Your Guide to Software Selection

Understanding Software as a Medical Device (SaMD)

Within the general field of healthcare, Software as a Medical Device or SaMD is a particular new category of software resource with a specialized role. Understanding more about what SaMD is and how it works can benefit a company looking at acquiring healthcare solutions.

What is SaMD?

Software as a Medical Device is commonly defined as software that is designed for a medical purpose, and that is not part of a medical hardware device.

Software as a Medical Device is contrasted with a secondary category of healthcare software, software that is in a medical device for medical purposes. To be considered SaMD, software must not principally drive a hardware device.

SaMD software products serve different purposes, generally related to diagnosis, disease prevention, modernizing care, or treatment of an illness or injury. Other types of Software as a Medical Device tools control conception or otherwise deal with reproductive outcomes.

Who’s Watching?

One of the groups regulating and monitoring the emergence of Software as a Medical Device is the International Medical Device Regulators Forum or IMDRF. A SaMD IMDRF working group presents information on Software as a Medical Device classification, including the responsibilities of a manufacturer, and labeling and instruction standards for these types of software.

Another group with an interest in SaMD is the U.S. Food and Drug Administration – the FDA has released various guidelines on SaMD that will help control the process of using this type of software in the field.

Software as a Medical Device Guidelines

Various FDA SaMD guidelines work to make more universal consistent rules for software classified as Software as a Medical Device.

One such rule is that the Software as a Medical Device must support clinical vocabulary for its use — this has to do with proper instruction and linguistic design in the interface. Another rule has to do with addressing clinical evaluation methods and clinical evidence relevant to the use of the SaMD software.

The FDA says Software as a Medical Device products should also have various recommendations attached to the software for analytical purposes, and that manufacturers should outline potential adverse consequences.

Given the uniqueness of SaMD and the proposed framework—is there any impact on currently regulated devices or any possible adverse consequences?” ask the regulating groups as one of eight essential aspects of guidance for SaMD.

SaMD Life Cycle

In general, the makers of SaMD products are supposed to be gathering specific kinds of information, analyzing that data, and delivering it along with the software as evidence that the software in question has been designed for safety and effectiveness.

No matter what medical field SaMD is a part of, whether it’s oncology, radiology, or general patient care, the interface must support clinical work in specific ways, and the software should be fully documented for identifying its role and its place within the clinical environment.

Outcomes for Software Sellers

The bottom line is that when a piece of healthcare or medical software is categorized as Software as a Medical Device, that’s going to generate its own unique regulatory requirement. Vendors need to know how this classification applies, and what it means for vendor products. This is in addition to other major healthcare regulatory programs such as the Health Insurance Portability and Accountability Act or HIPAA, which closely governs a patient’s medical data and information.

Think about how guidance and standards from the FDA and other groups impact a company’s use of SaMD products, and how it drives the conversation between the customer and the vendor. Ask relevant questions before purchase to understand how these tools will help clinicians to provide a higher quality of care to patients.

Michael ShearerUnderstanding Software as a Medical Device (SaMD)

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