1)), requests for extensions of approvals in principle ($4,308, s 8), transfer and amendment of licences ($4,967, ss 10-12), annual licence fees tiered by licensed patient capacity (s 9) and fees for applications for review of Secretary’s decisions (s 13). These create upfront and recurring monetary obligations on licensees.
Information, recordkeeping and display obligations: The Regulation mandates clinical records (Schedule 2, s 12), registers (patient register s 16, procedure register s 105, birth register s 53), monthly encounter records to the Secretary (s 27), and conspicuous display of the facility licence in the entrance foyer (s 25) and large practitioner pecuniary interest notices (s 24).
Incident handling and review: The Regulation adopts the Incident Management Policy for defining reportable incidents and prescribes notification timelines,licensee must notify the Secretary no later than two business days after a reportable incident (s 18(2)) and SAE review teams must provide incident reports within 70 days (s 18(3)). It also prescribes types of SAE review methods (s 19) and permissive disclosures by assessors to secure legal advice, representation or to notify insurers (s 20).
Pecuniary interest rules and transparency: Section 23 lists specified interests that count as pecuniary interests in a facility and extends that to relatives (s 23(2)). Section 24 sets multiple methods of notification to patients and others, plus formatting rules for notices (size, font dimensions and display locations) with specific minimum physical dimensions (s 24(3)).
Concurrent licensing and operational linkages: Several classes must be concurrently licensed or hold additional licences where particular services are provided: e.g. cardiac surgery requires concurrent intensive care (level 2) licensing (Schedule 3 Part 3, s 10); surgical class facilities must also be anaesthesia class facilities (Schedule 3 Part 19, s 104). Some class standards require specialist staffing, equipment, or facilities (see multiple Schedule 3 parts).
Transitional and repeals: The 2017 Regulation is repealed (s 28(1)) and transitional savings preserve acts or matters that had effect under the 2017 Regulation immediately before repeal (s 28(2)). A transitional change alters the lipoaspirate threshold for certain cosmetic surgery provisions until 1 March 2025 (s 29).
Together these concepts create a modular regulatory regime: class definitions determine which Schedule 3 parts apply; Schedule 2 imposes systemic obligations on environment, clinical care, records and quality; fees and reporting create revenue and administrative flows; external guidelines supply technical content that licensees must operationalise.
Who it affects
Primary regulated entities: The direct legal addressees are licensees of private health facilities (Schedule 2, s 6(3) requires licensee to ensure conduct in accordance with licensing standards). The Regulation prescribes fees that the licensee must pay for application, annual licensing, amendments, transfers and reviews (ss 7-13). Licensees therefore bear the direct financial and compliance burdens.
Practitioners and staff: Medical practitioners, nurses, midwives and allied health staff are affected through qualification, staffing and notification requirements. The Regulation prescribes minimum qualifications and experience for director of nursing (s 15) and staffing ratios or qualifications in intensive care, emergency, rapid opioid detoxification and other classes (Schedule 3, Part 8 s 39; Part 6 ss 26-27; Part 16 ss 91-92). Practitioners who hold, or whose relatives hold, pecuniary interests in facilities face notification obligations and must disclose those interests by statement, written notice and conspicuous notices in practice premises and the facility (ss 23-24).
Patients and patient representatives: Patients are affected by safety, privacy and information obligations: patient registers and clinical records must be maintained (Schedule 2 s 12; s 16), patients must receive written separation instructions (Schedule 2 s 17), and privacy obligations are emphasised (Schedule 2 s 20). The Regulation requires provision for nutrition and feeding for overnight patients (Schedule 2 s 10).
Insurers and legal advisers: The Regulation explicitly permits licensees to disclose assessor advice to obtain legal advice, representation or to notify insurers about incidents (s 20). Insurers are implicated because the Regulation allows disclosure of incident information for insurance claims but also places time-limited SAE reporting obligations on review teams (s 18(3)).
Secretariat and regulators: The Secretary of the Ministry of Health is the recipient of multiple notifications and reports. Licensees must notify the Secretary of fires (Schedule 2 s 6(3)), reportable incidents within two business days (s 18(2)), monthly encounter record statements within 14 days of month end (s 27(3)), and other information as prescribed (s 27(1)). The Secretary also has powers to attach licence conditions (implied by concurrent licensing requirements and references to licence-specified dates for guideline versions).
Third‑party service providers and premises owners: The Regulation prescribes that interests in clinical or administrative services provided to the facility are pecuniary interests if they fall within s 23(1)(g)-(i). Owners or corporations that hold legal or equitable interests in the premises are captured by the pecuniary interest definition (s 23(1)(d)-(f)), which brings landlords, property investors and corporate licensees into scope.
Specific named entities / demonstration facility: The Regulation creates a bespoke carve‑out for a single Birthing on Country demonstration facility (Part 10 Division 3 ss 56-59), limiting its location and imposing tailored midwifery staffing and policy requirements. That facility is the only one that may have modified Schedule 2 readings (s 59).
Facilities providing cosmetic surgery: Cosmetic surgery is restricted to facilities licensed as a cosmetic surgery class facility (s 14). The Schedule 1 definition lists procedures that trigger the cosmetic class; for fat transfer and liposuction thresholds a transitional rule temporarily alters the volume threshold to 2.5 litres until 1 March 2025 (s 29). This affects surgeons, clinics and clinics’ licencing status.
Legal advisers and tribunals: The Regulation prescribes a fee for applications for review of the Secretary’s decision under the Act (s 13). While the Regulation does not itself set out merits review procedures, it interacts with the Act’s review framework. Legal advisers handling licensing challenges, incident-related matters or pecuniary interest disputes will be operationally affected.
Overall, the Regulation allocates obligations, costs and information flows predominantly to licensees and practitioners, while the Secretary, SAE review teams and the Ministry of Health function as the central administrative and enforcement nodes.
Key duties and rights
The Regulation imposes concrete duties on licensees, practitioners and facilities and establishes some limited permitted disclosures and rights.
