How to Create a More Enabling Environment for Digital Health in Europe

At our recent Digital Health App’ero, Zina Chatzidimitriadou led a discussion with key industry players Aleksandra Appelfeld of Philips and Megan Coder of the Digital Therapeutics Alliance on what changes the industry would like to see in order to make Europe more hospitable to digital health products. We set out the top five themes that emerged, and a space to watch for the next decade.

1. Software-based digital therapeutics are emerging as patients take a more active role in the management of their conditions. A clear and robust framework is needed to enable patient trust, create a formalised pathway for patient input, and support the development of these tools. Companies can develop high-quality digital health tools with better chances of approval and reimbursement by seeking patient input and ensuring their products meet an identified need, have good usability, and are cost-effective.
2. Digital health tools harvest large volumes of data. However, the European regulatory landscape is largely fragmented, with different national interpretations of the GDPR and different technical standards. Harmonisation, seamless exchange of data, and interoperability at the EU level are critical to enable the digital environment. There are currently attempts to address this through the proposed Data Act, the Data Governance Act, and the draft European Health Data Space Regulation, all of which fall under the umbrella of the EU Digital Strategy. It is, therefore, important that these proposals be implemented uniformly and that international standards development follows a similar path.
3. The interplay of these proposed laws with the draft Artificial Intelligence Act and the medical device regulatory framework must be considered carefully. All the newly published pieces of legislation (with the exception of the EHDS Regulation) are horizontal initiatives, rather than being specific to a single sector. This results in provisions that may not be well suited to the specificities of healthcare technologies and, as currently drafted, could result in duplications, delays and uncertainties.
4. We are seeing an increasing number of strategic partnerships and collaborations, both public/private and cross-industry. These are best enabled by a regulatory system that is well-defined, robust and flexible. However, there are currently areas of legal uncertainty — for example in the spaces of companion diagnostics and telehealth. The requirements on regulatory assessment, scientific advice, labelling, reimbursement, and the obligations on each party would benefit from clarification.
5. It is vital that digital health products and services can be reimbursed. With each EU member state following its own procurement and reimbursement systems, market access remains a fragmented landscape, with some countries being more advanced than others. The setting of common standards in this area is desirable. It would be useful if the Digital Health Alliance’s recently published DTx Value Assessment & Integration Guide could function as a blueprint for similar initiatives.

The COVID-19 pandemic showed the value and ability to act in an agile way in order to bring innovative and life-saving products to the EU market. With the current momentum of legislative reform in the European healthcare and digital setting, Europe can create a more enabling environment for digital health.

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.