Software as a Medical Device

Software as a medical device (SaMD) is part of the revolutionary development in digital health technology. It represents software that can execute at least one medical function, such as detect medical conditions, inform healthcare providers, clinical staff and propose treatments.

The International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators from around the world, defines SaMD as software intended for medical purposes that performs these purposes without being part of the hardware of the device.

Which medical purposes apply to SaMD?

Among medical purposes applicable to SaMD are the:

  • diagnosis;
  • prevention;
  • monitoring;
  • treatment and alleviation of disease or injury;
  • replacement, modification or support of the anatomy or physiological process;
  • supporting or sustaining life;
  • control of conception.

SaMD may interface with other medical devices (MDs) and operate on a general-purpose computing platform (non-medical purpose). It may be used in combination with other products, including medical devices. It can also be connected to a hardware medical device, into which it is not embedded. Specialised software for diagnosing conditions, estimating risks or finding peculiarities in tissue images by employing machine learning algorithms are all examples of legitimate SaMDs.

When is software not classified as a medical device?

On the other hand, software that manages processes or data – or is integral to the function of hardware, such as accelerator control subsystems or a motor controller in an automated hospital bed – is not software as a medical device. The latter, namely, is not the same as its hardware. A manufacturer can embed software in the hardware of a healthcare device without applying for the classification of the software itself as a medical device.

Are mobile apps classified as SaMD?

Many mobile apps that support a healthy lifestyle are not SaMDs. But suppose an app uses the embedded capabilities of the mobile device – its hardware features (i.g. the camera or light source) and sensors – forming a composite software, sensor and computing platform. In that case, the app becomes a medical device. Apps that control a medical device remotely, using WI-FI or Bluetooth, are deemed to be SaMD as they are accessories to the medical device. Regulating agencies categorise an app at the same risk classification level as the medical device the app controls.

Some mobile apps can control or adjust a medical device through Bluetooth or WiFi features. Regulatory bodies consider these apps to be SaMDs because they supplement the medical device as a user control-interface. The manufacturer must classify such software at the same level as the controlled device.

Which medical standard governs SaMDs?

The medical standard that, besides being focused on MD software in general also governs SaMDs, is IEC 62304 – Medical device software – Software life cycle processes.

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