Connectivity in medical devices creates new diagnostic and treatment opportunities, yet at the same time increases the risks of cyberattacks—including their consequences for patient safety and data privacy. Now the new IEC 81001-5-1 standard provides clear technical requirements for manufacturers and developers to ensure the cybersecurity of their products across their life cycle.
Connected medical devices have many advantages but require a higher level of security. If the medical industry doesn’t improve its cybersecurity posture, it could endanger patient privacy and lives.
Taking these compliance challenges into account will allow healthcare organizations to prepare for compliance audits, but more importantly it will help institutions address issues that result in a negative patient outcome.
“Velentium is committed to educating the next generation of aspiring engineers and plans to expand this initiative to additional universities around the country, ultimately creating a certification course.”
The revised cybersecurity draft publication is not intended to be a checklist for healthcare organizations to follow, but rather a guide to help them comply with the HIPAA Security Rule.
Numerous studies have explored the challenge of helping patients adhere to their medication regimens. One promising solution is “smart” medication blister packs with embedded sensors that enable caregivers to remotely monitor if—and when—doses are removed. But they can only be used if they are cyber-hardened against today’s dangerous and ever-evolving cybersecurity risks.
Old justifications or business reasons for security gaps are obsolesced. We need robust medical device cybersecurity, but we need it in a manner that is workable by both MDMs and HDOs.
Patient-administered healthcare is one of the fastest-growing segments in the medtech industry. When the patient becomes the operator, usability requirements are vastly different than those of trained clinicians, which elevates considerations in the design process.
With the ever-increasing adoption of connected devices, the agency is emphasizing the need for effective cybersecurity.
The total $8.4 billion fiscal year 2023 budget request is 34% higher than the agency’s 2022 appropriated funding level.
