Source – Healthware Group
On 9 June 2023, the European DTx Policy Coalition was established by Healthware Group and the Digital Therapeutics Alliance (DTA). In order to promote equitable access and adoption of safe and efficient digital therapeutics (DTx) and digital medical devices (DMDs), the joint team has now developed a dedicated website and published an initial report.
In order to create comprehensive best practices frameworks for the use of DMDs, including DTx, “DTx Policy Pathways: The Evolving Scenario in Europe; Landscape Analysis & Converging Trends” brings together the collective knowledge and efforts of not only the European DTx Policy Coalition, but also stakeholders and representatives from Ministries of Health, national trade associations, and European trade associations.
His first paper identifies convergent trends and possible areas of harmonization and scalability throughout Europe while providing clarity on current and changing legislation and Health Technology Assessment (HTA) criteria applicable to DTx.
While this is going on, the recently launched website www.dtxpolicylandscape.org aims to promote equitable digital healthcare for patients all over the world by providing tools and resources that will empower clinicians, decision-makers, and policymakers to recognise and incorporate DTx within regional and national frameworks.
All ecosystem stakeholders should be able to continue to obtain credible information and regular updates on the fast changing global situation through the website, which is designed to serve as a dedicated resource. In order to promote scalable, egalitarian, and sustainable integration of digital healthcare globally, it encourages information exchange and cooperation, promotes the creation of appropriate and enabling legislation, and supports system preparedness.
These changes coincide with an increase in the number of nations in Europe and beyond that have created or are creating access and reimbursement guidelines for DTx and the larger DMD category. While some nations now promote systemic acceptance of clinically approved DMDs and offer fair access to them, others still lack frameworks that are appropriate for the situation.
“With DTx and, more generally, Digital Medical Devices delivering meaningful clinically-validated health outcomes, it is important to enable equitable and sustainable access to them and defining fit-for-purpose appraisal criteria and adequate access and reimbursement policies is a key. We are proud to join forces with the Digital Therapeutics Alliance as knowledge partner, to support all ecosystem stakeholders through in-depth knowledge, continuous monitoring of the evolving scenario and curation of valuable resources on www.dtxpolicylandscape.org, to help scale systemic integration and impact of DTx and digitally-enhanced care.”
– Alberta Spreafico, Managing Director Digital Health & Innovation at Healthware Group
