# Shifting Sands of SaMD Cybersecurity Regulations

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-07-06
- Length: 33m
- Episode: 270
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-06-shifting-sands-of-samd-cybersecurity-regulations
- Listen: https://podcast.greenlight.guru/episode/shifting-sands-of-samd-cybersecurity-regulations

## Summary

Chris Gates, Director of Product Security at Velentium, critiques the FDA's new draft guidance on cybersecurity for Software as a Medical Device (SaMD), arguing it imposes massive burdens on manufacturers without improving security. He highlights the PATCH Act's legacy device clause, which may force manufacturers to end support for older products due to unsustainable compliance costs. Gates advocates for aligning with existing consensus standards like ISO 14971 and NTIA SBOM definitions rather than creating new, misaligned regulatory artifacts.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-06-shifting-sands-of-samd-cybersecurity-regulations#t=0) Introduction: Chris Gates and Velentium
- [2:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-06-shifting-sands-of-samd-cybersecurity-regulations#t=173) The PATCH Act and Legacy Device Mandate
- [5:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-06-shifting-sands-of-samd-cybersecurity-regulations#t=355) ISO Standards and EU Harmonization
- [9:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-06-shifting-sands-of-samd-cybersecurity-regulations#t=563) Regulatory vs. Consensus Standards
- [14:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-06-shifting-sands-of-samd-cybersecurity-regulations#t=871) Software Bill of Materials (SBOM) Issues
- [21:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-06-shifting-sands-of-samd-cybersecurity-regulations#t=1260) Ongoing Testing and Resource Demands
- [23:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-06-shifting-sands-of-samd-cybersecurity-regulations#t=1420) Critique of FDA Guidance Development Process
- [30:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-06-shifting-sands-of-samd-cybersecurity-regulations#t=1824) Call to Action: Submitting Comments

## Topics

- [Security & privacy](https://hardwarepodcasts.com/topic/security-and-privacy)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)

## Most relevant to

early-stage companies

## Mentioned

- Velentium (company)
- FDA (company)
- PATCH Act (other)
- ISO 14971 (other)
- NTIA (company)
- CISA (company)
- NIST (company)
- IMDRF (company)
- Greenlight Guru (company)

## Related episodes from other shows

- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (Let's Combinate)
- [#000: How New IoT Security Regulations Will Shape the Industry's Future](https://hardwarepodcasts.com/podcast/coredump-sessions/2024-09-17-000-how-new-iot-security-regulations-will-shape-the-industrys-future) (Coredump Sessions)
- [134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities) (Let's Combinate)
- [140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-12-140-medical-device-diagnostics-cybersecurity-3rd-party-software-sboms-evaluating) (Let's Combinate)
- [#008: Navigating the Changing IoT Security Landscape: A Survival Guide for Product Leaders](https://hardwarepodcasts.com/podcast/coredump-sessions/2025-05-13-008-navigating-the-changing-iot-security-landscape-a-survival-guide-for-product) (Coredump Sessions)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-06-shifting-sands-of-samd-cybersecurity-regulations. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.