TGA medical device changes – guidance for health care professionals
A new regulatory framework for custom-made medical devices and 3D printing commenced on 25 February 2021.
What does this mean for allied health care professionals?
Join this presentation and hear about the regulatory changes from Rebecca Bateson of the Therapeutic Goods Administration. Rebecca will be providing:
- The background around the regulatory environment for medical devices
- An overview of the changes
- Specific examples demonstrating the impact of the new framework
- Information about the deadlines and transition periods for impacted devices
- Next steps for impacted stakeholders
Executive staff members from Australian Physiotherapy Association (APA), Dan Miles, Occupational Therapy Australia (OTA), Samantha Hunter and Australian Hand Therapy Association (AHTA), Wendy Rowland, will also be part of the webinar and will help to facilitate the session with the TGA to help two way communication for the changes. A Q&A session will follow the presentation.
Preparation for the webinar
In order to get the most out of the session, it is recommended that all participants read through:
• The overview of the framework on the TGA's website; and
• Answers to frequently asked questions
If there are some examples that would be useful to raise at the session, please feel free to email them to policy@australian.physio or raise them at the webinar.
Event location
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Australian Physiotherapy Association Privacy Policy
Our Commitment to Your Privacy
Your privacy is very important to the Australian Physiotherapy Association (APA). As part of the normal operation of the APA’s website, the APA may collect certain information from you. This privacy policy details what information the APA collects, how it uses that information and what your rights are regarding any information collected by APA. The APA is subject to certain requirements of applicable Australian, United States and Canadian law and strives to meet the requirements of the Australian Privacy Principles and the applicable United States and Canadian privacy laws.
The APA sustains your right to nondiscrimination with respect to the exercise of your rights under this policy all applicable law.
Your information and Your Right to Privacy
You can elect to provide the APA with as much or as little information as you choose although the APA requires a minimum set of information from you in order to provide you with access to the APA’s website. What you provide is your choice.
The APA will under no circumstances sell, rent, release, disclose, disseminate, make available, transfer or otherwise communicate orally, in writing, or by electronic or other means, your personal information to a third party for monetary or other valuable consideration. The APA has partnerships with commercial organisations and those partners will, from time to time, request that the APA send information to people on the APA database as part of the partnership. Any APA or partner information is sent by the APA and data is not provided to any third party unless required by law.
The APA may disclose personal information to the following service providers to satisfy standard operating procedures of the APA and to the best of its knowledge, the APA has entered into written contracts with those service providers to limit the use of personal information by those service providers to the business purpose of those contracts:
- IT and website service providers
- Marketing and communications agencies
- Agencies that conduct member surveys on our behalf
- Mailing houses
- Printers that print and distribute our publications and marketing material
- Lingel Learning – hosting of the APA’s online CPD services
The APA will update the above list of service providers as and when required and from time to time.
By using the APA’s website and the APA’s services (as defined below), you acknowledge and accept that the APA will use your personal data as set out in this privacy policy. If you do not accept this privacy policy, please immediately stop using the APA’s website and/or the APA’s services or any part of them. In these circumstances, you will not be able to register or purchase anything further using the APA’s website.
For the purposes of the clause above, the APA’s services are defined as the services provided by the APA in relation the following areas:
- APA’s Membership
- Professional Development Education materials
- Conference related activities
- APA’s Resource materials
- Employment via vacancy advertising
- Membership benefits via third party providers
The APA is the controller responsible for your personal data. It has appointed a privacy officer who is trained and is responsible for overseeing issues of privacy. If you have any questions about this privacy policy, including requests to exercise your legal rights relating to this policy, please contact the privacy officer at privacy@australian.physio. Records of your requests will be maintained by the APA.
The APA’s website may include links to third-party websites, plug-ins and applications. Clicking on those links or enabling those connections may allow third parties to collect or share data about you. The APA do not control these third-party websites and are not responsible for their privacy statements. The APA strongly recommends you read the privacy policy of every website you visit.
