News & Analysis as of

Pharmaceutical Industry Data-Sharing

Wilson Sonsini Goodrich & Rosati

FDA Finalizes Guidance for Using Real-World EHRs and Medical Claims Data to Support Regulatory Decisions for Drug Products

As part of the Real-World Evidence Program, the U.S. Food and Drug Administration (FDA) has released the final guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

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

Foley & Lardner LLP

IP Toolbox Is Crucial In AI-Powered Drug Discovery

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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

Akerman LLP - Health Law Rx

FTC’s Enforcement Action Against GoodRx Breathes New Life into Decade Old Regulation

The Federal Trade Commission (FTC) didn’t mince words. On September 2021, it called out the health app industry for failing to understand the agency’s Health Breach Notification Rule (HBNR) and for not disclosing its...more

BCLP

Do pharmaceutical companies that sell personal information comply with the requirement to post a “Do Not Sell My Personal...

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Yes. While only one of the pharmaceutical companies within the Fortune 500 states that they sell personal information, the company that has disclosed the sale of information is posting a “Do Not Sell My Personal...more

BCLP

Have pharmaceutical companies disclosed whether they “sell” personal information?

BCLP on

Most have, but some have not. While the majority of pharmaceutical companies within the Fortune 500 affirmatively state that they do not sell personal information, a significant minority have been silent, or unclear, about...more

BakerHostetler

Blockchain Applications Advance for Healthcare and Payments, CFTC Prioritizes Cryptocurrencies, QuadrigaCX Saga Continues

BakerHostetler on

Blockchain Initiatives in Healthcare and Other Industries Target Data Integrity, Speed and Analytics - Last week, a not-for-profit alliance of life sciences industries firms announced an expansion of its blockchain project...more

Hogan Lovells

A new year, a new disclosure: ICMJE requires registrations for clinical trials beginning in 2019 to include disclosure of data...

Hogan Lovells on

Clinical trials starting patient enrollment this year must include a "data sharing plan" in their trial registrations (such as on ClinicalTrials.gov), according to a policy published by the International Committee of Medical...more

Hogan Lovells

Blockchain technology in life sciences will enable more efficient and accurate health care delivery

Hogan Lovells on

Blockchain—the tamper-proof electronic ledger network technology—first made headlines with the rise of cryptocurrencies like Bitcoin. Independent of that boom-and-bust cycle, the life sciences industry is now exploring ways...more

Bass, Berry & Sims PLC

Congress Takes Action to Curb the Opioid Crisis

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In a bipartisan effort to combat the opioid crisis, H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the Act), was enacted on October 24,...more

Troutman Pepper

Negotiating the Tension Between Transparency and Privacy

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Making individual patient-level data available for other research presents companies with challenges, but researchers and companies can take steps to minimize the risks. Originally published in Drug and Medical Device,...more

Foley & Lardner LLP

New Report Outlines 5 Year Plan to Achieve Cancer Moonshot

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The Cancer Moonshot Task Force has just released its 5 year plan for implementing President Obama’s “Cancer Moonshot” program (“Report”). The initiative, announced during President Obama’s 2016 State of the Union Address, is...more

McDermott Will & Emery

CMS Releases Broad Data on Prescribing Patterns of Physicians and Providers Under Medicare Part D

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In a highly anticipated and scrutinized decision, the Centers for Medicare & Medicaid Services (CMS) released a new public data set on April 30, 2015, that includes detailed data regarding the prescribing patterns of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Quest Diagnostics and Inserm Launch BRCA Data-Sharing Initiative

Last week, diagnostics services provider Quest Diagnostics and Inserm, the French National Institute of Health and Medical Research institution, announced the launch of BRCA Share, a new datashare initiative that will provide...more

Cooley LLP

Blog: 23andMe Advances Its Goal of Creating Commercialized Database from Consumer Genetic Testing

Cooley LLP on

On January 12, 23andMe announced an agreement with Pfizer to provide the drug company with access to anonymous, aggregated information from consumers who bought 23andMe’s test over the past seven years to learn about their...more

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