Duties on licensees (principal/operator obligations)
Ensure conduct of the facility conforms to licensing standards that apply to the facility (Schedule 2, s 6(3)). Failure may attract a maximum penalty of 5 penalty units, subject to the knowledge and reasonable expectation defence in s 6(4).
Hold and display the facility licence conspicuously in the entrance foyer while the facility is conducted (s 25). Maximum penalty 5 penalty units.
Provide monthly encounter record statements in the approved form to the Secretary within 14 days after the end of each month (s 27(1)-(3)). Maximum penalty 5 penalty units.
Notify the Secretary of a reportable incident no later than 2 business days after the incident (s 18(2)). SAE review teams must provide incident reports within 70 days (s 18(3)).
Notify the Secretary as soon as practicable of certain council orders made under environmental planning or local government acts in relation to the premises (s 26(1)-(2)). Maximum penalty 5 penalty units.
Maintain buildings, equipment and supplies in good working order and have appropriate maintenance programmes for specified systems (Schedule 2 Part 1 s 3).
Maintain and transfer clinical records when licences change hands or when the facility ceases to operate (Schedule 2, s 12(2)-(3)).
Ensure that appropriate staffing levels and qualifications are in place (Schedule 2 s 11; Schedule 3 parts relevant to the facility class, e.g. s 39, s 91).
Duties on practitioners
Practitioners with pecuniary interests in a private health facility must notify persons of those pecuniary interests using multiple methods (statement, written notice, notices at the facility and at each office) (s 24(1)). Notices must contain specified content and meet minimum size and legibility specifications (s 24(2)-(3)).
Practitioners must comply with facility policies and procedures when attending to patients, including adherence to clinical governance and the medical advisory committee’s processes (Schedule 2 s 16; Part 10 s 49-50 on maternity care).
Information and disclosure rights and exceptions
The Regulation allows a licensee to disclose advice or information for the narrow purposes of obtaining legal advice, obtaining legal representation, or notifying an insurer about an incident (s 20). That is a permitted disclosure carve‑out from otherwise protected assessor material under the Act (see s 45 reference).
Incident reviewers may divulge or communicate information to specified committees for authorised research or investigations under the Health Administration Act 1982 (s 21(1)), including named bodies like SCIDUA, CHASM and the NSW Maternal and Perinatal Mortality Review Committee (s 21(2)).
Procedural duties relating to admission, transfer and separation
Facilities must adopt admission policies, review them triennially and submit them to the medical advisory committee (Schedule 4 Part 1 s 1(1)-(2); Schedule 2 s 16). Facilities must not admit patients except in accordance with the admission policy (Schedule 4 Part 1 s 1(3)).
Facilities must maintain procedures for patient transfer to other private facilities or public hospitals where required by the patient’s clinical condition (Schedule 2 s 18; multiple class parts set time and distance requirements for transfer in particular classes, e.g. rapid opioid detoxification s 90).
On separation each patient must be given a clear written explanation of follow-up recommendations and arrangements (Schedule 2 s 17).
Safety and quality duties
Facilities must have written infection control, incident management, disaster and fire safety policies and comply with them (Schedule 2 Parts 1-3, ss 6, 7, 13, 21).
Facilities must comply with external clinical and infrastructure standards (Australasian Health Facility Guidelines, Building Code of Australia, ANZCA and other specialty guidelines) as in force on licence issue or on a later date specified in the licence (Schedule 2 s 1-2; Schedule 3 parts).
Rights and administrative features
The Regulation provides a mechanism to request review of Secretary’s decisions under the Act; the Regulation prescribes an application fee for that review (s 13).
Licensees may be shielded from an offence under s 6(3) if they were unaware of the circumstances and could not reasonably be expected to have been aware (s 6(4)). That is an affirmative protection for licensees in limited circumstances.
Concurrent licensing and conditions
Some classes are subject to concurrent licensing duties (cardiac surgery must be licensed as intensive care level 2, Schedule 3 Part 3 s 10; surgical class must also be anaesthesia class, Part 19 s 104). Licence conditions may require specific infrastructure, staffing or support services as assessed by the Secretary (e.g. maternity level 2 can admit before 34 weeks only where the Secretary is satisfied a condition is met, Part 10 s 48(3)(b)).
Collectively the duties create a compliance architecture focused on structural safety, staffing, recordkeeping, incident reporting and transparency about financial interests. Rights are limited and primarily procedural (limited permitted disclosures, right to administrative review subject to a fee, and a narrow defence to some offences).
Penalties and enforcement
The Regulation sets out a mix of monetary fees, administrative reporting requirements and criminal penalties expressed in penalty units. Enforcement is administered through the Secretary (multiple notification and reporting obligations are to the Secretary) and through the Act’s enforcement architecture as it applies to licence conditions and contraventions.
Penalty structure in the Regulation
Several obligations carry a maximum penalty of 5 penalty units where non‑compliance constitutes an offence. Examples include the licensee’s duty to ensure conduct complies with licensing standards (Schedule 2 s 6(3)), the duty to display the facility licence conspicuously (s 25), the duty to notify the Secretary of council orders (s 26(2)), and the duty to provide monthly encounter record statements (s 27(1)). The Regulation consistently uses 5 penalty units as the cap for a number of administrative breaches.
The Regulation also prescribes fees for administrative actions (application, extension, transfer, amendment, review) rather than setting fines for failing to pay. Prescribed fees are: application for licence $8,454 (s 7(1)); request for extension of approval in principle $4,308 (s 8); transfer, amendment and review application fees $4,967 (ss 10-13); and annual licence fees ranging from $7,531 to $18,520 depending on licensed maximum patient accommodation (s 9 table).
Enforcement actors and processes
The Secretary is the central enforcement and compliance recipient: receives notifications of fires (Schedule 2 s 6(3)), reportable incidents (s 18(2)), monthly encounter records (s 27(3)), and notices about council orders (s 26(2)). The Secretary can impose licence conditions (implied by references to licence-specified dates and conditions in Parts such as maternity) and is the decision‑maker entitled to review under the Act (s 13 prescribes fee for application for review of Secretary’s decision under the Act, s 24).
