Posted: July 18 2022
ANDHealth, Australia’s leading digital health commercialisation organisation, has announced the extension of its partnership with the Therapeutic Goods Administration (TGA) to support Australia’s fast-growing digital health sector.
The extended partnership will see TGA fund ANDHealth to deliver industry-wide training to over 350 participants from the Australian digital health sector in the next 12 months. The program includes 10 virtual workshops and over 150 hours of direct one-to-one coaching for digital health SMEs seeking to navigate Australia’s Software as a Medical Device (SaMD) regulatory environment, supporting them to accelerate the commercialisation of their products.
The announcement is in response to the growing investment from global governments, pharmaceutical companies, and healthcare providers into digital health solutions, and an increased focus from regulators on the clinical claims made by these new innovations.
ANDHealth CEO and Managing Director Bronwyn Le Grice said, “Pursuing appropriate regulatory pathways can be a real strategic advantage for companies both locally and globally. Global regulators are increasingly focusing on clinical claims made by digital health products and, as with any clinical claim, it’s critical that a company has appropriate evidence to substantiate those claims. In fact, for customers and users, it’s a prerequisite that digital health products can point to their safety and efficacy.”
“Our partnership with the TGA puts Australia’s emerging digital health innovators in the best position to effectively navigate the regulatory environment and pursue clinical programs that make their ground-breaking health technologies globally marketable.”
Since September 2021, ANDHealth and the TGA have supported 192 companies to increase their understanding of regulatory requirements, including the type of evidence required when seeking regulatory approval with the TGA, when regulatory approval is not required, how to list a device on the Australian Register of Therapeutic Goods (ARTG), and the differences between Australia and other international markets.
Le Grice continued, “There has been positive progress for Australia’s digital health regulatory environment since the TGA released its draft guidance for SaMD in 2020. This established a clear regulatory path for evidence-based digital health products. Our partnership with the TGA has demonstrated that digital health companies benefit from targeted and qualified support to understand the regulatory environment in which they operate.”
Adjunct Professor John Skerritt, Deputy Secretary of Health and Head of the TGA said, “Australia is seeing a shift toward the adoption of evidence-based digital health interventions to help prevent, manage and treat health conditions. To meet this increasing demand, and set Australia’s digital health industry up for success, we must equip companies with skills to navigate the regulatory landscape of the products they are developing. We are delighted to continue our collaboration with ANDHealth to support this.”
In the first six months of the partnership, every webinar offered by ANDHealth under the partnership was booked out; 94 per cent of participants agreed that the one-on-one coaching they received increased their ability to navigate either the SaMD regulations or the regulations pertaining to their digital health solution or both; 97 per cent said the program increased their knowledge of SaMD regulation.
First Two TGA Software as a Medical Device Webinar Dates Announced – Book Now
All of our previous SaMD Regulation webinars were booked out – secure your spot now for our upcoming webinars!
Webinar 1: An Overview: SaMD Regulation by the TGA
11am – 12pm (AEST)
Wednesday 3 August 2022
Register here.
Webinar 2: SaMD Regulation for Clinical Decision Support Software Companies
11am – 12pm (AEST)
Wednesday 7 September 2022
Register here.
Direct one-to-one coaching is also available through our Office Hours – Navigating TGA SaMD Guidance program. Book here.
Apply Now for the 2022 UCSF Health Hub Digital Health Awards!
The healthcare industry’s largest award celebration is back! Apply now for the 2022 UCSF Health Hub Digital Health Awards. The winners will be announced at this year’s HLTH conference in Las Vegas. Applications close 30 July (AEST).
ANDHealth is excited to partner with UCSF | Health Hub for the 4th annual UCSF Digital Health Awards, to honour outstanding innovations in the digital health industry that are dramatically transforming the future of healthcare.
The UCSF Digital Health Awards are considered the “Oscars of Healthcare” and are one of the biggest awards events in healthcare. The Awards are supported by hospital systems, including UCSF, accelerators, incubators, innovation networks, physicians, payers, providers, and VCs.
This year, 2,000+ companies are expected to apply across 11 selected award categories, including telehealth, remote & hospital diagnostics, and patient cost savings to win a coveted trophy and recognition as the best in their category selected by an exceptional panel of thousands of healthcare innovation experts.
The quarterfinalists and finalists will be announced through a series of events leading up to the Grand Finale, which will take place at the annual HLTH Conference in Las Vegas on 14 November.
New in 2022 is the “Wilson Sonsini Rising Star” track for each category. Rising Stars are earlier stage firms – many first or pre-revenue – that show the most promise.
The application deadline is Friday 29 July 2022, at 11:59 pm PST (Saturday 30 July 2022 at 4:59 pm AEST). Learn more and apply now.
