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FDA is seeking “legislative authorities” to enable the office to require medical device manufacturers to adhere to strict cybersecurity policies, including the development of a Software Bill of Materials (SBOM).

Yesterday, the United States Department of Commerce released The Minimum Elements for a Software Bill of Materials (SBOM), in accordance with President Biden Executive Order 14028 on Improving the Nation’s Cybersecurity. For those who have been following the National Telecommunications and Information Administration (NTIA) SBOM work, you won’t find any surprises in the release. The document thoroughly describes the SBOM, provides motivation for the SBOM as a standard security document, and ma…

On May 12, 2021 President Biden signed the Executive Order on Improving the Nation’s Cybersecurity, which we previewed in a recent post, into law. The fifteen-page document includes various cybersecurity enhancement recommendations such as the Software Bill of Materials (SBOM) and review and revision of governmental procedures, such as the Federal Acquisition Regulation (FAR), all with associated timelines for completion.

On May 12, 2021 President Biden signed the Executive Order on Improving the Nation’s Cybersecurity, which we previewed in a recent post, into law. The fifteen-page document includes various cybersecurity enhancement recommendations such as the Software Bill of Materials (SBOM) and review and revision of governmental procedures, such as the Federal Acquisition Regulation (FAR), all with associated timelines for completion.

On May 12, 2021 President Biden signed the Executive Order on Improving the Nation’s Cybersecurity into law. In spite of being only fifteen pages in length, the executive order is detailed and complex. It’s quite easy to become overwhelmed by the dependencies between requirements and deadlines for completion. In this document, we have attempted to reduce this complexity by highlighting certain key aspects of the executive order and suggesting actions that can be taken now to help prepare your…

The software bill of materials (SBOM) is on its way to being recognized as a key security document and the primary enabler of software transparency across all industries. In healthcare, FDA (US Food and Drug Administration) included the SBOM in the first draft of their Premarket Guidance in 2018, but they referred to it as a CBOM (Cybersecurity Bill of Materials). Today, SBOM, which is a detailed list of software components found in a product or system, has become the more accepted terminolog…