Serious adverse event review teams appointed under the Act must provide incident reports in accordance with the Act s 47 no later than 70 days after the incident (s 18(3)). The Regulation prescribes the methods of review that qualify (s 19), linking SAE processes to external investigation frameworks and providing timelines for reporting that enable regulatory follow-up.
Disclosure and information exchange rules grant certain powers to incident reviewers to divulge information to specified committees conducting authorised research under the Health Administration Act 1982 (s 21). This creates a channel for regulatory bodies and improvement bodies to use incident information.
Compliance enforcement mechanisms in practice
The Regulation relies principally on licensing as the compliance lever. Failure to meet licensing standards can be enforced via sanctions available under the Act,this Regulation prescribes the standards and some direct penalty provisions for administrative obligations. The repeated insertion of 5 penalty‑unit maxima for certain failures creates a standard administrative fine level for breaches of many non‑technical obligations.
The Regulation also imposes reputational and operational enforcement through mandatory notifications (incident reporting within two business days, s 18(2)), which trigger SAE reviews and potential follow-up by the Secretary or other bodies. Prompt notification may lead to regulatory inquiries, amendments to licences or temporary conditions.
Key enforcement risks and uncertainties that the Regulation introduces
Penalties are expressed in penalty units; the Regulation does not specify the monetary value of a penalty unit (that is set under other statutory frameworks). Licensees must therefore track the applicable penalty unit value when assessing risk.
Several obligations depend on compliance with external standards “as in force on the issue of the licence” or on a later date specified in the licence (Schedule 2 s 1). That construct allows the Secretary, via licence conditions, to require upgrades to meet newer versions of externally authored guidelines; such dynamic references create enforcement exposure where a facility may be out of date with the version the Secretary has specified.
Some enforcement consequences are not spelled out in the Regulation itself (for example suspension or revocation procedures), because those are within the Act. The Regulation prescribes thresholds, duties and penalties for particular contraventions; enforcement steps beyond monetary penalties sit with the Act’s enforcement and administrative review architecture.
In sum, enforcement combines recurring financial obligations, administrative fines for particular breaches, mandatory notifications triggering regulatory scrutiny and SAE review timelines. Licensees’ exposure is both monetary and operational (licence conditions, SAE outcomes and potential disciplinary action under the Act).
How it interacts with other laws
The Regulation is highly cross‑referenced and designed to operate in concert with the Private Health Facilities Act 2007 (the Act) and a range of other statutory instruments, codes and professional guidelines. Key intersections and operative mechanics follow.
Primary statutory backstop: the Act
The Regulation operates under and fleshes out the Act. Many provisions explicitly state their connection to sections of the Act (for example, licencing standards,the Act sections 5 and 65(3), s 6 of the Regulation; classes,the Act s 10(1), s 5 of the Regulation). Duties to notify the Secretary, SAE review timeframes and definitions are framed as prescribed content for the Act. Administrative review of Secretary’s decisions under the Act is preserved; the Regulation merely prescribes the fee (s 13).
Building, planning and local government law
The Regulation requires compliance with the Building Code of Australia for parts of buildings used as private health facilities (Schedule 2 s 2; various Schedule 3 parts reference class‑specific building code requirements). It also imposes a duty on licensees to notify the Secretary if orders are made under the Environmental Planning and Assessment Act 1979 s 9.34 or the Local Government Act 1993 s 124 in relation to the premises (s 26). These are direct interfaces with planning and local government enforcement regimes.
Health and patient privacy statutes
Clinical records safekeeping and transfer obligations reference the Health Records and Information Privacy Act 2002 for the safekeeping of clinical records when a facility ceases to operate (Schedule 2 s 12(3)). Incident notification, adverse event reporting and the capacity for reviewers to disclose information to committees for research link to the Health Administration Act 1982 (s 21) and its Part 2A committees, creating cross‑agency pathways for information sharing.
Professional regulation and national law
The Regulation sits alongside and defers, in part, to the Health Practitioner Regulation National Law (NSW) for matters such as what constitutes a pharmacy business and endorsement of midwives (Schedule 2 s 14(c); Part 10 Division 3 s 58(2)). It requires that dispensaries be under a pharmacist and that certain dispensing tasks be supervised by a pharmacist (Schedule 2 s 14). Where the Regulation requires qualifications such as “recognised postgraduate qualification in intensive care”, that conceptually tracks to nationally recognised professional standards and the minimum standards published by the relevant colleges (Schedule 3 Part 8 s 39 referencing Minimum Standards for Intensive Care Units).
External clinical and technical guidelines
The Regulation imposes compliance with many external guidance documents. Examples:
Australasian Health Facility Guidelines for facility design and inpatient accommodation (Schedule 2 s 1; Schedule 4 s 2).
Building Code of Australia for particular classes and building parts (Schedule 2 s 2; Schedule 3 parts).
ANZCA position statements and guidelines for anaesthesia and monitoring (Schedule 3 Part 1 s 2).
Clinical society guidelines for chemotherapy, cardiology, cardiac surgery, radiotherapy, neonatal care, intensive care standards, etc. (various Schedule 3 parts).
These external documents are incorporated by reference with the operative tense “as in force” on licence issue or on a later date specified in the licence, creating potential legal interplay between licence conditions and evolving external standards.
Health administration and review bodies
The Regulation allows incident reviewer disclosures to committees authorised under the Health Administration Act 1982 s 23(1), naming SCIDUA, CHASM and the Maternal and Perinatal Mortality Review Committee (s 21). Those committees operate under different statutory authorities and have investigative or review mandates; the Regulation provides an information exchange bridge.
Local and national regulatory interplay
The Regulation includes obligations that intersect with national therapeutic product reporting (Therapeutic Goods Administration) and complaint handling bodies (Health Care Complaints Commission) by requiring incident management systems to provide for notifying appropriate authorities (Schedule 2 s 21(3)(b)).
Administrative law and judicial review
The Regulation prescribes fees for applications for review of Secretary’s decisions under the Act (s 13). It therefore interfaces with administrative review, merits review or judicial review pathways that arise under the Act and broader administrative law principles, though the Regulation itself does not create new tribunals.
