Part 2Australian Immunisation Register

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An Act to establish and provide for an immunisation register, and for related purposes ## Part 1—Preliminary #### 1 Short title This Act may be cited as the Australian Immunisation Register Act 2015. #### 2 Commencement (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms. ```html <table cellspacing="0" cellpadding="0" style="width:355.55pt; border-collapse:collapse"><thead><tr><td colspan="3" style="width:344.85pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Commencement information</td></tr><tr><td style="width:74.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Column 1</td><td style="width:180.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Column 2</td><td style="width:68.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Column 3</td></tr><tr><td style="width:74.35pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Provisions</td><td style="width:180.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Commencement</td><td style="width:68.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Date/Details</td></tr></thead><tbody><tr><td style="width:74.35pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">1. The whole of this Act</td><td style="width:180.7pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">1 January 2016.</td><td style="width:68.4pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">1 January 2016</td></tr></tbody></table> ``` > Note: This table relates only to the provisions of this Act as originally enacted. It will not be amended to deal with any later amendments of this Act. (2) Any information in column 3 of the table is not part of this Act. Information may be inserted in this column, or information in it may be edited, in any published version of this Act. #### 3 Simplified outline of this Act This Act establishes a register of information about vaccinations. The purposes of the register relate to supporting Australian vaccination programs, and vaccination matters more broadly. Sensitive information in the register is protected. #### 4 Definitions In this Act: > AI register means the Australian Immunisation Register. > approved form means a form approved under subsection 29(1). > arrangement includes a contract or deed. > Chief Executive Medicare has the same meaning as in the Human Services (Medicare) Act 1973. > civil penalty provision has the same meaning as in the Regulatory Powers Act. > commercial‑in‑confidence has the meaning given by section 5. > family assistance has the same meaning as in the A New Tax System (Family Assistance) Act 1999. > general practitioner has the same meaning as in the Health Insurance Act 1973. > healthcare identifier has the same meaning as in the Healthcare Identifiers Act 2010. > healthcare identifier information for a person has the meaning given by section 5B. > legal personal representative, of an individual, means: (a) a parent or guardian of the individual, if the individual is under the age of 18 years; or (b) a trustee of an estate of the individual, if the individual is under a legal disability; or (c) a person who holds an enduring power of attorney granted by the individual. > parent: without limiting who is a parent of anyone for the purposes of this Act, a person is the parent of another person if the other person is a child of the person within the meaning of the Family Law Act 1975. > personal information has the same meaning as in the Privacy Act 1988. > prescribed body means a person prescribed by the rules for the purposes of this definition. > protected information means personal information, relevant identifying information or information that is commercial‑in‑confidence, to the extent that this information: (a) is obtained under, or in accordance with, this Act; or (b) is derived from a record of information that was made under, or in accordance with, this Act; or (c) is derived from a disclosure or use of information that was made under, or in accordance with, this Act. > provider identification information has the meaning given by section 5A. > purposes of the AI register means the purposes set out in section 10. > recognised vaccination provider means: (a) a general practitioner; or (b) an individual, or body, endorsed to administer vaccines in Australia, if the endorsement: (i) is for purposes that include the purposes of the AI register; and (ii) is by the Commonwealth, a State or a Territory. > Regulatory Powers Act means the Regulatory Powers (Standard Provisions) Act 2014. > relevant identifying information for an individual means the following: (a) the individual’s name, contact details, date of birth, gender and Indigenous status; (b) the individual’s medicare number (within the meaning of Part VII of the National Health Act 1953) (if any); (c) the individual’s healthcare identifier (if any); (d) the name and contact details of a legal personal representative of the individual if the individual is incapable of managing his or her health affairs; (e) any other information of a kind prescribed by the rules for the purposes of this definition that identifies the individual. > relevant vaccination means a vaccination administered: (a) in Australia; or (b) outside Australia, if information about the vaccination is given to a recognised vaccination provider. > rules means the rules made under section 31. > Secretary means the Secretary of the Department. > vaccine preventable disease means a disease listed as a vaccine preventable disease in the latest edition of the Australian Immunisation Handbook