TGA Medical Device Regulations: Why Penetration Testing Is Essential

The Therapeutic Goods Administration (TGA) is essential to the safety and effectiveness of medical devices in Australia. Under the TGA medical device regulations, with the increasing incorporation of software into devices and increased connectivity through networks, security against cyber threats is one of the most important considerations for medical devices. One way to protect them is through penetration testing to identify vulnerabilities before they can be exploited.

Understanding the TGA Medical Device Regulations

As part of the TGA medical device regulations outlining the safety and performance requirements for medical devices before they can be sold. The TGA states that medical devices must be secure against cyber threats or cyber risks.

 

They require that devices are designed to, where possible, mitigate risks to patients. Therefore, manufacturers must demonstrate safety processes that include clear protection of devices against cyber threats to comply with the regulations imposed by the TGA.

 

Explore our penetration testing services for the healthcare industry to address industry-related regulations.

Types of Penetration Testing Performed on Medical Devices

Penetration testing is an important phase to verify that medical devices are secure and meet their safety requirements for the TGA medical device regulations. Because medical devices are complex and tend to have increased connectivity, it is necessary to conduct various types of testing to assess vulnerabilities across all components of a medical device. 

1. Network Penetration Testing

Network penetration testing assesses a device’s security posture based on its connection to networks. It simulates an attack on the device to determine if there are points of unauthorized access. As devices become more connected to the network, network testing is critical to ensure you are aware of the risk of hacking and are able to keep the device in compliance with safety requirements.

2. Application Layer Testing

Application layer testing specifically focuses on determining the security of the software applications for medical devices, such as mobile applications or cloud-based applications. This testing provides opportunities to identify vulnerabilities due to insecure coding, data leakage, and authentication issues, never leaving the device as a vector for a malicious cyberattack, demonstrating both patient data protection and the device’s integrity.

3. Physical Device Testing 

Physical device testing involves assessing the device’s hardware components to discover any potential physical vulnerabilities in medical device security. This also includes scrutiny of ports, interfaces, and firmware to prevent access through physical means. Because access to the physical components of medical devices can enable serious compromise of security, this testing will help protect a medical device when performed thoroughly.  

4. IoT and Embedded Device Testing 

With the abundance of Internet of Things (IoT) devices in healthcare, testing the IoT-connected systems is critical to the security of these medical devices. IoT penetration testing identifies the security of embedded hardware, wireless communication, and cloud integration in a medical device system. This testing helps to identify vulnerabilities and the potential for exploitation of devices in the integrity of the healthcare ecosystem to operate devices.  

5. Compliance-Focused Penetration Testing

Compliance-focused penetration testing satisfies testing that meets specific regulatory requirements, such as the Therapeutic Goods Administration (TGA) in Australia or the Food and Drug Administration (FDA) in the United States. This type of testing involves performing assessments on the manufacturer’s process of meeting industry standards and/or regulatory guidelines, along with documented evidence of compliance. 

 

Download our Sample Penetration Testing Report to understand how we report and mitigate vulnerabilities.

Conclusion 

Penetration testing is a crucial aspect of both the development and ongoing maintenance of medical devices, not merely a regulatory mandate under the Australian TGA Medical Device Regulations, but also a foundational aspect of patient safety, device quality, and consistency within a medical device’s device design history file.

  

Manufacturers who identify and remediate cybersecurity weaknesses and knocks before they become an issue otherwise known as ethical hacking. Theses are following best practices and ensuring compliance with some of the TGA legislation. 

 

Ongoing (and preferably, regular) penetration testing is an important part of maintaining the security and integrity of a medical device in a world where connected health is becoming an increasingly prominent part.

Source:https://qualysec.com/tga-medical-device-regulations/