Design tailored for manufacturing
Cybersecurity
Ensuring Medical Device Cybersecurity from the Development Stage
Health data theft, hacking of connected implants, or critical medical devices—threats to the medical sector are numerous. The consequences of an attack can be severe.
Insulin pumps, infusion pumps, pacemakers, prosthetics, implants—there is a wide variety of medical devices, and they are increasingly connected. Cybersecurity has thus become a crucial concern for the entire healthcare sector.
- Patient Protection: Attacks on active medical devices can endanger patients’ lives by disrupting device functionality.
- Data Confidentiality: Active medical devices collect sensitive medical data, and a security breach could result in violations of patient privacy.
- Data Integrity: Medical data must remain accurate and reliable. An attack could compromise this data, affecting patient care.
At Tame-Care, our teams prioritize the cybersecurity of your medical devices, leveraging their expertise to protect against potential cyber threats such as unauthorized access, data breaches, and malware attacks.
Our Support
Cybersecurity Risk Assessment
Our team conducts risk analyses to identify potential threats and vulnerabilities in electronic medical devices. This assessment is vital to anticipate risks related to data compromise, service disruption, or unauthorized system access.
Secure Design
During the development of new devices, our design office incorporates security principles from the outset. This includes implementing encryption mechanisms, authentication protocols, and access controls to safeguard sensitive medical data and communication between devices.
Development of Security Protocols
Our engineers develop security protocols and risk management policies to ensure device protection throughout their lifecycle. These protocols cover strategies for security updates, vulnerability management, and incident response to cybersecurity threats.
Security Testing and Validation
We perform penetration testing and security audits to validate the robustness of implemented security measures. Our team simulates potential attacks to assess device resilience against real-world threats.
Regulatory Compliance
At Tame-Care, we ensure that your medical devices comply with cybersecurity regulatory requirements, such as those enforced by the FDA in the United States or European regulations like the MDR (Medical Device Regulation) and the NIS (Network and Information Systems) directive. This includes documentation and certification of the security measures implemented.
The Challenges of Cybersecurity
A Risk to Patient Health
While these new devices offer significant health benefits, they are becoming increasingly vulnerable and may even pose risks to patient safety. Although no incidents have been reported to date, researchers warn that it is possible to deliver a fatal shock to a pacemaker, alter the readings of a cardiac monitor, or modify the dosage of an insulin pump.
Protecting Assets and Health Data
In the healthcare sector, protecting assets and data is a necessity. Exploiting a vulnerability can have harmful consequences, directly affecting the safety of care and the health of patients.
Addressing New Threats Associated with Emerging Technologies
Medical devices integrating software are increasingly connected (Wi-Fi, radiofrequency, Bluetooth, etc.) and must confront new threats arising from technological advancements, particularly in the realm of cybersecurity and malicious attacks.
Preventing All Malicious Attacks
It is essential to take the necessary measures to prevent any malicious attacks on their medical devices (MDs), thereby avoiding data breaches and the misuse of the medical devices they bring to market.
Contact
Offers tailored to the different stages of your project
High-value-added services
