News & Analysis as of September 7, 2025

Cybersecurity › Digital Health › Machine Learning

+ Follow

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now. less -

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on 8/22/2025

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Vital Signs: Digital Health Law Update | Spring 2024

Jones Day on 7/22/2024

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Skadden, Arps, Slate, Meagher & Flom LLP on 4/4/2024

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

Software and Digital Health Policies Issued by FDA

Akin Gump Strauss Hauer & Feld LLP on 4/6/2023

Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more

Health Canada paving the way for more AI/ML medical devices

Smart & Biggar on 12/1/2021

Since 2018, Health Canada has undertaken an initiative to adapt its regulatory approach to better support digital health technologies, specifically medical devices. Key focus areas include artificial intelligence, software as...more

Vital Signs: Digital Health Law Update | Summer 2021

Jones Day on 8/13/2021

NOTE FROM THE EDITORS - The "dog days of summer" certainly provide a welcome, if brief, break in the extremely rapid pace of statutory, regulatory, and various other policy and industry efforts applicable to digital health....more

A Look Ahead: US FDA And Medical Device Regulations In 2021

Lowenstein Sandler LLP on 3/11/2021

The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

Vital Signs Digital Health Law Update | Winter 2021

Jones Day on 1/29/2021

Note from the Editors - Digital technologies have transformed almost every aspect of the health care and life sciences industry—from electronic health records and telemedicine, to diagnostics and therapeutics augmented by...more

Full Speed Ahead – FDA’s Digital Health Center of Excellence to Host Listening Sessions

Wiley Rein LLP on 10/23/2020

On September 22, 2020, the U.S. Food and Drug Administration (FDA) announced the establishment of the Digital Health Center of Excellence (DHCE) within FDA’s Center for Devices and Radiological Health (CDRH). Bakul Patel will...more

FDA Launches Digital Center of Excellence and ONC Updates HIPAA Security Risk Assessment Tool

Troutman Pepper Locke on 10/7/2020

Why It Matters - In order to safeguard their information, health care and life science organizations should remain vigilant in monitoring DHCoE developments and initiatives, including any policy/regulation clarifications...more

10 Results

/

View per page

Page: of 1