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TGA ‘stepping up’ regulation of AI scribes in healthcare | Information Age

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Australia’s Therapeutic Goods Administration (TGA) says it is “stepping up its efforts” to regulate digital scribes, including those using artificial intelligence technology, following calls for greater oversight of the software as it becomes increasingly prevalent in healthcare settings.

AI scribes typically use large language models (LLMs) to quickly transcribe and summarise discussions between patients and healthcare practitioners.

Some systems are also able to suggest potential treatments, write referral letters, make follow-up phone calls, propose billing opportunities, and draft healthcare plans.

Experts have called for advanced AI scribes to be regulated as medical devices by the TGA, given the sensitive data they handle and their ability to make medical recommendations, as Information Age reported in August.

The TGA announced on Friday it was reviewing AI scribes amid concerns some systems were introducing features “such as diagnostic and treatment suggestions”, which may need to be considered medical devices and thereby formally regulated before being sold or advertised.

While most AI scribes do not include such features yet, a TGA review published in July found software which did propose diagnoses or treatment options were “potentially being supplied in breach of the [Therapeutic Goods] Act”.

The TGA had begun responding to complaints and reports of non-compliance, it said, while also addressing “unlawful advertising and supply” of some AI scribes.

“We may take targeted action in response to alleged non-compliance,” the regulator said.

The TGA did not comment on how many complaints or reports of non-compliance it had received.

The regulator said it encouraged consumers to report concerns through its website.

Australian firms welcome regulatory scrutiny

Australian companies such as Heidi Health and Lyrebird Health have seen significant success in the AI scribe industry, amid competition from smaller providers such as i-scribe and mAIscribe — all of which were contacted for comment.

Heidi Health co-founder and CEO Dr Thomas Kelly told Information Age his team “welcome the TGA’s sharpened compliance focus”.

While Kelly said Heidi did not currently have features which would render it a medical device under the TGA definition, he said the firm would engage with the regulator “if we ever introduce features that give Heidi a therapeutic purpose”.

“Proportionate, risk‑based enforcement protects patients and ensures a level playing field for responsible developers,” he said.



Australian AI scribe company Heidi Health says its software does not yet meet the definition of a medical device. Image: Heidi Health / YouTube

Akuru, the health tech company behind i-scribe, said while its product also did not meet the definition of a medical device, it welcomed “the regulator’s latest focus on taking targeted action” against unregulated products which provided diagnostic advice or treatment suggestions.

“We know the scribing market is crowded, and unfortunately, some solutions do cross that line,” Akuru medical director Dr Emily Powell said in a statement.

“… We welcome wider regulatory guidance that empowers clinicians to make informed decisions about secure, compliant, and appropriate software.”

Adoption ‘running ahead of governance’

University of Queensland associate professor of business information systems Dr Saeed Akhlaghpour, who has studied the use of AI scribes in healthcare, described the TGA’s focus on such technology as “a positive move” given their increasing use.

“Bringing AI scribes under safety and medical-device rules gives patients greater peace of mind, reduces legal uncertainty for clinicians, and offers vendors a clearer, more predictable path to compliance,” he said.

“The reality is that adoption is already running ahead of governance — industry surveys suggest nearly half of Australian doctors are already using, or planning to use, AI scribes.

“That scale of uptake makes timely guardrails essential now, not later.”

Regulators in the United States, European Union, and United Kingdom were also “moving to treat scribe tools that go beyond transcription as clinical technologies, not just productivity aids”, Akhlaghpour said.



Akuru, the Australian company behind i-scribe, says it welcomes the TGA’s scrutiny of digital scribe software. Image: i-scribe / Supplied

Expert calls for ongoing reviews

Australian AI governance expert Dr Kobi Leins — who last month told Information Age she was turned away from a medical practice after not consenting to its use of an AI scribe — said ongoing industry-wide expert reviews and training were needed to maintain public confidence.

“Where the data goes and how it is collected and stored is critical, as implications may be profound if shared with insurers, employers, or others — and in the case of genetic and family related health, may have implications for family members not present,” she said.

Ongoing reviews of AI scribes needed to be triggered when systems were “modified, connected, or repurposed”, said Leins, who called for such reviews to analyse “cybersecurity, AI, ethical, legal, vulnerability, medical and other lenses … to capture the wide range of risks and legal compliance required”.

“Included in that review needs to be a plan for ongoing training of the medical profession as to how to use the tools effectively, including seeking consent and always providing the option to opt out,” she said.

“Ensure independent deep expertise to review, not vendor reviews … and ensure that vendors — like with cybersecurity — have the responsibility to notify of changes to systems to practitioners.”

Healthcare professionals should “regularly assess” digital scribe software before using it, including when software updates may introduce new functionality or change data protection and privacy safeguards, the TGA said in August.

