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Upping Your Game: Episode 1 – Meeting Hui Chen’s Challenge
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Innovation in Compliance: Exploring the Fractional COO Model with La Tonya Roberts
FCPA Compliance Report: From Compliance to Commercial Value: Removing Friction with AI
Compliance Tip Of the Day: Using AI to Transform Whistleblower Response
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10 For 10: Top Compliance Stories For the Week Ending April 26, 2025
Compliance and AI: Transforming Compliance Through AI with Marcelo Erthal
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Compliance Tip of the Day: Leveraging AI for Real-Time Third-Party Risk Management
Compliance Tip of the Day: AI and Predictive Analytics
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AI in Employment: Navigating the Legal Landscape with Lessons from I, Robot — The Good Bot Podcast
Daily Compliance News: April 22, 2025, The Upping Your Game Edition
Artificial intelligence (AI) has transformed scientific research and innovation, yet as previously discussed, the Polanyi Paradox remains a significant obstacle to using AI to generate creative solutions or breakthrough...more
Cautious Optimism for Deal Making. The general consensus is that we will likely see an increase in M&A and capital market transactions in the life sciences sector in 2025....more
The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A)....more
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more
Welcome to our ninth 2024 issue of Decoded - our technology law insights e-newsletter. How are States Using Generative Artificial Intelligence? and Employee AI Adoption Cools Globally - Why this is important: As...more
Life science companies will have to grapple with unique questions in complying with the European Artificial Intelligence Act, including the scope of the law’s research exemption and the use of AI in personalized medicine and...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
MIT Report Details New Cybersecurity Risks - “Cloud misconfigurations, more sophisticated ransomware, and vendor exploitation attacks are contributing to rising cyberattacks.” Why this is important: Worldwide spending...more
Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more
HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more
The Federal Trade Commission recently published a blog post regarding the privacy of DNA. What do you need to know? •Protecting biometric information – including genetic data – is a top FTC priority. (See FTC Biometric...more
Are Automakers Making Sufficient Efforts to Protect Customer Data? With the ever-expanding Internet of Things, data privacy is a growing concern in today’s digital age. The automotive industry is no exception. The National...more
Artificial intelligence (AI) is nothing new to the healthcare industry, as many organizations and clinicians have utilized such tools in some capacity for many years. Imaging-related AI to support radiologists is not...more
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
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
The Inflation Reduction Act (IRA), signed into law in August 2022, impacted a wide range of tax laws and touched many aspects of government. Significantly, part of the IRA provides Medicare with the ability to negotiate the...more
Navigating the complex landscape of drug discovery requires innovative strategies and interdisciplinary collaborations spanning biotechnology, pharmacology, medicine and engineering. As the cost of developing new drugs...more
Artificial intelligence (“AI”) will likely drive many complex medical devices in the near future. But as with all things, AI can sometimes fail. Companies relying on AI to elevate their medical devices above the competition...more
When negotiating a digital health collaboration agreement between a tech company and a life sciences company, whether for the development of artificial intelligence or other software, the provision of data hosting and...more
On May 16 the second edition of our new global series, Life Sciences and Health Care Horizons, took place in London featuring two panel discussions that focused on the challenges and opportunities in two of the sector’s...more