Transitional and repeal mechanics
The Regulation repeals the Private Health Facilities Regulation 2017 and preserves acts or matters that had effect under the old regulation immediately before repeal (s 28). This ensures continuity of existing arrangements and legal relationships while replacing the previous instrument.
In short, the Regulation is not a stand‑alone instrument; it operates as a detailed subordinate instrument that delegates technical content to external standards and relies on multiple other statutes for enforcement, professional regulation, patient privacy, planning control and administrative review. Practitioners and licensees must align compliance with both the Regulation and the web of external laws and guidelines it references.
Amendment history
The Regulation contains internal amendment notations and explicit repeal and transitional provisions. The text itself documents recent amendments; the following reproduces those entries as they appear in the instrument.
Repeal and replacement
The Regulation repeals and replaces the Private Health Facilities Regulation 2017 (s 28(1)). The transitional savings clause provides continuity: an act, matter or thing that immediately before the repeal had effect under the 2017 Regulation continues to have effect under the new Regulation (s 28(2)).
Specific amendment annotations in the text
Section 4 (Definition of “private health facility”) includes an amendment note: "s 4: Am 2024 (638), Sch 1[1]". That indicates that s 4 was amended by an instrument recorded as 2024 (638), schedule 1, item [1].
Section 5 (Classes of private health facilities) includes an amendment note: "sch 1: Am 2024 (638), Sch 1[2]".
Section 6 (Licensing standards) and multiple fee provisions list amendment annotations: "s 7: Am 2024 (598), Sch 2[1]; 2025 (452), Sch 3[1]" for the application fee s 7; s 8 has "Am 2024 (598), Sch 2[2]; 2025 (452), Sch 3[2]". Section 9 (annual licence fees) shows "s 9: Am 2024 (598), Sch 2[3] [4]; 2025 (452), Sch 3[3] [4]". Sections 10-13 show similar amendment annotations referencing 2024 (598) Sch 2 and 2025 (452) Sch 3. Schedule 3 also carries "sch 3: Am 2024 (638), Sch 1[3]". Schedule 5 shows "sch 5: Am 2024 (638), Sch 1[4]".
Transitional provision specific to cosmetic surgery
Section 29 provides a transitional modification: references to 500 mL of lipoaspirate in specified cosmetic surgery definitions are, until the beginning of 1 March 2025, taken to be references to 2.5 litres of lipoaspirate. The specific provisions affected are Schedule 1, s 5(2) paragraphs (h) and (i) and Schedule 3, s 23(2)(a) and (b) (s 29). This is an explicit temporary amendment mechanism within the Regulation.
Documented amendment entries are the Regulation’s own marginal or inline amendment notes. The instrument records multiple amending instruments and schedules by year and numeric identifier (for example 2024 (598), 2024 (638), 2025 (452)), and ties amendment items to particular sections or schedules. The Regulation therefore contains within its text a traceable amendment history for key provisions, particularly those dealing with the definition of private health facility, classes, and the fee structure.
Practical implication of amendments
The presence of amendment annotations indicates that the Regulation has been recently updated in multiple respects: class definitions (notably s 4), fee schedules (s 7-13), and licensing standards (Schedule 3). Transitional rules (s 29) temporarily alter substantive thresholds. Because the Regulation often links compliance to external guidelines “as in force” when a licence is issued or as later specified in a licence (Schedule 2 s 1), both the Secretary’s use of licence conditions and later amending instruments will matter in practice.
What the Regulation does not record
The Regulation does not record any case law or judicial interpretations. It also does not set the monetary value of a penalty unit (that is determined elsewhere). The amendment annotations identify the amending instruments by year and schedule rather than full titles or explanatory memoranda; to trace legislative intent or parliamentary debates, one must consult the cited amending instruments and their explanatory materials.
In summary, the Regulation replaces the 2017 instrument, includes a set of documented amendments in 2024 and 2025 for definitions and fees, and contains a transitional rule for cosmetic surgery thresholds. The inline amendment notations provide pointers to the statutory amending instruments for further documentary history.
Litigation history
The Regulation itself does not include or cite any judicial decisions, and the text contains no references to cases, judicial interpretations or tribunal rulings. Therefore there is no litigation history recorded within the instrument.
Areas that commonly generate disputes (and hence are potential sources of litigation or tribunal review)
Interpretation of pecuniary interests and disclosure obligations. Section 23 prescribes categories of pecuniary interests (holder of the licence, shareholdings of 5% or more, interests in premises, interests in clinical or administrative services) and extends the definition to relatives (s 23(2)). Section 24 prescribes multiple notice forms and specific display requirements (size, font, locations). Disputes could arise over what constitutes a “pecuniary interest” in a particular factual matrix, whether the required notices have been adequately given, and whether the prescribed size and content standards are met.
Licence conditions tied to external standards. The Regulation repeatedly requires compliance with external guidelines “as in force on the issue of the licence” or a later licence-specified date (Schedule 2 s 1; s 2). Litigation or administrative review could concern whether a licence condition validly required compliance with a later guideline version, whether such a condition was lawful, or whether the licensee was given adequate notice or time to comply.
Timeliness and content of incident reporting. The Regulation imposes strict notification timelines (reportable incident notified to the Secretary no later than two business days, s 18(2); SAE review reports within 70 days, s 18(3)). Disputes may arise about whether notifications were received, whether an event qualified as a “reportable incident” (given the definition references an external Incident Management Policy), and the sufficiency of SAE reports.
Application of concurrent licensing and admission restrictions. For classes such as cardiac surgery and surgical facilities, the Regulation requires concurrent licences and sets admission gestation limits for maternity facilities (Part 10 s 48-50). Administrative review may be sought where the Secretary imposes conditions allowing or restricting admissions or requiring concurrent licences.
Administrative review and fee disputes
The Regulation prescribes a fee for applications for review of the Secretary’s decision under the Act (s 13). Challenges about whether a fee is payable, whether a fee was lawfully prescribed, or whether the Secretary’s decision was reasonable would engage administrative review rights under the Act and judicial review in the courts.