The APA adheres to the principles set out in data protection law when handling personal information and data. These principles require personal information and data to be:
- Processed lawfully, fairly and in a transparent manner
- Collected and used only for specified, explicit and legitimate purposes that are compatible with previously disclosed purposes, unless first providing you with notice and obtaining your consent otherwise. The limited sensitive information collected by the APA under this Privacy Policy will not be used or disclosed for a secondary purpose unless the secondary purpose is directly related to the primary purpose of collection and within your reasonable expectations
- Adequate, relevant and limited in collection to what is necessary and in relation to the purposes for which it is processed
- Accurate and, where necessary, kept up to date
- Not kept in a form which permits identification of data subjects for longer than is necessary for the purposes for which the data is processed
- Processed in a manner that ensures its security using appropriate technical and organisational measures to protect against unauthorised or unlawful processing and against accidental loss, destruction or damage
- Not transferred to another country without appropriate safeguards being in place
- Made available to data subjects and to allow data subjects to exercise certain rights in relation to their personal data
The APA is also responsible and accountable for ensuring that it can demonstrate compliance with the data protection principles listed above.
Collecting Information
The APA may collect, use, store and transfer different kinds of personal data about you. It collects and process personal data about you when you:
- Access and use the APA’s website and the APA’s services
- Register an account on the APA’s website
- Leave a comment on the APA’s website
- Place an advertisement on the APA’s website
- Buy a product through the APA’s website
- Make an enquiry about a particular product on the APA’s website
- Submit a general enquiry to the APA’s website
- Enter a competition on the APA’s website or otherwise with the APA
- Create a wish list on the APA’s website
- Subscribe to the APA’s digital newsletter
- Leave your feedback or review on the APA’s website
- Manage your marketing preferences with the APA
- Make a payment through the APA’s website
In addition to the other information mentioned in this policy, the APA may hold the following information about you:
- Name, address, telephone number(s)
- Whether you are of Aboriginal or Torres Strait Islander descent
- Date of birth
- Email address
- Educational qualifications
- Occupation
- Transaction details associated with services we have provided to you
- Additional information provided by the APA to you
- Information you have provided to the APA via client surveys
The only sensitive information the APA will collect about you is whether you are of Aboriginal or Torres Strait Islander descent. The APA will not collect any other sensitive information about you such as your health information and will not use the sensitive information collected for the secondary purpose of direct marketing.
The APA may also collect, use and share aggregated data such as statistical or demographic data. Aggregated data is derived from your personal data but is not considered personal data under data protection law as it does not directly or indirectly reveal your identity. For example, the APA may aggregate data about your use of the APA’s website to calculate the percentage of users accessing a specific feature. Likewise, the APA may aggregate data that it collects through your use of the APA’s website in order to produce certain benchmarking reports. However, if the APA combines or connects aggregated data with your personal data so that it can directly or indirectly identify you, the APA treats the combined data as personal data which will be used in accordance with this privacy policy.
If the APA proposes to collect information about you that you would not reasonably expect, you will be provided with “just in time” notice when that information is collected.
The information collected by us will be retained for 7 years, being no longer than is reasonably necessary for the purposes disclosed to you in this privacy policy and otherwise.
Access to Personal Information
You have the right to access, review, correct and alter any personal information that the APA stores about you. Should you wish to access this information please contact the APA’s privacy officer. Unless the access you request will require special steps or significant resources, there will be no charge for providing you with this access.
To request to change or correct your personal information you must login to your account with your unique login and password via the APA website.
If you would like to request for:
- specific pieces or categories of information which the APA has collected about you;
- the sources from which that information was collected;
- the purpose for which that information was collected; or
- deletion of any parts of your information held by the APA,
please contact the APA’s privacy officer by phoning +61 3 9092 0888 or by email privacy@australian.physio
Opt-Out
By choosing to register on the APA website or as a member of the APA, you may receive information from the APA about membership, the APA’s services, partner information and offers. The APA uses this method to communicate quickly with you. You have the right to refuse inclusion on a mailing list. You can make a request to remove your email address from a mailing list by contacting the APA’s privacy officer at privacy@australian.physio.
