Editor’s Note: Please note that this article is the first in a series dealing with software as a medical device and the issues that plague digital health companies, investors, clinicians, and other organizations that use software and medical devices. I am happy to announce. We address various considerations such as technology, data, intellectual property, licenses and contracts.
The intersection of software, technology, healthcare, and the prevalence of software as a medical device in healthcare has become commonplace, driving important innovation. The term Software as a Medical Device (SaMD) has been defined by the International Medical Device Regulators Forum as “software intended to be used for one or more medical purposes that is not part of a hardware medical software that performs a purpose”. In other words, a SaMD need not be part of a physical device to achieve its intended purpose. For example, SaMD may be an application on a mobile phone and not connected to a physical medical device.
As SaMD grows in popularity, those building and using SaMD also need to have a firm grasp of legal and regulatory considerations to ensure successful use and commercialization. Over the next few weeks, we will address some of the more common issues faced by digital health companies, investors, innovators and clinicians as they develop, use and commercialize his SaMD. The Food and Drug Administration (FDA) has already approved a significant amount of his SaMD, including over 500 of his algorithms that employ artificial intelligence (AI). A notable example is his FDA-cleared SaMD, including wearable technology for remote patient monitoring. A doctor prescribed video game therapy for a child with ADHD. A fully immersive virtual reality tool for both physical therapy and mental health. End-to-end software that generates 3D printed models to better plan surgeries and reduce surgery time. With this rapid innovation comes a number of legal and regulatory considerations, which we discuss through this SaMD blog series.
General Intellectual Property (IP) Considerations for SaMD
This edition introduces advanced standards that can be used to protect innovations in three categories of software for biomedical applications: SaMD, software within medical devices, and software used to manufacture or maintain medical devices, including clinical trial collaborations. I will explain our intellectual property strategy. Seeking other forms of protection such as sponsored research agreements, patent applications, trade secrets.
SaMD License and Third Party Agreements
This edition provides a practical and comprehensive clarification of engagement with third parties in the context of (i) developing new SaMDs or (ii) improving or testing existing SaMDs. Data and IP may be owned or licensed in substance, so long as such license protects the future interests of the licensee. Such ownership and licensing are especially important in one of our focus areas, AI and machine learning.
FDA Considerations for SaMD
This edition explores how the FDA regulates SaMD. This includes the components of regulated devices, legislative action to encourage innovation, and the FDA’s approval of clinical decision support software, general health applications, and other mobile medical devices. It also explores various regulatory pathways on software cybersecurity issues that SaMD and the FDA are currently focusing on.
Medical regulatory and reimbursement considerations for SAMD
This edition covers the intersection of remote monitoring services and SaMD, prescribing digital therapeutics and how they intersect with SaMD, licensing and distributor considerations related to SaMD commercialization, and device-specific code for SaMD. Describes the growing trend to seek
Our hope is that this series will serve as a starting point for digital health companies, investors, innovators, and clinicians to tackle the development and use of SaMD as part of their business and clinical services.
Foley helps you manage the short-term and long-term impacts of regulatory change. We have resources to help you resolve these and other important legal considerations related to business operations and industry-specific issues. If you have any questions, please contact the authors, Foley relationship partners, or our Healthcare Practice Group.