Software, Data Privacy, Medical Devices

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

DLA Piper on 1/16/2025

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

Four Steps to Maximize AI Innovation in Medtech

Goodwin on 11/4/2024

Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....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

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

Data Privacy + Cybersecurity Insider - February 2019 #4

Robinson & Cole LLP on 3/4/2019

In an effort to phase out what many in the security world believe are threats to the cybersecurity posture of governmental agencies and private entities alike, John Quinn, the Chief Information Officer of the State of...more

Building a Health App? What You Need to Know

Mintz - Health Care Viewpoints on 9/18/2017

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