The group proposes a Hippocratic Oath for medical device manufacturers
Advocacy group I Am the Cavalry is urging organizations that manufacture and distribute medical devices to adopt a cybersecurity version of the Hippocratic Oath.
The group, which advocates for better security in life-impacting computers like those used in modern cars, medical devices or critical infrastructure, has published an open letter to the health-care industry, calling for a commitment to five principles when creating, using and maintaining medical devices.
Those principles are security by design, collaboration with security researchers, ensuring that evidence of potential failures is captured and preserved for later analysis, safeguarding critical elements under the assumption that they’ll operate in adverse conditions and providing easy-to-install security updates.
These principles are similar to the ones listed in the Five Star Automotive Cyber Safety Program that I Am the Cavalry proposed to the auto industry in 2014.
The group’s open letter to medical device manufacturers and other health-care industry stakeholders goes into specific details about how to achieve those five goals. The recommendations include: avoiding unprotected remote access, supply chain rigor, avoiding known flaws, implementing known methods and processes of receiving vulnerability reports and interacting with external security researchers, providing incentives for external researchers, tamper-resistant logging, isolation and segmentation of components, securing the update process and more.
Security researchers have found serious vulnerabilities in many types of medical devices in recent years, including flaws that could allow hackers to alter the dosage of insulin and drug infusion pumps or remotely access pacemakers to deliver potentially deadly shocks.
The U.S. Food and Drug Administration has taken note of these issues and seems decided to drive some change. Earlier this week the agency published draft cybersecurity guidance for medical device manufacturers, specifically focused on planning for, assessing and responding to vulnerabilities.
Some manufacturers are already on board with the proposal. Germany-based Dräger, a company that produces patient monitoring technologies, has had a coordinated vulnerability disclosure policy since last year and views I Am the Cavalry’s proposals as the basis for establishing cybersafety norms in the medical device industry.
