The evolution of SaMD and a new normal
Marzio Ghezzi, CEO at Mia-Care outlines the increasing normalisation of data driven and patient-centric care.
Software is a feature of everyday life. It’s in our cars, laptops, and phones, and we use it, directly or otherwise, for most things. It’s also ubiquitous in the healthcare sector where the digital age is gradually transforming the way patient care is delivered. Software as a Medical Device (SaMD) - standalone software for medical functions - is an emerging concept that could reimagine how healthcare is managed, monitored, and delivered.
SaMD is specifically intended for medical purposes and doesn’t need to be integrated into a physical device to serve its intended purpose. For example, imagine a mobile app developed specifically for recording an individual’s electrocardiogram (ECG) data. The application works independently and doesn’t require specialist intervention, allowing patients to monitor their health and share regular updates with clinicians. Whereas the software used to power an MRI scanner works in conjunction with other technologies and healthcare professionals to analyse data and, therefore, is not considered SaMD.
Why is there a need for SaMD? The UK’s healthcare system constantly grapples with several historic challenges, including the fragmentation of information systems. This disparity of information between healthcare providers hinders effective communication and directly impacts data sharing and care coordination.
Additionally, resourcing constraints contribute to delayed access to medical services and challenge effective patient management. Furthermore, data security and privacy concerns loom large, with strict adherence to regulations such as the General Data Protection Regulation (GDPR) paramount to patient confidentiality.
SaMD can bridge the gap between technology, traditional healthcare, and compliance in the UK. It can promote patient empowerment and better inform clinicians' decision-making processes. Here, we discuss the challenges of adopting SaMD, its long-term benefits and how patient-centric, data-driven care could become the new norm sooner than you think.
The challenges of widespread adoption
The journey towards widespread SaMD integration isn’t without its challenges. Developing this type of software requires two to three times the number of resources regular programs do. Making it an impractical option for some companies as validating tools for SaMD can place unrealistic time constraints on development teams.
There are also stringent regulatory requirements which extend beyond national boundaries. The European Medical Device Regulation (MDR) was introduced in May 2021 and is a robust framework for medical device regulation across the European Union, including the UK. The MDR mirrors the Medicines & Healthcare products Regulatory Agency (MHRA) in Britain and underscores a commitment to patient safety and data security. The convergence of these two frameworks fosters consistency and interoperability in deploying SaMD but also makes the compliance process more complex.
Navigating the intricacies of these regulations requires a joined-up approach. Collaboration becomes a transcontinental imperative. Ensuring compliance with MDR and MHRA enhances the credibility and access to SaMD within the broader European market, opening avenues for cross-border partnerships and shared advancements in healthcare technology.
As well as regulatory challenges, there is resistance to change within the healthcare sector, which presents another hurdle. For example, those clinicians accustomed to traditional practices may be reluctant to adopt SaMD and technology. Overcoming this resistance requires comprehensive education and training programmes, which highlight the tangible benefits of SaMD, such as reducing day-to-day workloads and improving the decision-making process that informs patient treatments.
To facilitate greater ease of adoption of SaMD, healthcare providers, regulatory bodies, and technology developers must work together. They need to establish clear guidelines that align with ethical considerations and identify a clear roadmap for the development and certification of the technology.
Enhanced patient care
By fostering a culture of interoperability and connectivity, SaMD bridges the divide between disparate healthcare systems, enabling seamless sharing of patient information and enhanced care coordination. Remote patient monitoring, a hallmark of SaMD, empowers healthcare professionals to track patients' health beyond traditional clinical settings, leading to early detection of health issues and timely interventions.
The implementation of SaMD doesn’t just benefit healthcare providers. It promotes patient empowerment and encourages individuals to take an active role in their health management. Patient-facing applications and remote monitoring tools allow individuals to track their health metrics, receive personalised insights, and actively participate in preventative care, aligning with the overarching ethos of patient-centric healthcare.
Efficient data management sits at the heart of SaMD and could streamline numerous processes within the UK’s healthcare system. For example, digitised patient records powered by SaMD offer a centralised point of patient information, enabling authorised healthcare providers to make informed decisions on their treatment pathways. The advanced algorithms and machine learning capabilities of SaMD could improve diagnostic accuracy, paving the way for quicker identification of health conditions, personalised treatment plans and improved patient outcomes.
But how do we get to this point? Technology provides some solutions. Using automation to speed up certification and regulatory compliance can accelerate the integration of SaMD into healthcare settings. For example, automating processes such as initial tracking, change requests, testing and creating technical documents for certification reduces the burden on development teams and healthcare providers.
Positive steps have been taken. The MHRA recently announced its Software and AI as a Medical Device Change Programme Roadmap, which underscores the UK’s commitment to leading the way in regulatory innovation in SaMD and artificial intelligence. The document details the MHRA’s aim to protect patients and the public whilst ensuring the responsible acceleration of innovation through safety, streamlined processes and international convergence.
The future of healthcare
The evolution of SaMD represents a transformative leap for the healthcare sector, offering a pathway to enhanced patient care and streamlined processes. However, despite its undeniable potential, the widespread adoption of SaMD must still clear several hurdles. Once these challenges have been navigated, the rewards are significant, including breaking down silos between healthcare systems and empowering clinicians with access to real-time patient information.
Technology is central to increased adoption. Automation reduces the burden on healthcare providers and clinicians. Working alongside collaboration, education, and innovation, SaMD can reimagine the UK’s healthcare landscape, where patient-centric, data-driven care becomes the new normal.