From Evidence to Exit: Building Credible Health Tech | Dr Saira Ghafur (Co-Founder of Provea Health & Lead for Digital Health at Imperial College)

Cybersecurity and Evidence Generation Strategies for Founders

“The market was flooded with all these new tools and technologies that people were using, but no real evidence base behind them. Now we’re in this space where we need evidence. — Dr Saira Ghafur

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Dr Saira Ghafur is a medical doctor specialising in respiratory medicine, an academic and leader for digital health at Imperial College London, and co-founder of two startups, including Prova Health, where she serves as Chief Medical Officer. Her work spans cybersecurity in healthcare, evidence generation for digital health technologies, and translating research into practical applications that improve healthcare systems.


What you'll learn:

  • Why healthcare cybersecurity attacks have grown fivefold and become increasingly sophisticated and state-sponsored

  • The unique challenges of healthcare cybersecurity compared to other critical sectors like finance or energy

  • How to build resilient health systems that can continue providing care during cyberattacks

  • Why digital health technologies remain a "wild west" when it comes to evidence generation

  • The importance of gathering different types of evidence throughout a product's lifecycle—from qualitative user research to clinical outcomes and economic evidence

  • How simulation and synthetic patient data can help evaluate digital health tools in low-risk environments

  • The challenges of creating evidence for AI in healthcare and why data quality is fundamental

  • Lessons learned from co-founding two healthcare startups as a clinician


Key Takeaways

Cybersecurity is healthcare's blind spot: Despite healthcare's increasing digitisation, research into cybersecurity resilience lags far behind other critical sectors, creating significant vulnerabilities.

Resilience requires planning for multiple catastrophes: Healthcare organisations must prepare not just for cyber attacks but for compounding disasters, like a cyber attack followed by a mass casualty event.

Evidence generation must match the product lifecycle: Early-stage technologies need qualitative user research, while mature products require real-world evidence gathering—one size doesn't fit all.

Data accessibility is crucial but challenging: Access to high-quality healthcare data remains difficult, especially for smaller innovators who can't afford to clean and curate it properly.

Secure data environments offer a path forward: Creating spaces where innovators can access data without it leaving the secure environment addresses both security concerns and patient fears.

Economic evidence is increasingly essential: With constrained healthcare budgets, proving value for money has become non-negotiable for digital health technologies.


Where to Find Dr Saira Ghafur

LinkedIn


In This Episode

00:00 - Introduction to cybersecurity in healthcare
01:04 - How cyber threats have evolved in healthcare
04:45 - Building resilient healthcare systems
08:47 - The research landscape in healthcare cybersecurity
11:17 - Digital health technologies and evidence generation
15:48 - Regulatory challenges in digital health
21:45 - Using simulation for evidence generation
26:02 - Evidence generation for AI in healthcare
31:44 - The importance of high-quality data
34:32 - Economic evidence in digital health
36:35 - Lessons learned as a clinician founder


Referenced:

  • Challenges for the evaluation of digital health solutions - A call for innovative evidence generation approaches (Paper)

  • Safeguarding our healthcare systems: A global framework for cybersecurity (Paper)

  • FDA - Software as a medical device (Website)

  • NICE - Evidence standards framework (ESF) for digital health technologies (Website)

  • PECAN - Fast Track Digital Tools in France (Website)

  • DiGA - Fast Track Digital Tools in Germany (Website)

  • Prova Health (Website)

  • Generating economic evidence for digital health solutions (White paper)

  • Trust through evidence: Evidence generation for AI solutions in healthcare (White paper)

  • Be Smarter than your lawyer and your VC (Book)


Contact Information:

If you have any feedback, questions or if you'd like to get in touch, reach out at jono@clinicalchangemakers.com

Music Attribution: Music by AudioCoffee from Pixabay

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