The medical software industry has progressed quite rapidly in the past few years.

Today, the industry has access to fast, precise, integrated, and robust medical software that can work as a virtual assistant of doctors, keeping the entire patient’s data log for easy access, monitoring, reviewing, and analyzing.

Interestingly, the technology landscape is quickly taking the medical industry by storm.

Today it’s not just the massive, integrated medical software that is improving the healthcare for patients, rather simple and standalone software like wearables are also contributing to the overall improvement of the healthcare services.

The software as a medical device is essentially the standalone software, which acts as a medical product in itself.

Since it’s a standalone medical device that acts as a virtual assistant for clinical decisions, these software are highly sought after by hospitals and healthcare institutions to improve the overall quality of healthcare services offered to patients.

In recent years, Software as a Medical Device (SaMD) has seen rapid adoption and since there is no hardware component involved in the device.

Integration of SAMD is a relatively easier process with few barriers to the adoption and large scope for improvement with fast real-time feedbacks from doctors and healthcare practitioners.

The rapid adoption of the Software as a Medical Device also brings in unique challenges for healthcare regulators, as well as, device development companies.

In fact, SaMD is the latest area where new regulations are being made to ensure the adoption of the technology while safeguarding the safety of the patients and clinical effectiveness.


The Federal Drug Agency (FDA) classified Software as a Medical Device (SaMD) is a category of software that is explicitly developed to perform one or multiple medical functions.

According to this definition, the SaMD includes mobile apps, and software with the capabilities to diagnose, prevent, treat, and cure diseases and other medical conditions.

The defining feature of Software as a Medical Device from other categories of medical software is that it doesn’t need any actual hardware.

This is to say that such devices can be used along with other non-medical computing platforms, which are connected to general-use hardware or virtual networks.

SaMD: Wellness and Prevention

Small wearable medical devices including wearables are one category of SaMD. Such devices are classified by the FDA as low-risk devices that are associated with promoting wellness and disease prevention.

Then there are more complex and intricate SaMD which are used to make clinical decisions.

One such example of Software as a Medical Device service is the Clinical Decision Support System (CDSS), which is a comprehensive and integrated medical software that offer medical practitioners including doctors, and other paramedic staff assistance to reduce the burden of data analysis and make well-informed medical decisions.

It is improving overall healthcare services offered by the hospitals and clinics.

Such SaMDs also acts as early warning system alerting doctors and physicians with potentially conflicting drugs, as well as, alerting the paramedical staff to any potential problem that may arise in the future.


While the Software as a Medical Device (SaMD) is in no position to replace the role of doctors; at least anytime soon, this software is definitely capable of assisting doctors to make well-informed clinical decisions.

This can be achieved using superior analytical processing capabilities of the software and automating various administrative and routine tasks; thus significantly reducing the management burden from medical practitioners and paramedic staff.

Some of the defining characteristics of Software as a Medical Device (SaMD) includes:

 Enhanced Healthcare Services

SaMDs greatly reduce the management burdens from doctors and paramedic staff by automating various administrative and routine tasks.

These software also assist doctors to make well-informed clinical decisions for the treatment and cure of decisions using superior analytics capabilities.

Subsequently, by implementing SaMDs hospitals and clinics are in a better position to improve their efficiency and effectiveness, as well as, enhance the quality of their healthcare services.

Quicker Innovation

Software as a Medical Device (SaMD) inherently supplements the functionalities of traditional medical devices employing software solutions that are swifter, and cheaper than the other alternatives.

Also, such software employs state-of-the-art technologies to share and integrate data across multiple platforms using cloud services of connective medical devices. Subsequently, SaMD enables faster evolution of healthcare services.

SaMD – The Barriers

While Software as a Medical Device (SaMDs) comes as powerful medical devices aimed to significantly improve the quality of healthcare services, such devices also have inherent risks.

One of the most prevailing risks associated with such medical devices is the cyber-security and data breach.

While the practice management software industry is highly regulated, still there is an existing threat of patients’ crucial information and privacy getting stolen with cyber-security threats.

Under such threats, the hospitals and developers aren’t just threatened by the administrative penalties, but also reputation and financial penalties.

Apart from the cyber-security, complex regulatory requirements like HIPPA, evolving preferences of consumers, and higher initial investment are some of the other barriers that impede the development of the medical software industry greatly.

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