Author | Lightnews

Hardian Health @hardianhealth.com · Jun 19

The hype around AI doesn't match the reality of healthcare, and there's a reason for that.

On the Health Horizons podcast, @drhughharvey.hardian.health breaks down why adoption is slower than expected and why regulation isn’t a blocker, but vital to building trust ⬇️
open.spotify.com/show/7IdAAVK...

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Hardian Health @hardianhealth.com · Jun 11

Why do so many AI startups get regulation wrong?

They leave it too late.

It’s not the tech that holds them back. It’s timing, assumptions, & early decisions made without the right input.

We share 5 common pitfalls in our latest blog.
🔗www.hardianhealth.com/insights/ai-regulatory-strategy-startups

Hardian Health @hardianhealth.com · Jun 3

🤝 We’re partnering with NXGN to support the next generation of health and biotech founders with all their regulatory needs.

Members get:
🔹 Free 1h consult
🔹 20% off services
🔹 Tailored strategies

Building in healthtech & thinking about regulation? Get in touch ➡️ www.hardianhealth.com/contact

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Hardian Health @hardianhealth.com · May 29

Just because your product works doesn’t mean it’ll be adopted.

As Lucy Gregory says, safety and efficacy are only half the story. Health economics shows where a product fits, what it costs & how it compares.

Need support? Start here:
🔗 www.hardianhealth.com/contact

Hardian Health @hardianhealth.com · May 28

🩻 Heading to #UKIO2025? So are we!

@drhughharvey.hardian.health, our MD, will speak in Session D4 on digital tech – covering the future of diagnostics, therapy & sustainability in healthcare.

🗓 3 June | 🕒 15:40 | 📍 Room 3A

Drop him a message to connect.

🔗 www.ukio.org.uk

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Hardian Health @hardianhealth.com · May 22

🎙️ Our MD @drhughharvey.hardian.health revealed some hard truths on The Healthtech Podcast with James Somauroo about regulatory status transparency in healthtech.

The intended use must match your public marketing; otherwise, you’re at risk of hefty fines.

➡️ open.spotify.com/episode/5iis...

Hardian Health @hardianhealth.com · May 20

🔓 Unlocking economic value in healthcare starts with the right questions.

Lucy Gregory, our Health Economics Consultant, helps turn real-world impact into insight for payers, policymakers, and product teams alike.

Need support? ➡️ www.hardianhealth.com/contact

Hardian Health @hardianhealth.com · May 15

🎙️ Our MD @drhughharvey.hardian.health joined Dr James Somauroo on The Healthtech Podcast to explore what healthtech founders get wrong, how to get it right, and why success means treating regulation as part of your business model, not a blocker.

🎧 open.spotify.com/episode/5iis...

Hardian Health @hardianhealth.com · May 14

Our latest study, led by our Consultant Health Economist Lucy Gregory and published in Value in Health, shows how the AI tool BoneView could save the NHS millions a year

Read the blog to discover how ➡️ www.hardianhealth.com/insights/bud...

Budget Impact Analysis of AI Fracture Detection in the NHS

Explore how health economics research reveals the real-world value of AI in radiology, beyond clinical efficacy, through NHS-focused case studies.

www.hardianhealth.com

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Hardian Health @hardianhealth.com · May 8

🩺 If your AI scribe is intended for summarising or prompting decisions, the MHRA may classify it as a medical device.

New NHS guidance confirms these tools may need a QMS and evidence of clinical safety & classifications are still evolving.

Read more: www.england.nhs.uk/long-read/gu...

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Hardian Health @hardianhealth.com · May 6

🧢 100 days of Trump – what does it mean for medical AI?

Our MD @drhughharvey.hardian.health joins Felix Beacher on the Medical AI Podcast to unpack how deregulatory moves in the US could ripple across global healthcare, tech, and safety standards.

🎧 Listen: open.spotify.com/episode/7ph7...

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Hardian Health @hardianhealth.com · May 2

🤔 How much evidence is enough for AI medical device approval in the EU? We hear this question all the time, but there isn't a clear answer.

Our latest blog discusses the new CORE–MD AI Risk Score framework & what it means for developers?

Read ➡️ www.hardianhealth.com/insights/cor...

CORE–MD: A Path to Clearer AI Device Evidence Standards?

