How to pass the patent eligibility test for Software as a Medical Device

Kathleen Daley is a partner at Finnegan, Henderson, Farabow, Garrett & Dunner. [Photo courtesy of Finnegan]

There’s “significantly more” to it than a good idea for an SaMD algorithm.

Kathleen Daley, Angeline Premraj and Jason Zhang, Finnegan

Technology continues to change the practice of healthcare, and one area where this has become evident is the increasing prevalence of software aimed at healthcare applications. This can include software that is integral to a medical device, software used in the manufacture or maintenance of a medical device, or software that is itself the medical device, also known as Software as a Medical Device (SaMD).

SaMD is an area of tremendous growth in the medical healthcare field. However, there is still significant unpredictability in the patent eligibility of SaMDs. This article provides an overview of the challenges facing the patent eligibility of SaMDs and…

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Software as a medical device: Here’s how the regulatory landscape is changing

When it comes to software as a medical device, the regulatory landscape is quite complex.

Nach Davé, Premier Research

[Image from Pixabay]

Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and analyzing healthcare data to manage disease. Powered by analytics, SaMD accelerates the diagnosis and treatment of a wide range of medical conditions and is automating certain aspects of patient care, saving time and improving health outcomes. Because the technology is relatively new, however, the regulatory environment is still evolving as regulators scramble to keep pace with innovation.

Health providers are increasingly deploying SaMDs to facilitate patients’ pain management, arrhythmia management, and blood glucose monitoring. Some applications require daily use by the patient — sometimes multiple times a day — while remaining compliant with good clin…

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