Correspondence with TGA on advertising guidelines

Summary! :
No before and afters that contain scheduled substances.
New guidelines to come in the next month.

Dear Woodrow 

The TGA regulates the advertising of therapeutic goods through the administration of the Therapeutic Goods Act 1989 (the Act) and subordinate legislation. Ahpra as you would be aware, regulates Australia's registered health practitioners. Together with the National Boards, Ahpra sets standards and policies that all registered health practitioners must meet. 

Any party who advertises therapeutic goods must comply with the requirement of the Act, including health practitioners.

Advertising goods only available on prescription from a suitably qualified health practitioner to the public is prohibited under the Act including some goods regulated as medical devices that contain prescription only substances. Specifically, it is an offence against s 42DL(10) of the Act, and a breach of s 42DLB(7), to advertise therapeutic goods where the advertisement refers to substances, or goods containing substances included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard (Scheduled Substances) other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

An advertisement in relation to therapeutic goods includes any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of therapeutic goods. In this context ‘indirect intent’ is measured according to the likelihood the audience of the material would reasonably consider the information/material is intended to promote the use or supply of therapeutic goods.

Advertisements for health services are not subject to the requirements of the Act unless the advertisement also promotes the use or supply of a therapeutic good. In most cases where an advertisement for a health service refers to a therapeutic good the advertisement for a health service will also be an advertisement for a therapeutic good. Reference to Scheduled Substances must not be made in advertisements for therapeutic goods. The TGA interprets ‘references to’ in this context as including any reference that is likely to draw the audience member’s mind to a Scheduled Substance. The reference therefore does not have to be explicitly made for the provision in the Act to be invoked. For example the reference could be made by naming ingredients, trade names, specific product and colloquial names or any of their abbreviations. It could also be made by using words that the audience is likely to identify as a scheduled substance. The TGA considers that references to ‘wrinkle-reducing injections’ and the like is a reference to Scheduled Substances because consumers are likely to reasonably conclude that the goods are injectable goods only available on prescription.

Before and after photos are generally used for promotional purposes. If the photos are used to promote a service or a health practitioner’s capabilities, this is outside the TGA’s remit. However, if it is clear to the consumer that the ‘after’ photo is a result of the administration of a therapeutic good that contains a Scheduled Substance, this would be prohibited under the Act.

These limitations do not apply to advertisements for medical devices that DO NOT contain substances included in Schedule 4 of the Poisons Standard. These goods can be advertised to consumers as long as the advertisements are compliant with all the legislative provisions related to advertising therapeutic goods. 

As identified in the email from the TGA, guidance on how to promote cosmetic services compliantly in terms of the Act will be published on the TGA website soon.

I hope this clarifies any confusion – in a nutshell, in this context, the TGA has authority only in relation to the advertising of therapeutic goods. If promotional material relates solely to non-surgical (or surgical) cosmetic services and does not also promote the use or supply of therapeutic goods, it will not be within the TGA’s remit.  

Draft non-surgical guidelines

Non surgical guidelines

Use of images including ‘before and after’ images

See also False, misleading or deceptive advertising and Advertising that creates an

unreasonable expectation of beneficial treatment in the broader advertising guidelines.

6.1 Images must not be used in advertising non-surgical cosmetic procedures when the use of the

image is likely to mislead the public because the image gives the impression that it represents

the outcome of a non-surgical procedure where this is not the case. Examples of misleading

images include airbrushed, soft-filter or modified images where these modifications remove

wrinkles, smooth complexions or otherwise attempt to portray a ‘perfect’ outcome, and the use

of models or celebrities where it is not established that the model or celebrity had undertaken

the non-surgical cosmetic procedure.

6.2 Images of people aged under 18 years of age must not be used in advertising of non-surgical

cosmetic procedures.

6.3 All images used in advertising that are intended to show the outcomes of non-surgical cosmetic

procedures must include a prominent warning that the outcomes shown are only relevant for Public consultation:

6.4 ‘Before and after’ images in advertising may create unrealistic expectations and both the

‘before’ and ‘after’ images must be used responsibly to provide only realistic information about

the outcome of the non-surgical cosmetic procedure. The broader advertising guidelines list the

requirements for ‘before and after’ images in advertising. These requirements include that both

the ‘before and after’ images are genuine. In the context of non-surgical cosmetic procedures

this means the images used in advertising must be of actual patients who have had the

procedure being advertised performed by that health practitioner.

