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Guidepost Solutions LLC

Change Healthcare Ransomware Attack: 10 Lessons Learned

Why does it matter to you? In February of 2024, Change Healthcare, a prominent player in the healthcare industry, fell victim to a ransomware attack that sent shockwaves through its systems and networks. The incident...more

Manatt, Phelps & Phillips, LLP

The FDA and the Future of AI Oversight

In January 2024, the U.S. Government Accountability Office (GAO) issued a report highlighting current obstacles to the U.S. Food and Drug Administration’s (FDA) timely and effective regulation of artificial intelligence (AI)...more

Health Care Compliance Association (HCCA)

Privacy Briefs: October 2023

Report on Patient Privacy 23, no. 10 (October, 2023) Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals will pay California $49 million to resolve allegations that they unlawfully disposed of hazardous waste,...more

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

ArentFox Schiff on

Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

Epstein Becker & Green

FDA Oversight of AI Software Developed by Health Care Providers

Epstein Becker & Green on

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

Foley & Lardner LLP

Software as a Medical Device: Challenges Facing the Industry

Foley & Lardner LLP on

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

Knobbe Martens

AI & the FDA

Knobbe Martens on

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

Foley & Lardner LLP

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

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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

Rivkin Radler LLP

Artificial Intelligence Now Powers Orthodontics

Rivkin Radler LLP on

Align Technology, the manufacturer of the Invisalign system of orthodontic braces, recently announced the release of an improved artificial intelligence-assisted smartphone app that can direct an Invisalign wearer when to...more

Robinson+Cole Data Privacy + Security Insider

FBI Issues Notice to Health Industry Highlighting Risks of Unpatched Medical Devices

The FBI issued a Private Industry Notification targeted to the health care sector on September 12, 2022, warning that it has “identified an increasing number of vulnerabilities posed by unpatched medical devices that run on...more

King & Spalding

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

King & Spalding on

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

Polsinelli

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

Polsinelli on

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

Fenwick & West LLP

Digital Health Investments Dominated by Software Plays in July

Fenwick & West LLP on

Healthcare software dominates the list of top digital health investments in July. Of the 10 digital health companies that received venture, private equity or angel investments of $10 million or more, six provide software...more

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