As part of its regulatory review of software and AI-based medical devices, the administration wants to hear from developers and users.
The Therapeutic Goods Administration is seeking input on digital mental health tools as part of its review of regulations that apply to software-based medical devices.
It’s doing it via its Digital Mental Health Tools Regulatory Environment survey which is open until 1 December.
“There is growing interest in using software and artificial intelligence in healthcare delivery, including where it is used to support people with mental health conditions,” said the TGA’s announcement.
“[The TGA] is reviewing the regulations that apply to software-based medical devices – including digital mental health tools – that are used to screen, diagnose, monitor and/or treat patients experiencing mental health conditions.”
The survey is collecting information about:
- types of DMHTs available;
- intended user groups;
- mental health conditions DMHTs are used for; and
- functions performed by DMHTs.
The TGA wants to hear from people and organisations who are involved in the development of DMHTs, supplying DMHTs for other people to deploy, or deploying DMHTs for use through publicly available platforms like app stores, websites or in healthcare settings for use by professionals.
There was no mention of evaluating the outcomes of DMHT use as a treatment.
The TGA is also seeking public submissions as it updates chapter one of its Good Manufacturing Practice Guidelines, which deals with the pharmaceutical quality system.
The Pharmaceutical Inspection Co-operation Scheme updates include revision of the chapter to incorporate changes introduced in ICH Q9(R1) on Quality Risk Management, and additional guidance for the conduct of product quality reviews.
These updates have been developed by a joint PIC/S and European Medicines Agency Inspectors Working Group.
The TGA wants to hear from Australian manufacturers of therapeutic goods, including active pharmaceutical ingredients and sunscreens intended for human use. The updates do not apply to blood products, certain cell therapies or biologicals containing live animal material.
The PIC/S has requested that feedback is submitted via peak bodies or via a survey. Consultations close on 3 December.
IHACPA releases consultation paper
The Independent Health and Aged Care Pricing Authority has released a consultation paper on The Future of IHACPA Classifications.
The classifications underpin activity-based funding and are instrumental in enabling consistent reporting, performance measurement, health service research and clinical information management.
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Related
The International Statistical Classification of Diseases and Related Health Problems, 11th revision, is a clinically current and modern digital classification.
The consultation covers many areas related to the implementation of ICD-11, including:
- implications for current development of the International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Australian Modification (ICD-10-AM);
- impact on Australian Refined Diagnosis Related Groups and other ABF classifications that use ICD-10-AM; and,
- opportunities to align and integrate IHACPA’s classifications.
“We will use the feedback gathered to (a) understand stakeholder views on the implementation of ICD-11; (b) identify any risks, challenges or support required in implementing ICD-11; (c) ensure IHACPA’s classifications continue to meet the needs of Australia’s healthcare system; and (d) seek feedback on opportunities to align IHACPA’s classifications using ICD-11,” said the authority.
Submission can be made via email to submissions.ihacpa@ihacpa.gov.au or via the survey. Submissions close on 7 November.
