Let’s be honest—navigating digital health app regulations can feel like a full-time job. Between data laws, clinical safety standards, cybersecurity requirements, and now the growing buzz around AI transparency, it’s no wonder so many health innovators (and decision-makers) feel overwhelmed.
I’ve been there too. As someone who’s spent the last decade working at the intersection of digital health and regulation, I’ve seen firsthand how confusing, inconsistent, and sometimes contradictory the rules can be. But here’s the good news: it doesn’t have to be this hard. At ORCHA, we work with health systems, regulators, and developers every day to make sense of the rules—and put them into practice. Because ultimately, we all want the same thing: safe, effective, trustworthy digital health tools in the hands of the people who need them.
So, what are the most common pain points I see?
- Ever-changing standards – What was compliant six months ago might not cut it today.
- Regulatory overload – CE marks, DTAC, ISO, MHRA, DIGA, GDPR... the acronyms alone are enough to make your head spin.
- AI anxiety – Emerging guidance on algorithm transparency and risk management is vital—but adds another layer of complexity.
- Global inconsistencies – What’s approved in one country might not meet the bar in another.
My advice? Break it down. Focus on five things:
- Start with the user – Compliance is essential, but don’t let it drown out your focus on usability and outcomes, clinical evidence is critical in compliance everywhere!
- Map your journey – Know where your product sits: Is it a wellness tool? A medical device? Your path depends on it.
- Build in quality early – Retrofitting compliance is painful (and expensive). Bake in standards from day one.
- Stay close to the right sources – Whether it's MHRA, NICE, NHS DTAC, DIGA or the EU’s MDR, go straight to the guidance.
- Don’t go it alone – No one expects you to be a regulatory expert. Work with people who live and breathe this stuff.
This isn’t just a box-ticking exercise—it’s about earning trust from patients, clinicians, and health systems. And when we get it right, the payoff is huge: more adoption, better outcomes, and safer, smarter care.
We’re here to make that easier. Fewer headaches. Better health. If you’re trying to navigate the regulatory maze and feeling stuck—drop me a message. Let’s untangle it together.
