Startup entrepreneurs are driving the digital transformation of healthcare but regulatory fragmentation hinders their potential. European policy makers can support startups scaling digital health innovation across borders by building a level playing field.
The digital health sector has grown exponentially in the last year. Venture funding totalled a record $14.8 billion globally, a 66% increase over 2019. Doctors and patients seek out digital health tools more than ever before, a trend that is expected to continue post-COVID.
This growth has created enormous potential to improve health outcomes, reduce healthcare inequalities and increase life expectancy. Digital health startups are leading the way in innovation for healthcare: from predicting patients’ cancer risk and improving the treatment of rare diseases to addressing mental health issues.
The question is: what can policy makers do to facilitate the integration of digital health innovation across European healthcare systems?
The uptake of digital health and eHealth infrastructure varies greatly across European countries. In Germany, for example, doctors are starting to prescribe health apps as a part of the patient pathway, while some of the Member States are lagging behind in the adoption of interoperable electronic health records.
Reducing regulatory fragmentation and introducing common standards would greatly support digital health adoption. Currently, before digital therapeutic products can enter the market, they need to go through clinical validation, authorization and regulatory compliance processes. This pathway often has to be repeated again when scaling to another country in the EU, making it difficult, if not impossible, for many startups to scale-up. Agreeing on a cross-border set of principles would be a game-changer for startups. For example, if an RCT (randomised controlled trial) study conducted in one Member State would be automatically acknowledged in the others.
Fostering best practices to increase patients’ access to innovations could be another major driver. For example, the path to reimbursement of digital apps. As most Europeans rely on publicly funded healthcare, wide scale access to innovations will not be achieved until public systems embrace and integrate digital health products. A few countries like Germany already have certain frameworks in place, while many others are considering it. While the financing of healthcare systems cannot be regulated at the EU level, the European Commission could collect and disseminate best practices and introduce benchmarks to monitor progress and encourage the adoption of a more unified approach.
The momentum to accelerate the digitalization of healthcare and reduce barriers to innovation is at an all-time high. Earlier this month, the EU Health Coalition, which combines 40 organisations across the health community, called on the EU to establish a permanent body to improve access to health innovation. EU initiatives, such as the proposal for the European Health Data Space and the EU4Health programme, aim to bridge the gaps in eHealth infrastructure and its interoperability, support the uptake of digital solutions and harmonize the rules around health data use.
Building a level playing field, facilitating best practices and increasing patients’ access to digital innovations should be policy priorities. By speaking to startups, policy makers can support the digital health ecosystem and the adoption of digital health solutions in Europe.
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