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...

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

🤝 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

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

🩻 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

🎙️ 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...

🔓 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

🎙️ 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...

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...

🩺 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...

🧢 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...

🤔 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...

🎙️ “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...

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 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...

🏆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...

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 👇

❤️‍🩹 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...

🔍 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

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...

🥴 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...

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

⚖️ 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...

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...

🎯 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...

👀 Of course by now, everyone has read the FDA’s latest guidance on the ground rules for discussing unapproved uses of medical devices... But just in case you haven't, here's a quick rundown of the Do's & Don'ts 👇 Read our blog for a full breakdown ➡️ www.hardianhealth.com/insights/wha...

Are you making the most of FDA resources? Guilford Street Labs used FDA guidance to refine their regulatory strategy for PD Predict, streamlining development. Early engagement with regulators can be a game-changer for UK companies. Need support? ➡️ www.hardianhealth.com/contact

🎙️ AI models predict text, not medical reasoning—so what needs to change? @drhughharvey.hardian.health joined SergeiPolevikov, TiyaLaCroix & AlexKoshykv on Digital Health Inside Out to cut through the AI hype in healthcare. Watch here ⬇️ 🔗 www.youtube.com/watch?v=o6

📢 Hardian joins CERSI-AI to advance AI & digital health regulation! As a grant partner, we’re helping build smarter, faster regulatory pathways. That means we're scaling HaRi to create a global AI medical device resource. Learn more about CERSI-AI 👉 www.cersi-ai.org/home

🔎 Missed our talk at the Global AI Conference on getting radiology AI through FDA? No fear; we have @drhughharvey.hardian.health's key recommendations 👇 🔹 510(k) works if a predicate exists 🔹 Use FDA pre-sub for early feedback 🔹 US data is key for US regulators 🔹 No reimbursement = no market

🇦🇹 Heading to the European Congress of Radiology? @drhughharvey.hardian.health will be on the ground exploring the latest in imaging, AI & precision medicine. If you’re attending, get in touch! 📅 26 Feb – 1 Mar 📍 Austria Center Vienna! 🔗 Event details: events.siemens-healthineers.com/ecr

📢 Mind your language! Do you know what you can & can't say about your medical device? The FDA released guidance stating how companies should communicate information about medical products to healthcare providers. We share the key takeaways in our new blog ➡️ www.hardianhealth.com/insights/wha...

Looking forward to the Radiology AI Summit in London tomorrow? @drhughharvey.hardian.health, our MD, will be there to stay ahead of the latest in AI-driven imaging & regulation. If you’re attending & want to connect let us know 👇 Check out the full agenda➡️ www.radiologyaisummit.com/agenda

🛠️ The FDA has issued a major update for developers of AI-enabled medical devices. Vendors are being encouraged to be transparent in their product communications, including limitations, providing evidence, & safety considerations. Full guidance here ⬇️ www.prnewswire.com/news-release...

Do you know how many AI-enabled medical devices are approved for use in the UK? It’s a simple question, but the answer isn't straightforward. In our latest blog, we explore the current difficulties in tracking AI-enabled devices & what needs to change. Read⬇️ www.hardianhealth.com/insights/how...

For Guilford Street Laboratories, securing Breakthrough Designation for PD Predict was only the starting point. With help from us, the access to FDA resources is helping them map a path to pre-market approval & accelerate product development. Need help? ➡️https://www.hardianhealth.com/contact

🚨The new EU Health Technology Assessment Regulation is now in effect. It unifies the evaluation of high-risk devices, streamlining approvals and reducing duplication. This means faster market access and better collaboration with regulators. ➡️ www.ema.europa.eu/en/news/new-...

Did you catch our MD @drhughharvey.hardian.health on the Future Medicines AI podcast? He shares his expert insights into the challenges and opportunities in #healthcare #AI and explains what it takes to successfully bring AI #medicaldevices to market. Listen here ➡️ www.fmai-hub.com/videos/navig...

💡 What’s the reality of AI adoption in radiography? Members of the Hardian team have co-authored a paper in the Journal of Medical Imaging and Radiation Sciences, exploring how radiographers are using AI tools in practice. Read the full paper ➡️ www.sciencedirect.com/science/arti...

How do you navigate the FDA Breakthrough Designation pathway with confidence? Guilford Street Laboratories cleared their FDA review without a single non-conformity thanks to sprint sessions & meticulous planning from Hardian. Need help with your submission?➡️https://www.hardianhealth.com/contact

📋 Ready to elevate your QMS game? Part 2 of our QMS blog shares the practicalities of implementing & managing a QMS effectively. Whether you’re just starting out or optimising your existing system, this is your go-to guide for navigating the process⬇️ www.hardianhealth.com/insights/imp...

🔮 What’s next for healthtech regulation in 2025? Our MD @drhughharvey.hardian.health shares predictions on shifting regulatory frameworks and what that might been for AI and medical device regulation. Read Hugh’s insights and share the trends you’re watching this year 👀⬇️

🎄 Merry Christmas from Hardian Health! This year, we’ve supported breakthrough designations, navigated evolving regulations, and worked with healthtech pioneers to bring safe, effective solutions to market. Here’s to 2025 – another year of tackling regulatory challenges!

How do you keep FDA submissions on track under pressure? Guildford Street Labs tackled a one-day FDA query during their Breakthrough Designation journey for PD Predict with Hardian’s support. Need help navigating your milestone? Contact us ➡️ www.hardianhealth.com/contact

The MHRA is reshaping medical device regulations, and your input can help! A new consultation may change UKCA marking, IVD classification, international reliance, & extended transition periods for EU-based #regulations. Have your say before Jan 5th ⬇️ www.gov.uk/government/n...

Guildford Street Labs has earned FDA Breakthrough Device Designation for PD Predict and we supported with #regulatory guidance, a #QMS, & AI compliance at every step along the way. Read the full blog ➡️ www.hardianhealth.com/insights/how...

👀 No #regulatory green light yet for LLMs in #healthcare. The FDA emphasises the need for new evaluation mechanisms, transparency, and collaboration to ensure safe, effective integration of LLMs into healthcare. Read more ➡️ jamanetwork.com/journals/jam...

We ❤️ our #healthtech community! Check out the beautiful people who attended our annual Hardian health tech Summit this year www.hardianhealth.com/hts24