In Germany, the most controversial issue is the proper handling of data, first and foremost its use and security. What hurdles still exist?
Dr Thiel: Germany lacked a strategic direction for digital health until this year which was a major barrier. A vision about why to use data and to what impact is still missing. Different activities have taken place in siloes through top-down approaches, which resulted in solutions that did not meet the reality of the users.
The planned opt-out approach for the ePA (electronic medical record) is positive, but low-threshold access and user centricity is key. Legislative provisions are there, although finding (financial) incentives for nationwide implementation of solutions remains a major task. Also, the self-governance of the German healthcare system comprising various bodies with vested interests and veto power can lead to easily allowed logjams.
It will be interesting to see whether the gematik as the envisaged national digital agency can drive a vision and coordinate a national, centralized approach with all relevant stakeholders. At empirica, we are closely observing these developments.
Generally speaking, how can a better balance be struck between innovation regulation?
Dr Thiel: With the speed at which innovations are advancing, it is imperative to ensure safety and effectiveness through appropriate regulation that enables innovation. It is a question of "better" rather than "how much" regulation. Decision-makers need to listen to the needs of users and industry stakeholders, and also look abroad and learn. Aligning the enabler (policy) side, demand and supply side is a major challenge. Facilitating such alignment is a focus of the EU-funded Digital Health Uptake (DHU) project, coordinated by us at empirica.