Richard Poate, Senior Manager of TVSD, describes some of the requirements that need to be tested during the initial design process of connected devices.
Healthcare cyber transformation
Connected healthcare products with remote access are becoming a growing area, but these systems can be the target of cyberattacks. This is because all the risks associated with remote connections and their ease of use by third parties are often not taken into account.
Therefore, there are multiple regulatory, ethical, and business reasons to ensure that all digital healthcare and medical devices are thoroughly tested and safe. This includes compliance with global regulatory requirements such as the EU In Vitro Diagnostic Medical Device Regulation (IVDR) and Medical Device Regulation (MDR). It also includes regional requirements for the US FDA, Health Canada, China’s National Health Products Agency, and Japan’s Ministry of Health.
However, there is not yet a unified standard for cybersecurity in medical devices. Regulators around the world are catching up with this situation, but there are some cybersecurity standards that provide guidance with a focus on medical devices.
MDCG 2019-16 Guidance on cybersecurity for medical devices. This is one of the most important guidelines for MDR implementation. IEC / TR 60601-4-5 Safety-related technology for medical devices Security specifications (currently under development) IEC 81001-5-1-Application of risk management to IT networks incorporating medical devices (currently under development) UL 2900-2 ―― 1-Cybersecurity support for US Food and Drug Administration industry and regulators
Cybersecurity should be based on a well-structured development and testing process. For example, after major software changes, vulnerability scanning or penetration testing should be repeated, at least partially. Manufacturers should consider security-related tests for changes and perform regression tests to show that the changes were not negative. Impact of device cybersecurity.
Currently, there is no law requiring testing, but most guidance documents indicate that testing should be done. Therefore, due to global regulations and privacy laws, it cannot be skipped. Therefore, it is the manufacturer’s responsibility to prove in due diligence that they have taken appropriate steps to bring a safe product to market.
The EU MDCG 2019-16 document provides manufacturers with guidance on how to meet all relevant essential requirements of Appendix I of the MDR and IVDR on cybersecurity. When assessing risk according to Appendix I of the MDR, it is important to include security issues in the risk assessment. During the risk management process, manufacturers need to anticipate or assess potential exploitation of security vulnerabilities that may be the result of reasonably foreseeable misuse.
Front line of defense
There are several standards and industry guidance available worldwide, but they are not complete, approved or required. However, these represent the front lines of defense, and as a first step, designers and manufacturers should consider them safe by design and take a proactive approach to cybersecurity. It is also important to keep standards and regulations up-to-date and ensure that they are functioning up-to-date. Similarly, by following the development of the test framework, we will attend appropriate standard workshops (eg European standard CEN-CENELEC events) and provide guided, robust and cost-effective solutions.
While digitization and improved connectivity offer great opportunities, unpredictable risks and serious vulnerabilities can be exploited by new forms of cybercrime. Therefore, security that is resistant to implants, wearables, mobile connections, and devices that use public networks is paramount. It is important to remember that there is no bad user behavior, only scenarios that the designer or manufacturer could not identify. Also, you should not expect patients to bear the additional security burden, as it is the manufacturer’s responsibility to ensure up-to-date compliance with all standards and to constantly check the cyber-tolerance status of the device.
The Internet of Medical Things (IOMT) has transformed healthcare. However, increased medical device connectivity makes people more vulnerable to cyberattacks and puts people at risk by using them, which never existed before.
Therefore, continued investment in cybersecurity is important to keep up with both technological developments for a competitive advantage, as well as effective countermeasures against hacker attacks. Therefore, all digital healthcare and medical devices must be thoroughly tested and secured and comply with global and regional regulatory requirements.
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