A two-year transition period is planned before the new Medical Products Bill takes effect, which will regulate software as a medical device - including artificial intelligence used for therapeutic purposes.

Tim Vines, manager, therapeutics, strategy, policy and legislation, Ministry of Health, told the MTANZ Conference on June 30 that all essential policy decisions have now been made and that drafting instructions are to be issued this year, but the bill will not be introduced to Parliament before the November election.

The Ministry's indicative timeline is to introduce the bill to Parliament in early 2027. It would then go to the Health Committee for a public consultation process of around six months and could be passed by Parliament by the end of 2027.

A two-year transition period is planned before the law comes into force to allow secondary legislation to be developed, for Medsafe to prepare operationally, and for any necessary IT systems to be put in place. 

Vines said that the bill will regulate software that has a therapeutic purpose, including uses of AI.

Things like patient management software, e-prescribing systems, and AI note-taking scribes are not intended to be regulated as medical devices. 

However, if software moves beyond note-taking into suggesting diagnosis or treatment options, it would be considered to have a therapeutic purpose and would likely be captured under the new regulatory framework.

Vines told the audience that AI is an emerging field and that ongoing discussions with the sector will be needed to determine how New Zealand balances support for innovation against patient safety considerations. 

He said the new bill also extends the regulation of clinical trials to medical devices, a change from the current framework under the Medicines Act, and that this will need to reflect the differences between medicine trials and the typical product development cycles for medical devices.

Image: Tim Vines, manager, therapeutics, strategy, policy and legislation, Ministry of Health speaking at MTANZ Conference 2026

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The rapid rise of connected medical devices such as continuous glucose monitors and smartphone apps that control insulin pumps is leading New Zealand's medicines regulator to rethink how patients get critical safety alerts and recall notices.

Chris James, group manager at Medsafe, told the MTANZ conference on June 30 that while digital connectivity opens new channels for reaching patients to notify them of safety issues or recalls, it also creates significant gaps that regulators and importers or manufacturers need to address.

The devices increasingly allow companies to contact patients directly through apps or through the device itself, which can assist with recalls but also introduces new uncertainties.

"How many people will get an alert and just push it without looking, how many people will just ignore an alert, how many people are not using an app when they should?" he asked.

James said the stakes are high as devices like continuous glucose monitors, which can feed data directly into insulin pumps, carry serious risks if a safety issue is not addressed. 

"With some of these devices, if you have issues, they can be very serious very quickly, so it is about trying to make sure we are getting out to every single patient who may be impacted."

Medsafe's medical device team is just three people responsible for all post-market regulation of medical devices in New Zealand. James said they rely heavily on the companies importing or manufacturing devices to communicate quickly and accurately when issues arise.

James told attendees that recall letters must be approved by Medsafe before being distributed and the regulator also expects a report back. 

He said this is becoming increasingly important as direct patient contact through apps and devices becomes more common, raising questions about how many patients were successfully reached and whether there is any ongoing risk.

Image: Chris James, group manager at Medsafe, speaking at the MTANZ conference

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A new Health Technology Evaluation Pathway and Health Technology Investment Plan aim to bring consistency and transparency to how new medical technologies are assessed and funded in New Zealand’s health system, the health minister says. 

Speaking at the Medical Technology Association of New Zealand (MTANZ) HealthTech Week 2026 conference, Simeon Brown said Health New Zealand manages around 350,000 pieces of clinical equipment nationally, with an estimated replacement value of approximately $3 billion.

Around a quarter of this clinical equipment is already beyond its recommended lifespan and much of it is unconnected.

He said the new evaluation pathway and investment plan are designed to work together to address gaps in how the country evaluates and adopts new health technologies.

"Health technologies continue to emerge with frequent requests for new technologies to be publicly funded," Brown said. 

"At the same time, obsolete technologies and outdated clinical practices can persist, while uneven access across the country means some communities miss out entirely."

Jason Power, acting director of Planning Funding and Outcomes at Health NZ said the 10-year investment plan focuses on clinical equipment and devices and is being developed alongside Pharmac.

He said the pace of decision-making is not keeping up with how quickly the technology environment moves and a central goal of the plan is scaling proven technologies more quickly across the system. 

"We pilot, we trial, but how do we get scalability urgent and quickly?" Power asked.

Remote monitoring and telehealth also feature prominently in the plan, particularly for rural and hard-to-reach communities.

Power said Health New Zealand is encouraging industry to engage early in the process as the organisation wants to partner around emerging technologies.

Working groups are being established between Health New Zealand and Pharmac, with industry representatives expected to play a key role in shaping the new technology evaluation and funding framework.

Brown said the new Medical Products Bill, replacing the Medicines Act, will allow most devices to rely on approvals from overseas regulators to be approved in New Zealand.

The bill will also apply to some health software defined as ‘software as a medical device’, in a way that “supports rather than stifles innovation”, he said.

Image: Health Minister Simeon Brown

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Healthpoint has launched a free AI-assisted service navigation tool that helps New Zealanders find health services by describing what they need in their own words.

‘Ask Healthpoint’ uses Healthpoint's directory of 12,000 verified health services to return specific, locally relevant results such as opening hours, contact details, and whether an appointment is needed.

"It is one of the first of its kind," says Healthpoint chief executive Kate Rhind. 

"It is built to search through the trusted national health data on Healthpoint. It has been rigorously tested by both end users and service providers over the past 12 months. It is free, available now, and can be used in multiple languages."

The tool is designed for people who may not know the right clinical term or where to start. Ask Healthpoint identifies which types of services match what someone has described and presents a curated list of nearby options with practical details.

