{"id":"F2025L00081","name":"Private Health Insurance (Medical Devices and Human Tissue Products Levy) Regulations 2025","slug":"private-health-insurance-medical-devices-and-human-tissue-products-levy-regulations-2025","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":105859,"registerId":"commonwealth-F2025L00081-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This instrument is the Private Health Insurance (Medical Devices and Human Tissue Products Levy) Regulations 2025.","sortOrder":0},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"#### 2 Commencement\n\n (1) Each provision of this instrument 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.\n\n```html\n

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this instrument

The day after this instrument is registered.

6 February 2025

\n```\n\n> Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.\n\n (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under the Private Health Insurance (Medical Devices and Human Tissue Products Levy) Act 2007.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n> Note: The expression human tissue product, used in this instrument, is defined in the Act.\n\n In this instrument:\n\n> Act means the Private Health Insurance (Medical Devices and Human Tissue Products Levy) Act 2007.","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Levy amount imposed for ongoing listing of listed items","content":"#### 5 Levy amount imposed for ongoing listing of listed items\n\n For the purposes of subsection 4(3) of the Act, the amount of the levy for the financial year starting on 1 July 2025 is $355.","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Exemptions from levy","content":"#### 6 Exemptions from levy\n\n For the purposes of subsection 5(5) of the Act, human tissue products are exempt from levy.","sortOrder":5}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This regulation appears to serve its original narrow purpose: setting the annual levy amount and exemptions under the parent Act. There is no evidence of scope creep — it does exactly what the enabling Act contemplates (setting the levy amount for a specific financial year and specifying exemptions)."},"complexity_factors":["Extremely short instrument — only 6 sections","Minimal defined terms — only 1 ('Act') plus a note referencing another definition in the parent Act","No cross-references beyond basic references to the parent Act (subsections 4(3) and 5(5))","No conditional logic, exceptions, or nested provisions","Straightforward operative provisions: one sets a dollar amount, the other creates a blanket exemption","Standard commencement and authority provisions using boilerplate language"],"plain_english_summary":"This regulation fixes the fee (levy) at $355 for 2025–26 that private health insurers must pay to keep each listed medical device on government coverage schedules, while explicitly exempting human tissue products from the charge. It affects insurers (who fund the listing system) and indirectly consumers (through potential premium impacts), and funds administration of which items are covered."},"flash_summary":{"complexity_score":2,"scope_assessment":{"changed":false,"description":"The instrument does not change the scope of the levy scheme established by the Act. It only sets the levy amount for the year starting 1 July 2025 and declares human tissue products exempt; liability, collection methods and definitions remain those provided in the Act (regs 3–6)."},"complexity_factors":["Very short instrument — two substantive decisions: a numeric levy and an exemption (regs 5–6).","Relies on the primary Act for liability, collection mechanics and the definition of 'human tissue product' (regs 3–4); determining who pays requires consulting the Act.","Fixed single-year numeric figure ($355) reduces interpretative complexity but requires administrative updates and notifications to affected parties (reg 5).","Commencement is immediate (the day after registration), imposing an administrative timing constraint for implementation (reg 2).","Minimal ministerial or administrative discretion contained within the instrument; no new procedural or reporting regimes created.","Compliance burden is concentrated on administrators and those already within the Act’s remit rather than introducing broad new obligations (regs 3,5,6)."],"plain_english_summary":"These Regulations fix the medical devices and human tissue products levy for the financial year starting 1 July 2025 and specify that human tissue products are exempt. Mechanically, they set the levy amount at $355 and take effect the day after registration. The Rules operate under the existing Private Health Insurance (Medical Devices and Human Tissue Products Levy) Act 2007 and therefore affect persons and items subject to that Act’s levy and its collection and compliance arrangements."}},"importantCases":[],"_links":{"self":"/api/acts/private-health-insurance-medical-devices-and-human-tissue-products-levy-regulations-2025","history":"/api/acts/private-health-insurance-medical-devices-and-human-tissue-products-levy-regulations-2025/history","analysis":"/api/acts/private-health-insurance-medical-devices-and-human-tissue-products-levy-regulations-2025/analysis","conflicts":"/api/acts/private-health-insurance-medical-devices-and-human-tissue-products-levy-regulations-2025/conflicts","importantCases":"/api/acts/private-health-insurance-medical-devices-and-human-tissue-products-levy-regulations-2025/important-cases","documents":"/api/acts/private-health-insurance-medical-devices-and-human-tissue-products-levy-regulations-2025/documents"}}