Computer technology and software capabilities are increasing exponentially in every industry in the modern world. Healthcare is at the cutting edge of software development, and Software as Medical Devices (SaMD) is one of the most important parts of current advances in medical care. The U.S. Food and Drug Administration (FDA) cites the International Medical Device Regulators Forum in defining SaMD as “software intended to be used for one or more medical purposes that perform these purposes with being part of a hardware medical device.” In other words, SaMD are programs used to perform medical services using data and analysis rather than physical devices or testing. In this article, Dr. Joel Arun Sursas discusses some current SaMD developments.
SaMD software operates independently of medical hardware to provide medical analysis or a medical function. For example, a program that takes patient data and assesses it to determine proper medication types and dosages is a SaMD. Analytical programs that use artificial intelligence to analyze MRI images to diagnose cardiovascular conditions are SaMD. SaMDs generally include programs that use inputs for analysis of medical conditions and treatment recommendations.
Software that operates a medical device is not SaMD. For example, software that controls medical pumps, motors, or record-keeping systems support hardware systems and are not medical devices standing alone.
Why Classification of Software as SaMD by the FDA Is Important
Software developers that produce SaMD face a regulatory framework vastly different from ordinary software programs. The FDA requires clinical evaluations for SaMD applications and has specific regulations for quality management and control during development. FDA premarket approval requires studies made up of appropriate clinical data. Before approving a SaMD, the FDA will analyze the software’s efficacy and safety. SaMD developers are held to quality standards similar to drug and hardware device developers.
Intellectual Property Issues for SaMD Developers
As SaMD are treated for regulatory purposes like hardware medical devices or drugs, developers must be aware of the particular intellectual property issues involved. Unlike ordinary software, which is treated like other scientific or literary creations for intellectual property law, SaMD is generally treated like a drug or other medical device. Different levels of protection are available through utility patents, design patents, and private contractual protections.
About Dr. Joel Arun Sursas
Dr. Joel Arun Sursas is a Medical Doctor and Health Informatician who designs and implements the latest technological developments to solve administrative problems in healthcare. His primary focus is on developing technological advances between doctors and engineers to improve patient outcomes through improved monitoring while protecting patient privacy. Dr. Sursas’s interest in the field of Medical Informatics emerged when he began working as a Project Officer for PACES — the Patient Care Enhancement System for Singapore Armed Forces (SAF). At the SAF, he worked with multiple doctors and engineers on the largest Electronic Medical Record (EMR) system in Singapore. He also developed a data analytics platform to assess epidemiological data throughout the system. Dr. Sursas is currently serving as Head of Clinical Affairs for Biorithm, a medical device start-up company working to move fetal surveillance from hospitals into home settings, revolutionizing the obstetric practice globally.