Aside from complying with the TGA’s rules, AI scribes used in healthcare may also need to uphold obligations under laws such as the Privacy Act, Cyber Security Act, and Australian Consumer Law, the regulator added.





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Who Powers The AI Revolution—Tech Giants, Utilities Or Both?

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Artificial intelligence may run on silicon chips, but its real fuel is electricity. After two decades of steady demand, AI and data centers are causing electricity consumption to soar, which will require utilities and tech giants to collaborate or confront each other. Either way, the aim is for the country to quickly upgrade its network to meet this AI-driven energy surge.

Companies like Meta, Oracle, and OpenAI are building large campuses that require reliable, continuous power. This expansion is testing the capacity of a grid designed for a slower digital economy and prompting utilities, regulators, and tech firms to reconsider their roles, partnerships, and investments.

“Utilities know how to capitalize the cost of building a transformer like the back of their hand, but can’t capitalize a cloud subscription,” Elizabeth Cook of the Association of Edison Illuminating Companies told the audience during a podcast in which we appeared together. That bias toward physical assets has historically limited investment in operations, data analytics, or predictive tools.

Utilities have traditionally been low-risk, capital-heavy institutions. They invest in tangible infrastructure —poles, wires, substations—where costs can be depreciated and returns are assured. The utility industry states that its members often choose to be the first to come in second, implying they let more agile companies lead.

Tech giants can move quickly on high-risk, high-reward projects. Kim Getgen, founder of InnovationForce that hosted the podcast, notes that one hyperscaler can outspend the entire energy sector many times over—by some estimates, as much as fortyfold.

AI mega-data centers like Stargate, backed by Oracle, SoftBank, and OpenAI, are projected to generate $30 billion in annual revenue by 2028. These firms can build data centers in 12–18 months, while new power plants and transmission lines take at least five years to construct and connect. Why’s that?

Utilities make money by persuading commissions to approve capital spending, but operational investments—like grid analytics—generate lower returns. Tech companies, on the other hand, operate in a free market, giving them more flexibility to quickly allocate capital to meet fast-growing demand.

AI’s Soaring Power Demand

According to the International Energy Agency, data center electricity demand worldwide will increase by 130% by 2030. The Department of Energy’s Lawrence Berkeley National Laboratory stated that data centers used about 4.4% of total U.S. electricity in 2023 and, depending on the growth of the rest of the economy, are projected to use between 6.7% and 12% of total U.S. electricity by 2028. It cautions that this depends heavily on AI adoption rates and efficiency gains.

The U.S. faces an unprecedented challenge in expanding its grid. Jeff Weiss, executive chairman of Distributed Sun, explained during a virtual press event hosted by the United States Energy Association: “We need to triple the grid. Everything we do today takes 10 years. We need to figure out how to do it in two.” In practice, that means tripling capacity—not literally rebuilding three new grids. One-third of that new capacity will be needed just to support data centers.

Existing generation, transmission, and workforce limits create bottlenecks. Supply chains for turbines, transformers, and other essential parts are insufficient for quick expansion. Regulatory permitting and interconnection procedures, designed for slower growth, cause further delays. High-powered transmission lines, which span multiple states, are extremely difficult to construct.

Despite having speed and capital advantages, tech giants cannot simply replace utilities. They must follow the same permitting, siting, and interconnection rules. So, it doesn’t matter if you are Google or the hometown utility. Meeting with stakeholders and complying with regulators is part of the process.

“You have to deal with the same federal laws, the same citing, the same public support, and the same supply chain,” says Tom Falcone, president of the Large Public Power Council, during the USEA event. “We deal with these issues in our social construct, in the laws and regulations that we have, and we all have to comply with them.”

However, the problem persists: data centers eager to run advanced AI models urgently need power. Utilities, limited by permitting timelines, supply chain issues, and workforce shortages, rarely meet that urgency. Derek Bentley, partner at Solomon Partners, highlighted the gap at the press event: “You can build a data center in 12 to 18 months. But a new power plant takes five years, plus years more to connect.”

Hybrid Solutions and Partnerships

This isn’t just inconvenient; it’s a fundamental mismatch between the 21st-century digital economy and a 20th-century grid. Progressive utilities are, therefore, working with data centers to develop hybrid solutions.

Indeed, some data centers are colocating with natural gas or nuclear facilities, sometimes combined with renewables and battery storage to enhance scale and reliability. These behind-the-meter setups—where power is generated on-site rather than solely from the grid—are becoming more common. These partnerships enable data centers to access power quickly while maintaining grid stability.

That relieves the burden on the central network, which lowers the risk of blackouts and congestion. Still, for those data centers connected to the main grid—in front of the meter—it results in higher revenues for utilities.

“Hyperscalers are more agile than many utilities, and they are more entrepreneurial and have the capital,” says Clinton Vince, head of the U.S. energy practice at the Denton law firm, during the USEA event. “I do think utilities have been working very well with hyperscalers, although the slower utilities will be disadvantaged tremendously.”

