Milan, Italy and Washington DC, US 12 June 2023 – Following the formation of the European DTx Policy Coalition by Healthware Group and the Digital Therapeutics Alliance (DTA) in June 2022, the joint team presented its inaugural report “DTx Policy Pathways: the evolving scenario in Europe; Landscape Analysis & Converging Trends” and a dedicated website ( on Friday, June 9th at the official press conference of the DTA Summit 2023, held in Washington DC.

Through the European DTx Policy Coalition, the Digital Therapeutics Alliance and Healthware Group, as the official knowledge partner, have been actively engaging stakeholders and representatives from Ministries of Health, national trade associations, and European trade associations. Their collective efforts aim to establish comprehensive best practice frameworks for the utilization of digital medical devices (DMD), including digital therapeutics (DTx).

Their first report DTx Policy Pathways: the evolving scenario in Europe; Landscape Analysis & Converging Trends” provides clarity on existing and evolving policies and Health Technology Assessment (HTA) criteria applicable to Digital Therapeutics (DTx), identifying converging trends and potential areas of harmonization and scalability across Europe.

An increasing number of countries across Europe, as worldwide, have developed or are developing appraisal criteria, access, and reimbursement policies for DTx and the broader Digital Medical Device (DMD) category. While paving new pathways, there is also a patchwork of nomenclatures and approaches being applied and while some countries are already providing equitable access and fostering systemic uptake of clinically-validated DMDs, others lack fit-for-purpose frameworks – ultimately limiting equitable, scalable, and timely access to clinically-validated DMDs.

To address this challenge, this initial DTx Policy Report is focused on providing clarity on existing and evolving policy frameworks in Europe. The report details fit-for-purpose appraisal criteria being applied in countries with formal frameworks in place, analyzing requirements through the common lens of the Health Technology Assessment (HTA) Core Model®. Converging trends are also identified to help inform areas of potential harmonization and scalability across Europe and globally.

The tools and resources featured on the website, are designed to provide best practices on DTx integration into healthcare, empowering clinicians, decision makers, and policymakers to recognize and include DTx within regional and national frameworks. By providing these resources, the website will contribute to driving equitable digital healthcare for patients globally.

We have the privilege of working with policymakers and payors from across the world to chart ways to provide equitable patient access to digital therapies,” said Megan Coder, Chief Policy Officer & Founder of Digital Therapeutics Alliance. “During this first phase of the Coalition, we’ve developed a comprehensive set of resources for decision makers to enable greater clarity and harmonization in how digital therapeutics are evaluated and implemented. Moving closer to a globally recognized framework for digital therapies will provide patients and caregivers with new opportunities to optimize how they receive and benefit from healthcare.

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 define fit-for-purpose appraisal criteria and adequate access and reimbursement policies is a key,” explained Alberta Spreafico, Managing Director Digital Health & Innovation at Healthware Group. “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, to help scale systemic integration and impact of DTx and digitally-enhanced care.

Since its inception, Healthware has been focused on assisting life science companies in communicating, connecting, and building innovative solutions which enable better healthcare. Whether it’s new ways to market innovative drugs or digital solutions, fostering the growth of the ecosystem through thought leadership, or building ground-breaking patient solutions, our focus has always been built on a clear vision of Future Health. I’m proud of the work our team has done in collaboration with the DTA to help support the adoption and access of DTx globally thru the development of this valuable resource”, said Roberto Ascione, CEO at Healthware Group.

Join the effort to deliver scalable, equitable digital healthcare to patients globally! Visit for more information and to download the report.


Healthware Group

Healthware Group is a full-service agency and innovation consultancy, founded by digital health pioneer Roberto Ascione, providing marketing, advisory, customer engagement and media services, medical communications and education, and advanced technology capabilities.

Leveraging +20 years of digital health heritage and thought leadership, Healthware’s dedicated Digital Health & Innovation division is a leading think tank, advisory and commercialization partner for digital medicines. Through its unique knowledge of the evolving scenario, interdisciplinary expertise, digital medicines Actionable Insights Database (AID) and ecosystem partnerships, it offers end-to-end support to ideate, scout, develop, validate, and especially launch and enable equitable access to and systemic adoption of digital medicines.

The media and community division offers premium content and platforms to gather insights, foster thought leadership, enable market shaping and create connections. Healthware Group has co-hosted and produced the premier global digital health conference, Frontiers Health, for nearly a decade.

With a team of 200+ professionals in Salerno, London, New York, Milan, Rome, Helsinki, and a joint venture with EVERSANA INTOUCH, Healthware Group has a combined reach of 2000+ people in over 15 offices across Europe, the US, and Asia. Additionally, the Healthware Global Network, one of the largest international networks of independent healthcare agencies, provides deep local expertise in over 25 countries.

For more information, please visit and follow us on LinkedIn and Twitter.

Digital Therapeutics Alliance

Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors to improve clinical and health economic outcomes. Founded in 2017, the Digital Therapeutics Alliance is a 501(c)(6) non-profit trade association of industry leaders and stakeholders engaged in the evidence-driven advancement of digital therapeutics. As the leading international organization on digital therapeutic thought leadership and education, the Digital Therapeutics Alliance provides patients, clinicians, payors, and policymakers with the necessary tools to define, evaluate, and utilize DTx products.

DTA is mission driven to advance digital therapeutics globally by:

  • Establishing the formal definition of a digital therapeutic and core principles to which all DTx products must adhere
  • Enabling clinicians and decision makers to adopt and integrate DTx products into healthcare to improve patient and population clinical and economic outcomes
  • Assisting policymakers as they work to recognize digital therapeutics within national and regional regulatory frameworks
  • Educating end users about DTx products and their short- and long-term value
  • Collaborating with DTA member companies and ecosystem stakeholders to optimize industry impact

To learn more, please visit: or follow us on LinkedIn.



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Digital Therapeutics Alliance

Autumn Brennan
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