1. The whole of this instrument

25 February 2021.

25 February 2021

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