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Life Sciences Data Privacy Medical Devices

Gardner Law

Why Every Manufacturer Needs a Robust Information Security Program

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Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more

Hogan Lovells

Life Sciences & Health Care Horizons 2025

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Our 2025 Life Sciences and Health Care Horizons edition is now live! Explore the latest global insights from the U.S., Asia-Pacific, Europe, Latin America, and the Middle East on the key issues and emerging trends shaping the...more

MoFo Life Sciences

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

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Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks,...more

Husch Blackwell LLP

Raising Capital in a Highly Regulated Market

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For early-stage life sciences and health tech companies, raising capital is about more than demonstrating scientific promise. Investors are increasingly focused on regulatory preparedness, reimbursement strategy, and risk...more

Hutchison PLLC

Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley

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What if the key to understanding and improving brain health lies in a breakthrough approach to neurodata? For Rob Cooley, founder and CEO of Nuream, unlocking the potential of brainwave data has the power to transform...more

Husch Blackwell LLP

Structuring the Right Deals for Growth in Life Sciences

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Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions. Whether a company is developing AI-driven diagnostics, biotech therapies, connected medical devices, or...more

McDermott Will & Schulte

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Troutman Pepper Locke

2025 SCOPE Conference Emphasizes AI and Better Technologies to Improve Patient Outcomes

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The 2025 SCOPE Conference (Summit for Clinical Ops Executives), held last week in Orlando, FL, brought together more than 4,500 industry leaders, innovators, and experts in the clinical operations field. ...more

Morrison & Foerster LLP

2024 Healthcare Fraud Enforcement Year in Review

In 2024, as in years past, healthcare fraud enforcement by the U.S. Department of Justice (DOJ) was substantial. Federal actions under the False Claims Act (FCA) alone resulted in $1.67 billion in settlements and judgments...more

A&O Shearman

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

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The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more

Dickinson Wright

Part 3: Key Takeaways from Claim Examples in the 2024 AI Patent Eligibility Guidance

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This is the third post in a 3-part series. Below, we describe Example 49 which focuses on using AI to assist with a medical treatment....more

Hogan Lovells

Life Sciences Law Update - Key developments for pharma and medical device companies in EU and Germany, France, UK, Italy and Spain...

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Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need to revise the MDR and IVDR published; Compliance: CSRD still not implemented in...more

American Conference Institute (ACI)

[Event] 2nd Annual Life Sciences AI Summit - February 20th - 21st, New York, NY

Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - December 2024

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Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more

Goodwin

Four Steps to Maximize AI Innovation in Medtech

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Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more

Morgan Lewis

EU High Court Allows GDPR Claims in Business Litigation, Expands Scope of ‘Health Data’ Impacting Life Sciences and Consumer...

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The Court of Justice of the European Union (CJEU), the EU’s highest court, recently announced its significant Lindenapotheke decision, permitting companies to use the General Data Protection Regulation in business-to-business...more

Gardner Law

[Ongoing Program] SESSION 3: Privacy Policy Pop Quiz – Are You Ready? - August 8th, 1:00 pm - 1:45 pm CT

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Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

Gardner Law

[Ongoing Program] SESSION 2: Do I Really Need A Privacy Officer, DPO or CISO? - July 18th, 1:00 pm - 1:45 pm CT

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Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

Gardner Law

[Ongoing Program] SESSION 1: 10 Things You Should Know About Privacy, Consent, and HIPAA - June 13th, 1:00 pm - 1:45 pm CT

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Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

Wilson Sonsini Goodrich & Rosati

[Event] Medical Device Digital Health Conference - June 13th - 14th, San Francisco, CA

Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

Alston & Bird

Why the New EU-U.S. Data Privacy Framework May Be Good News for Life Sciences Companies in the U.S.

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BACKGROUND - U.S.-based life sciences companies can be subject to the European Union (‘EU’) General Data Protection Regulation (‘GDPR’), even if they do not have any subsidiary, affiliate or other physical presence in the...more

Wilson Sonsini Goodrich & Rosati

[Ongoing Program] 2023 Medical Device Digital Health Conference - June 16th, San Francisco, CA

Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more

Wilson Sonsini Goodrich & Rosati

[Ongoing Program] MDC 2023 Reception & Dinner Women’s Networking Event & Program - June 15th, Menlo Park, CA

Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more

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