published by the Government Printer. > Note: The Handbook could in 2015 be viewed on the Department’s website (http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/Handbook10‑home). #### 5 Meaning of commercial‑in‑confidence Information is commercial‑in‑confidence if a person demonstrates to the Minister that: (a) release of the information would cause competitive detriment to the person; and (b) the information is not in the public domain; and (c) the information is not required to be disclosed under a law of the Commonwealth, or of a State or Territory; and (d) the information is not readily discoverable. #### 5A Meaning of provider identification information If a recognised vaccination provider administers a vaccine, or is given information about a relevant vaccination, at a place where the provider practices the provider’s profession, then each of the following is provider identification information for the provider: (a) the provider’s name and contact details; (b) if a number known as a provider number has been allocated by the Chief Executive Medicare to the provider in respect of that place—that number; (c) if a number known as the AIR provider number has been allocated to the provider for the purposes of this Act—that number. #### 5B Meaning of healthcare identifier information (1) Each of the following is healthcare identifier information for a person: (a) if the person is a healthcare provider that has a healthcare identifier—the healthcare identifier; (b) if the person is an individual healthcare provider linked to a healthcare provider organisation that has a healthcare identifier—the healthcare identifier for the healthcare provider organisation. (2) In subsection (1), the following terms have the same meaning as in the Healthcare Identifiers Act 2010: (a) healthcare provider; (b) healthcare provider organisation; (c) individual healthcare provider; (d) linked. #### 6 Act binds the Crown This Act binds the Crown in each of its capacities. However, it does not make the Crown liable to a pecuniary penalty or to be prosecuted for an offence. ## Part 2—Australian Immunisation Register ### Division 1—Simplified outline #### 7 Simplified outline of this Part The Australian Immunisation Register is established to keep information about vaccinations of individuals. The purposes of the register relate to supporting Australian vaccination programs, and vaccination matters more broadly. Recognised vaccination providers are required to report certain information in relation to certain relevant vaccinations that have been administered. This information will be included in the register. A recognised vaccination provider may be required to give information, or be given a formal warning, if the provider is not complying, or has not complied, with the requirement to report. Individuals can opt out from receiving certain information from the register. They can also request for their information in the register not to be disclosed for certain purposes. Payments relating to vaccinations may be made on behalf of the Commonwealth. ### Division 2—Establishment, contents and purposes #### 8 Establishment of the register (1) The Commonwealth must establish and keep a register to be called the Australian Immunisation Register. (2) Parts of the register may be kept separate from each other, and be called different names. > Note: For example, the parts of the register dealing with vaccinations given through school programs could be kept separately and be called the Australian School Vaccination Register. (3) The register is not a legislative instrument. #### 9 Contents of the register The AI register may include the following: (a) relevant identifying information for each individual who has, or could have, a relevant vaccination; (b) information provided by a recognised vaccination provider about each relevant vaccination, including: (i) the day of the vaccination; and (ii) information about the vaccine administered; and (iii) if the vaccine was administered in Australia—provider identification information and healthcare identifier information for the recognised vaccination provider who administered the vaccine; and (iv) if the vaccine was administered outside Australia—provider identification information and healthcare identifier information for the recognised vaccination provider who has been given information about the vaccination; (c) relevant identifying information for each individual who is assessed by a general practitioner, a paediatrician, a public health physician, an infectious diseases physician or a clinical immunologist as: (i) not requiring a vaccination because the individual has contracted a disease or diseases, and as a result has developed a natural immunity; or (ii) having a medical contraindication to a vaccine, and as a result should not receive a vaccination; (d) information about each of those assessments, including: (i) the day of the assessment; and (ii) information about the vaccine relevant to the assessment; and (iii) the name and contact details of, and healthcare identifier information for, the general practitioner, paediatrician, public health physician, infectious diseases physician or clinical immunologist who conducted the assessment; and (iv) if a number known as a provider number has been allocated by the Chief Executive Medicare to that general practitioner, paediatrician, public health physician, infectious diseases physician or clinical immunologist in respect of the place at which the assessment was conducted—that number; (e) other information relating to vaccinations of individuals. #### 