6.5 ‘Before and after’ images used in advertising must be presented so that the most prominent or

first image seen is either a combined or composite of both the ‘before’ and ‘after’ images or the

‘before’ image. Advertising where the ‘after’ image is the most prominent image may create

unrealistic expectations.

6.6 ‘Before and after’ images must be as similar as possible in content, lighting, camera angle,

background, framing and exposure, posture, clothing, and makeup. This is to ensure that the

comparisons of ‘before and after’ images are genuine and are not influenced by factors such as

the use of lighting, makeup, facial expression, clothing, or varied angles to improve the ‘after’

image.

6.7 ‘Before and after’ images used in advertising of non-surgical cosmetic procedures must not be

edited or enhanced, for example through the use of filters, retouching, grey-scaling and similar

techniques, as this can be misleading about the results of procedures by enhancing results or

minimising bruising. Registered health practitioners should also consider the timing of ‘after’

images.

When using ‘before and after’ images in advertising non-surgical cosmetic procedures

the ‘after’ image should specify how long after the procedure the image was taken.

6.8 Photographs, videos, or any other imagery used in advertising of non-surgical cosmetic

procedures must be used responsibly, for the purposes of information and/or education about

the non-surgical cosmetic procedures only. Some examples of features that are more likely to

be considered to be focused on entertainment and to trivialise non-surgical cosmetic

procedures include, but are not limited to:

a. imagery that includes music, dancing, singing, or comedic comments

b. editing that is not directed at presenting information (such as a montage of cosmetic

procedures or outcomes, and/or bodies)

c. imagery with a voice-over where the voice-over is not educative or informative.

6.9 The use and descriptions of photographs, videos and images in non-surgical cosmetic

procedures advertising must not:

a. idealise or sexualise non-surgical cosmetic procedures through the use of sexualised

images, such as poses suggestive of sexual positions, parting of legs, hands placed near

genitals or positions that imply sexual readiness, or gratuitous nudity. Other examples of

inappropriately idealised and sexualised images include, but are not limited to,

photographs, videos or images showing sexualised clothing, such as lingerie or sexual

paraphernalia, simulated undressing, such as pulling down underpants or a bra strap, oiled

bodies and similar

b. use icons, such as emojis, to indicate an emotional reaction to an image

c. use lifestyle shots, for example, images taken on a beach, poolside, on a bed, chair, in a

bedroom or hotel roomPublic consultation:

d. capture, or purport to capture, emotional reactions of patients, such as patients giving

‘thumbs up’ or crying with happiness after a non-surgical cosmetic procedure

e. be accompanied by captions or descriptions that idealise non-surgical cosmetic procedures

or minimise the risk of procedures. Examples include, but are not limited to, ‘more natural’,

‘ideal’

, ‘perfect’, ‘instant’, and similar

f. name patients or contain links to a patient’s social media or other digital media account.

6.10 Registered health practitioners must prioritise patients’ interests, dignity, and privacy ahead of

TGA Schedule 4 Advertising - IMPORTANT UPDATE FOR ADVERTISING YOUR RESULTS

update from tga.

——-

To ensure the consistent application of the legislation related to the advertising of therapeutic goods across all industry sectors, the Therapeutic Goods Administration (TGA) has updated our position on references (even in generalised terms) to cosmetic injectables in advertising.

As your members are aware, it is an offence against s42DL(10) and a breach of s42DLB(7) of the Therapeutic Goods Act 1989 (the Act) to advertise where the advertisement refers to substances, or products containing substances, included in Schedule 3, 4 or 8 (but not in Appendix H) to the current Poisons Standard.

The promotion of a health service as a means to obtain a prescription medicine is a form of advertising prescription medicines. Decisions about treatments that involve the use of prescription medicines should be made by a doctor in consultation with each individual patient. It is not legal to influence consumers about the use or supply of prescription medicines through advertising.

For the cosmetic industry this means that while the advertising of the service provided remains outside the jurisdiction of the Act, if such an advertisement refers to a schedule 4 substance or a product containing that substance (even in general terms such as wrinkle reducing injection') the advertisement will in almost all cases be considered an unlawful advertisement for therapeutic goods.

To support the consistent application of legislation related to the advertising of therapeutic goods across all industry sectors, on 18 December 2023. previously published guidance which included certain terms considered at the time to be acceptable was removed from our website.

These terms included anti-wrinkle injections' and 'dermal fillers'.

This is because these terms refer to (by drawing the audience's mind to) prescription only products. Alternatives to these references to support advertising of services remain availabie, for example:

“ our clinic can provide consultations on reducing the appearance of wrinkles “

Welcome to 2024

Some exciting updates as we head into the 2024.

