The healthcare sector is rapidly adapting to new technology. On one hand we have the internet of medical things (IoMT) going mainstream with advances in smart medical devices while on the other hand, we have Software as a Medical Device (SaMD) is also growing in popularity.
In this article, we will cover all you need to know about going into building software as a medical device and the regulations you need to be mindful about when doing so.
Classification of medical software
Medical devices are generally classified under four subcategories.
- Software as a medical device (SaMD): Standalone medical software without an associated hardware device.
- Software in a medical device (SiMD): Software that is integrated into medical equipment or smart medical devices
- Software as an accessory to a medical device (SaAMD): The software here functions as an adjuvant to an existing medical device.
- General-purpose medical software that isn’t a medical product: These includes
What is software as a medical device
According to the international medical devices regulator’s forum (IMDRF), software as a medical device is defined as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
Any software that is an entity on its own without an associated hardware device can be classified as SaMD.
For example, the software that computes the drug dosage based on patient data can be classified as a SaMD whereas a software within a device that dispenses medication is not SaMD.
The U.S. Food and Drug Administration gives a comprehensive listing of what can and cannot be classified as SaMD.
Software as a medical device can range from software that allows a smartphone to view images obtained from a magnetic resonance imaging (MRI) medical device for diagnostic purposes to Computer-Aided Detection (CAD) software that performs image post-processing to help detect breast cancer.
The classification of software as a medical device does not depend on where the software runs, whether in the cloud, in a smartphone or a server.
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Applications of Software as a Medical device
SaMD has already found widespread application in the healthcare industry.
It can be deployed across a wide range of devices such as computers, tablets as well as mobile phones. Through its data processing capabilities, SaMD is increasingly being used by healthcare practitioners and the general public alike.
Some of the applications of the SaMD technology include
- Preventative health solutions
- Diagnostic software
- Chronic disease management software
- Patient engagement and remote monitoring applications
- Patient compliance and drug adherence solutions
- Digital therapeutics
Mobile applications in the health and fitness niche, including diagnostic, preventative, or treatment based apps, all fall under the umbrella of software as a medical device.
Who regulates software as a medical device?
The international medical devices regulator’s forum (IMDRF) and the Food and Drug Administration (FDA) are the two entities that look at approving and regulating software as a medical device.
The IMDRF presents information on SaMD classification, including the responsibilities of a manufacturer, risk categorization, quality management systems as well as labelling, instruction standards and clinical evaluation for this software.
The SaMD working group (WG) chaired by FDA was formed in 2013 to develop guidance supporting innovation and bolster the timely availability of SaMD on a global scale.
FDA guidelines for developing SaMD
Responsibility of compliance
The legal responsibility for ensuring compliance with the regulatory norms lies with the manufacturer of the SaMD.
These include both pre-market requirements such as adherence to stringent quality measures as well as post-market regulations such as reporting of adverse events and corrective actions.
Labels and intentions for use
The recommendations and intended purpose of use of the software need to be explicitly stated and attached with the software. The potential adverse consequences should also be outlined by the manufacturer.
Supporting clinical vocabulary
Software as a medical device needs to have supportive clinical vocabulary and linguistic design in the interface in order to expel any room for error within the resultant application.
Any modifications made in the SaMD lifecycle including the maintenance phase fall under SaMD changes. These changes can fall under the following categories
- preventive- correction of latent faults before they become operational faults,
- corrective- set right the problems discovered within the software,
- adaptive- keeping pace with the changing environment, and
- perfective- improving existing performance.
Framework components for modernizing Software as a Medical Device regulations
FDA is currently working on modernizing the SaMD regulations which comprise of the following three core components.
Regulatory development kit
The RDK is a software module that gives the users a step-by-step process to guide them through the regulatory process. It contains tools to clarify the requirements at every stage of the process and provide answers to the frequently asked questions.
It can also function as a platform for discussing best practices across domains, thus pioneering innovation in the healthcare industry.
FDA pre-certification program
The pre-cert program is a risk-based and organized approval process for the healthcare organizations that exhibit a commitment to quality and excellence.
The healthcare software developers get access to the key pre and post-market information thus accelerating the process for them.
Since the level of level is computed, the regulatory requirements are modified on the basis of risk computation. Consecutively, higher risk products would have greater requirements than their lower risk counterparts.
Real-world data capability
SaMDs connect to the internet to collect the real-world clinical as well non-clinical data across a large number of data points. SaMD can analyze the collected data to iterate on the device, helping make it more accurate, intelligent, and patient-centered.
Stringent data security norms need to be in place while collecting, storing and analyzing patient data in order to conform to the HIPAA privacy and security rule.
What lies ahead
As innovations continue to power up the field of SaMD, partnering with an experienced healthcare software development company like Arkenea, that are well versed with the stringent data protection requirements and HIPAA regulations can flatten the learning curve and get you better poised for success.
Arkenea is a pioneer in the development of healthcare software with a decade of core healthcare industry experience. Have a healthcare project you need to discuss? Get in touch with us for a free consultation and estimate.