The APA uses your email address, your mailing address and phone number to contact you regarding administrative notices, publications, and communications relevant to your use of the APA’s website, the APA’s services and your APA membership. If you do not wish to receive these communications, you have the ability to opt out by contacting the APA’s privacy officer at privacy@australian.physio.
From time to time, the APA arranges mailings from its partners (including corporate partners and endorsed product manufacturers/suppliers) using the contact information you have provided to the APA. These mailings aim to provide you with information and benefits available to you.
If you do not wish to receive information from the APA's partners you should advise your local APA Branch or notify the APA’s privacy officer at privacy@australian.physio. For any information about privacy, please contact the APA’s privacy officer by phoning 03 9092 0888 or by email privacy@australian.physio.
Notwithstanding the opt-out option as set out in this policy, you have the right to opt-in at anytime by contacting the APA’s privacy officer by phoning +61 3 9092 0888 or by email at privacy@australian.physio
Cookies
As part of the normal operation of the APA’s website, your internet browser will be sent a "cookie" (a temporary internet file). This cookie enhances the website's functionality with features such as membership logon and electronic ordering. By itself, this cookie can only identify your computer to the APA’s server; it is not used to identify you personally.
Your personal password to access the APA website protects your privacy. We recommend that you do not disclose, share or reveal this password to any other individual.
Change of Purpose
It is not anticipated that any information will be disclosed to overseas recipients other than those in Australia in accordance with this policy. If this were to change this page will be updated.
From time to time, the APA may decide to collect different kinds of information. If and when this occurs, the APA will update this privacy policy, notify you and obtain your consent.
Privacy Enquires
You have the right to complain regarding any aspect of your privacy rights. If you have a complaint please contact the privacy officer at privacy@australian.physio or on 03 9092 0888.
APA Membership
If you decide to become a member of the APA, and we hope that you do, the APA will ask you for additional personal details. You may also opt to provide the APA with more information such as special interest areas you may have, where you are employed and your date of birth. In these circumstances, relevant information is disclosed to the public on the internet via the APA's 'Find a Physio' online searchable database only. You must approve the use of your details on this database. Whether you decide to use this APA service is your choice.
Security
Your information is stored on the APA's server located in a secure data housing facility. While, it is important to recognise that "perfect security" does not exist on the internet, the APA is committed to using industry standard mechanisms to safeguard the confidentiality of your personal information such as firewalls, data encryption and Secure Socket Layers. In addition, the APA has implemented reasonable security measures to detect fraudulent identity verification activity and to prevent unauthorised access to or deletion of personal information in order to minimise cybersecurity risk.
Credit Card Information
The APA does not permanently store credit card information including anywhere on the APA website.
APA Members Privacy
The APA has a strong commitment to protecting your privacy and ensuring the confidentiality and security of personal information provided to the APA by you. As an organisation with an annual turnover of more than $3 million, the APA is required to comply with the Australian Privacy Act 1988 (Cth) as amended by the Privacy Amendment (Enhancing Privacy Protection) Act 2012 (Cth) and as otherwise amended from time to time, and applicable United States and Canadian privacy and data protection laws.
Information you have provided to the APA is used to:
- Process applications and renewals and to update your APA membership details and profile information
- Notify APA members and the public that you have met our requirements for credentialing (e.g. specialisation or titling)
- Provide information to consumers and others on the availability of physiotherapy services
- Conduct market research in order to identify and analyse the ongoing needs of APA members
- Ensure compliance with the APA's Constitution and Regulations
- Provide you with APA publications and information
- Provide you with access to and information about current and future member benefits.
