FDA and patent law create dual hurdles for AI-enabled medical technologies

AI reshapes healthcare by powering more precise and adaptive medical devices and diagnostic systems.

Yet, innovators face two significant challenges: navigating the US Food and Drug Administration’s evolving regulatory framework and overcoming legal uncertainty under US patent law.

These two systems, although interconnected, serve different goals. The FDA protects patients, while patent law rewards invention.

The FDA’s latest guidance seeks to adapt oversight for AI-enabled medical technologies that change over time. Its framework for predetermined change control plans allows developers to update AI models without resubmitting complete applications, provided updates stay within approved limits.

An approach that promotes innovation while maintaining transparency, bias control and post-market safety. By clarifying how adaptive AI devices can evolve safely, the FDA aims to balance accountability with progress.

Patent protection remains more complex. US courts continue to exclude non-human inventors, creating tension when AI contributes to discoveries.

Legal precedents such as Thaler vs Vidal and Alice Corp. vs CLS Bank limit patent eligibility for algorithms or diagnostic methods that resemble abstract ideas or natural laws. Companies must show human-led innovation and technical improvement beyond routine computation to secure patents.

Aligning regulatory and intellectual property strategies is now essential. Developers who engage regulators early, design flexible change control plans and coordinate patent claims with development timelines can reduce risk and accelerate market entry.

Integrating these processes helps ensure AI technologies in healthcare advance safely while preserving inventors’ rights and innovation incentives.

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Celebrity estates push back on Sora as app surges to No.1

OpenAI’s short-video app Sora topped one million downloads in under a week, then ran headlong into a likeness-rights firestorm. Celebrity families and studios demanded stricter controls. Estates for figures like Martin Luther King Jr. sought blocks on unauthorised cameos.

Users showcased hyperreal mashups that blurred satire and deception, from cartoon crossovers to dead celebrities in improbable scenes. All clips are AI-made, yet reposting across platforms spread confusion. Viewers faced a constant real-or-fake dilemma.

Rights holders pressed for consent, compensation, and veto power over characters and personas. OpenAI shifted toward opt-in for copyrighted properties and enabled estate requests to restrict cameos. Policy language on who qualifies as a public figure remains fuzzy.

Agencies and unions amplified pressure, warning of exploitation and reputational risks. Detection firms reported a surge in takedown requests for unauthorised impersonations. Watermarks exist, but removal tools undercut provenance and complicate enforcement.

Researchers warned about a growing fog of doubt as realistic fakes multiply. Every day, people are placed in deceptive scenarios, while bad actors exploit deniability. OpenAI promised stronger guardrails as Sora scales within tighter rules.

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UN cybercrime treaty signed in Hanoi amid rights concerns

Around 60 countries signed a landmark UN cybercrime convention in Hanoi, seeking faster cooperation against online crime. Leaders cited trillions in annual losses from scams, ransomware, and trafficking. The pact enters into force after 40 ratifications.

UN supporters say the treaty will streamline evidence sharing, extradition requests, and joint investigations. Provisions target phishing, ransomware, online exploitation, and hate speech. Backers frame the deal as a boost to global security.

Critics warn the text’s breadth could criminalise security research and dissent. The Cybersecurity Tech Accord called it a surveillance treaty. Activists fear expansive data sharing with weak safeguards.

The UNODC argues the agreement includes rights protections and space for legitimate research. Officials say oversight and due process remain essential. Implementation choices will decide outcomes on the ground.

The EU, Canada, and Russia signed in Hanoi, underscoring geopolitical buy-in. Vietnam, being the host, drew scrutiny over censorship and arrests. Officials there cast the treaty as a step toward resilience and stature.

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MLK estate pushback prompts new Sora 2 guardrails at OpenAI

OpenAI paused the ability to re-create Martin Luther King Jr. in Sora 2 after Bernice King objected to user videos. Company leaders issued a joint statement with the King estate. New guardrails will govern depictions of historical figures on the app.

OpenAI said families and authorised estates should control how likenesses appear. Representatives can request removal or opt-outs. Free speech was acknowledged, but respectful use and consent were emphasised.

Policy scope remains unsettled, including who counts as a public figure. Case-by-case requests may dominate early enforcement. Transparency commitments arrived without full definitions or timelines.

Industry pressure intensified as major talent agencies opted out of clients. CAA and UTA cited exploitation and legal exposure. Some creators welcomed the tool, showing a split among public figures.

User appetite for realistic cameos continues to test boundaries. Rights of publicity and postmortem controls vary by state. OpenAI promised stronger safeguards while Sora 2 evolves.

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Australia rules out AI copyright exemption

The Albanese Government has confirmed that it will not introduce a Text and Data Mining Exception in Australia’s copyright law, reinforcing its commitment to protecting local creators.

The decision follows calls from the technology sector for an exemption allowing AI developers to use copyrighted material without permission or payment.

Attorney-General Michelle Rowland said the Government aims to support innovation and creativity but will not weaken existing copyright protections. The Government plans to explore fair licensing options to support AI innovation while ensuring creators are paid fairly.