The CORE-MD AI Risk Score is a structured framework to guide the level of clinical evidence required for regulatory approval of AI medical device software.

www.hardianhealth.com

Hardian Health @hardianhealth.com · May 1

🎙️ “What’s the cost of non-compliance? Everything.”
@drhughharvey.hardian.health joins Shubs Upadhyay on the Global Perspectives podcast to unpack the risks of weak regulation in digital health – and why a strong mindset is key.

Watch the full episode ➡️ www.youtube.com/watch?v=fFrQ...

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Hardian Health @hardianhealth.com · Apr 17

Building a SaMD but unsure which ISO or IEC standards apply?

In our latest blog, we break down:
🔹 ISO vs IEC
🔹 How to embed them into your QMS
🔹 Why they matter for quality, safety & cybersecurity
🔹 Key standards for software & AI medical devices

Read more➡️ www.hardianhealth.com/insights/iso...

The ISO standards you need to know for SaMD - 2025 update

For all developers of SaMD and AIaMD, we break down the updated 2025 ISO and IEC standards you need to conform to.

www.hardianhealth.com

Hardian Health @hardianhealth.com · Apr 15

👀 The MHRA’s response to the RHC on AIaMD stops short of requiring public info on intended use, citing no legal route to enforce it.

Transparency shouldn’t be optional. That’s why we’re building HaRi – mapping intended uses across jurisdictions.

Read: www.gov.uk/government/p...

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Hardian Health @hardianhealth.com · Apr 10

🏆Building SaMD or SiMD for the NHS?

We’ve developed a structured method that connects the dots between top-down hazard analysis & bottom-up cybersecurity, clinical safety, & AI risk planning.

Align with ISO 14971:2019 & NHS expectations from the start ➡️ www.hardianhealth.com/insights/wha...

Hardian Health @hardianhealth.com · Apr 8

What’s the difference between IP assets & IP rights?

Your assets are the tech you create – the code, algorithms, & interfaces. IP rights are what protect them.

Our Senior IP Consultant Stephen explains how turning innovation into defensible value means knowing how to do both 👇

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Hardian Health @hardianhealth.com · Apr 3

❤️‍🩹 Healthcare regulation causing you grief?

Our MD @drhughharvey.hardian.health shares how founders move from denial to acceptance on the regulatory journey – and why those who plan early are the ones who launch successfully.

Read more ➡️ www.hardianhealth.com/insights/fiv...

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Hardian Health @hardianhealth.com · Apr 2

🔍 Knowing your competition starts with defining your intended use.

As our consultant Annemijn Eschauzier explains, it’s the foundation for mapping your market, benchmarking against competitors, and shaping a solid go-to-market strategy.

Need support? ➡️ www.hardianhealth.com/contact

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Hardian Health @hardianhealth.com · Mar 27

A @mayoclinic.org study highlights unregulated AI health tools reaching millions via app stores, without approvals or safety checks.

Enforcing existing regulations is key to building trust in LLM healthcare applications.

Read more: www.mcpdigitalhealth.org/article/S294...

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Hardian Health @hardianhealth.com · Mar 25

🥴 Anyone developing digital tools for mental health knows the regulatory landscape has been confusing at best…

The MHRA's new framework finally gives us some clarity, as Felicity, one of our Clinical Associates, explains in our latest blog.

Full breakdown ➡️ www.hardianhealth.com/insights/reg...

Hardian Health @hardianhealth.com · Mar 20

Guilford Street Labs needed a strong regulatory strategy that could stand up to scrutiny & secure FDA Breakthrough Designation.

With our support, they built a robust submission & navigated every challenge to keep the process on track.

Need support? ➡️ www.hardianhealth.com/contact

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Hardian Health @hardianhealth.com · Mar 19

⚖️ AI medical devices are only as effective as their regulations.

Set the bar too high, and innovation stalls. Too low, & patient safety is at risk. A new Nature Digital Medicine paper introduces CORE-MD, a framework to strike that balance.

Read more ➡️ www.nature.com/articles/s41...

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Hardian Health @hardianhealth.com · Mar 14

From June 2025, medical devices on the UK market will need to meet stricter post-market surveillance & follow-up requirements.

Key updates include:
🔹More structured processes
🔹Stronger adverse event reporting
🔹Clearer requirements for corrective actions

www.gov.uk/government/c...

Hardian Health @hardianhealth.com · Mar 11

🎯 A strong health economic case is key to reimbursement through NICE. Without one, even the best therapies can struggle.

At Hardian, we rigorously test models to assess real-world variability, ensuring a solid foundation for market access.

More here ➡️ www.hardianhealth.com/health-econo...