Alliance eyes European 'single market' for digital therapeutics

There's a growing body of evidence that digital therapeutics (DTx) can complement other therapies for a wide range of health conditions, reducing costs and improving patient engagement, but the sector runs the risk of being held back by a lack of clinical, regulatory and reimbursement standards.

A new partnership between the non-profit Digital Therapeutics Alliance (DTA) and digital health innovation organisation Healthware has now been formed to tackle that issue, aiming to bring together a coalition of experts from across Europe to develop a harmonised framework for the category.

A key part of that effort will be to advocate for greater recognition of the value that evidence-based DTx can deliver to healthcare system, and to develop an environment in which a new therapy can be quickly scaled from local to national and regional use across countries in Europe.

It is an important initiative, seeking to introduce clarity in some key challenges facing the emerging sector, such as establishing clinical evidence for a DTx to support approval and use, tackling data security and privacy issues, and ensuring health systems are ready and able to reimburse them.

"As we jointly develop this coalition, our aim is to enable full scale access to digital therapeutics throughout Europe to transform critical aspects of patient care," said Megan Coder, chief policy officer at the DTA. For now, DTx regulations in Europe are fragmented, even with the implementation of EU regulation 2017/745 on medical devices, which came into force on 26 May 2021 and encompasses DTx.

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