Challenges facing manufacturers in medical device technology
Data breaches continue to increase in Med Tech industry and the breaches are becoming more severe due to a massive increase in hacking incidents and ransomware attacks with internet connected devices. HIPPA requires data breaches to be reported to the U.S. Department of Health & Services Office for Civil Rights (OCR). If 500 or more individuals are impacted by a HIPPA violation, the individuals need to be notified within 30 days of discovery and the OCR and local media need to be notified within 60 days. The OCR publishes summaries of data breach reports on its “Wall of Shame” and was established under the HIPPA Breach Notification Rule and HITECH Act, and it lists the names and details of organizations under investigation. According to the HIPPA Journal’s data breach statistics, many of the hacking incidents occurred for months and in some cases years before they were detected. The incidents include employee errors, negligence, snooping on medical records and data theft by malicious insiders. The penalties for HIPPA violations can be severe. If violations have been allowed to persist for several years, multi-million-dollar fines are possible.
Integrating security in medical devices
It is an enormous responsibility to keep people and data safe; therefore, it is crucial for Med Tech manufacturers to take steps to comply with best practices in the device and software development processes.
Internationally recognized standard, ISO 14971:2019+A11:2021 can help manufacturers establish processes that include identification of hazards, the assessment of the related risks and the implementation of risk control measures, in order to create safe products. The risk management process should address the complete life cycle of the device from conception to decommissioning, making sure PHI or ePHI are properly disposed. Risks from poor design, failure in production processes, damage during shipping, software vulnerabilities, misuse by client, side effects, component failures and disposal need to be addressed. It is a requirement in ISO 14971 standard to maintain records of individuals who participated in the risk analysis and when it was carried out. It is recommended to document all training in risk management and periodically review and revise policies and procedures.
Similarly, ISO 13485:2016+A11:2021, an internationally recognized standard for quality management systems in the design and manufacturing of medical devices can help manufacturers and suppliers of medical devices meet rigorous regulatory requirements. Compliance with this standard facilitates entry into global markers and improves efficiency and effectiveness by streamlining manufacturing processes. ISO 13485 standard encompasses requirements for managing the entire lifecycle of the medical device, including design, development, manufacturing, distribution and post market monitoring. Medical device manufacturers should develop a Quality Management System (QMS) with policies, processes and procedures with the main purpose of managing quality in their products and satisfy the ISO 13485 requirements. Evaluation of the capability and performance of suppliers is an important part of this standard, and their performance must be monitored over time. Internal audits of the quality management system should be conducted periodically to ensure proper implementation, update and tracking of any changes.
The Cybersecurity and Infrastructure Security Agency (CISA) is advancing the Software Bill Of Material (S BOM) adoption as a key building block in software security and software supply chain management. SBOM is a machine-readable list of different components created during development of a software that provides greater transparency about risk and vulnerabilities. It contains the details in supply chain relationships. This enables better visibility of risk management and a greater awareness of potential vulnerabilities which can be processed via automation and addressed efficiently. SBOM can also help organizations maintain updates and accountability for different modules. Vulnerability Exploitability eXchange (VEX) is a an SBOM-related concept that is a standardized advisory to convey information about exploitability of vulnerabilities in software products.
It is imperative that Med Tech industry employ the best practices in product development, including cybersecurity in every step of the process. Digital Beachhead Inc specializes in helping Med Tech organizations with their cybersecurity requirement and compliance. We will help you keep up to date with the latest rules, the newest technologies and train your employees for cyber awareness.
