“Software as a Medical Device (SaMD)” – A New Trend in Healthcare
Software as a Medical Device (SaMD) is an innovative trend in healthcare. SaMD software bridges the gap between medical devices and information technology, using software to improve patient care. It has been growing steadily over the past few years, but only recently have we seen these products come into their own as a new way of delivering healthcare services. Let’s see also the SaMD definition.
Compared to traditional methods that require expensive equipment and training, SaMD can be used by any trained person with access to an internet-connected device. Simply put, the SaMD definition can be summed up by saying that it’s a “software-based medical device.” This means that instead of using metal and wires to diagnose diseases, doctors are turning to software developers who design mobile apps and other software solutions.
In this post, we explore what SaMD is all about, how it works, and whether healthcare institutions should consider using it in their practice!
What is SaMD?
SaMD is a software platform that provides diagnostics and treatment for patients. SaMD can improve patient care through its ability to collect data from the Internet of Things (IoT), which refers to any device with an internet connection.
The term “software” may sound harmless enough, but these programs still impact people’s lives by handling their health information—an extremely sensitive topic! There have been several cases were hacked, or poorly-designed SaMD has ended up in the wrong hands. For this reason, it’s important to make sure that a software developer is trustworthy before allowing them access to sensitive patient information.
In order for SaMD apps and other programs to be used by healthcare professionals, they must first pass regulatory compliance approval required by governing bodies, such as the Food & Drug Administration (FDA) or European Union Medical Device Regulation (EU MDR). The FDA regulates medical devices sold within the United States, while EU MDR oversees all products sold in Europe. Besides these two agencies, there are other institutions that define testing standards for SaMDs, including Underwriters Laboratories (UL), Association for the Advancement of Medical Instrumentation (AAMI), Canadian Standards Association (CSA), and Japan Industrial Standards (JIS).
The SaMD definition is constantly changing to include new technologies such as Artificial Intelligence, Machine Learning, Big Data Analytics, and the Internet of Things.
SaMD Software Platforms & Examples
There are hundreds of different SaMD software platforms available to healthcare providers today. Each product has its own set of features that make it unique from others on the market. While some SaMD software as a medical device has been in use for a few years, others are just getting started and may not be available.
Here is a list of examples of SaMD platforms:
- Patient monitoring & analytics solution
- Screening and diagnosis of medical conditions
- Noninvasive cardiac monitoring software solution for hospitals, clinics, and at home.
- Tools for managing clinical guidelines
- An EHR/EMR system to store patient records
- Clinical decision support system with intelligent assistants to answer medical questions from clinical staff members
- Digital assistant that provides patients access to their healthcare data when they need it most
- A mobile app designed for doctors to help improve patient experience through improved communication between the patient and care team. This includes an AI component that can provide basic assessments using natural language processing (NLP) technology. Patients will also receive reminders about upcoming appointments or medication changes based on machine learning algorithms that learn from previous patterns in order to better predict future behavior.
- Personalized healthcare service that allows patients to schedule appointments, order prescription refills, and view their medical records on a mobile device
There is no doubt about it—SaMDs have changed how doctors work! These new technologies allow physicians to perform diagnoses faster than ever before without taking up too much time during each appointment.
What are the Guidelines for the Implementation of Software as a Medical device SaMD?
Although SaMDs are beginning to take over the healthcare industry, they also come with their own set of risks. Unlike other medical devices that have been in use for many years and contain well-tested technology, software can be changed at any time by its developers without warning hospitals if something goes wrong.
To solve this issue, regulation has begun surrounding SaMD development across all industries, including healthcare providers (hospitals), insurance companies, third-party vendors that interact with patient data on a regular basis (such as pharmaceutical manufacturers), and independent programmers who create apps for consumers directly instead of businesses. These guidelines ensure that patients’ private information is protected from public access, along with making sure all products meet regulatory compliance standards before being released to the market for sale.
Moreover, each SaMD must undergo stringent testing before being released to the public in order to reduce the risk of any cybersecurity issues.
For instance the following standards would be applicable :
- IEC 80001-1:2021 – Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities; Section 3.5 MEDICAL DEVICE manufacturer(s)
- IEC 62304:2006 + AMD1:2015 – Medical device software — Software life cycle processes
- IEC 82304-1:2016 – Health software — Part 1: General requirements for product safety
SaMD Software as a Medical Device Lifecycle
As SaMDs continue to advance, so do the technologies used in their development. The software lifecycle will become shorter over time as more developers are able to create new products faster than ever before. Thanks to open source code and SaMD cloud computing services, it allows medical device manufacturers to launch products without spending too much on initial R&D expenses.
Whether it is general patient care, radiology, oncology, cardiology, or dermatology, the interface of SaMDs must be intuitive and easy to use.
With so many new technologies constantly being developed, it is important that patients understand what they mean when a doctor mentions the term “SaMD” during an appointment.
Although SaMDs are advancing many different aspects of healthcare, it is important to remember that they do not replace the doctor’s role in patient care.
The next generation of SaMD technology will continue to transform how patients receive treatment and manage their own health issues at home. With these new technologies come more potential risks than ever before, which makes regulation even more critical for both developers and users alike.
Finally, it is important to note that SaMDs are not limited to software. Medical devices include any technology created for use by the medical community, ranging from surgical tools used during procedures to wearable tech like smartwatches and fitness trackers.
If you need some help to deal with the cybersecurity in your medical device you can contact us for a preliminary discussion. We also provide service for software development lifecycle compliance. You can also look at our page for software development lifecycle.