The European Health Data Space (EHDS) Regulation is not an easy read.
Understanding what it means for your company, organization, product or project is even more difficult.
“Standardizing the exchange of health data across borders.” That’s it in a nutshell.
On the surface it looks clear enough, but start peeling back the layers and you’ll find it filled with ambiguity and uncertainty.
HL7 Europe has been working hard on the required FHIR Implementation Guides to support EHDS. They’re incomplete but they’re well under way. The support is there, but implementation on the ground is still lacking – especially in private healthcare businesses.
Bring up EHDS in a company meeting today and you’ll hear variations of the following
“But does that apply to us?”
“Technically we’re not data controllers, so…”
“It’s not OUR data, so we’re not responsible.”
“There’s plenty of time.”
Lots of opinions and talking heads. Very little hard knowledge.
The important deadline is March 2029, when provisions for primary and secondary use of data apply.
That’s three and a half years.
Sounds like a lifetime. No reason to start worrying just yet.
- Start with an initial exploratory phase of 1 year.
- Assume 18 months for implementation.
- Add on a buffer of 6 months for the unexpected.
- A further 3 months once legal and compliance start picking things apart.
And you’re out of time. That’s assuming you start today.
Have you ever seen a large IT project delivered on time? By a giant healthcare organization or MedTech company?
Neither have I.
The clock is ticking. How far along is your business?
Here’s a 2 page summary document courtesy of ChatGPT (caveat emptor).
Pay particular attention to “2.D Secondary Use Compliance.”
This is not being discussed as much as it should be. Not in the meetings I’ve been attending.
More on that later.
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