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French president Emmanuel Macron has announced plans to follow in Germany’s footsteps by making digital therapeutics available on prescription through the statutory health system.
In 2019 Germany introduced its DiGA Fast Track process for rapid approval, testing, piloting and evaluation of health apps, which is open to all companies in the European Union (EU).
Speaking at the HealthTech Innovation Days (HTID) event in Paris earlier this month, French President Emmanuel Macron announced: “We are also creating an immediate access procedure for market access for innovative products, the same way as in Germany. I’m very direct with you – we will just replicate what works in Germany.”
The DiGA initiative, created under the 2019 Digital Healthcare Act (DVG), means doctors can prescribe apps to the 73 million German citizens covered by public health, with costs reimbursed through health insurance. 
From 2020, medical apps for patients which are CE-marked as Class 1 and 2a low risk medical devices have been able to apply for fast-track market entry in Germany. There are currently 22 apps approved for reimbursement, of which almost 50% are focused on mental health.
WHY IT MATTERS
The ‘fast track’ process is aimed at easing the path for innovation into regular care. Under the initiative, developers no longer have to carry out randomised clinical trials to deliver evidence and can use other methods to demonstrate care benefits to the German Federal Institute for Drugs and Medical Devices (BfArM).
As well as providing reimbursement, the DiGA scheme can increase patient and provider awareness and trust in digital therapeutics.
THE LARGER CONTEXT
The European Commission is creating a common regulatory framework for digital transformation in all EU member states, including regulations for data privacy – GDPR, medical devices, artificial intelligence, and health technology assessment.
Meanwhile in South-West England, millions of people will be given access to digital health libraries, through a partnership between the Organisation for the Review of Care and Health Apps (ORCHA) and seven Integrated Care Systems (ICSs). Each library will provide hundreds of health apps relevant to different medical and lifestyle issues, with a focus on mental health support and weight management.
NHS Scotland has also launched a digital initiative to help adults suffering from anxiety and insomnia by providing free access to Big Health’s digital therapeutics apps Daylight and Sleepio.
ON THE RECORD
Armin Scheuer, VP of business development international at HIMSS, said: “There is no such thing as a European healthcare system. All healthcare is really within the responsibility of the members states. Nevertheless, the two biggest economies of the EU economy, Germany and France have started to align some of their approaches and at the same time these countries are really the engines of EU integration.
“We can expect that this process and many other steps currently happening could drive the development of a more aligned European health sector – certainly when it comes to digitalisation.”
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