July 2, 2024
Explore the critical steps for safeguarding Software as a Medical Device (SaMD), including establishing trust, SBOM management, communication channel security, and adherence to regulatory guidance. By focusing on these areas, industry stakeholders can ensure robust security of SaMD, passing regulatory requirements, and fostering adoption in these rapidly growing medical technologies.
FDA defines SaMD as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” This broad definition encompasses standalone solutions such as mobile applications, cloud-based applications, and algorithms, including those driven by artificial intelligence (AI), which can be marketed as medical devices.
The FDA categorizes Software as a Medical Device (SaMD) as one of three types of software related to medical devices, alongside software integrated into medical devices and software used for manufacturing or maintaining medical devices. Due to the unique nature and high connectivity of SaMD, the FDA considers these as “cyber devices” and has issued specific guidance to regulate their development, deployment, and maintenance.This guidance aligns with the broader regulatory framework for medical devices, but includes additional considerations for the distinct risks associated with SaMD.
Securing SaMD involves unique challenges compared to securing traditional web applications. The key differences stem from the nature of SaMD as connected devices that often handle sensitive patient data and clinical information. Here are some critical security considerations for SaMD:
To ensure robust security for Software as a Medical Device (SaMD), it is crucial to focus on key areas that will have the most significant impact. Here are the top priorities:
Focusing on these key areas helps developers and manufacturers effectively enhance the security of SaMD, ensuring regulatory compliance and protecting patient data.
SaMD represents a transformative shift in the medical device landscape, offering innovative solutions that improve clinical outcomes. However, the unique security challenges posed by these connected devices require a specialized approach. Adhering to FDA guidance, implementing robust encryption and securing communication channels are critical steps in safeguarding SaMD. By prioritizing these areas, stakeholders can ensure the security and efficacy of SaMD, fostering trust and confidence in these advanced medical technologies.
Navigating SaMD cybersecurity guidance can be a daunting process. Whether you’re looking for a place to start or have already started refining your cybersecurity strategy, with Medcrypt’s experienced team by your side, you can streamline your submission preparation, prioritize cybersecurity remediation, and achieve program maturity.
Our unique approach, coupled with a deep understanding of FDA expectations, ensures your medical devices are compliant and secure in an ever-evolving threat landscape. Trust Medcrypt to be your partner in achieving FDA cybersecurity readiness and ensuring the safety of your innovations.
Don’t know where to start? Start by taking our complimentary FDA Cybersecurity Filing Readiness Survey.
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