Absence of recorded cases
Because the Regulation does not record any decisions or examples of litigation, users must search case law databases, tribunal records or administrative determinations external to the instrument to identify how courts or tribunals have interpreted particular provisions. The Regulation does not itself provide precedent or guidance from judicial authorities.
In short, while the Regulation is silent about any litigation to date, it creates multiple concrete obligations and decision points that are typical loci for administrative review or court challenges: pecuniary interest definitions and disclosures (ss 23-24), licence conditions and dynamic standard references (Schedule 2 s 1), incident classification and reporting timeframes (s 18), and operational licensing decisions (concurrent licences, admission thresholds).
Gotchas
The Regulation contains several specific requirements and drafting features that may create traps for the unwary. These are concrete compliance risks drawn from the text.
Dynamic incorporation of external standards creates upgrade obligations
Many requirements refer to external guidelines “as in force on the issue of the licence, or if a later date is specified in the licence,on the later date” (Schedule 2 s 1). This permits a licence to require compliance with a future version of a guideline, which can impose upgrade costs at a licence holder’s expense. Licensees must check licence conditions for any later‑date specification and budget for potential upgrades to facilities, equipment or practices.
Multiple, specific and physically prescriptive disclosure formats for pecuniary interest
A practitioner’s obligation to notify of pecuniary interests requires four methods,verbal statement, written notice to the person, large notice displayed at the facility and notice displayed at each office (s 24(1)). Facility and office notices must be at least 2,500 cm2 with plain bold characters at least 1 cm high and contrasting colour (s 24(3)(a)-(b)). Failure to meet these precise formatting and placement rules may amount to an offence despite less conspicuous or otherwise accurate disclosures.
Fees are significant and multifaceted
Application fee $8,454 (s 7); annual licence fees range from $7,531 to $18,520 depending on licensed capacity (s 9); transfer and amendment fees $4,967 (ss 10-12). These are prescribed sums in the Regulation and will be payable irrespective of the facility’s revenue profile. Licensees planning acquisitions, transfers or expansions must factor these fixed costs into transactions.
Short deadlines for incident notifications and SAE reports
Licensees must notify the Secretary of a reportable incident within two business days (s 18(2)). SAE review teams must provide incident reports within 70 days (s 18(3)). These are tight procedural windows requiring clear internal incident-management procedures, rapid information collection and legal/claims coordination.
Cosmetic surgery threshold and transitional volume change
Cosmetic surgery may only be performed at licensed cosmetic surgery class facilities (s 14). The definition of cosmetic surgery includes fat transfer or liposuction involving more than 500 mL of lipoaspirate in 24 hours (Schedule 1 s 5(2)(h)-(i)), but there is a transitional provision that treats references to 500 mL as 2.5 litres until 1 March 2025 for specified provisions (s 29). Operators offering these procedures must track the transitional date and ensure licences or facility classes match the services actually offered.
Concurrent licensing requirements can complicate facility models
Surgical class facilities must also be licensed as anaesthesia class facilities (Schedule 3 Part 19 s 104). Cardiac surgery requires concurrent intensive care (level 2) licensing (Part 3 s 10). A facility operator proposing a new surgical offering must secure and maintain multiple licences and satisfy the distinct class standards for each, including staffing and infrastructure.
Licence display and council order notifications carry penalties
Display obligations for the licence (s 25) and obligations to notify the Secretary of council orders under environmental planning or local government law (s 26) carry maximum penalties of 5 penalty units. These are administrative but non‑trivial offences that may be overlooked in day‑to‑day operations.
Record retention and transfer at cessation of operation
Before ceasing operation the licensee must make arrangements for safekeeping of clinical records in accordance with the Health Records and Information Privacy Act 2002 and give the Secretary details of those arrangements (Schedule 2 s 12(3)). Failure to plan for records retention can create regulatory or privacy breaches and complicate successor arrangements.
Monthly encounter record statements are mandatory and time‑sensitive
Encounter record statements must be in a form approved by the Secretary and lodged within 14 days after month end (s 27). This imposes a recurring compliance obligation requiring systems to capture and transmit data in the approved template on a tight schedule.
Layered responsibilities and medical advisory committee approvals
Several obligations require facility policies, admission criteria and transfer procedures to be reviewed and approved by the medical advisory committee (Schedule 2 s 16; Schedule 3 parts e.g. maternity ss 52, 53, 58). Facilities must structure internal governance to secure timely committee approvals and to document those approvals.
Narrow permitted assessor disclosures; otherwise reviewer information pathways are constrained
The Regulation permits disclosure of assessor advice to legal advisers and insurers (s 20) and conferred limited disclosure rights to specified review committees (s 21). But outside those permissions, material from incident reviewers may be protected by the Act; licensees should not assume free disclosure of all incident reviewer material.
One-off demonstrative facility carve‑out
The Birthing on Country demonstration facility is a unique regulatory design (Part 10 Division 3 s 56-59). Operators elsewhere cannot rely on its modified readings of Schedule 2 (s 59), which provide bespoke midwifery references.
These “gotchas” are operational and legal features embedded within the Regulation’s wording. They create compliance traps concerning dynamic standard incorporation, precise signage and disclosure requirements, short reporting deadlines, concurrent licensing needs and significant fixed fees. Licensees and acquirers should map these items into compliance checklists and transaction diligence.
How to comply
Compliance with this Regulation requires a structured program combining licensing administration, clinical governance, record systems, physical infrastructure, staff credentialling and reporting workflows. The following steps follow directly from the Regulation and cite the relevant provisions.
Map class obligations and secure correct licences
Determine which Schedule 1 class(es) apply to the services provided (Schedule 1). If the facility will perform cosmetic surgery, confirm it is licensed as a cosmetic surgery class private health facility (s 14 and Schedule 1 s 5). For surgical activities check concurrent licensing requirements (Schedule 3 Part 19 s 104). For cardiac surgery, ensure concurrent intensive care level 2 licencing (Schedule 3 Part 3 s 10). Apply for the correct licence and pay the prescribed application fee ($8,454) per s 7(1).
