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Software Healthcare

DLA Piper

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

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The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

Proskauer - Health Care Law Brief

This New Year, California Imposes Guardrails on the Use of AI by Payors for Utilization Management Determinations

SB 1120 (the “Bill”), which takes effect on January 1, 2025, amends existing California law to adopt guardrails around the use of artificial intelligence tools for the purpose of utilization management. As discussed in a...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 10, December 2024

Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more

Mintz - Antitrust Viewpoints

Information Sharing in the Trump Administration

As January 20, 2025, approaches, antitrust practitioners and the business communities are searching for clues whether the incoming Trump Administration and its antitrust officials will continue the Biden Administration’s...more

Epstein Becker & Green

Unpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software

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For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more

Mogin Law LLP

Major Electronic Medical Records Firm ‘Squashing’ Competition, Antitrust Suit Claims

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Case pits newcomer against colossus said to control as much as 80-90% of the market. Particle Health Inc., a young healthcare data platform provider, has filed an antitrust complaint against Epic Systems Corp., the dominant...more

Morrison & Foerster LLP

Q3 2024: Quarterly Cartel Catch-Up

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Despite the summer doldrums, cartel enforcers around the world had several notable enforcement actions and, perhaps more importantly, signaled a busy fall and winter. In the United States, the Department of Justice’s...more

Mitratech Holdings, Inc

Ensuring I-9 Compliance for Reduced Risk in Healthcare Facilities

As the backbone of patient care, healthcare organizations must meet Form I-9 requirements. However, it can sometimes get lost in the hiring process. There are a lot of things happening at the same time during hiring!...more

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

Mitratech Holdings, Inc

What is Recruitment Marketing Software?

Are you struggling to attract, engage, and hire top talent for your organization? As the war for talent rages, traditional recruitment methods may no longer be enough. That’s where recruitment marketing software comes in....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

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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

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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

Cornerstone Research

5 Questions with Ben Handel: The Use of Algorithms in Healthcare

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We interview Professor Ben Handel of the University of California, Berkeley to gain his insights into the benefits, concerns of bias, and potential for the use of  algorithms in healthcare. You have been studying the use of...more

Foley & Lardner LLP

Protecting Innovations in SaMD & Biomedical Applications

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With the ever-growing adaptation of software in all realms of health care, the market for software for medical devices (SaMD) is forecasted to grow 16.7% per year over the next decade and surpass $5 billion by 2032....more

Robinson+Cole Data Privacy + Security Insider

MedEvolve OCR Settlement for $350,000 due to Alleged Failures to Protect Data

On May 17, 2023, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced a settlement with MedEvolve, Inc. for $350,000. MedEvolve provides practice and revenue cycle management and practice...more

Foley & Lardner LLP

Software as a Medical Device: Challenges Facing the Industry

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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

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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

J.S. Held

Litigation Surge From the Use of Tracking Technology & the Sharing of Healthcare and Personal Data

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Introduction: Tracking Software in the Healthcare Industry - Privacy-related concerns have become increasingly prominent in recent years, especially with the widespread use of third-party tracking tools such as tracking...more

Epstein Becker & Green

Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care

The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support (CDS) software. How has this document caused confusion for...more

Skadden, Arps, Slate, Meagher & Flom LLP

Key Questions Remain Despite FDA Attempts To Clarify Guidance on Clinical Decision Software

Clinical decision support (CDS) software has been recognized — including by government agencies — as having significant potential to increase quality of care and enhance health outcomes, and companies across the health care...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

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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

Pillsbury Winthrop Shaw Pittman LLP

Acquiring a Distressed Business in the United States: Key Issues for Prospective Buyers

Prospective buyers should prepare to take advantage of opportunities to acquire distressed businesses, as we are likely to see an uptick in distressed M&A soon. Prospective buyers seeking first-mover advantages should act...more

Nelson Mullins Riley & Scarborough LLP

FDA Concludes Software Pre-Cert Pilot Program, Noting Federal Legislative Action is Needed

The U.S. Food and Drug Administration (“FDA” or the “Agency”) has issued a final report discussing the results of its Software Precertification Pilot Program (the “Pilot Program”). Importantly, the September 26, 2022 report...more

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