@ShahidNShah
Guidance on Clinical Decision Support: Definitions and Transparency
The new FDA draft guidance for clinical decision support software is an important step forward but still has a long way to go.
Roughly two years after we reviewed the first FDA guidance on Clinical Decision Support (CDS), FDA issued new draft guidance. The FDA was criticized for not basing their first draft regulation criteria on use-case risk. Since then the International Medical Device Regulators Forum (IMDRF), which the FDA chaired, created a framework for organizing Software as a Medical Device (SaMD) by risk categories. While CDS is a very broad category that encompasses many functions, this guidance could have an outsize impact on the need to provide transparency in AI/ML platforms and algorithms for healthcare.
Continue reading at chilmarkresearch.com
Make faster decisions with community advice
- HIMSSCast: 5G and the future of AI in healthcare
- How Lean methodologies in healthcare can add value and improve the patient experience
- Kaiser Permanente researchers push the envelope with AI and NLP
- Meet the start-up: How a setback became an inspiration
- ONC: More patients are downloading their medical records and using portals
Next Article
-
HIMSSCast: 5G and the future of AI in healthcare
Healthcare AI expert Dr. Anthony Chang breaks down the relationship between stronger networks and smarter AIs. The increasing adoption of 5G in healthcare organizations and new developments in AI and …
Posted Sep 25, 2021 Artificial Intelligence