Federal Register of Legislation - Australian Government

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Determinations/Health as made
This instrument amends the Therapeutic Goods (Excluded Goods) Determination 2018 to exclude from the operation of the Therapeutic Goods Act 1989 certain low risk software-based products.
Administered by: Health
Registered 15 Jan 2021
Tabling HistoryDate
Tabled HR02-Feb-2021
Tabled Senate02-Feb-2021
Date of repeal 12 May 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Excluded Goods) Amendment (Software-based Products) Determination 2021

I, John Skerritt, as delegate of the Minister for Health, make the following determination.

Dated 13 January 2021

Adjunct Professor John Skerritt

Deputy Secretary

Health Products Regulation Group

Department of Health

 


Contents

1  Name........................................................................................................................................ 1

2  Commencement........................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Schedules................................................................................................................................. 1

Schedule 1—Amendments                                                                                           2

Therapeutic Goods (Excluded Goods) Determination 2018                                                         2

 

 


1  Name

                   This instrument is the Therapeutic Goods (Excluded Goods) Amendment (Software-based Products) Determination 2021.

2  Commencement

             (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.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this instrument

25 February 2021.

25 February 2021

Note:          This table relates only to the provisions of this instrument as originally made.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.

             (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.

3  Authority

                   This instrument is made under section 7AA of the Therapeutic Goods Act 1989.

4  Schedules

                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1Amendments

Therapeutic Goods (Excluded Goods) Determination 2018

1  Section 4

Insert:

health professional has the same meaning as in the Medical Devices Regulations.

Medical Devices Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.

serious, for a condition, ailment or defect, has the same meaning as in the Medical Devices Regulations.

serious disease has the same meaning as in the Medical Devices Regulations.

2  Schedule 1 (after table item 14)

Insert:

14A

software that is:

(a)   intended by its manufacturer to be used by a consumer for the self-management of an existing disease, condition, ailment or defect that is not a serious disease or serious condition, ailment or defect; and

(b)   not intended by its manufacturer to be used:

(i)      in clinical practice; or

(ii)     in relation to a serious disease or serious condition, ailment or defect; or

(iii)    for the purpose of diagnosis, treatment, or making a specific recommendation or decision about the treatment, of a disease, condition, ailment or defect that is not a serious disease or serious condition, ailment or defect

14B

software, or a combination of software and non-invasive hardware, that is:

(a)   intended by its manufacturer to be used by a consumer to promote or facilitate general health or wellness by measuring or monitoring (through non-invasive means) a physical parameter, such as movement, sleep, heart rate, heart rhythm, temperature, blood pressure or oxygen saturation; and

(b)   not intended by its manufacturer to be used:

(i)      in clinical practice; or

(ii)     for the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making a recommendation or decision about the treatment, of a serious disease or a serious condition, ailment or defect

14C

software that is:

(a)   intended by its manufacturer to be used by a consumer to improve general health or wellness by coaching, or encouraging behavioural change, in relation to personal or environmental factors, such as weight, exercise, sun exposure or dietary intake; and

(b)   not intended by its manufacturer to be used:

(i)      in clinical practice or to provide information to the consumer that would generally be accepted to require the interpretation of a health professional; or

(ii)     for the purpose of diagnosis, prognosis, or making a decision about the treatment, of a disease, condition, ailment or defect

14D

software that is:

(a)   intended by its manufacturer to be used as a patient reported outcome measures (PROMs) questionnaire or patient survey; and

(b)   not intended by its manufacturer to diagnose, screen for, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect

14E

software that is a digital mental health tool (including a cognitive behaviour therapy tool) based on established clinical practice guidelines that are referenced and displayed in the software in a manner that is reviewable by the user

14F

software that is:

(a)   intended by its manufacturer to enable communications, including the transmission of patient information, for the purposes of supporting the delivery of health services; and

(b)   not intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect

14G

software that is:

(a)   intended by its manufacturer to be used for the administration or management of health processes or facilities (including financial records, claims, billing, appointments, operating theatre management, hospital bed management, schedules, business analytics, admissions, inventory and workflow); and

(b)   not intended by its manufacturer to be used for the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making a recommendation or decision about the treatment, of a disease, condition, ailment or defect

14H

software that is intended by its manufacturer to be used for the sole purpose of storing or transmitting patient images

14I

software that is:

(a)   intended by its manufacturer to be used for the sole purpose of providing alerts to health professionals in relation to patient care; and

(b)   not intended by its manufacturer to:

(i)      replace the clinical judgement of a health professional; or

(ii)     diagnose, screen for, prevent, alleviate, treat, or make a decision about the treatment of, a disease, condition, ailment or defect

14J

software that is:

(a)   intended by its manufacturer to be used for clinical workflow management; and

(b)   not intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect

14K

software that is middleware and is:

(a)   intended by its manufacturer to connect or interface applications to an underlying operating system or another application, including by communicating or transmitting information; and

(b)   not intended by its manufacturer to:

(i)      control medical devices; or

(ii)     perform analysis, computation or logic that relates to the intended purpose of a medical device; or

(iii)    be used for the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making a recommendation or decision about the treatment, of a disease, condition, ailment or defect

14L

software that is a calculator and:

(a)   either:

(i)      uses relevant published clinical standards or authoritative sources to make calculations; or

(ii)     displays calculations and outputs in a manner that may be validated by the user; and

(b)   is not intended by its manufacturer to control the administration of a calculated dosage

14M

software, or a combination of software and hardware, that is an electronic health record (however named or described) and is:

(a)    intended by its manufacturer to be used in clinical practice by healthcare providers to collect, use, disclose and otherwise manage patient clinical data within or between healthcare facilities; and

(b)    not intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect

14N

software that is data analytics and is:

(a)   intended by its manufacturer to be used for the collection and analysis of class, group or population data; and

(b)   not intended by its manufacturer to be used for the purpose of diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation, of a disease, condition, ailment or defect in relation to individuals

14O

software that is a laboratory information management system (however named or described) and is not intended by its manufacturer to:

(a)   manipulate information or data to change, or generate new, diagnostic outputs (other than automating simple calculations or generating report comments); or

(b)   prevent, monitor, predict, make a prognosis of, treat or alleviate a disease, condition, ailment or defect