ARTICLE SUMMARY:
The recently enacted European Health Data Space Regulation could expand data access horizons but also raise serious data protection issues for device companies. We explore the EHDS and its medtech implications, with insights from health data expert Cécile van der Heijden, from Axon Lawyers.
Data is among the most vital resources for anyone attempting to develop or market medical technology. Companies face challenges collecting and accessing the data they need to support product development, regulatory requirements, payor needs, and other milestones. In addition, particularly in this age of AI, where more and more products are fundamentally defined by their underlying data, firms need to find ways to protect and preserve some control of data associated with their devices to maintain competitive advantages.
A new law enacted in the EU could have major impacts on both the data access and protection sides of the coin for medtech companies. The European Health Data Space Regulation, or EHDS Act, which entered into force on March 26, could provide a new horizon of opportunities for device and diagnostic companies to leverage data currently hidden in the sprawling, but segmented European healthcare landscape. On the flipside, it could challenge firms’ ability to shield their data from more unencumbered use, including by competitors.
The key provisions of the EHDS Act won’t kick in for another four to six years (March 2029 and March 2031 are the key deadlines), and the EU has yet to issue key implementing acts or set up the entities needed to manage the provisions of the law. But considering the timescale of device development and how long data needs to be retained, more medtech companies should be starting to think about EHDS as an important piece of the increasingly complex web of EU legislation targeting data and technology, says Cécile van der Heijden, an attorney at Axon Lawyers in Amsterdam.
We spoke to van der Heijden, who is an expert in data protection and privacy in the life sciences sector, about the opportunities and challenges of the EHDS Act for the medtech sector. “The first things companies should think about are, ‘What data can we access, and how can we make this work in our favor?’” van der Heijden states. “And the other discussion is, ‘Okay, what can we cover in the intellectual property rights of the data to avoid having to make the data we hold available to competitors?’”