The Copyright and AI Reference Group will focus on fair AI use, more explicit copyright rules for AI works, and simpler enforcement through a possible small claims forum.

The Government said Australia must prepare for AI-related copyright challenges while keeping strong protections for creators. Collaboration between the technology and creative sectors will be essential to ensure that AI development benefits everyone.

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‘Wicked’ AI data scraping: Pullman calls for regulation to protect creative rights

Author Philip Pullman has publicly urged the UK government to intervene in what he describes as the ‘wicked’ practice of AI firms scraping authors’ works for training models. Pullman insists that writing is more than data, it is creative labour, and authors deserve protection.

Pullman’s intervention comes amid increasing concern in the literary community about how generative AI models are built using large volumes of existing texts, often without permission or clear compensation. He argues that uninhibited scraping undermines the rights of creators and could hollow out the foundations of culture.

He has called on UK policymakers to establish clearer rules and safeguards over how AI systems access, store, and reuse writers’ content. Pullman warns that without intervention, authors may lose control over their work, and the public could be deprived of authentic, quality literature.

His statement adds to growing pressure from writers, unions and rights bodies calling for better transparency, consent mechanisms and a balance between innovation and creator rights.

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Suzanne Somers lives on in an AI twin

Alan Hamel says he’s moving ahead with a ‘Suzanne AI Twin’ to honor Suzanne Somers’ legacy. The project mirrors plans the couple discussed for decades. He shared an early demo at a recent conference.

Hamel describes the prototype as startlingly lifelike. He says side-by-side, he can’t tell real from AI. The goal is to preserve Suzanne’s voice, look, and mannerisms.

Planned uses include archival storytelling, fan Q&As, and curated appearances. The team is training the model on interviews, performances, and writings. Rights and guardrails are being built in.

Supporters see a new form of remembrance. Critics warn of deepfake risks and consent boundaries. Hamel says fidelity and respect are non-negotiable.

Next steps include wider testing and a controlled public debut. Proceeds could fund causes Suzanne championed. ‘It felt like talking to her,’ Hamel says.

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Fenland business to close as AI reshapes media work

A Fenland videographer says the rise of AI has forced him to close his business. David Johnson, who runs DMJ-Imagery in Chatteris, will wind up operations in April after client demand collapsed.

He believes companies are turning to AI tools for projects once requiring human filmmakers and editors. Work such as promotional videos, adverts, and scripting has increasingly been replaced by automated content generation.

Johnson said his workload ‘plummeted’ over the past year despite surviving the pandemic. He described AI-made work as lacking ‘passion or emotion’, arguing that human creativity remains an essential component to storytelling.

Despite this, the UK government says AI has vast economic potential, industry groups urge fairer protections for creatives. They argue that existing copyright laws do not adequately safeguard work used to train AI models.

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Adobe unveils AI Foundry for enterprise model building

Adobe has launched a new enterprise service allowing firms to build custom AI models. The platform, called Adobe AI Foundry, lets companies train generative AI on their branding and intellectual property.

Based on Adobe’s Firefly models, the service can produce text, images, video, and 3D content. Pricing depends on usage, offering greater flexibility than Adobe’s traditional subscription model.

Adobe’s Firefly technology, first introduced in 2023, has already helped clients create over 25 billion assets. Foundry’s tailored models are expected to speed up campaign production while maintaining consistent brand identity across markets.

Hannah Elsakr, Adobe’s vice president for generative AI ventures, said the tools aim to enhance, not replace, human creativity. She emphasised that Adobe’s mission remains centred on supporting artists and marketers in telling powerful stories through technology.

The company believes its ethical approach to AI training and licensing could set a standard for enterprise-grade creative tools. Analysts say it also positions Adobe strongly against rivals offering generic AI solutions.

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China leads the global generative AI adoption with 515 million users

In China, the use of generative AI has expanded unprecedentedly, reaching 515 million users in the first half of 2025.

The figure, released by the China Internet Network Information Centre, shows more than double the number recorded in December and represents an adoption rate of 36.5 per cent.

Such growth is driven by strong digital infrastructure and the state’s determination to make AI a central tool of national development.

The country’s ‘AI Plus’ strategy aims to integrate AI across all sectors of society and the economy. The majority of users rely on domestic platforms such as DeepSeek, Alibaba Cloud’s Qwen and ByteDance’s Doubao, as access to leading Western models remains restricted.

Young and well-educated citizens dominate the user base, underlining the government’s success in promoting AI literacy among key demographics.

Microsoft’s recent research confirms that China has the world’s largest AI market, surpassing the US in total users. While the US adoption has remained steady, China’s domestic ecosystem continues to accelerate, fuelled by policy support and public enthusiasm for generative tools.

China also leads the world in AI-related intellectual property, with over 1.5 million patent applications accounting for nearly 39 per cent of the global total.

The rapid adoption of home-grown AI technologies reflects a strategic drive for technological self-reliance and positions China at the forefront of global digital transformation.

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