- Process applications for and continue enrolment in the CPD online and face to face courses offered by the APA
- Provide you with the ability to advertise for job vacancies
- Provide you with the APA’s Resource materials to be utilised within your Practice
Consent / Opt-In
In accepting this privacy policy, you acknowledge and agree that:
- you consent to provide your personal information to the APA; and
- by providing your personal information to the APA that the APA, its related bodies corporate and partners and each of their officers, employees, agents and contractors are permitted to collect, store, use and disclose your personal information in the manner set out in this privacy policy and in accordance with Australian, the applicable United States and Canadian privacy and data protection laws.
Automated Decision Making
The APA does not use Automated Decision Making such as “profiling” in connection with decisions related to your work performance, economic situation, health, personal preferences, interests, reliability, behaviour, location or movements (where your consent is automatically given).
Standards of Privacy
The APA has established internal policies and procedures (including an IT and cyber security policy; an information and data retention and disposal policy and a privacy complaint and investigation procedure) to administer this privacy policy and we provide awareness and training to our employees and privacy officers in relation to it. The APA updates such policies and procedures to maintain the integrity and standards required.
Contact Us
Please do not hesitate to contact the APA if you have a concern or issue in relation to how it collects, stores, uses or discloses your information and data.
If your concern relates to your APA membership or another APA service please contact us by email to privacy@australian.physio or call or mail us as follows:
Australian Physiotherapy Association
Postal address: PO Box 437 Hawthorn BC VIC 3122
Telephone: +61 1300 306 622
Facsimile: (+61 3) 9092 0899
Member Declaration
Women's Pelvic Health Level 2 - Part B
Informed Consent
The APA Women’s Pelvic Health Physiotherapy Level 2 was developed by the Australian Physiotherapy Association (APA) and Women’s Health Training Associates (WHTA).
This course is delivered through a blended learning model, and uses a mix of teaching and learning approaches with a focus on active learning and learner-centred strategies. The Australian Physiotherapy Association is committed to diversity, inclusion and eliminating discrimination. We value and celebrate people of diverse gender identity, sex characteristics and sexual orientations.
By registering for the Part B face-to-face course, you are agreeing to volunteer as a model for both vaginal examination (VE) and digital rectal examination (DRE). Please note, there are very limited places allocated for people who have a valid contraindication to VE or DRE to attend and not be required to model. Valid exclusion from being a model for the VE and/or the DRE will be considered on a case-by-case basis on receipt of a request prior to the course.
A valid reason to not model for the vaginal examination practical is not necessarily a valid reason to not model for the rectal examination, and vice versa.
Valid reasons for not modelling for the VE practical include:
- first trimester pregnancy
- high risk pregnancy (eg symptomatic placenta praevia, incompetent cervix, previous premature rupture of membranes in current pregnancy)
- if you are a person who does not have a vagina
- 8 weeks postpartum with lochia still present,
- severe vestibulodynia
- an active genital herpes outbreak
Being on your menstrual period will NOT be accepted as a valid reason to not be a model for the vaginal examination practical as up to a quarter of the group are likely to have their menstrual period during the course. However, whilst virginity is not a contra-indication in clinical practice, it will be accepted as a valid reason to not model in the practicum if the participant wishes not to volunteer.
How to submit a request
The reasons for requests will be treated in strict confidence. If the request is accepted, organisers and presenters will only be informed that you are not modelling for VE or DRE. They will not be provided the reasons.
To submit a request not to model:
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Send an email that outlines:
- You are requesting to be allocated a non-volunteer place on the course
- Clearly identifies if you are requesting not to model for VE or DRE
- The reason for your request or request to speak to a presenter about your request
- Use the subject line: Women’s Pelvic Health L2 – request to not model
- Email the request to Karen.Ide@australian.physio or Joan.Condon@australian.physio
- All exemptions will be assessed by the course presenter & developer only and information will be kept confidential
IMPORTANT: For participants who have agreed to model:
It is a requirement that you notify the APA immediately in writing if your situation changes (prior to the course start date) and you cannot model. Whilst all attempts to accommodate you on the same course will be made, this cannot be guaranteed due to the need to have sufficient models on the course for the required learning.
APA installment policy
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10 May
Virtual Classroom View map
Non-member: $0.00
0.00: $Non-member