Budget for prescribed fees and administrative costs
Factor in the initial application fee (s 7), any extension or transfer fees (ss 8, 10-12), the prescribed fee for administrative review applications (s 13), and the annual licence fee according to licensed patient accommodation (s 9 table). Integrate these fees into acquisition and operation budgets.
Align premises and construction to code and specified guidelines
Ensure parts of buildings used as facilities comply with the Building Code of Australia or class‑specific building class requirements as prescribed (Schedule 2 s 2; Schedule 3 parts that reference building class requirements). For inpatient accommodation comply with the Australasian Health Facility Guidelines as in force on licence issue (Schedule 2 s 1; Schedule 4 s 2). Document versions that apply to your licence or seek the Secretary’s clarification if a later date is specified in the licence.
Establish and maintain written policies and procedural documents
Implement written policies for fire safety and emergency response (Schedule 2 s 6), disaster response (s 7), infection control (s 13), waste and hazardous substances (s 9), incident management (Schedule 2 Part 3 s 21), complaints (s 22), risk assessment and safety inspection programs (s 24). Policies should be reviewed consistent with specified periodicities (for example admission policies reviewed every 3 years Schedule 4 Part 1 s 1(2)) and submitted to the medical advisory committee where required (Schedule 4 Part 1 s 1(2)).
Clinical governance and medical advisory committee
Appoint a medical advisory committee and ensure at least one medical practitioner on the committee has no pecuniary interest in the facility (s 17). Seek and consider the committee’s advice when making admission policies (Schedule 2 s 16) and for transfer procedures, neonatal transfer protocols and other class-specific governance steps (e.g. maternity Parts 10 Division 2 s 52).
Staffing and credentialling
Appoint a director of nursing who meets the minimum qualifications (s 15: 5 years post-basic/postgraduate nursing experience and 1 year administrative experience). For intensive care and other classes meet the staffing and qualification requirements (Schedule 3 Part 8 s 39). Maintain records demonstrating staff qualifications, on-call arrangements and rosters.
Equipment, maintenance and back‑up systems
Maintain necessary medical equipment, resuscitation equipment and biomedical maintenance programs consistent with manufacturers’ specifications (Schedule 2 s 3-4). Ensure back‑up power supplies maintain lighting, operating theatres and life support (Schedule 2 s 8).
Records, registers and data submissions
Create and maintain clinical records for each patient as required (Schedule 2 s 12). Keep patient registers and enter particulars at admission and separation times (s 16). Maintain procedure registers for surgical procedures (Schedule 3 Part 19 s 105) and birth registers with specified retention of 25 years (Part 10 s 53). Implement systems to prepare and lodge the monthly encounter record statement in the Secretary’s approved form within 14 days after month end (s 27(2)-(3)). Ensure arrangements for record safekeeping and transfer if licences change hands or the facility ceases to operate (Schedule 2 s 12(2)-(3)).
Incident and SAE processes
Adopt the Incident Management Policy referenced in s 18 and implement an incident management system that identifies incidents, notifies appropriate authorities, investigates and manages outcomes (Schedule 2 s 21(1)-(4)). Train staff to notify the Secretary of a reportable incident no later than two business days after the incident (s 18(2)). Prepare to participate in SAE reviews and ensure necessary documentation is available for SAE review teams that must provide reports within 70 days (s 18(3)).
Pecuniary interest disclosures and signage
Screen practitioners and their close relatives for pecuniary interests as defined in s 23. Where a practitioner has a prescribed pecuniary interest, ensure notifications are given by statement, written notice, conspicuous notices at the facility and notices in all professional premises (s 24(1)-(2)). Produce facility notices meeting the minimum size (2,500 cm2), font size (at least 1 cm high) and contrast requirements, and display them where required (s 24(3)). Keep records of when and how notices were provided.
Licence display and council order reporting
Display the licence, the licence front page or a full-sized copy conspicuously in the entrance foyer while the facility is conducted (s 25). Monitor for orders made under EP&A Act s 9.34 or Local Government Act s 124 and notify the Secretary as soon as practicable after becoming aware (s 26).
Consumer-facing obligations
Ensure overnight patients’ nutritional needs are assessed and satisfied (Schedule 2 s 10). Provide written separation instructions for follow-up care (Schedule 2 s 17). Maintain patient privacy and ensure staff are trained to respect privacy (Schedule 2 s 20).
Transactional due diligence and transfers
When acquiring or transferring a licence, factor in the prescribed transfer fee (s 10) and ensure clinical records are transferred to the new licensee (Schedule 2 s 12(2)). For material alterations or extensions to a facility, apply under the Act and pay the prescribed fee for alterations/extensions (s 11).
Internal audit and quality improvement
Operate regular audits, quality outcome audits and risk assessments (Schedule 2 Part 3 ss 23-24). Maintain a written complaints policy and procedures for managing complaints and informing patients, relatives and carers about complaint procedures (Schedule 2 s 22).
Legal and insurer liaison
Use the permitted disclosure carve‑out to obtain legal advice, legal representation or to notify insurers in relation to incidents (s 20). Maintain communications protocols with insurers for incident claims.
Track transitional rules and amending instruments
Note the transitional increase of the lipoaspirate threshold to 2.5 litres until 1 March 2025 for specified cosmetic provisions (s 29). Track amendment annotations in the Regulation and seek updates where external guideline versions are referenced as applicable to your licence (Schedule 2 s 1).
Operational checklist and governance recommendation
Create a compliance calendar capturing: licence renewal dates and annual fee deadlines (s 9); monthly encounter record lodgement (s 27(3)); SAE and incident timelines (s 18); triennial reviews for admission, transfer and other specified policies (Schedule 4 Part 1 s 1(2); various Schedule 3 requirements); staff credential revalidation dates; and scheduled maintenance inspections per manufacturer’s specs (Schedule 2 s 3(2)). Assign legal and clinical leads responsible for pecuniary interest disclosures, SAE cooperation, and liaison with the Secretary.
