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Data Collection Life Sciences

Epstein Becker & Green

Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not...

As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs.  In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...more

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 110

Jones Day on

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

Houston Harbaugh, P.C.

23andMe Hack: The Legal Fallout From the Breach and What it Means in PA

Houston Harbaugh, P.C. on

In October of 2023, a hacker claimed online that they had 23andMe users’ profile information. We know this as a result of 23andMe’s required statement to the U.S. Securities and Exchange Commission (SEC) on December 1, 2023. ...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 9, September 2023

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

McDermott Will & Emery

Special Report - Decoding Genomic Data Security: Lessons from FTC’s Vitagene Enforcement and the NIST CSF Profile for Genomic Data

McDermott Will & Emery on

Remarkable progress in DNA and RNA sequencing have democratized the generation and analysis of genomic data across diverse industry sectors, including biopharmaceutical research, healthcare, consumer ancestry, law...more

Quarles & Brady LLP

Diving into the Washington My Health My Data Act - Part Ten: Operational Realities and Next Steps

Quarles & Brady LLP on

This is Part Ten in a series of legal updates on the Washington My Health My Data Act (“WMHMDA”), where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more

Quarles & Brady LLP

Diving into the Washington My Health My Data Act : Part Nine: Enforcement and Private Right of Action

Quarles & Brady LLP on

This is Part Nine in a series of legal updates on the Washington My Health My Data (“WMHMDA”) where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more

Quarles & Brady LLP

Diving into the Washington My Health My Data Act - Part Seven: Biometric Data

Quarles & Brady LLP on

This is Part Seven in a series of legal updates on the Washington My Health My Data (“WMHMDA”), where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more

Foley Hoag LLP - Security, Privacy and the...

Privacy and Security of Genetic Information: The FTC Is Putting Privacy and Security Promises of DNA Companies to the Test

In the FTC’s first case focused on the privacy and security of genetic information, the FTC alleges that San Francisco-based Vitagene, Inc. – now known as 1Health.io – failed to live up to its promises and unfairly changed...more

Quarles & Brady LLP

Diving into the Washington My Health My Data Act - Part Two: Consumers Covered by WMHMDA

Quarles & Brady LLP on

This is Part Two in a series of legal updates on the Washington My Health My Data Act (“WMHMDA”) where Quarles is doing a deep dive into the various factors and intricacies of the Act that are shaping up to create a sea of...more

Akerman LLP - Health Law Rx

The FTC Sends Another Warning to Digital Healthcare Platforms About Use of Tracking Pixels

The Federal Trade Commission (FTC) continues to prioritize the protection of consumers’ digital health information. The agency has demonstrated this commitment through enforcement actions against GoodRx and BetterHelp for...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 3, March 2023

Amazon Sued for Not Telling New York Store Customers about Tracking Biometrics - “Thanks to a 2021 law, New York is the only major American city to require businesses to post signs letting customers know they’re tracking...more

McDermott Will & Emery

Health Data in the EU and UK – Regulatory Trends and Developments

In light of the increasing number of enforcement incidents under the General Data Protection Regulation (GDPR), organisations active in the Health and Life Sciences sectors in the United Kingdom, the European Union (EU) and...more

Goodwin

An Overview of the Latest Human Genetic Resources Regime in China

Goodwin on

On July 1, 2019, the Administrative Regulations on Human Genetic Resources (人类遗传资源管理条例) (the “Regulations”) issued by the State Council of the People’s Republic of China (the “PRC”) came into effect. On October 17, 2020, the...more

Wyrick Robbins Yates & Ponton LLP

California’s New Genetic Testing Law Applies to 23andMe – AND Me (or my Company)?

Last month, California Governor Gavin Newsom signed Senate Bill 41, the Genetic Information Privacy Act (“GIPA”), a law that regulates “direct-to-consumer genetic testing companies” that handle the “genetic data” of...more

Hogan Lovells

FDA sheds light on benefit-risk assessments to inform decision-making throughout product lifecycle - Patient experience data can...

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The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a drug’s benefits, risks, and...more

Manatt, Phelps & Phillips, LLP

The Manatt State Cost Containment Update - October 2021: Health Data Corner

The Health Data Corner compiles the latest state health care data capacity innovations and policy developments, as well as showcases novel data analytic use cases emerging from states. Other developments featured here include...more

Butler Snow LLP

International Privacy Laws and Clinical Trials

Butler Snow LLP on

Recent developments in international privacy laws have complicated the conduct of clinical trials outside of the United States. Since the privacy law of the European Union – the General Data Protection Regulation or “GDPR” –...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 5

Hogan Lovells on

In Washington: The White House Coronavirus Task Force is warning that there may be a new fast-spreading U.S.A. variant of the coronavirus. "This fall/winter surge has been at nearly twice the rate of rise of cases as the...more

Sheppard Mullin Richter & Hampton LLP

On Your Mark, Get Set, Go: Life Science Companies Face A Challenging Year For Compliance With New Open Payment Program Data...

The Physician Payment Sunshine Act (the “Sunshine Act”) – a federal law first adopted as Section 6002 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) – requires the Centers for Medicare and Medicaid...more

Troutman Pepper

CCPA Amendment Further Harmonizes with HIPAA and Provides Additional Exemptions

Troutman Pepper on

On September 28, California Governor Gavin Newsom signed AB-713 into law, which relaxes some of the California Consumer Privacy Act (CCPA) compliance challenges faced by the health care and life science industries — more...more

McDermott Will & Emery

CCPA Amendment Update: California Legislature Approves Exceptions for HIPAA De-Identified Information and Other Health Data

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On August 31, 2020, the California legislature passed California AB 713, which amends the California Consumer Privacy Act (CCPA) to except from its requirements certain health information, including information that has been...more

BakerHostetler

Life Sciences: Connected Medical Devices in the Cloud During COVID-19

BakerHostetler on

The Pandemic has fast-tracked the use of telehealth services. Hussein Akhavannik discusses how medical device companies are looking to add to or expand remote monitoring capabilities. However, some capabilities raise legal...more

Epstein Becker & Green

On the Verge of CCPA Enforcement: What Should Companies Do to Comply?

Epstein Becker & Green on

On January 1, 2020 California Consumer Privacy Act (“CCPA”) largely came into effect, albeit with several last-minute modifications and a need to promulgate regulations. ...more

Morgan Lewis

Back to the Future but Still in Flux: Court Finds Law Requires ClinicalTrials.gov Posting of Ten Additional Years of Additional...

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The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more

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