Why Are Coding Standards Important for Medical Robotics Engineering?
Advances in medical robotics and healthcare technology — enabled by the Internet of Medical Things (IoMT), Machine Learning (ML), and Artificial Intelligence (AI) — mean that we are already seeing less invasive procedures, more accurate diagnoses, and more personalized treatment options for patients.
But these innovations depend on software which brings increased safety and security risks. That’s why it’s important to ensure your medical device software is safe and secure by meeting coding standards compliance.
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Back to topHow Are Medical Robots Being Used in Healthcare?
Modern medical robot systems are now working alongside humans and even performing complex surgeries — sometimes, without the need for a surgeon to even be in the same room as the patient. Autonomous robotic surgery, for example, lets the operator select from autonomously generated surgical plans, and the robot takes it from there.
Interest in surgical robotics has surged in recent years, and is only growing: while there are still hurdles to adoption, Bain & Company reports that 78% of U.S. surgeons are interested in embracing surgical robotics, with new specialties and types of surgeries poised for the adoption of medical robotics assistance.
Health tech is doing a lot outside the operating room, too. For example, a Nature study has revealed that an AI system can identify cancers from screening X-rays, outperforming humans at the same task in some instances. Wearables and remote patient monitoring (RPM) systems help both doctors and patients track changes in blood pressure or glucose levels. And at the administrative level, service robots in healthcare are helping with inventory and material transportation, prepping patient rooms and tracking medical supplies.
Soon, it may become commonplace for robot companions to keep patients company and to assist them during their hospital stay and beyond. And, with the rise in popularity of generative AI, patients may soon be able to more accurately check their symptoms with technology like Chat GPT before seeing their general practitioner (GP).
With recent advances in AI-assisted and fully autonomous robots, AI will be integrated into existing medical robotic platforms, further revolutionizing healthcare and medical device software as we know it.
Of course, it takes a lot of coordination and connectivity to keep these systems up and running, and, unfortunately, that’s where malicious actors try to hack in. It is imperative to ensure cybersecurity to keep medical devices and robots functionally safe and secure — in some cases, patient lives depend on it.
Back to topWhy Are Coding Standards for Medical Robotics Engineering Important?
The safety and security of code in healthcare devices and medical robots is important for a variety of reasons, from protecting patient privacy to improving patient quality of life and even saving lives. As most medical device security vulnerabilities are introduced during software development, it’s important to start checking for vulnerabilities early in the software development lifecycle, ideally as the code is being written.
As medical robot and medical device systems are growing in complexity and connectivity, coding standards are being used more and more to help ensure developers write code that is consistent, safe, and secure. Fortunately, there are many existing standards that development teams can apply to medical robotics systems specifically, so those organizations needing to prove compliance can lean on existing guidance and regulations.
Recent legislation and government regulations also address the cybersecurity of robotics in healthcare and medical devices in general. For example, H.R. 7667 specifies that medical device manufacturers must follow certain processes and procedures to keep software secure, as well as demonstrate compliance with the regulations.
📕 Related Reading: A Software Leader's Guide to H.R. 7667
The U.S. FDA and Europe’s MDR have also provided updated cybersecurity guidelines and stricter regulations to address security risks in invasive medical devices, but are equally applicable to medical robotics and other healthcare devices, particularly those used in surgical procedures.
Common Standards and Guidelines for Medical Robotics Software
The FDA, MDR, and other regulatory organizations recommend following key standards to help medical robotics developers put safety and security first throughout the SDLC.
IEC 62304
One of the most relevant international standards for medical robotics software, IEC 62304, “medical device software — software lifecycle processes,” is a functional safety standard that provides safety-related processes for the design and maintenance for software in medical devices. It also recommends the use of a coding standard as part of the software development process.
IEC 81001-5-1
IEC 81001-5-1 is a relatively new cybersecurity standard that applies more broadly to healthcare software and IT systems — medical robotics included. It extends beyond standards like IEC 62304 to include cybersecurity considerations at every phase of the software development lifecycle.
MISRA C/C++
Originally developed for the automotive industry, MISRA C/C++ is a coding standard that applies equally to any safety-critical system including medical robotics. It is widely used by embedded developers in many industries and ensures that code is safe, secure, reliable, and portable.
CERT
CERT is a secure coding standard that supports programming languages such as C and C++. The standards help developers detect security risks and recommend ways in which to improve code quality.
In addition to using these standards and guidelines, organizations should also review the OWASP Top 10 and the CWE Top 25 to keep up with the latest software and hardware security vulnerabilities and weaknesses.
Back to topHow Static Analysis Supports the Safety and Security of Medical Robots
An efficient means to ensure that medical robotics software is compliant to coding standards and is secure is to use static analysis, which is recommended by the FDA as well as the International Medical Device Regulations Forum (IMDFR).
A static analysis tool — such as Perforce’s Helix QAC and Klocwork — helps you improve software quality, demonstrate compliance, and ensure security. Using static analysis, you can enforce coding standards, detect vulnerabilities early in the development process, test code faster, and report on compliance over time.
Helix QAC and Klocwork are also certified for use for safety-critical systems by TÜV-SÜD, including IEC 62304 up to Software Safety Class C.
See for yourself how Perforce static analysis tools can help you enforce medical robotics software security, safety, and compliance. Request your free 7-day trial.
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