By translating each prescriptive clause into operational steps, maintaining documentary evidence and aligning facilities with the external standards referenced by the Regulation, a licensee can manage the Regulation’s compliance burden and reduce enforcement exposure.
(l) surgical procedures, other than dental procedures, performed on patients who are administered the following—
(i) general anaesthetic,
(ii) epidural anaesthetic,
(iii) major regional anaesthetic,
(iv) sedation resulting in deeper than conscious sedation.
s 4: Am 2024 (638), Sch 1[1].
Part 2 Licensing of private health facilities
Part 2 Licensing of private health facilities
Part 2 Licensing of private health facilities
Division 1 Classes of private health facilities
Division 1 Classes of private health facilities
Division 1 Classes of private health facilities
5 Classes of private health facilities—the Act, s 10(1)
5 Classes of private health facilities—the Act, s 10(1)
5 Classes of private health facilities—the Act, s 10(1)
Schedule 1 prescribes the classes of private health facilities.
6 Licensing standards—the Act, ss 5 and 65(3)
6 Licensing standards—the Act, ss 5 and 65(3)
6 Licensing standards—the Act, ss 5 and 65(3)
(1) Schedule 2 prescribes licensing standards that apply to all private health facilities.
(2) Schedule 3 prescribes licensing standards that apply to specified classes of private health facilities.
(3) The licensee of a private health facility must ensure the facility is conducted in accordance with the licensing standards that apply to the facility.
Maximum penalty—5 penalty units.
(4) A licensee is not guilty of an offence under subsection (3) if the licensee—
(a) was not aware of the circumstances giving rise to the alleged offence, and
(b) could not reasonably be expected to have been aware of the circumstances.
Division 2 Fees
Division 2 Fees
Division 2 Fees
7 Application for licence—the Act, s 6
7 Application for licence—the Act, s 6
7 Application for licence—the Act, s 6
(1) For the Act, section 6(2)(f), the prescribed fee is $8,454.
(2) For the Act, section 6(2)(f), the following particulars and documents are prescribed—
(a) for a private health facility operated by a corporation, other than a church or religious organisation—the extract of particulars, within the meaning of the Corporations Act 2001 of the Commonwealth, for the current year,
(b) for a private health facility operated by a church or religious organisation—
(i) a certificate of incorporation for the organisation, or
(ii) if the church or organisation is incorporated by an Act—a copy of that Act.
s 7: Am 2024 (598), Sch 2[1]; 2025 (452), Sch 3[1].
8 Request for extension of approval in principle—the Act, s 8
8 Request for extension of approval in principle—the Act, s 8
8 Request for extension of approval in principle—the Act, s 8
For the Act, section 8(4), the prescribed fee is $4,308.
s 8: Am 2024 (598), Sch 2[2]; 2025 (452), Sch 3[2].
9 Annual licence fees—the Act, s 14
9 Annual licence fees—the Act, s 14
9 Annual licence fees—the Act, s 14
For the Act, section 14(1), the prescribed fee is—
(a) for private health facilities of any class that provide for the accommodation of patients admitted for more than 24 hours—the fee determined in accordance with the table to this section, or
(b) for other private health facilities—$7,531.
| Maximum number of patients facility is licensed to accommodate | Fee |
| Fewer than 51 | $7,531 |
| 51–75 | $9,363 |
| 76–100 | $11,194 |
| 101–150 | $14,857 |
| 151–200 | $16,689 |
| More than 200 | $18,520 |
s 9: Am 2024 (598), Sch 2[3] [4]; 2025 (452), Sch 3[3] [4].
10 Transfer of licence—the Act, s 15
10 Transfer of licence—the Act, s 15
10 Transfer of licence—the Act, s 15
For the Act, section 15(3)(b), the prescribed fee is $4,967.
s 10: Am 2024 (598), Sch 2[5]; 2025 (452), Sch 3[5].
11 Alterations or extensions to private health facilities—the Act, s 16
11 Alterations or extensions to private health facilities—the Act, s 16
11 Alterations or extensions to private health facilities—the Act, s 16
For the Act, section 16(2)(b), the prescribed fee is $4,967.
s 11: Am 2024 (598), Sch 2[5]; 2025 (452), Sch 3[5].
12 Amendment of licence—the Act, s 17
12 Amendment of licence—the Act, s 17
12 Amendment of licence—the Act, s 17
For the Act, section 17(2)(e), the prescribed fee is $4,967.
s 12: Am 2024 (598), Sch 2[5]; 2025 (452), Sch 3[5].
13 Application for review of Secretary’s decision—the Act, s 24
13 Application for review of Secretary’s decision—the Act, s 24
13 Application for review of Secretary’s decision—the Act, s 24
For the Act, section 24(2)(b), the prescribed fee $4,967.
s 13: Am 2024 (598), Sch 2[5]; 2025 (452), Sch 3[5].
Part 3 Conduct of private health facilities
Part 3 Conduct of private health facilities
Part 3 Conduct of private health facilities
14 Restriction on where cosmetic surgery may be performed—the Act, s 33A
14 Restriction on where cosmetic surgery may be performed—the Act, s 33A
14 Restriction on where cosmetic surgery may be performed—the Act, s 33A
Cosmetic surgery must not be performed at a private health facility unless the private health facility is a cosmetic surgery class private health facility.
15 Qualifications for director of nursing of facility—the Act, s 37
15 Qualifications for director of nursing of facility—the Act, s 37
15 Qualifications for director of nursing of facility—the Act, s 37
For the Act, section 37(2), the minimum necessary qualifications are—
(a) 5 years of post-basic or post-graduate nursing experience, and
(b) 1 year of administrative experience in a position equivalent to, or more senior than, nursing unit manager in a private health facility or public hospital.
16 Register of patients—the Act, s 38
16 Register of patients—the Act, s 38
16 Register of patients—the Act, s 38
For the Act, section 38(4), a staff member of a private health facility must enter the following particulars in the register of patients—
(a) for particulars relating to a patient received at the facility—when the patient is admitted to the facility,
(b) for particulars relating to a patient separated from the facility—when the patient ceases to be a patient of the facility.
