Why Are Coding Standards Important for Medical Robotics?
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 all these innovations depend on software which brings increased safety and security risks. That’s why it’s important to ensure your medical device software code is secure by complying to coding standards.
Read along or jump ahead to the section that interests you most:
- The Rise of Medical Robotics in Healthcare
- Why Are Coding Standards for Medical Robotics Important?
- Common Standards and Guidelines for Medical Robotics Software
- How Static Analysis Supports Medical Robotics Security
The Rise of Medical Robotics in Healthcare
You’re likely aware of medical robotic-assisted surgery, which the National Library of Medicine points out has been commonly used in operating rooms since the 1980s. This is a less invasive surgical option than traditional methods. With the incredible advancements and innovations in the modern world, today’s medical robots are helping to perform more advanced medical procedures than ever before — sometimes, without the need for a surgeon to even be in the same room as the patient.
For example, a company in the Middle East is developing a way for surgeons to guide a microscopic robotic arm to perform spinal surgery using Augmented Reality (AR) images of the patient during the operation.
Medical robots are also doing a lot more independently of the surgeon. Autonomous robotic surgery lets the operator select from autonomously generated surgical plans, and the robot takes it from there.
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).
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 functional and secure – in some cases, patient lives depend on it.
Why Are Coding Standards for Medical Robotics 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. In many cases, development teams need to be able to prove compliance to these coding standards and industry regulations for medical device software.
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.
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.
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.
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 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.
How Static Analysis Supports Medical Robotics Security
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.