By Phil Englert
The evolving landscape of healthcare technology, with an increasing focus on software-driven and cloud-based medical devices, presents significant challenges and opportunities for healthcare technology management (HTM) professionals.
We don’t need Bob Dylan’s prophetic anthem for change to remind us of the everlasting change in healthcare technology. Medical devices are increasingly designed to send data to a cloud for data aggregation, analysis and distribution to caregivers. Additionally, the FDA recognizes software as a medical device which is not dependent on specific supporting hardware but rather can be installed on a variety of traditional computer devices including laptops, tablets and mobile devices.
Healthcare technology management professionals — sometimes called “biomeds” or clinical engineers — are traditionally responsible for keeping medical technologies operational. They traditionally focus on the physical products known as medical devices. Assigning and affixing an asset tag has long been part of the incoming inspection process. As medical devices diverge into more software-based technologies and less physical products, HTM must disrupt traditional processes to manage software-driven and cloud-based medical device technologies. With many years of operational benchmarking in the health care environment, I want to continue the conversation within the HTM community and add a few personal insights along the way.
The first step is opening the aperture and welcoming the challenge of managing more ethereal assets. If your organization relies on The Joint Commission accreditation process, then all medical equipment must be included in the medical device inventory. The inventory must include high-risk devices that includes all life support equipment and any other device which if it fails may result in serious injury or death to a patient of staff. FDA Software as a Medical Device (SaMD) used the International Medical Device Regulators Forum (IMDRF) definition as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
In 2014, the IMDRF SaMD working group1 recognized four classes of medical devices including Category IV “that provides information to treat or diagnose a disease or conditions in a critical situation or condition is a Category IV and is considered to be of very high impact.” The IMDRF provides an example for each category. For Category IV one example is “SaMD that performs diagnostic image analysis for making treatment decisions in patients with acute stroke, i.e., where fast and accurate differentiation between ischemic and hemorrhagic stroke is crucial to choose early initialization of brain-saving intravenous thrombolytic therapy or interventional revascularization.”
More recently, software execution is moving from local execution to cloud-based solutions. The article “Hey You, Get On the Cloud: Safe and Compliant Use of Cloud Computing with Medical Devices”,2 published in BI&T magazine in January 2021 highlights the rapid adoption of cloud computing with medical devices along with the compliance issues and risk management challenges. The easy scalability combined with the elastic and inexpensive compute instances is evidenced by the growth of AWS, Google, Microsoft, Oracle and IBM. It didn’t take long for medical device manufacturers and healthcare delivery organizations to take advantage of this trend that had more and more medical devices feeding data to cloud environments.
To manage this diffusion of where health care data originates and is managed, HTM professionals will need to acquire and enhance their skills and understanding of software development, data analytics, cybersecurity and cloud computing. Understanding how software interacts with medical devices and how data is collected, processed and transmitted to the cloud is crucial to identifying all the system components to evaluate for inclusion or exclusion in the medical equipment management plan. As medical devices become more connected and reliant on the cloud, the risk of cybersecurity threats increases. HTM professionals must become adept at assessing and mitigating cybersecurity risks to ensure the safety and integrity of patient data and device functionality. With cloud-based technologies, many medical devices can be remotely monitored and updated. HTM professionals should be proficient in remote monitoring tools and techniques to ensure devices remain in optimal condition and to troubleshoot issues remotely.
The healthcare technology field is continually evolving. HTM professionals should be adaptable and open to innovation, staying current with emerging technologies and best practices in the industry. Hybrid computerized maintenance management system (CMMS) and configuration management database (CMDB) will be needed to track both hardware and software as well as the upstream sources or dependencies. As more devices and systems communicate with each other through the cloud, HTM professionals should have expertise in interoperability standards and protocols to ensure seamless data exchange and device integration within health care ecosystems. Managing and interpreting the vast amount of data generated by software-driven medical devices is crucial. HTM professionals need skills in data analytics to make sense of this data and provide valuable insights for patient care. Collaborating closely with device manufacturers and software developers is essential. HTM professionals should have the ability to communicate with vendors to address technical issues, updates and maintenance requirements for software-driven devices.
Dylan ends his song with a warning. “And the first one now / Will later be last / For the times they are a-changin’”
Bob Dylan’s anthem of hope urges us to recognize the eternal nature of change and to embrace its’ happening. The role of HTM professionals is expanding beyond traditional medical device maintenance to encompass a broader range of skills related to software, data management, cybersecurity and cloud technologies. To effectively manage software-driven and cloud-based medical device technologies, HTM professionals must embrace these changes and continuously update their knowledge and skills to ensure the highest level of patient care and safety. The time to work this into the HTM skills and processes is now.
Phil Englert is the director of medical device security for Health-ISAC.
References
1) https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-140918-samd-framework-risk-categorization-141013.pdf
2) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641424/