17 Medical advisory committee—the Act, s 39
17 Medical advisory committee—the Act, s 39
17 Medical advisory committee—the Act, s 39
(1) For the Act, section 39(1), the licensee of a private health facility must appoint to the medical advisory committee for the facility at least 1 medical practitioner who does not have a pecuniary interest in the facility.
(2) In this section—
pecuniary interest in a private health facility means an interest referred to in section 23(1).
Part 4 Response to incidents
Part 4 Response to incidents
Part 4 Response to incidents
18 Reportable incident—the Act, ss 41 and 49H
18 Reportable incident—the Act, ss 41 and 49H
18 Reportable incident—the Act, ss 41 and 49H
(1) For the Act, section 41, definition of reportable incident, a reportable incident means an incident of a type set out in Appendix D of the Incident Management Policy published in Government Gazette No 292 of 30 October 2020.
(2) If a reportable incident occurs in a private health facility, the licensee must notify the Secretary of the incident no later than 2 business days after the day of the incident.
(3) A serious adverse event review team appointed under the Act, section 46 must provide an incident report in accordance with the Act, section 47 no later than 70 days after the day of the incident.
19 Serious adverse event review—the Act, s 41
19 Serious adverse event review—the Act, s 41
19 Serious adverse event review—the Act, s 41
For the Act, section 41, definition of serious adverse event review, the following types of review are prescribed—
(a) NSW Health Concise Incident Analysis set out in Appendix E of the Incident Management Policy published in Government Gazette No 292 of 30 October 2020,
(b) NSW Health Comprehensive Incident Analysis set out in Appendix F of the Incident Management Policy published in Government Gazette No 292 of 30 October 2020,
(c) Systems Analysis of Clinical Incidents: The London Protocol published in August 2004 by Imperial College London.
20 Disclosure of assessor advice—the Act, s 45
20 Disclosure of assessor advice—the Act, s 45
20 Disclosure of assessor advice—the Act, s 45
For the Act, section 45(1)(e), a licensee may disclose advice or information—
(a) to obtain legal advice, or
(b) to obtain legal representation, or
(c) to notify an insurer of an incident and to provide information in relation to an insurance claim.
21 Disclosure of information by incident reviewers—the Act, s 49D
21 Disclosure of information by incident reviewers—the Act, s 49D
21 Disclosure of information by incident reviewers—the Act, s 49D
(1) For the Act, section 49D(d), the information may be divulged or communicated to a committee for the purposes of research or an investigation that the committee is authorised to conduct under the Health Administration Act 1982, section 23(1).
(2) In this section—
committee means a council, committee or advisory body appointed under the Health Administration Act 1982, section 20 and includes the following—
(a) the Special Committee Investigating Deaths Under Anaesthesia (SCIDUA),
(b) the Collaborating Hospitals Audit of Surgical Mortality (CHASM),
(c) the NSW Maternal and Perinatal Mortality Review Committee.
22 Notification of incidents and exchange of information—the Act, s 49H(g) and (h)
22 Notification of incidents and exchange of information—the Act, s 49H(g) and (h)
22 Notification of incidents and exchange of information—the Act, s 49H(g) and (h)
A licensee of a private health facility (the original licensee) may notify an incident to, or exchange information with, another licensee, or a relevant health services organisation, if, in the opinion of the original licensee, the notification or exchange of information may assist—
(a) the other licensee to exercise a function under the Act, Part 4, or
(b) the relevant health services organisation to exercise a function under the Health Administration Act 1982, Part 2A.
Part 5 Miscellaneous
Part 5 Miscellaneous
Part 5 Miscellaneous
23 Pecuniary interests in private health facilities—the Act, s 58
23 Pecuniary interests in private health facilities—the Act, s 58
23 Pecuniary interests in private health facilities—the Act, s 58
(1) For the Act, section 58(4), the following interests are prescribed as pecuniary interests in a private health facility—
(a) an interest as a holder of the licence to conduct the facility,
(b) an interest in a corporation, other than a public company, that is the licensee of the facility,
(c) a holding of 5% or more of the issued share capital of a public company that is the licensee of the facility,
(d) a legal or equitable interest in the premises at which the facility is conducted,
(e) an interest in a corporation, other than a public company, that has a legal or equitable interest in the premises,
(f) a holding of 5% or more of the issued share capital of a public company that has a legal or equitable interest in the premises,
(g) an interest in clinical or administrative services provided to the facility, other than an interest in fees from medical or dental services provided to patients of the facility,
(h) an interest in a corporation, other than a public company, that has an interest in clinical or administrative services provided to the facility,
(i) a holding of 5% or more of the issued share capital of a public company that has an interest in clinical or administrative services provided to the facility.
(2) For the Act, section 58(5), a practitioner has a pecuniary interest in a private health facility if a relative of the practitioner has an interest of a kind referred to in subsection (1) in relation to the facility.
(3) In this section—
relative, of a practitioner, means a spouse, de facto partner, parent, child or sibling of the practitioner.
24 Notification of pecuniary interests—the Act, s 58
24 Notification of pecuniary interests—the Act, s 58
24 Notification of pecuniary interests—the Act, s 58
(1) For the Act, section 58(2), a practitioner who is required to notify a person of the practitioner’s pecuniary interest in a private health facility must notify the person of the interest—
(a) by a statement made by the practitioner to the person, and
(b) by written notice given by the practitioner to the person, and
(c) by a notice displayed at the private health facility, and
(d) by a notice displayed in each office or other professional premises of the practitioner.
(2) The statement or notice must—
(a) include the full name of the practitioner to whom the notice relates, and
(b) identify the private health facility in which the practitioner has a pecuniary interest, and
(c) specify the nature and extent of the interest.
(3) A notice referred to in subsection (1)(c) or (d) must—
(a) be at least 2,500cm2, and
(b) contain text in plain, bold characters that are—
This is an opening excerpt, not the complete document.