10 Purposes of the register (1) The purposes of the AI register are to facilitate the following: (a) establishing and keeping an electronic database of records relating to vaccinations of individuals; (b) collecting, analysing and publishing statistics, and other information, about vaccination coverage across Australia and parts of Australia; (c) monitoring vaccination coverage across Australia and parts of Australia; (d) monitoring the effectiveness of vaccines and vaccination programs in preventing vaccine preventable diseases; (e) identifying any parts of Australia at risk during disease outbreaks because of the number of unvaccinated individuals in those parts; (f) checking an individual’s vaccination status by that individual or by a recognised vaccination provider; (g) checking an individual’s vaccination status: (i) by (or on behalf of) the Commonwealth; and (ii) to the extent that this is necessary for determining eligibility for family assistance; (h) advising an individual when he or she is, or was, due to receive doses of a vaccine; (i) certifying when a course of vaccination has been completed; (j) promoting individuals’ health and well‑being by giving information on new developments associated with vaccinations to them and to recognised vaccination providers; (k) payments relating to vaccinations; (l) research relating to vaccinations; (m) anything incidental to any of the above paragraphs. (2) For an individual who is incapable of managing his or her health affairs: (a) paragraph (1)(f) also applies to checking of the individual’s vaccination status by a legal personal representative of the individual; and (b) paragraphs (1)(h), (i) and (j) also apply to advising, or giving a certificate or information to, a legal personal representative of the individual. ### Division 2A—Reporting obligation etc. #### 10A Requirement to report information relating to certain relevant vaccinations Relevant vaccination administered in Australia (1) If: (a) a recognised vaccination provider administers a relevant vaccination in Australia; and (b) the relevant vaccination: (i) is of a kind prescribed by the rules; and (ii) is administered in the circumstances prescribed by the rules; the provider must report, within the period prescribed by the rules and in the manner prescribed by the rules, the information prescribed by the rules for that vaccination for inclusion in the AI Register. (2) Subsection (1) does not apply if the recognised vaccination provider reasonably believes that complying with that subsection is likely to pose a risk to the health or safety of an individual. > Note: A defendant bears an evidential burden in relation to the matter in this subsection (see section 96 of the Regulatory Powers Act). Relevant vaccination administered outside Australia (3) If: (a) a recognised vaccination provider is given information about a relevant vaccination that was administered outside Australia; and (b) the relevant vaccination: (i) is of a kind prescribed by the rules; and (ii) was administered in the circumstances prescribed by the rules; the provider must report, within the period prescribed by the rules and in the manner prescribed by the rules, the information prescribed by the rules for that vaccination for inclusion in the AI Register. (4) Subsection (3) does not apply if the recognised vaccination provider reasonably believes that complying with that subsection is likely to pose a risk to the health or safety of an individual. > Note: A defendant bears an evidential burden in relation to the matter in this subsection (see section 96 of the Regulatory Powers Act). Civil penalty provision etc. (5) A person is liable to a civil penalty if the person contravenes subsection (1) or (3). Civil penalty: 30 penalty units. (6) Subsection 93(2) of the Regulatory Powers Act does not apply in relation to a contravention of subsection (5) of this section. #### 10B Secretary may require recognised vaccination provider to give information (1) If the Secretary reasonably believes that a recognised vaccination provider is not complying with subsection 10A(1) or (3), the Secretary may, by written notice, require the provider to give, within the period specified in the notice and in the manner specified in the notice, information relating to that non‑compliance. (2) The period specified in the notice must not be shorter than 14 days after the notice is given. (3) A person is liable to a civil penalty if the person fails to comply with a notice given to the person under subsection (1). Civil penalty: 30 penalty units. #### 10C Secretary may give formal warning to recognised vaccination provider If the Secretary reasonably believes that a recognised vaccination provider may have contravened subsection 10A(1) or (3), the Secretary may, by written notice given to the provider: (a) inform the provider of that matter; and (b) warn the provider that the provider may be liable to a civil penalty under subsection 10A(5). ### Division 3—Requests about personal information in the register #### 11 Requests about personal information in the register (1) An individual may, in the approved form, request that the individual not be given by (or on behalf of) the Commonwealth: (a) any advice of a kind referred to in paragraph 10(1)(h); or (b) any certification of a kind referred to in paragraph 10(1)(i); or (c) any information of a kind referred to in paragraph 10(1)(j). > Note: The request could be made by a legal personal representative of an individual who is incapable of managing his or her health affairs (see subsection 10(2)). (2) An