"A person could simply say or type something like 'I have a sore ear' and Ask Healthpoint will provide available options in the area," Rhind explains. 

The tool was developed over 12 months with 25 rounds of testing across more than 600 real-world scenarios, including sensitive areas such as mental health and emergency care. 

Associate health minister and minister for mental health Matt Doocey says it addresses a well-documented barrier to care. 

"Not knowing where to go or who to talk to has been reported as the reason for unmet mental health needs in one third of children and more than a quarter of adults. This new platform will help remove those barriers and guide people to the right support," Doocey says.

The tool supports te reo Māori, Samoan, and many other languages and Healthpoint says language recognition will keep improving over time.

"Ask Healthpoint is a navigation tool, not a replacement for your doctor, nurse, or helpline," Rhind says. 

"Its goal is to make it even simpler to find a health service that can help you, no matter the time of day, no matter the type of health concern, even if you don't understand medical terms or English is not your first language."

For people in rural and smaller communities, Healthpoint says the tool can make a meaningful difference by surfacing options such as online GP consultations, pharmacies, helplines, and community health providers that people may not have known were available to them.

Organisations can embed the tool on their own websites as a widget, integrated with a single line of code. 

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Health organisations should start mapping how they collect patient information indirectly now, in preparation for compliance with the new Rule 3A of the Health Information Privacy Code, says Privacy Commissioner Michael Webster.

Speaking at the Future of Healthcare in Aotearoa Conference on June 25, he also said health organisations need to be sure of where patient data ends up before rolling out AI tools, saying sensitive health information could be feeding into AI training models without patient knowledge and consent.

Rule 3A came into force on May 1 as part of the Privacy Amendment Act and directly affects how health organisations handle information gathered from third parties, including referrals, other health agencies and external platforms.

Webster talked about health organisations creating an “information map” showing how they are collecting and receiving information and the need to notify patients about it.

"That might be as simple as having signage up at your business that notifies people of how information will be passed on and collected," he said. 

"Underneath that, the full description of what might happen can be found online."

An exception to Rule 3A is if an organisation has reasonable grounds to believe someone else has already notified the patient but Webster said that belief needs to be backed by evidence, not assumption.

When asked about AI he said the key concern is ensuring that confidential patient conversations do not end up training the large language models that underpin the tools clinicians rely on.

Webster recommended organisations do a privacy impact assessment before deploying any significant new AI tool, treating it as standard due diligence to understand what the tool does and how it handles data.

He noted that a cybersecurity advisory issued recently flagged increasing cyber threats driven by AI and said health organisations should start treating a data breach as an ‘when not if’ event.

He spoke about four privacy law reform priorities his office is advocating for which are; the right to erasure; financial penalties for serious breaches; stronger accountability provisions requiring organisations to publicly disclose their privacy practices; and oversight requirements for automated decision-making systems

A fifth priority has come from the Managed My Health inquiry, which involves extending liability for security failures to third-party service providers.

The Office of the Privacy Commissioner has published detailed guidance on Rule 3A, including worked examples, through its Poupou Matatapu resource hub. 

Image: Privacy Commissioner Michael Webster

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Health NZ has extended the timeline for rolling out the Shared Digital Health Record, citing the need to do security and due diligence checks before patient data can be shared.

This follows three major data breaches affecting New Zealand health providers in the space of three months.

Immunisation and medication data, originally expected to be available through the Shared Digital Health Record earlier in 2026, is now expected to be shared later in the year. 

Primary care data has also been pushed back with clinician access now expected from mid-2027, rather than mid-2026.

An update from Health New Zealand links the delay to requirements under the Government Digital Delivery Agency's (GDDA) Information Sharing Standard, which it must comply with before sharing personal information with third parties, including primary care practices and clinics.

Health NZ says that four steps must be completed before data sharing can start; an information sharing and security awareness initiative, due diligence checks, signing of the Health NZ Information Access and Use Agreement, and patient notification about the new data service.

The New Zealand health sector has recently suffered what one expert described as a “feeding frenzy” pattern of cyberattacks. Three breaches; at ManageMyHealth, MediMap, and Auckland-based private healthcare provider IntraCare, occurred within three months of each other in late 2025 and early 2026.

The ManageMyHealth breach was detected on 30 December 2025, MediMap was compromised in February 2026, and IntraCare detected unusual activity within its IT environment on 20 March 2026.

In response, Health NZ is rolling out an information sharing and security awareness initiative running from the end of June to August 2026. The initiative is aimed initially at Primary Health Organisations (PHOs) and their primary care practices, as well as providers of telehealth, urgent care, and after-hours services.

Support available includes webinars, a security checklist, quick reference guides, learning modules, a central online hub, regional workshops with PHOs, and targeted support for practices as requested. 

A Security Checklist for health service providers, developed in collaboration with General Practice New Zealand (GPNZ), is based on the National Cyber Security Centre's Minimum Cyber Security Standards and aligned to the Cyber Security Capability Maturity Model (CS-CMM). Organisations wanting to share information with Health NZ must meet at least CS-CMM Level 2, described as the "Baseline" rating.

The checklist covers ten standards, including risk management, security awareness, asset management, secure configuration, patching, multi-factor authentication, detection of unusual behaviour, least privilege access, data recovery, and response planning.

Once due diligence is complete, Health NZ will sign an Information Access and Use Agreement with health service providers, and a separate agreement with IT vendors.

Health NZ describes the initiative as a collaboration rather than a compliance exercise where the organisation is looking to “partner with providers to build confidence, capability, and consistency across the system”.

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