News & Analysis as of

Artificial Intelligence Clinical Trials

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

DLA Piper

FemTech and the use of AI

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Due to an exponential growth in the investment in female health and wellbeing, Forbes and Dealroom reported that 2023 saw 1.14 billion USD raised collectively across 120 deals in ‘FemTech’. ...more

Foley & Lardner LLP

Artificial Intelligence: Is the Health Care Sector Ready for the Rollout?

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On July 17, 2024, Foley & Lardner LLP hosted the Boston Health Care AI & Technology Investor Summit with Endeavor Venture Funds, bringing together hundreds of attendees in person and virtually to discuss issues surrounding...more

Foley & Lardner LLP

Challenges in AI-Enabled Biomarker Discovery

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Patient biomarkers are now used in personalized medicine to predict disease progression, minimize side effects, and maximize therapeutic benefits in the treatment of disease. In oncology, the use of biomarkers has increased...more

McDermott Will & Emery

Real-World Data Back in the Spotlight at FDA

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On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making...more

Proskauer - Health Care Law Brief

OIG Reports that Clinical Trials Lack Diverse Subjects: What Role Can Artificial Intelligence Play?

As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more

McDermott Will & Emery

Key Takeaways | Clinical Research Technology (ClinTech)

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During this session, the panelists discussed how stakeholders in the clinical research market can leverage new technologies to better identify subjects, optimize trial conduct and reduce costs. For example, common use cases...more

Husch Blackwell LLP

The Overturning of Chevron Deference: Implications for AI in Medical Research

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In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - June 2024

Welcome to the June edition of Akin Intelligence. This month, the General Services Administration (GSA) launched its first AI-focused cohort of Presidential Innovation Fellows (PIF), bringing together experts from across the...more

Proskauer - Trade Secrets

Litigating Trade Secrets in Biotech, Life Sciences, and AI: The High-Stakes Battle Over Clinical Trial Innovations

In the rapidly evolving biotech and life sciences sectors, the importance of trade secrets has grown significantly. Companies are investing heavily in research and development to create cutting-edge treatment therapies....more

McDermott Will & Emery

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

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The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

Manatt, Phelps & Phillips, LLP

The Transformative Potential of AI in Health Care Delivery & Administration

An effective AI governance model will allow health systems to take advantage of innovative technologies, while mitigating risks to patients. There have been a lot of attention-grabbing headlines about AI replacing physicians,...more

Epstein Becker & Green

Unpacking Averages: Growth of AI/ML in Medicine as Evidenced by Clinical Trials

Most people have seen the growth in artificial intelligence/ machine learning (AI/ML)-based medical devices being cleared by FDA. ...more

Holland & Knight LLP

Holland & Knight Health Dose: May 21, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

TransPerfect Legal

GDPR Compliance: At the Intersection of AI and Life Sciences

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Late last month, the Association of Corporate Counsel (ACC) hosted a panel on artificial intelligence and how it is rapidly transforming the life sciences sector, allowing companies to leverage large datasets to accelerate...more

Hogan Lovells

2024 Life Sciences & Health Care Horizons

Hogan Lovells on

While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent regulatory changes and those on the...more

Hogan Lovells

FDA AI & Medical Products Paper advocates for a tailored risk-based regulatory framework

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The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination...more

Mintz - Health Care Viewpoints

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more

Husch Blackwell LLP

Avoiding the Landmines on the Path to HealthTech Innovation

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Every year, I look forward to the SXSW Interactive Health & MedTech Track, which showcases and explores the future of healthcare technology being created by innovators, entrepreneurs, and tech enthusiasts. This year is no...more

Holland & Knight LLP

Holland & Knight Health Dose: February 27, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Hogan Lovells

AI/ML: European Medicines Agency joins the fray

Hogan Lovells on

The European Medicines Agency (EMA) has finally joined the discussion on artificial intelligence (AI) and machine learning (ML), releasing a draft reflection paper on the use of these technologies throughout the medicinal...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

ArentFox Schiff

Legal Implications of AI in the Life Sciences Industry

ArentFox Schiff on

Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more

American Conference Institute (ACI)

[Event] The National Forum on IP Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies - March 21st -...

Hosted by American Conference Institute (ACI), the National Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies will highlight leveraging technology, safeguarding IP, and securing...more

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