Digital therapeutics (DTx) are evidence-based therapeutic interventions driven by software to prevent, manage, or treat a medical disorder or disease. The pressing question of whether there is a need for an international treaty, harmonization or national legislation to address the specific issues raised by digital therapeutics was a focal point during a recent panel discussion at the AIPPI World Congress. Experts from Canada, Brazil, India and Europe gathered to examine the evolving landscape of DTx, highlighting the major roadblocks to their adoption and integration into existing health models.
The ongoing transformation of healthcare technology took center stage as panelists emphasized the significance of early adoption and the critical need for regulatory and intellectual property frameworks to support these innovations. The discussion began with an exploration of the definition of digital therapeutics, noting that it has become more standardized in recent years. The Digital Therapeutics Alliance (DTA) has provided a framework for understanding these technologies as software interventions designed to treat, manage, or prevent diseases. However, the lack of specific legal definitions and regulations across jurisdictions poses challenges for stakeholders in this rapidly evolving field.
As the conversation progressed, panelists acknowledged that digital therapeutics often fall under the umbrella of medical devices, complicating their classification and approval processes. They explored the varied approaches to digital therapeutic regulations in different regions, noting that while some countries have adopted frameworks influenced by European standards, others remain without clear guidelines.
Roberto Rodrigues, a partner at RNA Law in São Paulo, noted that in Brazil, a significant portion of innovation disputes is emerging from startups, highlighting the ongoing integration of technology from larger pharmaceutical companies. He pointed out that research and development (R&D) is increasingly occurring within smaller companies.
Throughout the session, panelists addressed key roadblocks to the adoption of digital therapeutic solutions, including intellectual property protection and reimbursement challenges. They shared insights into how various countries are navigating these issues, emphasizing the importance of understanding local contexts and regulatory environments.
– Cathy Li, reporting from Hangzhou
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