Software As A Medical Device (SaMD) a form of digitaltechnology, it is a standalone program that can help physicians determine treatment options or even provide early diagnosis of life-threatening conditions.

While SaMD has the potential to deliver huge benefits to the healthcare system, the International Forum of Medical Device Regulators (IMDRF), a group of medical device regulators working towards the goal of international regulatory harmonization, has recognized that SaMD introduces new challenges for the regulation of medical devices.

Many non-traditional medical device manufacturers, such as SaMD software developers, have found themselves in unknown medical device regulatory territory. On the other hand, regulators face the challenges of software regulation which can have frequent updates, which could change the security and / or effectiveness of the software. The ability to download software from the Internet also presents risks, as the traditional physical boundaries of containment no longer exist.

Given that growth in this industry is expected to continue for many years, how do regulators balance the need to sustain the pace of innovation while ensuring that these medical devices remain safe and effective?

Key Highlights 

SaMD is defined as software intended to be used for one or more medical purposes which fulfill those purposes without being part of a hardware medical device.

SaMD has enormous potential to improve the health system, but is accompanied by new challenges for both regulators and industry, such as monitoring, cybersecurity and interoperability.

IMDRF is working with medical device stakeholders to find regulatory convergence and harmonization in this space.

SaMD: Opportunities and Challenges for Life Sciences

Regulators and industry must accept a globally implemented device coding and identification standard to identify and track SaMDs throughout their life. They differ from a traditional medical device that can be physically tagged with a unique device identifier. Another challenge for SaMD is software security. Cyber security vulnerabilities can present risks when using the medical device. It can allow the attacker to remotely take control of the device, modify its functionality and affect the security or effectiveness of the device, or disclose confidential information.

Currently, the FDA is piloting a software pre-certification program to help inform the development of a future regulatory model for digital health technology, such as SaMD. The program first examines the software developer to demonstrate a strong culture of quality and organizational excellence, which differs from the traditional approach of examining a medical device.

Digital Health Canada: SaMD, cybersecurity and artificial intelligence

In 2018, as part of the Drug and Device Regulatory Review initiative, Health Canada established the Division of Digital Health (DHD) at the Office of Medical Devices. DHD focuses on the pre-market review of digital health technologies and contributes to the development of better ways to advance and adapt regulatory approaches to digital health technologies, while ensuring that they remain safe and effective.

DHD has developed peer-review capabilities to keep up with these innovative software products and the challenges that come with them.

Regulatory challenges of SaMD include:

Medical device regulations establish rules to inform the categorization of medical devices from lowest to highest risk. Some SaMDs don't quite fit the categorization system created with traditional medical devices in mind. Artificial intelligence is already improving some SaMD applications in the field of image-based healthcare by continuously learning from the data provided by the software. But how does a regulator ensure that there are no unwanted consequences for the software's intended purpose when the software delivers the result? Health Canada currently co-chairs an IMDRF Cybersecurity Working Group with the FDA to develop standards and best practices for addressing cyber security risks.

Industry Perspectives: SaMD Innovations and Challenges in Canada

The industry appreciates the efforts of regulators and the IMDRF to align regulatory processes with the SaMD. This has helped simplify the classification and registration of these types of medical devices and spurred innovation on the part of software developers. Health Canada's current draft SaMD guidance document has been helpful, but questions remain about how to classify certain software, how to manage software updates and usability, and how to meet cybersecurity requirements. The industry will continue to work with regulators to seek clarity on policies and processes so that SaMD developers are aware of the regulatory requirements they must meet to bring their product to market.