The booming of digital health: Where do we stand with regulation and assessment frameworks?

Maximize your World Hospital Congress experience

Bookings are now available for SDA Bocconi School of Management’s masterclass during Congress registration at special discounted rates.

When: 27 October 2023 (post-congress), 14:00-16:00

Where: Lisbon Congress Centre, Portugal

This masterclass dives into the burgeoning field of digital health, focusing on the current state and challenges of regulation and assessment frameworks. The explosive growth of digital health technologies, including mobile apps, wearables, telehealth, and AI-driven solutions, is revolutionizing healthcare delivery. However, these advancements also introduce unique regulatory and evaluative complexities. This course explores how regulatory bodies like the FDA and EMA are adapting traditional regulatory frameworks to accommodate digital health technologies. Key topics include data privacy, cybersecurity, and the iterative nature of software-based medical devices and ai-driven decision-making.

The masterclass also examines health technology assessment (HTA) in digital health, discussing the difficulties posed by these technologies’ heterogeneity and dynamic nature. We delve into novel approaches to assess not only clinical effectiveness but also factors such as user engagement, usability and system interoperability. Participants will gain a comprehensive understanding of the progress and ongoing challenges in digital health regulation and HTA, and engage in critical discussions on the future directions needed to ensure safe and effective implementation of digital health technologies.

Learning objectives

  1. Defining and differentiating digital health, mobile health, digital medicine and digital therapeutics.
  2. Understanding existing gaps in HTA and regulation on digital health
  3. Discussing the risk of hype
  4. Identifying possible future scenarios based on recommendations

Target participants

  • Hospital and healthcare managers
  • Policymakers
  • Health IT developers
  • Physicians interested in digital health
  • Young professionals
  • Pharmaceutical and medical devices companies
  • Anyone interested in the intersection of health, technology, and policy.

If you have any questions about the programme, you can email Tom Sneddon.


Registration rates

WHC Delegate Non-delegate
The booming of digital health IHF Members – € 140
Non-members – € 160
Lower-middle income countries – € 75
Low-income countries – € 50
IHF Members – € 280
Non-members – € 320
Lower-middle income countries – € 150
Low-income countries – € 100
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