The Central Social Insurance Medical Council’s (Chuikyo) medical materials subcommittee basically approved the outlines of the evaluation rules for software as a medical device (SaMD) under health insurance programs on November 12. Based on examples in the past, SaMD that…
To read the full story
Related Article
- Chuikyo OKs FY2022 Drug Pricing Reform Outline; Spillover Exclusion, Mega Seller Rule
December 23, 2021
- Public-Private Collaboration Needed to Refine SaMD Regulatory System
November 26, 2021
- Trade Groups Urges New Reimbursement Fee Evaluation for SaMD
August 26, 2021
- Chuikyo to Compile Proposal on SaMD Reimbursement by Year-End
August 5, 2021
- Chuikyo to Discuss Evaluation Rule for SaMD toward Next Reimbursement Reform
May 27, 2021
REGULATORY
- PMDA to Adopt General-Purpose AI in FY2025, Eyes Specialized Tools for Reviews and Safety Work
December 8, 2025
- Japan Likely to Extend Generic-Name Prescribing Premium to Biologics to Spur Biosimilars
December 8, 2025
- Aspirin, CAR-T and Other Products under PMDA Safety Review
December 8, 2025
- R&D Tax Credit Draws Broad Calls for Maintenance, Expansion: LDP Meeting
December 8, 2025
- Another LDP Study Group Submits Emergency Proposal Urging Drug Pricing Overhaul
December 5, 2025
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…





