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Mastering Medical Device
What You Need to Know About the New Cybersecurity Regulations for Medical Device with Milton Yarberry
Nov 14, 2023
Milton Yarberry, Director of Project Management at Integrated Computer Solutions, discusses the impact of the Patch Act by the FDA on medical device cybersecurity. The podcast covers software affected, key takeaways, impact on legacy devices, and how medical device companies will be affected. It also explores challenges in implementing cybersecurity regulations, the importance of usability in medical devices, lack of regulation for software in healthcare settings, challenges of incorporating late information in development, and the importance of marketing in medical device development.
49:16
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Quick takeaways
- The Protecting and Transforming Cyber Health Care (PATCH) Act, implemented by the FDA, aims to regulate cybersecurity in medical devices and ensure that all medical devices with software prioritize cybersecurity.
- Software in medical devices, whether software as a medical device (SaMD) or software in a medical device (SiMD), must meet specific regulatory requirements, including having a vulnerability plan, a software bill of materials, and protocols for responding to potential cyberattacks.
Deep dives
Importance of Software in the Medical Device Industry
Software plays a crucial role in delivering quality and efficient medical care. While safety has always been a priority in the medical device industry, software presents different challenges due to its faster pace and unique requirements. Regulatory bodies are addressing these challenges by implementing regulations like the Protecting and Transforming Cyber Health Care (PATCH) Act. This act aims to ensure cybersecurity in all medical devices with software, whether software as a medical device or software in a medical device.
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