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Software Healthcare

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

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

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

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

Mintz - Health Care Viewpoints

California Attorney General Probes Bias in Health Care Algorithms

A spurt of letters from California Attorney General Rob Bonta to leaders of hospitals and other health care facilities sent on August 31, 2022 signaled the kickoff of a government probe into bias in health care algorithms...more

White & Case LLP

Broadened scope of Critical Infrastructure Regulation will increase FDI screening in Germany

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On 1 January 2022, the second amendment to the German Regulation for Critical Infrastructure ("Critical Infrastructure Regulation"/BSI-KritisV) entered into force. It will broaden the definition of Critical Infrastructures,...more

King & Spalding

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

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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

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - February 2019 #4

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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

Hogan Lovells

Obama Administration Issues Changes to Iran Sanctions Regulations That Benefit Exporters of Medicine, Medical Devices and...

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On December 23, 2016, the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”) published a number of changes to the Iranian Transactions and Sanctions Regulations (“ITSR,” 31 C.F.R. Part 560) that expanded the...more

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