JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
Scientists are generally pleased to learn that their papers are being discussed and cited. Discussion on one platform, however, is a cause of consternation: PubPeer. No scientist wants to learn that their paper is being...more
Join us for an eye-opening webinar, "Debunking Digital Deceptions: The Truth Behind Election Claims and the Fight for Integrity", where we delve into the riveting journey of Bob Zeidman, a pioneer in software forensics....more
Given its growing role as the “pharmacy to the world,” FDA Commissioner Robert Califf, M.D., recently took a trip to India and offered some of his (and FDA's) views upon his return. During his visit, Commissioner Califf met...more
The U.S. Securities and Exchange Commission’s (SEC) impending cyber disclosure rule, slated to commence on 15 December 2023, underscores an imperative shift towards a more transparent and accountable cybersecurity posture for...more
U.S. companies can now self-certify to permit personal data to freely flow from the Europe to the United States. U.S. organizations can now self-certify their compliance with the EU-U.S. Data Privacy Framework (DPF) to...more
On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more
The British Virgin Islands ("BVI") Data Protection Act, 2021 ("DPA") came into force on 9 July 2021. It was introduced so the BVI would have a data protection framework which is broadly similar to EU and UK standards. To...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
Artificial intelligence (AI) and algorithmic models are used extensively in the financial services sector across a broad range of business areas. Two-thirds of respondents to a survey conducted jointly by the UK’s Prudential...more
Alternative data is big business. Globally, buy-side firms spent $1.71 billion on it during 20201, over half of all hedge funds use it to make investment decisions, and it is increasingly used to validate the sustainability...more
On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab application based on the ORIENT-11 trial conducted exclusively in...more
Human health is a fundamental need of the society. The pharmaceutical industry has played a pivotal role in providing mankind with drugs for preventive and curative care. COVID-19 has further underscored the immense...more
As time passes, the amount of data involved in corporate investigations is still growing at a steady rate, as does the stringency of data-related regulations. Both have a significant impact on almost every corporate/internal...more
ACI’s Practical Guide to FCPA Data Analytics will take place on July 19 – 20, 2021 (EDT). This is a uniquely interactive event on how to harness data analytics, AI and machine learning for FCPA compliance, investigations and...more
As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more
The United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) has proposed to amend the organic regulations to strengthen oversight and enforcement of the production, handling, and sale of organic...more
You may have previously read Seyfarth Shaw’s excellent analysis of Lex Machina’s Trade Secret Litigation Report. There are some big picture trends in the report that reflect the trade secret litigation landscape in the...more
Digital health technologies have brought a number of significant breakthroughs to clinical trial programs, including faster patient recruitment, more efficient data collection, and better tracking of biometric information....more
SEC Tells Firms to Stop Missing the Basics on Cybersecurity - The SEC’s Office of Compliance Inspections and Examinations (OCIE) reported in a recent Risk Alert that many investment advisers and broker-dealers are failing to...more
On March 25, 2019, the Department of Justice (DOJ) announced that Duke University agreed to settle a qui tam False Claims Act case for $112.5 million. The whistleblower, who pursued the case on the government’s behalf when...more
Technology is rapidly changing the way investment advisers deliver services to their clients. Funds are now using a range of technology solutions, from advanced trading algorithms to artificial intelligence and machine...more
Our Food, Drug & Device/FDA Group breaks down the new Food and Drug Administration guidance on data integrity for current good manufacturing practices (CGMPs) and what it means for the drug industry....more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more
Earlier this week, the Bureau of Consumer Financial Protection (BCFP) released a 50-State Complaint Snapshot. Credit reporting, debt collection, and mortgage continued to be the top three categories of complaints both...more