Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
ORGANIZATION
JaDHA Creates Hypothetical Case Collection to Push Two-Stage Approval of SaMD
The Japan Digital Health Alliance (JaDHA) has drawn up a collection of hypothetical cases of therapeutic software as a medical device (SaMD) in a bid to add impetus to the development of these products envisioning the two-step approval pathway. JaDHA…
To read the full story
Related Article
- Regulatory Panel Members Want Clearer Standard for SaMD Efficacy in 2-Stage Approval Scheme
December 27, 2023
- MHLW Notification Outlines 2-Stage Approval Scheme for SaMD
November 21, 2023
- With 2nd Strategy Penned, Can Japan Play Catch-Up with US & Europe in SaMD Push?
October 3, 2023
- Japan Unveils 2nd Package Strategy for SaMD
September 7, 2023
- MHLW to Unveil Draft of 2nd Package Strategy for SaMD on Sept. 6
August 31, 2023
- SaMD Could Be Eligible for 2-Stage Approval System: MHLW
June 1, 2023
- Japan Deregulation Panel Proposes Two-Step Approval Scheme for SaMD
December 23, 2022
- Public-Private Collaboration Needed to Refine SaMD Regulatory System
November 26, 2021
- MHLW Aims to Set Up Evaluation Index, Sakigake System for SaMD by March
June 18, 2021
- MHLW Launches New Office to Fuel SaMD Commercialization
April 6, 2021
- MHLW Formulates Package Strategy for SaMD Commercialization, Eyes Sakigake Scheme
November 26, 2020
ORGANIZATION
- Labor Union Group Submits Request, Urges Drug Pricing Overhaul amid Inflation
December 3, 2025
- Wholesalers Urge Caution on Debating 2% Buffer without Bigger Reform Picture
November 28, 2025
- Labor Federation Files Request for 5% Drug Price Hike with Health Minister
November 28, 2025
- Japan PBSS Launches to Buttress Drug Discovery via Grassroots Networks
November 26, 2025
- Labor Group Presses Lawmakers to Reflect Rising Costs in Drug Prices
November 26, 2025





