Software as a Medical Device (SaMD)

Last week I had a terrible headache so I turned to a popular source of answers to health-related questions – WebMD. The website indicated a number of potential causes – a migraine, a brain hemorrhage, meningitis… I had entered a rabbit hole of information. I spent hours searching for what caused the throbbing in my head. While I looked, I drank a glass of water and my headache disappeared. At the end I discovered that I didn’t drink enough water.

What is SaMD?

Fortunately, medical professionals will soon have sophisticated software to help them diagnose ailments or decide treatment plans. The International Medical Device Regulators Forum (IMDRF) is a voluntary group that works with the U.S. Food and Drug Administration (FDA) to develop definitions and guidelines for software to be used as medical devices (SaMD). A medical device could be anything used for human beings for the medical purpose of one or more of the following:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
  • investigation, replacement, modification, or support of the anatomy or of a physiological process,
  • supporting or sustaining life,
  • control of conception,
  • disinfection of medical devices,
  • providing information by means of in vitro examination of specimens derived from the human body;

and that does not rely on pharmacological, immunological, or metabolic means. SaMD does not require hardware and can be run on platforms accessible to non-medical users, such as mobile apps.

SaMD must serve a medical purpose and we should use it to inform diagnosis and/or treatment. Taking contraception as an example, a birth control pill is not a device. However, an app that tracks basal temperature and secretions via user input is. Software that interfaces with hardware, e.g. to drive a pacemaker, does not fall into this category.

The 20th Century Cures Act, developed by the FDA limits the use of SaMD in the United States. The Act mandates that approved software in the United States must allow health professionals to independently review recommendations given by the SaMD so that they are not over reliant on the recommended treatment or diagnosis of the SaMD.

Overcoming Bias

Implicit or subconscious bias is commonplace in healthcare. It often disproportionately impacts care received by people of color and women. Negative attitudes are not only important in the perception of patients, they often help to determine outcomes. Implicit attitudes can be one of the most significant factors in determining patient outcomes. [1]

Now, imagine a tool that can remove bias by compiling healthcare data from a patient and making a point-of-care plan and checklist to make sure that each patient receives the same level of care. This is just one of the problems that emerging software could address.

Lack of Physicians

The World Health Organization (WHO) estimates there is a global shortage of 4.3 million healthcare professionals. Most of this shortage manifests itself in African and Asian nations. However, even in America, statistically rural areas often have less than 53 doctors to every 100,000 people compared to urban areas which can average 300 doctors per 100,000 people. [1] The Association of American Medical Colleges (AAMC) predicts a national shortage will become more acute as the nation’s population ages.

When there aren’t enough doctors to go around, patients must contend with longer waits for appointments and higher costs when they are finally seen. In addition, physicians become overworked and stressed, resulting in lower quality care. A new tool to help doctors more efficiently diagnose and treat would allow them to see more patients and open the possibility for other healthcare professionals to fill any gaps even in remote and disadvantaged regions.

What does SaMD look like?

Most software that falls into the medical device category is fairly simple and serves a singular purpose. These solutions include apps that remind patients to take medication or track the efficiency of those drugs based on information input by patients. They can range from glucose monitoring apps that recommend insulin doses based on blood glucose levels to apps that remind women to take their birth control pill.

Software as a medical device can lead to better triage and more efficient care while simultaneously improving compliance, reducing bias, and making healthcare more widely accessible. As more options arise, world regulatory bodies will continue adjusting their guidelines and recommendations, but simple software solutions can make healthcare available to more people throughout the world and increase the quality of care for everyone.


There are new and more sophisticated software in development to help medical professionals diagnose ailments and decide on treatment plans, reduce bias, and provide care to areas of the world where doctors are in short supply. A medical device can be as anything to be used for human beings in the medical field. Medical devices can help support or sustain life, control conception, and provide information by means of in vitro examination of specimens derived from the human body. SaMD must serve a medical purpose.

Medical devices can also help improve access to physicians. In America there are less than 53 doctors to every 100,000 people. Major cities average about 300 doctors per 100,000 people. When there aren’t enough doctors to go around, patients must contend with longer waits for appointments and higher costs when they are finally seen. Physicians also become overworked and stressed which results in lower quality care.

SaMD includes apps that remind patients which medication to take and when. It tracks the efficiency of those drugs by having patients input medical information. Software as a medical device can lead to better triage and more efficient care, drive better treatment compliance, help reduce bias, and make healthcare more widely accessible.

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