individual may, in the approved form, request that personal information on the AI register relating to or identifying: (a) the individual; or (b) if the individual is a legal personal representative of another individual who is incapable of managing his or her health affairs—that other individual; not be disclosed from the AI register for one or more purposes of the AI register. (3) The Commonwealth must comply with a request under this section as soon as practicable. ### Division 4—Payments relating to the register #### 12 Payments relating to vaccinations (1) The Minister may, on behalf of the Commonwealth, make a payment to a recognised vaccination provider in relation to: (a) the provider’s administrative costs incurred in reporting information for inclusion in the AI register; or (b) the provider: (i) identifying an individual who is overdue for a relevant vaccination; and (ii) administering the vaccination; and (iii) reporting information about the vaccination for inclusion in the AI register. (2) The Minister may, on behalf of the Commonwealth, make a payment: (a) for the purposes of the AI register; and (b) in circumstances of a kind prescribed by the rules for the purposes of this subsection. ### Division 5—Alternative constitutional bases #### 13 Alternative constitutional bases (1) Without limiting its effect apart from this section, this Act also has the effect it would have if the purposes of the AI register were, by express provision, confined to purposes relating to: (a) the provision of pharmaceutical benefits; or (b) the provision of medical services (without any form of civil conscription); or (c) census or statistics; or (d) external affairs, including: (i) giving effect to an international agreement to which Australia is a party; or (ii) addressing matters of international concern; or (e) a Territory or a Commonwealth place (within the meaning of the Commonwealth Places (Application of Laws) Act 1970); or (f) the implied power of the Parliament to make laws with respect to nationhood; or (g) the executive power of the Commonwealth; or (h) matters incidental to the execution of any of the legislative powers of the Parliament or the executive power of the Commonwealth. (2) A term used in this section and the Constitution has the same meaning in this section as it has in the Constitution. ## Part 4—Dealing with protected information in the register #### 21 Simplified outline of this Part Information can be collected for inclusion in the AI register. Section 23 makes it an offence if a person, while unauthorised to do so, discloses or uses protected information. The main authorisation relates to disclosure or use for the purposes of the register. There are also a number of exceptions to the offence. #### 22 Authorised dealings with protected information Uploading personal information etc. to the AI register (1) A person may collect, make a record of, disclose or otherwise use: (a) personal information; or (b) relevant identifying information; or (c) information that is commercial‑in‑confidence; if the person does so for the purposes of including the information in the AI register. > Note: This subsection is an authorisation for the purposes of other laws, including the Australian Privacy Principles. Using or disclosing protected information in the AI register (2) A person may make a record of, disclose or otherwise use protected information if: (a) the person does so for the purposes of the AI register, and the person is: (i) an officer or employee of the Commonwealth or of an authority of the Commonwealth; or (ii) engaged by the Commonwealth, or by an authority of the Commonwealth, to perform work relating to the purposes of the AI register; or (iii) an officer or employee of, or is engaged by, a person referred to in subparagraph (ii) to perform work relating to the purposes of the AI register; or (iv) a prescribed body; or (v) a recognised vaccination provider; or (b) the person is authorised to do so under subsection (3); or (c) the person does so for the purposes of performing the person’s functions, or exercising the person’s powers, under this Act; or (ca) the person does so for the purposes of including information in the register kept under Part 2 of the National Cancer Screening Register Act 2016; or (d) the person is required or authorised to do so by or under a law of the Commonwealth or of a State or Territory; or (e) the person does so for the purposes of court or tribunal proceedings, or in accordance with an order of a court or tribunal; or (f) the person does so for the purposes of a coronial inquiry, or in accordance with an order of a coroner. > Note 1: This subsection is an authorisation for the purposes of other laws, including the Australian Privacy Principles. > Note 2: Protected information is not limited to information in the register (see section 4). It can also cover information that: (a) is obtained as the result of a disclosure from the register, whether directly or indirectly because of one or more on‑disclosures; or (b) is derived from information that was in the register. (3) The Minister may, in writing, authorise a person to make a record of, disclose or otherwise use protected information for a specified purpose that the Minister is satisfied is in the public interest. (4) Paragraph (2)(a) does not apply to personal information to the extent that a disclosure under that paragraph would be contrary to a request in force under subsection 11(2). #### 23 Offence relating to protected information A person commits an offence if: (a) the person obtains information; and (b) the information is protected information; and (c) the person makes a record of, discloses or otherwise uses the information; and (d) the making of the record, or the disclosure or use, is not authorised by section 22. Penalty: Imprisonment for 2 years or 120 penalty units, or both. #### 24 Exception for use in good faith Section 23 does not apply to a person to the extent that the person makes a record of, discloses or otherwise uses protected information in good faith and in purported compliance with section 22. > Note: A defendant bears an evidential burden in relation to the matters in this section (see subsection 13.3(3) of the Criminal Code). #### 25 Exception if unaware information is commercial‑in‑confidence Section 23 does not apply to a person if: (a) the person makes a record of, discloses or otherwise uses protected information; and (b) the information is commercial‑in‑confidence; and (c) the person does not know that the information is commercial‑in‑confidence. > Note: A defendant bears an evidential burden in relation to the matters in this section (see subsection 13.3(3) of the Criminal Code). #### 26 Exceptions relating to the person to whom the protected information relates (1) Section 23 does not apply to a person if: (a) the person discloses protected information to the person to whom the information relates; or (b) the person is the person to whom the protected information relates; or (c) the making of the record, or the disclosure or use, of the protected information is in accordance with the express or implied consent of the person to whom the information relates. > Note: A defendant bears an evidential burden in relation to the matters in this subsection (see subsection 13.3(3) of the Criminal Code). (2) Subsection (1) applies as if a reference in that subsection to the person to whom the protected information relates includes a reference to the person’s legal personal representative if the person is incapable of managing his or her health affairs. #### 27 Exception for disclosure to person who provided the information Section 23 does not apply to a person if: (a) the person obtains protected information from another person; and (b) the person discloses that information to the other person. > Note: A defendant bears an evidential burden in relation to the matters in this section (see subsection 13.3(3) of the Criminal Code). ## Part 5—Other matters #### 28 Simplified outline of this Part This Part deals with other matters, such as civil penalties, approved forms, delegations and rules. #### 28A Civil penalty provisions Enforceable civil penalty provisions (1) Each civil penalty provision of this Act is enforceable under Part 4 of the Regulatory Powers Act. > Note: Part 4 of the Regulatory Powers Act allows a civil penalty provision to be enforced by obtaining an order for a person to pay a pecuniary penalty for the contravention of the provision. Authorised applicant (2) For the purposes of Part 4 of the Regulatory Powers Act, each of the following persons is an authorised applicant in relation to the civil penalty provisions of this Act: (a) the Secretary; (b) an SES employee, or an acting SES employee, in the Department. Relevant court (3) For the purposes of Part 4 of the Regulatory Powers Act, each of the following courts is a relevant court in relation to the civil penalty provisions of this Act: (a) the Federal Court of Australia; (b) the Federal Circuit and Family Court of Australia (Division 2); (c) a court of a State or Territory that has jurisdiction in relation to the matter. #### 29 Approved forms (1) The Minister may, in writing, approve a form for the purposes of a provision of this Act. (2) A request required by a provision of this Act to be in the approved form must be given to the person specified in the form for that purpose. #### 30 Delegation Delegation by the Minister (1) The Minister may, in writing, delegate his or her functions or powers under subsection 22(3) (about authorising disclosures etc.) to: (a) a person who holds or performs the duties of an SES Band 3 position, or an equivalent or higher position, in the Department; or (b) the Chief Executive Medicare. (2) The Minister may, in writing, delegate his or her functions or powers under: (a) section 5 (about commercial‑in‑confidence information); or (b) section 12 (about payments relating to vaccinations); or (c) section 29 (about approved forms); to an SES employee, or an acting SES employee, in the Department or to the Chief Executive Medicare. (3) In performing a function, or exercising a power, under a delegation, the delegate must comply with any directions of the Minister. Delegation by the Secretary (4) The Secretary may, in writing, delegate the Secretary’s functions or powers under section 10B or 10C of this Act to an SES employee, or an acting SES employee, in the Department. (5) In performing a function, or exercising a power, under a delegation, the delegate must comply with any directions of the Secretary. #### 31 Rules (1) The Minister may, by legislative instrument, make rules prescribing matters: (a) required or permitted by this Act to be prescribed by the rules; or (b) necessary or convenient to be prescribed for carrying out or giving effect to this Act. (2) To avoid doubt, the rules may not do the following: (a) create an offence or civil penalty; (b) provide powers of: (i) arrest or detention; or (ii) entry, search or seizure; (c) impose a tax; (d) set an amount to be appropriated from the Consolidated Revenue Fund under an appropriation in this Act; (e) directly amend the text of this Act.