# Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-12-02
- Length: 31m
- Episode: 238
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-12-02-why-fda-is-prioritizing-clinical-decision-support-software-why-you-should-care
- Listen: https://podcast.greenlight.guru/episode/why-fda-is-prioritizing-clinical-decision-support-software-why-you-should-care

## Summary

Mike Drues of Vascular Sciences explains the FDA's new priority to finalize guidance on Clinical Decision Support (CDS) software, which provides patient-specific information to enhance healthcare. He details how the FDA currently uses enforcement discretion for low-risk CDS tools, such as telehealth platforms, but warns that this status is fragile and could change if inaccurate information leads to patient harm. Drues outlines four specific boundaries that would trigger FDA regulation, including software that analyzes medical images or provides diagnosis recommendations, and emphasizes the critical need for rigorous validation, usability testing, and data privacy measures even in the absence of immediate regulatory oversight.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-12-02-why-fda-is-prioritizing-clinical-decision-support-software-why-you-should-care#t=0) Introduction: Mike Drues and Vascular Sciences
- [1:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-12-02-why-fda-is-prioritizing-clinical-decision-support-software-why-you-should-care#t=113) Defining Clinical Decision Support Software (CDS)
- [4:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-12-02-why-fda-is-prioritizing-clinical-decision-support-software-why-you-should-care#t=250) Why CDS is the FDA's Top Priority for 2022
- [9:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-12-02-why-fda-is-prioritizing-clinical-decision-support-software-why-you-should-care#t=560) Examples of CDS: Telehealth, AI, and the ER Kiosk
- [14:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-12-02-why-fda-is-prioritizing-clinical-decision-support-software-why-you-should-care#t=871) CDS vs. General Wellness Devices and Enforcement Discretion
- [22:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-12-02-why-fda-is-prioritizing-clinical-decision-support-software-why-you-should-care#t=1333) The Four Boundaries That Trigger FDA Regulation
- [25:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-12-02-why-fda-is-prioritizing-clinical-decision-support-software-why-you-should-care#t=1501) The Necessity of Validation, Usability, and Liability Management

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Security & privacy](https://hardwarepodcasts.com/topic/security-and-privacy)

## Most relevant to

early-stage companies

## Mentioned

- Green Light guru (company)
- Vascular Sciences (company)
- WebMD (product)
- Theranos (company)

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- [172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-22-172-regulatory-ai-innovations-drugs-fda-database-regulatory-intelligence-strateg) (Let's Combinate)
- [How to Speed Up Safety Critical Processes](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-27-how-to-speed-up-safety-critical-processes) (The Pragmatic Embedded Podcast)
- [104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-27-104-new-fda-guidance-hf-vs-design-validation-critical-tasks-pre-ind-hf-studies-w) (Let's Combinate)

## Citing this page

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