As with all new technology with great promise, connectivity in medical devices comes with new risks. The medical device industry needs more sound, rigorous, and scalable methods to generate and use evidence of cybersecurity risk. Read more about the new approaches device manufacturers should consider.
On Dec 29, President Biden signed into law a $1.7 trillion omnibus spending bill that has significant implications for healthcare as well as for how security for medical devices are regulated and enforced. Manufacturers must now include evidence of security controls and security testing, as well as plans to maintain device’s security posture through updates and patches, all supported by documented evidence, e.g., a software bill of materials for commercial, open-source, and off-the-shelf software components.
SBOMs (Software Bill of Materials) have come into the spotlight in recent years, especially after the White House released the Cybersecurity Executive Order. As more organizations adopt standard operating procedures (SOPs) to generate SBOMs on a regular basis, what do you do once you have an SBOM? Read more to find out.
Cybersecurity used to be seen as a compliance initiative in healthcare but has become a patient safety and business imperative in recent years. For MDMs, tying market delays and metrics to a lack of security will inspire faster action. For HDOs, assessing strategies for incoming devices can start to shift the tide in how risks expand.
The core competency of healthcare is healthcare. Whether innovating new clinical treatments, enabling data sharing across a care team or discovering novel ways to enhance the quality of life, healthcare knows clinical care. The challenge faced in prioritizing medical device-based cybersecurity is that the buyers of medical devices haven’t been able to push for it as part of their purchase criteria.