Popular, Software, Food and Drug Administration (FDA)

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

Gardner Law on 7/2/2025

The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

King & Spalding on 1/13/2025

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

Mintz - Health Care Viewpoints on 3/13/2024

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

FDA Finalizes Premarket Cybersecurity Guidance for Medical Devices

King & Spalding on 10/11/2023

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

Navigating the Regulatory Landscape: FDA Approval and Patent Protection for Software as a Medical Device

Knobbe Martens on 8/18/2023

Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving...more

FDA Oversight of AI Software Developed by Health Care Providers

Epstein Becker & Green on 8/10/2023

Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more

Privacy Briefs: June 2023

Health Care Compliance Association (HCCA) on 6/9/2023

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

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on 5/26/2023

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

Software as a Medical Device: Challenges Facing the Industry

Foley & Lardner LLP on 5/16/2023

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

AI & the FDA

Knobbe Martens on 4/26/2023

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

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

Ankura on 4/26/2023

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

The Evolving FDA Regulatory Landscape of Artificial Intelligence

Gardner Law on 3/29/2023

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

FDA’s Latest Twist on Digital Health Oversight Brings Big Shift

Cooley LLP on 1/3/2023

Facing novel, swiftly evolving technologies in the digital health space, the US Food and Drug Administration has been trying to balance fostering innovation with providing reasonable assurance of safety and effectiveness...more

Wondering if Your Digital Health Product or Service is Subject to FDA Regulations?

Foley & Lardner LLP on 11/28/2022

The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business, and...more

New Standard Maps Medical Device Software Development Standard to Health Software and Health IT Cybersecurity

King & Spalding on 2/9/2022

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

Medical Devices in the App Store? U.S. Regulation of Mobile Medical Applications

Lippes Mathias LLP on 8/23/2021

Since the start of the COVID-19 pandemic, more people than ever have downloaded and used mobile applications, or apps, to communicate with their doctors, manage prescriptions, and streamline much of the healthcare activity...more

Global Healthtech CEO Connect: Software As A Medical Device In The U.S. And EU Recap

MoFo Life Sciences on 4/12/2021

On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device...more

FDA Appointment Signals Increased Attention on Medical Device Cybersecurity

Sheppard Mullin Richter & Hampton LLP on 2/10/2021

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

Three Considerations for AI Healthcare Application Developers and Users

Morgan Lewis on 2/2/2021

The applications of artificial intelligence (AI) are seemingly innumerable with benefits reportedly as prolific as the technology behind them, including in the healthcare space. To keep pace, the US Food and Drug...more

FDA Issues Proposal on Oversight of Artificial Intelligence and Machine Learning Software

Morgan Lewis on 5/29/2019

The Food and Drug Administration’s recent discussion paper suggests a new regulatory approach for evaluating postmarket changes to artificial intelligence and machine learning software devices, but further clarity is needed...more

FDA Proposes Regulatory Framework for Artificial Intelligence/Machine Learning Software as a Medical Device

King & Spalding on 4/10/2019

On April 2, 2019, the U.S. Food and Drug Administration (“FDA” or “Agency”) proposed a new regulatory framework to address the development and marketing of artificial intelligence and machine learning-based software as a...more

FDA Tackles Digital Health Software Devices with New Pre-Certification Review Plan

King & Spalding on 1/23/2019

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

Health Hackers: Problems in Applying Traditional Products Liability Theories to Latent Cyber-Vulnerabilities in Medical Devices

Butler Snow LLP on 10/16/2015

October is National Cyber Security Awareness Month (yes, that’s a thing), so it seems fitting to write about an unprecedented alert recently released by the FDA to health care providers that warned of a medical device’s...more

Mobile Health Devices and Cybersecurity: Federal Guidance for Management of Threats in Medical Devices

Polsinelli on 8/21/2015

New Technology = New Threats - With new technology comes new security concerns. But when that new technology is in the medical field, the cybersecurity vulnerabilities can be particularly devastating. The...more

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