National Sales Manager

Exciting Announcement: Welcoming Colleen Perriman as National Sales Manager
We are thrilled to announce the newest addition to our team, Colleen Perriman, who brings an exceptional wealth of experience, knowledge, and insight to Clinical Imaging Australia. With over 20 years of remarkable achievements in the aesthetics industry, Colleen's expertise and background as a qualified nurse, former state business manager for Teoxane, and dermal therapist uniquely position her to understand all facets of the aesthetic equation.
We are confident that Colleen's remarkable skills and deep understanding of the industry will greatly benefit our team and our clients. For any enquiries, please feel free to contact Colleen at hello@clinicalimaging.com.au. We are looking forward to the positive impact Colleen will have on our team and the outstanding contributions she will make to our company's ongoing success.

AI Enhancements

Update: Introducing AI Chat Bots!
We are thrilled to announce the arrival of our new AI chat bots! Designed to provide instant support and answers, these cutting-edge bots come equipped with a wealth of website knowledge, training resources, and technical sales information.

They are ready to assist with navigation, support requests, and training, streamlining your experience and empowering your team with quick and comprehensive solutions.

Client Portal

New resources for clients

We are excited to announce the recent launch of a comprehensive new page dedicated exclusively to our valued registered clients.

Client Portal

This innovative client portal page serves as a hub for our esteemed clients, offering seamless access to our cutting-edge Academy, dedicated Support services, as well as the latest news tailored specifically for their needs.

Creative Cloud discontinued

Embracing a New Era of Enhanced File Management

In late 2023, Adobe, the parent software company behind Lightroom Classic, announced the cessation of hosting synced files as part of its portfolio. This change presents a remarkable opportunity for us and our clients, as we transition to more secure and feature-rich platforms that offer enhanced benefits and flexibility.
Over the past nine years, our reliance on Adobe has occasionally led to frustrations for both us and our clients due to the lagging pace of features compared to competitors like Microsoft OneDrive and Google Drive. However, this development marks a positive shift as we embrace new platforms that address these shortcomings and provide several key benefits:


1. Selective Sync: With the implementation of selective sync, users gain complete control over which files they choose to download to their connected devices. This proactive approach eliminates the frustration of automatic downloads experienced with Adobe that would fill up hard drives.
2. Two-Factor Authentication: The adoption of two-factor authentication enhances security measures, instilling peace of mind for both our team and clients regarding the safety of stored files and data.
3. Effortless Integration: The seamless integration with Microsoft Outlook and Gmail for file attachments streamlines workflows, enhancing convenience and productivity for all parties involved.
4. Auto-Sync with Mobile Devices: The newfound ability for auto-sync with a range of devices, including iPads, iPhones, and Android devices, simplifies accessibility and ensures files are readily available while on the move.
By transitioning to these new platforms, we are not only addressing existing challenges but elevating our file management practices to better cater to the evolving needs of our clients. This transition signifies a significant step forward, providing an array of benefits and innovations that will enhance the client experience and streamline our operations. We are excited about the positive impact this change will bring, and we are committed to ensuring a smooth and seamless transition for all our clients.

What do we do from here?

You essentially have two options for cloud storage going forward.

We will create a new account for you in Microsoft Onedrive and migrate all your data to the new platform. You will receive new training assets and updated manuals via our Client Portal .

This will come at no additional charge to you and is included in your Service Agreement

Simply fill out the form below and our team will contact you once installed.

If you already have an IT agency managing your cloud data, they can simply assign at least 1TB of storage your email of choice and contact us on hello@clinicalimaging.com.au with the new details.

Toolbar updates November 2023 :

Consent

In a major update to patient experience and safety - we have implanted a mandatory Consent button which disables to user from shooting if the patient has not completed consent forms required by AHPRA guidelines.

6.10 Medical practitioners must prioritise patients’ interests, dignity and privacy ahead of marketing or advertising opportunities. Medical practitioners must:

a. have fully informed consent from patients, separate from the consent to surgery, to use their image in any advertising

Filter accuracy

As we prepare for our dermatology paper we have updated our filters to reflect Fitzpatrick skin types scale.

