Medico-legal obligations

National Cosmetic Medicine Summit

4/3/17 | Kate Gillman – Head of Medico-Legal Advisory Service

Cosmetic injectables

Advertising

Privacy

Facilities

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Medico – legal obligations

Is the proposed procedure

for the dominant

purpose of achieving a

more desirable

appearance or boosting

self – esteem?

Cosmetic guidelines – do they apply?

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> Scenario 1 – Dr D’s nurse sees the patients, orders

the medications and administers

> Scenario 2 – Dr D is asked by a nurse in a country

town to sign off “standing orders” for patients she

has seen in her beauty therapy business. She has

been through the consent process and sends the

forms to Dr D. He is paid for each standing order

signed.

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Cosmetic Injectables

> Major

> Does it involve involve cutting

beneath the skin?

– breast augmentation

– breast reduction

– rhinoplasty

– surgical face lifts

> liposuction.

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> Minor

> It does not involve cutting

beneath the skin, but may involve

piercing the skin:

– non-surgical cosmetic varicose

vein treatment

– laser skin treatments

– use of CO2 lasers to cut the skin

– mole removal for purposes of

appearance

– laser hair removal

– dermabrasion

– chemical peels

– injections

– micro-sclerotherapy

– hair replacement therapy.

Cosmetic Injectables

Major Procedures – adults

7 day cooling off period between the patient giving informed

consent and performing the procedure.

Deposit not payable until after 7 days from giving informed

consent.

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Cosmetic guidelines – cooling off periods

Major procedure

Cooling off period of at least 3

months between patient consent

and procedure.

Patients must be referred for

evaluation to psychologist,

psychiatrist or GP

Queensland – must be in

patient’s best interests - chapter

5A - Public Health Act 2005

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Minor procedure

Cooling off period of at least 7

days.

Are there indications of

underlying psychological

problems that may make the

patient unsuitable for the

procedure?

Cosmetic guidelines – under 18 years

Consultation with doctor

required

– In person

– Skype

Not on the phone or online

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Patient remains under direct care of

doctor

Delegation of administration to

nurses

Doctor has to be contactable and

able to respond if required

Doctors and nurses require

necessary training

Cosmetic guidelines – schedule 4 injectables

> The Medical Board’s 2010

“Good Medical Practice: A

Code of Conduct for Doctors in

Australia”

“Assessing the patient, taking into

account the history, the patient’s

views, and an appropriate

physical examination…”

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> The Medical Board’s

Guidelines for Technology

Based Patient

Consultations (2012)

“Make a judgment about

the appropriateness of a

technology-based

patient consultation and

in particular, whether a

direct physical

examination is

necessary.”

Cosmetic guidelines – telehealth standards

Advertising must not:

make misleading claims

offer an inducement such as a gift or

discount (unless the relevant terms

and conditions are also included)

use testimonials or purported

testimonials about the service or

business

create an unreasonable expectation of

beneficial treatment

encourage the indiscriminate or

unnecessary use of a regulated health

service.

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Further information from Medical

Board (26 October 2016)

must not advertise health benefits of

their services when there is not

acceptable evidence that these

benefits can be achieved

any information you publish about

your services has to be factual and

verifiable

care needs to be taken using certain

words in advertising including: safe,

cure and effective

Advertising Guidelines – Medical Board

Guaranteed results – no down time

“This is the best doctor ever! I am so happy with my

surgery and his bedside manner is fantastic!”

10% discount on all procedures – limited time only, ends

December. Further 10% if you refer a friend.

Finance can be arranged.

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Advertising obligations

> Advertising Guidelines and

Social Media Policy

> Practitioners are responsible for

the style and content of all

advertising material and social

media sites

> Section 115 of the National Law

restricts the use of specialist titles

to practitioners registered in a

recognised speciality.

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> Therapeutic Goods Act

Therapeutic goods containing

prescription only medications

(schedule 4 or 8 medicines)

cannot be advertised using the

active ingredients or the trade

names of medications in

advertising.

Refer to generic phrases -

“cosmetic injections” or “anti-

wrinkle injections”.

Advertising and Social Media

> AMA Position Statement –

Advertising and Public

Endorsement

> A doctor may receive a financial

or other material benefit for

promoting health care, or non

health care, related products or

services.

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> Where a doctor recommends a

product or service in which he or

she has a financial interest, this

should be disclosed to the patient

at the time the recommendation

is made

> For example, where the doctor

recommends a product or service

that he or she is paid to publicly

endorse.

Advertising and Endorsements

Privacy Policy required - APP 1

Security of medical records –

APP 11

Right to request access to

medical records - APP12

Clinical photography

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Privacy obligations

> Applies to “eligible data breaches”

(Section 26WE).

> a reasonable person would

conclude that there is a likely risk

of serious harm to any of the

affected individuals as a result of

the unauthorised access or

unauthorised disclosure

> You must notify affected individuals

as well as the Australian

Information Commissioner, unless

an exception applies

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> The notification requirement will

be limited where remedial action is

taken that limits the potential

harm:

• action would lead a reasonable

person to conclude that the access or

disclosure would not be likely to

result in serious harm to affected

individuals, or

• action following a loss of personal

information with the result that

unauthorised access or unauthorised

disclosure of the information does not

occur.

Privacy Amendment(Notifiable Data Breaches) Bill 2016

> NSW - Private Health Facilities

Amendment (Cosmetic Surgery)

Regulation 2016- (March 2017)

> Cosmetic surgical procedures to be

performed in licensed facilities

> fat transfer more than 2.5 litres of

lipoaspirate

> liposuction more than 2.5 litres of

lipoaspirate

> South Australia - Health Care

(Miscellaneous) Amendment Act

2016

> Prescribed health services in

licensed premises

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Facilities

Cosmetic

> Visual disturbance following Botox

around eyes

> Lump from fillers on cheek

> Traumatic neuroma on forehead from

Botox

> Partial right sided weakness to face

following Botox

> Failure to discuss alternatives to

fillers

> Lack of supervision of nurses

> Ineffective treatment

> Failure to explain risks of liposuction

> DVT following liposuction

> Chemical peel scarring

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Laser

> Scarring following tattoo removal

> Ineffective tattoo removal on ankle

> Infection following laser resurfacing

> Broken capillaries on nose –scarring

> Burns to face – settings too high

> Hyperpigmentation – failure to warn

of risks

> Eye damage – lack of safety goggles

> Laser hair removal – burns,

blistering, erythema

> Failure to obtain informed consent

Cosmetic and Laser procedures – complaints

> Patient assessment and selection-

decline procedure if not in patient’s

best interests

> Informed consent process

> Clearly documented time when

informed consent is provided and

cooling off periods expire

> Written financial consent process

> Written discharge information and

follow up care

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> Ensure advertising complies with

Medical Board guidelines, Social

Media Policy and TGA guidelines

> Monitor social media sites and

remove testimonials from sites you

control

> Have a privacy policy easily

accessible for patients

> Secure medical records and retain

for 7 years (adults) / 25 years

(children)

Cosmetic medico-legal obligations

General disclaimer

The information in this presentation is general information relating

to legal and/or clinical issues within Australia (unless otherwise

stated). It is not intended to be legal advice and should not be

considered as a substitute for obtaining personal legal or other

professional advice or proper clinical decision-making having

regard to the particular circumstances of the situation.

While we endeavour to ensure that documents are as current as

possible at the time of preparation, we take no responsibility for

matters arising from changed circumstances or information or

material which may have become available subsequently. Avant

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Important notices

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