He highlights Meta and Entergy, which are partnering in Louisiana to build major infrastructure supporting Meta’s largest and newest data center, called Hyperion. It will be powered by both fossil fuels and renewable energy.

However, the main criticism is that the regulatory system encourages stagnation. Bud Albright, senior adviser at the National AI Association, pointed out during the press event that “The regulatory format is inadequate today to do the kind of build-out that we need, whether it’s behind the meter or in front of the meter.”

Beyond formal oversight, he adds that public opinion also plays a role. Communities wary of new data centers and transmission lines must understand the broader economic and technological benefits of these projects, from jobs to national competitiveness. Utilities and tech companies must prioritize education and outreach to demonstrate the benefits of their services.

Regulation and Public Perception

Rate design is also under review. Pacific Gas & Electric, for example, requires data centers to pay initial interconnection costs and recover them later as the facility earns revenue. This method ensures costs are shared fairly and stops residential customers from subsidizing commercial loads.

“Affordability is top of mind for us,” says Karen Omelas, director of large load program management for Pacific Gas & Electric. “But we see data centers as beneficial load.”

The energy mix is shifting. Solar and battery storage are expanding rapidly. In fact, storage is becoming a crucial tool to meet peak demand, helping utilities and hyperscalers manage load efficiently. Still, reliable, dispatchable power remains essential. Natural gas fulfills much of this need, while coal is dirtier, expensive, and increasingly irrelevant for electricity production.

All of this highlights a bigger truth: the ongoing transformation is a once-in-a-lifetime event. It’s not about who has the largest balance sheet or who is the most nimble. It’s about collaboration at scale. Utilities need to adopt new tools, rethink their operational models, and partner with the very tech companies they might have once seen as rivals. Meanwhile, tech firms must accept that building computers is one thing; powering them responsibly, reliably, and safely for the masses is another.

For policymakers, the challenge remains just as urgent. Innovation in regulation, faster permitting processes, and public education are essential to prevent congestion that could impede the digital economy. Without action, the infrastructure supporting AI—and the industries it drives—are at risk. And it won’t be because of a lack of creativity or ambition, but because of slow, outdated rules.

The AI revolution isn’t just about chips or advances in machine learning. It’s about wires and power plants. It’s also about the invisible links connecting millions of servers to millions of homes. AI’s ultimate limitation is less about computer intelligence and much more about how fast the grid can expand.



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AI in Hydrogen Operations: Powering the Future of Clean Energy

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The global energy landscape is undergoing a dramatic transformation, and hydrogen is emerging as a cornerstone of the clean energy revolution. But producing, storing, and transporting hydrogen safely and efficiently is no small feat. Enter artificial intelligence (AI), a technological ally that is revolutionizing the way industries manage hydrogen operations. From optimizing production processes to enhancing storage safety and streamlining logistics, AI is redefining what’s possible in the hydrogen sector.

Rising Momentum for AI in Hydrogen

The AI in hydrogen operations market is gaining rapid traction worldwide. Climate concerns, the expansion of green hydrogen facilities, and significant research and development efforts by leading nations are fueling this growth. AI technologies such as machine learning, predictive analytics, digital twins, and automation are being integrated across hydrogen production, storage, and transportation to enhance operational efficiency, safety, and cost-effectiveness.

Europe currently dominates this market, holding 37.1% of the global share in 2024, thanks to stringent decarbonization policies and government-backed initiatives like the EU Hydrogen strategy and the European Green Deal. Meanwhile, Asia Pacific is poised to witness the fastest growth, driven by ambitious projects in countries like India, China, and Japan targeting carbon neutrality through hydrogen adoption.

Key Trends Shaping the Market

Safety & Reliability Through AI: Hydrogen is highly volatile, making safety a top priority. AI-powered monitoring systems can predict equipment failures and detect leaks in real time, minimizing downtime and financial losses. Hybrid models combining fluid dynamics and machine learning are increasingly used to predict leak behavior and prevent accidents.

Optimized Supply Chains: AI streamlines the complex logistics of hydrogen distribution. By analyzing data on transportation routes, geographical factors, and economic considerations, AI identifies the most efficient and cost-effective paths from production facilities to end-users.

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Driving Forces Behind Market Growth

High-Performance Electrolysers: AI optimizes electrolysers — essential for producing green hydrogen from renewable energy. By analyzing real-time sensor data such as temperature, current density, and pressure, AI dynamically adjusts operations for maximum efficiency. Companies like Honeywell are introducing AI-powered solutions like Protonium to make green hydrogen production scalable, cost-effective, and energy-efficient.

Increasing Hydrogen Production: AI’s predictive capabilities help maximize hydrogen output while minimizing waste and energy consumption. From detecting leaks to optimizing storage and transportation, AI opens doors to safer, more efficient, and cost-effective hydrogen operations globally.