Save Metadata

As we migrate certain installs to .jpg workflow only - we have updated our software to allow for keyword tags to migrate from Lightroom Classic through to explorer windows

Fresh Webinar

As part of our partnership with Fresh clinics we are excited to present our first Webinar :

Build Your Own: https://app.freshclinics.com.au/org-owner/product/64dc106e38e59a0864234bfd
Beginners Photography Package: https://app.freshclinics.com.au/org-owner/product/64b74e099516a5fd25fd020b

Skin Filters

In 2014, I first encountered a UV woods lamp and noted its potential for replication through the utilization of raw photography data acquired from a calibrated camera under specific conditions.

In 2017, we established computer code to extract this acquired data, incorporating an analysis of both photo damage and vascularity. Over time, this development has proven to be an invaluable tool for dermatologists, dermal therapists, and injectors in their examination of patient skin.

Although "skin health" is not a concept that immediately springs to mind for most patients, it is, in fact, the fundamental purpose for capturing these images – to document the skin's overall health.

This documentation includes aspects such as its luminosity, plumpness, and degree of wrinkling, which can all be effectively showcased using these filters.

Our Melanin filter is specifically designed to display the concentration of melanin within the epidermis, while our vascular filter highlights areas where blood vessels are located closest to the skin's surface.

Conditions that can be showcased :

Solar keratosis

Photoaging 

Hyper pigmentation 

Rosacea 

Melasma 

Dermatitis 

Acne

Vitiligo 

Ketatosis Pilaris ( Woodrow has this not fun! ) 

Eczema 

Hypertrophic scarring 

Rhinophyma

Spider Veins

Varicose veins

The cost of poor data management.

The Power of Cloud: Enhancing Efficiency and Safeguarding Patient Data
As we embark on a new era of technological advancement and innovation, we are thrilled to announce that starting from 2024, Clinical Imaging Australia will be transitioning to cloud-only databases, with a particular focus on partnering with Office365 and Sharepoint, while gradually moving away from Adobe Creative Cloud. This strategic move represents a significant leap forward for our organization and, more importantly, for the quality of patient care.

The cloud, with its vast array of capabilities and opportunities, holds immense potential for revolutionizing the healthcare industry. One of the most remarkable advantages lies in its ability to streamline patient flow and optimize operational efficiency. Gone are the days of cumbersome, physical servers that required constant maintenance, updates, and backups. Instead, our systems will now seamlessly connect to the cloud, allowing for instant access to patients' medical records and imaging data whenever and wherever needed.
By embracing the cloud, we can bid farewell to the nightmares we have witnessed over the past decade. Horror stories of crashing servers, incidents of staff misconduct, and heart-wrenching breaches of patient confidentiality will become relics of the past. We cannot emphasize enough how crucial it is to ensure the safety and security of sensitive medical information.

The recent Medibank private incident in 2022 serves as a stark reminder that even the largest organizations can fall victim to scams and breaches, highlighting the urgency for change.

Our transition to cloud-only databases brings with it an unparalleled level of data safety. By entrusting renowned platforms such as Office365 and Sharepoint, we can rest assured that industry-leading security measures and protocols are in place to protect against potential threats. From encryption to multi-factor authentication, our systems will be fortified, leaving no room for compromise.

Moreover, the cloud offers a revolutionary approach to cataloging and organizing patient data. We understand the importance of efficient retrieval and analysis of medical records, which is why we have developed a system that leverages valuable information. By categorizing patient data, such as their name, date of birth, and the capture date of specific procedures, along with relevant keywords like "filler" or "lips," we have created a comprehensive and intuitive search function. This feature allows our medical professionals to access patient information instantaneously, empowering them to make swift, accurate diagnoses and provide the highest level of care.

As Clinical Imaging Australia embraces cloud-only databases, we embark on a journey towards a future defined by efficiency, safety, and excellence in patient care. The cloud has become the cornerstone of our operations, promising seamless integration, enhanced security, and significantly improved patient flow. We invite you to embrace this shift with us and look forward to witnessing the transformative impact it will have on our organization and, ultimately, the lives of our cherished patients. Together, we can redefine the meaning of advanced healthcare delivery.

The importance of ongoing training.

Continuous training is crucial in all industries, but particularly in a clinical setting. Through my years of experience, I have observed that clinicians may occasionally adopt a "casual" attitude towards their photography, disregarding the gravity of the task at hand.

Furthermore, the frequent turnover of staff poses its own challenges, as we invest time and effort into training our initial team, only to have new members join without proper onboarding. This worst-case scenario not only reflects poorly on our products, but also directly impacts the overall patient experience.

Dr Lee Walker utilising an our system at Teoxane Training academy, Sydney Australia.

To address these issues, in early 2023, we proudly launched our new training Academy at www.clinicalimaging.com.au/orientation