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Drafting Software Patents In A Post-Alice World
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This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more
On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more
The U.S. Food and Drug Administration (FDA) recently released its draft guidance with a proposal to add a Section VII. to the Premarket Cybersecurity Guidance to support obligations under Section 524B of the Food, Drug and...more
We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more
On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more
Privacy Briefs: June 2023 - Long-term care pharmacy network PharMerica disclosed a breach involving more than 5.8 million patients, making it the largest breach reported to the HHS Office for Civil Rights (OCR) in the last...more
Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. Companies that once only developed hardware-based solutions for...more
Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations...more
The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more
On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more
As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more
The International Electrotechnical Commission (IEC) and the International Organization for Standards (ISO) recently published a cybersecurity standard that has received limited press but may have a significant impact on...more
The U.S. Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data. DHT can take the form of hardware and...more
In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be posting a series detailing the history...more
At the beginning of February, the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) appointed Professor Kevin Fu as the first ever Acting Director of Medical Device Cybersecurity. Fu’s...more
On October 16, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced the list of priority guidance documents that CDRH intends to publish this fiscal year (FY-2021)....more
In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more
On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...more
From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more
Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more
Please join us for this complimentary CLE webinar. With increasing healthcare costs and the transition to value-based reimbursement, never has the need for connected medical devices been so great – and never have the...more
The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more