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CMO Series EP100 - Celebrating 100 episodes and exploring the future of professional services marketing
Medical Device Legal News with Sam Bernstein: Episode 10
PODCAST: Williams Mullen's Trending Now: An IP Podcast - Paralegal Insights: A Collaborative Trademark Practice, Series 3
JONES DAY PRESENTS®: Enhancing Trade Secret Protection in Remote Work Environments
Investigative Power: Utilizing Self Service Solutions for Internal Investigations?
Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Software Escrow: An enterprise resiliency tool every legal department should have in their toolbox (with Don Dennis Jr.)
ASG LegalTech CEO Soumya Nettimi Talks Covid, Racial Injustice and The Future of Legal Payments: On Record PR
E8: Interview with Cookiebot CEO on Technical Solutions to GDPR Readiness
New Revenue Recognition Standard-Part III, Shaking Up the Software Industry?
Unfair and Unbalanced-Episode 19
FCPA Compliance Report-Episode 286-Use of Technology in Supply Chain Risk Management
Compiling Successful IP Solutions for Software Developers
Drafting Software Patents In A Post-Alice World
Polsinelli Podcasts - Hear How the SCOTUS Ruling May Impact Patent-Eligible Subject Matter for Software
IP|Trend: New Era in Protection of Software by Intellectual Property Law?
What are the Implications of Alice v. CLS?
What Does the Supreme Court Ruling in Alice v. CLS Mean to a Software Entrepreneur?
FCPA Compliance and Ethics Report-Episode 11 with Eddie Cogan
Even before the Biden administration issued a landmark executive order on October 30, 2023, establishing new standards for artificial intelligence (AI) safety and security, the US Food and Drug Administration (FDA) had been...more
Immersive technologies are at the forefront of innovation in the consumer technology and life sciences industries, but regulators are struggling to fit these devices, which blend clinical software with commercial headsets,...more
regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD). Several years ago, the FDA upgraded its...more
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
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
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
Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving...more
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
If there is one thing that everyone can agree on, it is that health is an important factor in life. In 2021, over 3 million people died in the United States with heart disease and cancer topping the list....more
Life sciences industry has regulatory compliance at the center of all its operations, so maintaining the integrity of data has always been a pressing need for this industry globally. Regulators such as the United States Food...more
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
Our survey analyzed the terms of 194 venture financings closed in the second quarter of 2022 by companies headquartered in Silicon Valley. While the number of venture financings were down in the second quarter compared to...more
Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more
In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the...more
Wilson Sonsini Goodrich & Rosati’s 2021 Technology and Life Sciences IPO Report presents analysis related to 179 initial public offerings and 6 direct listings completed by U.S.-based technology and life sciences companies...more
Our survey analyzed the terms of 287 venture financings closed in the fourth quarter of 2021 by companies headquartered in Silicon Valley. Key Findings - • Valuation results again reached new record highs, with the...more
The International Electrotechnical Commission (IEC) and the International Organization for Standards (ISO) recently published a cybersecurity standard that has received limited press but may have a significant impact on...more
FDA is actively monitoring the use of AI and machine learning (ML) software in medical devices and clinical developments, and has taken a number of first steps in building out a regulatory framework. In 2021, FDA published...more
Effective October 5, 2021, the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) released a final rule applying export controls to software (a) designed for certain nucleic acid assemblers and synthesizers...more
On October 5, 2021, the U.S. Commerce Department’s Bureau of Industry and Security (BIS) published a final rule amending the Export Administration Regulations (EAR) to include new controls on genetic editing software and...more
What This Means for the FDA and the Industry - The COVID-19 pandemic has spurred the development of digital health products utilizing artificial intelligence (AI) and machine learning (ML). When the pandemic passes, there...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
After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new risk classification regime (in part 3), in this part 4 of our...more
The new classification rules for software-based medical devices (“SaMDs”) and personalised medical devices introduced by the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 commences this week,...more
The applications of artificial intelligence (AI) are seemingly innumerable with benefits reportedly as prolific as the technology behind them, including in the healthcare space. To keep pace, the US Food and Drug...more