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Software Developers Medical Devices

WilmerHale

AI-Powered Medical Devices Bring Patent and Regulatory Pitfalls

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Artificial intelligence and machine learning are transforming the medical device industry. Simultaneously, companies are working to gain Food and Drug Administration approval and obtain intellectual property protection for...more

A&O Shearman

Telemedicine software under scrutiny – German court classifies dermatology software as class IIa medical device under the MDR

A&O Shearman on

Telemedicine is getting more and more relevant to the healthcare industry, offering unprecedented access to medical services and enhancing patient care. However, telemedicine software providers often struggle with the...more

Mintz - Health Care Viewpoints

Colorado AI Systems Regulation: What Health Care Deployers and Developers Need to Know

As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more

Gardner Law

What Does FDA Think of AI?

Gardner Law on

Speaking at CES 2024 earlier this year, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf expressed significant concerns about the FDA’s ability to effectively regulate artificial intelligence (AI) in the...more

Wilson Sonsini Goodrich & Rosati

FDA Finalizes Clinical Decision Support (CDS) Software Guidance

In September 2022, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Clinical Decision Support Software,” representing a shift from what was proposed in the 2019 draft guidance. The guidance document is...more

Hogan Lovells

Evolution of FDA regulation of AI-based technology

Hogan Lovells on

Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...more

Wiley Rein LLP

FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions

Wiley Rein LLP on

On November 3, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance, Content of Premarket Submissions for Device Software Functions, a significant publication that has the potential to impact a variety...more

McDermott Will & Emery

FDA Issues Good Machine Learning Practice Guiding Principles

McDermott Will & Emery on

On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more

Lippes Mathias LLP

Medical Devices in the App Store? U.S. Regulation of Mobile Medical Applications

Lippes Mathias LLP on

Since the start of the COVID-19 pandemic, more people than ever have downloaded and used mobile applications, or apps, to communicate with their doctors, manage prescriptions, and streamline much of the healthcare activity...more

MoFo Life Sciences

FDA’S Plan For AI/ML-Based Software As Medical Devices: Progress And Concerns

MoFo Life Sciences on

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more

MoFo Life Sciences

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 3 Of 6)

MoFo Life Sciences on

Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) under the new EU Medical Device Regulation 2017/745 (“MDR”) in...more

Nutter McClennen & Fish LLP

Code Red: The FDA’s Artificial Intelligence/Machine Learning Action Plan Poses Potential Risks for Medical Device Makers

Q: The FDA’s stance on a regulatory framework for artificial intelligence and machine learning (AI/ML) software as a medical device is continuously evolving. Could you explain the history? A: Artificial intelligence (AI) is...more

Wilson Sonsini Goodrich & Rosati

Electronic Gaming Legal Newsletter - December 2020

Games vary in difficulty from the first levels of Candy Crush to the final bosses of Sekiro: Shadows Die Twice. They vary in visual fidelity from the ASCII characters of Dwarf Fortress to the high-detail, motion-capture shown...more

Mintz - Health Care Viewpoints

FDA Updates Digital Health Guidances to Align with 21st Century Cures Act

On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more

Akin Gump Strauss Hauer & Feld LLP

New Draft Policy on Clinical Decision Support Software Highlights FDA’s Release of Six New Digital Health Guidance Documents

• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions. • The revised draft guidance on CDS further elaborates on how to make CDS...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Series of Guidance Documents Aimed at Medical Software Regulation

The U.S. Food and Drug Administration (FDA) continues advancing regulatory policies tailored to the digital health community. On September 26, 2019, the agency issued a series of guidance documents that interpret several of...more

McDermott Will & Emery

To Market, To Market: FDA’s Digital Health Precertification Program

McDermott Will & Emery on

In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more

McDermott Will & Emery

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Emery on

In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more

Sheppard Mullin Richter & Hampton LLP

Medical Devices - Artificial Intelligence and Reactions to FDA’s Proposed Oversight

In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical...more

Akin Gump Strauss Hauer & Feld LLP

FDA’s AI White Paper: To Be or Not to Be, That is the Question

• FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML). • The white paper distinguishes three...more

Mintz - Health Care Viewpoints

FDA 2018 Year in Review (and a Few Thoughts on 2019)

As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more

K&L Gates LLP

K&L Gates Triage: Artificial Intelligence in Health Care

K&L Gates LLP on

Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Strives to Adapt Regulatory Approach to Rapidly Evolving Digital Health Space

Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more

Wilson Sonsini Goodrich & Rosati

Digital Health Report - Q2 2018

Evaluating Prospective Partners When Scaling Your Digital Health Company (Part 1) - Picture this: You have built a digital health company that could revolutionize healthcare delivery; upend diagnostic processes; accelerate...more

Jones Day

FDA Releases Software Precertification Working Model

Jones Day on

On April 26, 2018, the U.S. Food and Drug Administration ("FDA") released an initial working model for its Software Precertification ("Pre-Cert") Pilot Program. The Pre-Cert Program is an effort by FDA to develop a new, more...more

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