Technology Spotlight

Machine Learning & Deep Learning: Dominating the market with a 28.5% share in 2024, ML algorithms analyze vast datasets to improve electrolysis efficiency, accelerate catalyst discovery, and reduce energy consumption.

Digital Twin Technology: Expected to grow at the fastest rate, digital twins simulate entire hydrogen plants, allowing operators to optimize operations and anticipate challenges before they arise.

Applications & Deployment

Hydrogen Production Optimization: AI-driven optimization remains the largest application segment, enhancing energy efficiency, reducing waste, and supporting sustainable hydrogen production.

Hydrogen Storage Management: The fastest-growing segment, AI ensures safe and efficient storage, a critical factor given hydrogen’s volatile nature.

Cloud & Hybrid Deployment: Cloud-based solutions dominate due to scalability and cost-efficiency, while hybrid deployments are gaining momentum for their flexibility, speed, and security.

End-Use Industries

The energy & power sector is the largest adopter of AI-powered hydrogen operations, leveraging AI for predictive maintenance, grid stability, and renewable energy integration. Meanwhile, transportation & mobility is the fastest-growing segment, where AI optimizes hydrogen refueling logistics, ensuring safety and cost-effectiveness.

Global Market Insights

Europe: Strong decarbonization policies and government incentives drive Europe’s leadership in AI-powered hydrogen operations.

Asia Pacific: Ambitious national programs in India, China, and Japan are accelerating growth, targeting millions of tons of green hydrogen production and carbon neutrality by 2030-2060.

Spotlight on Innovation

Recent developments highlight AI’s transformative impact. In July 2025, the world’s largest green hydrogen and ammonia facility was launched in China, fully powered and managed by AI-based renewable energy systems, producing 320,000 tons of green ammonia annually. Similarly, researchers at the University of Toronto leveraged AI to discover new alloys, enhancing the efficiency and affordability of hydrogen production.

Leading Players in the Market

Key companies driving innovation include IBM, Microsoft, Google, Amazon Web Services, Siemens Energy, Schneider Electric, Honeywell, ABB, Rockwell Automation, and Tata Consultancy Services, among others. These players are combining AI, digital twins, and predictive analytics to unlock the full potential of hydrogen as a clean energy source.

AI is no longer just a technological enhancement — it is a strategic necessity for the hydrogen economy. From safer operations to optimized production, AI enables hydrogen to emerge as a reliable, sustainable, and scalable energy solution for a decarbonized future. With global investments pouring in and technological innovations accelerating, the next decade promises a transformative journey for AI in hydrogen operations.
You can place an order or ask any questions. Please feel free to contact us at sales@precedenceresearch.com |+1 804 441 9344



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Latest News In Cloud AI – Rezolve Ai Expands Retail Power With Brain Suite Technology

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Rezolve Ai recently announced strong results for the first half of 2025, underscoring the rapid adoption of its AI platform in the global retail sector. The company highlighted its successful integration of AI innovations, crypto-enabled checkout, and its expansion efforts in the U.S. and Europe as key drivers of accelerated revenue growth and increased market presence. Positioned at the intersection of AI and retail, Rezolve Ai is capitalizing on a $30 trillion global opportunity by enhancing customer engagement and operational efficiency through its Brain Suite technology. This development underlines the growing influence and application of AI in retail, reflecting a broader trend toward AI-driven solutions across industries.

Elsewhere in the market, Alibaba Group Holding (NYSE:BABA) was a notable mover up 12.9% and finishing the session at $135.00. At the same time, Ruijie Networks (SZSE:301165) lagged, down 11.6% to end the day at CN¥91.54.

Apple’s expansion in emerging markets and service ecosystem growth could rapidly stabilize margins. Discover more about this investment narrative by exploring the full thesis.

For a deeper understanding, revisit our Market Insights article on Agentic AI, highlighting current opportunities and urgent challenges across industries.

Best Cloud AI Stocks

  • Alphabet (NasdaqGS:GOOGL) closed at $212.91 up 0.6%, near its 52-week high.
  • Apple (NasdaqGS:AAPL) closed at $232.14 down 0.2%.
    On Monday, the company previewed its newest store, Apple Hebbal, in Bengaluru, marking its first in South India.
  • Microsoft (NasdaqGS:MSFT) closed at $506.69 down 0.6%.
    This week, the company announced its first in-house AI models, MAI-Voice-1 and MAI-1 Preview, marking its move toward developing proprietary AI technology.

Turning Ideas Into Actions

This article by Simply Wall St is general in nature. We provide commentary based on historical data
and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice.
It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your
financial situation. We aim to bring you long-term focused analysis driven by fundamental data.
Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material.
Simply Wall St has no position in any stocks mentioned.

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